COVID-19
Conditions
Keywords
COVID-19, SARS-COV-2, coronavirus, IL-6, sarilumab, acute respiratory distress syndrome, treatment
Brief summary
Phase 2: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 regardless of disease severity strata. Phase 3 Cohort 1: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with critical COVID-19 receiving mechanical ventilation at baseline. Phase 3 Cohort 2: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 receiving mechanical ventilation at baseline.
Detailed description
Phase 2 and Phase 3 Cohort 1 completed. Cohorts 2 and 3 terminated early based on Phase 3 Cohort 1 results.
Interventions
DRUGSarilumab
Single or multiple intravenous (IV) doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria.
DRUGPlacebo
Single or multiple intravenous (IV) doses of placebo to match sarilumab administration
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR), result from any specimen (or other commercial or public health assay) within 2 weeks prior to randomization and no alternative explanation for current clinical condition * Hospitalized with illness of any duration with evidence of pneumonia, requires supplemental oxygen and/or assisted ventilation and meets one of the following: * Phase 2 and Phase 3 Cohort 1: Meets 1 of the following criteria at baseline: * Severe disease OR * Critical disease OR * Multi-system organ dysfunction OR * Immunocompromised * Phase 3 Cohort 2: Patients must be receiving mechanical ventilation to treat respiratory failure due to COVID-19 * Phase 3 Cohort 3: Patients must be receiving supplemental oxygen to treat hypoxemia delivered by one of the following devices: * Non-rebreather mask, OR * High-flow device with at least 50% FiO2, OR * Non-invasive positive pressure ventilator * Ability to provide informed consent signed by study patient or legally acceptable representative * Willingness and ability to comply with study-related procedures/assessments Key
Exclusion criteria
* In the opinion of the investigator, not expected to survive for more than 48 hours from screening * Presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (ANC) less than 2000 mm3, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 x upper limit of normal (ULN), platelets \<50,000 per mm3 * Treatment with anti-IL 6, anti-IL-6R antagonists, or with Janus kinase inhibitors (JAKi) in the past 30 days or plans to receive during the study period * Current treatment with the simultaneous combination of leflunomide and methotrexate * Known active tuberculosis (TB), history of incompletely treated TB, suspected or known extrapulmonary TB, suspected or known systemic bacterial or fungal infections * Participation in a double-blind clinical research study evaluating an investigational product (IP) or therapy within 3 months and less than 5 half-lives of IP prior to the screening visit (The use of remdesivir, hydroxychloroquine, or other treatments being used for COVID-19 treatments in the context of an open-label study, Emergency Use Authorization (EUA), compassionate use protocol or open-label use is permitted) * Any physical examination findings, and/or history of any illness, concomitant medications or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study * Known systemic hypersensitivity to sarilumab or the excipients of the drug product * Phase 3 Cohort 2 and Cohort 3 only: * Known or suspected history of immunosuppression or immunodeficiency disorder * Patients who require renal replacement therapy for acute kidney injury at randomization or who required renal replacement therapy within 72 hours prior to randomization * Patients who have circulatory shock requiring vasopressors at randomization or within 24 hours prior to randomization * Use of extracorporeal life support (eg, ECMO) or, in the opinion of the investigator, there is a high likelihood that extracorporeal life support will be initiated within 48 hours after randomization NOTE: Other protocol defined inclusion /
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in CRP Levels at Day 4 in Participants With Serum IL-6 Level Greater Than the ULN (Phase 2) | Baseline and Day 4 | Percent Change from Baseline in C-Reactive Protein (CRP) Levels at Day 4 in Participants with Serum Interleukin 6 (IL-6) Level Greater than the Upper Limit of Normal (ULN) Least Squares (LS) means estimate of percent change from baseline at Day 4 (raw scale) for each treatment group is based on the Analysis of Covariance (ANCOVA) model. It is defined as anti-log of the estimate of dependent variable minus 1, i.e., (exp\[ln(CRP at day 4/Baseline CRP)\]-1. Negative numbers imply improvement in CRP. |
| Percentage of Participants With at Least a 1-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale in Participants With Critical COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 1) | Day 22 | The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity |
| Percentage of Participants With at Least 1-point Improvement in Clinical Status Using the 7-point Ordinal Scale in Participants With COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 2) | Day 22 | The ordinal scale is an assessment of the clinical status of a participant The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Observed Creatinine Values Across Study Days (Phase 3) | Days 1, 4, 15 and 29 | — |
| Number of Days With Fever (Phase 2) | Up to Day 29 | Defined as ≥38°C (oral), ≥38.4°C (rectal or tympanic) or ≥37.6°C (temporal or axillary) |
| Percentage of Participants Alive, Off Oxygen (Phase 2) | At Day 29 | — |
| Number of Days of Resting Respiratory Rate >24 Breaths/Min (Phase 2) | Up to day 29 | — |
| Time to Improvement (2 Points) in Clinical Status Assessment in Severe or Critical Patients With Serum IL-6 Levels Greater Than the Upper Limit of Normal (Phase 2) | Up to Day 29 | Time to improvement (2 points) in clinical status assessment on the 7-point ordinal scale in severe or critical participants with serum IL-6 levels greater than the upper limit of normal (ULN). The ordinal scale is an assessment of the clinical status of a patient. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity |
| Time to Improvement (2 Points) in Clinical Status Assessment in Severe or Critical Patients With All Serum IL-6 Levels (Phase 2) | Up to Day 29 | Time to improvement (2 points) in clinical status assessment on the 7-point ordinal scale in severe or critical participants with all serum IL-6 levels. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity |
| Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, in Patients With Documented Fever at Baseline (Phase 2) | Up to Day 29 | Time to resolution of fever for at least 48 hours without antipyretics or until discharge, whichever is sooner, in patients with documented fever ≥38°C (oral), ≥38.4°C (rectal or tympanic), or ≥37.6°C (temporal or axillary) at Baseline. Resolution of fever is defined as postbaseline body temperature \<37.2°C (oral), or \<37.6°C (rectal or tympanic) or \<36.8°C (temporal or axillary). |
| Time to Resolution of Fever for at Least 48 Hours Without Antipyretics by Clinical Severity (Phase 2) | Up to day 29 | Resolution of fever is defined as body temperature \<=36.8 C (axilla or temporal) or\<= 37.2 C (oral) or \<37.6 C (rectal or tympanic) for at least 48 hours without antipyretics or until discharge. Resolution of fever is defined only in participants with presence of fever at baseline. |
| Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2) | Up to Day 29 | Resolution of fever is defined as body temperature \<=36.8 C (axilla or temporal) or\<= 37.2 C (oral) or \<37.6 C (rectal or tympanic) for at least 48 hours without antipyretics or until discharge, by baseline IL-6 levels. Resolution of fever is defined only in participants with presence of fever at baseline. |
| Time to Improvement in Oxygenation for at Least 48 Hours (Phase 2) | Up to day 29 | Improvement in oxygenation defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2 |
| Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2) | Up to day 29 | Time to Improvement defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2 |
| Time to Resolution of Fever and Improvement in Oxygenation for at Least 48 Hours (Phase 2) | Up to day 29 | Resolution of fever defined as postbaseline body temperature \<37.2°C (oral), or \<37.6°C (rectal or tympanic) or \<36.8°C (temporal or axillary) Improvement in oxygenation defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2 |
| Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Days 1, 3, 5, 8, 11, 15 and 29 | Percentage of participants in each clinical status category using the 7-point ordinal scale from Baseline (Day 1) up to Day 29. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity |
| Time to Discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and Maintained for 24 Hours (Phase 2) | Up to day 29 | NEWS2 was used to standardize assessment of acute-illness severity, track clinical condition of participants and to alert clinical teams to participant deterioration. NEWS2 score was based on 7 clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0, 1, 2, and 3 was allocated to each parameter except supplemental oxygen (a score of 0 or 1 was allocated) and level of consciousness (a score of 0 or 3 was allocated), where 0 = normal health condition to 3 = worst health condition; higher score indicated more severity. All scores were summed to get an aggregate score. Aggregate NEWS2 score ranged from 0 to 19, with higher scores meaning more severity/higher risk: low risk (score 0 to 4); low to medium risk (score of 3 in any individual parameter); medium risk (score 5 to 6); high risk (score 7 to 19). |
| Change From Baseline in NEWS2 Scoring System (Phase 2) | Days 3, 5, 8, 11, 15 and 29 | NEWS2 was used to standardize assessment of acute-illness severity, track clinical condition of participants and to alert clinical teams to participant deterioration. NEWS2 score was based on 7 clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0, 1, 2, and 3 was allocated to each parameter except supplemental oxygen (a score of 0 or 1 was allocated) and level of consciousness (a score of 0 or 3 was allocated), where 0 = normal health condition to 3 = worst health condition; higher score indicated more severity. All scores were summed to get an aggregate score. Aggregate NEWS2 score ranged from 0 to 19, with higher scores meaning more severity/higher risk: low risk (score 0 to 4); low to medium risk (score of 3 in any individual parameter); medium risk (score 5 to 6); high risk (score 7 to 19). |
| Number of Days With Hypoxemia (Phase 2) | Up to day 29 | — |
| Number of Days of Supplemental Oxygen Use (Phase 2) | Up to day 29 | — |
| Time to Saturation ≥94% on Room Air (Phase 2) | Up to day 29 | — |
| Number of Ventilator Free Days (Phase 2) | Up to Day 22 | Summary of Ventilator-free days during study in Participants using Invasive Mechanical Ventilation at Baseline |
| Number of Participants Who Initiated Mechanical Ventilation After Baseline (Phase 2) | Up to Day 29 | — |
| Number of Days in an Intensive Care Unit (ICU) in Participants Who Were Not in ICU at Baseline (Phase 2) | Up to Day 29 | — |
| Number of Days of Hospitalization Among Survivors (Phase 2) | Up to day 29 | — |
| Number of Deaths Due to Any Cause | Up to day 60 | Number of deaths due to any cause (All-Cause Mortality) |
| Percentage of Participants With at Least 1-point Improvement in Clinical Status Using the 7-point Ordinal Scale in Participants With Critical COVID-19 (Phase 3 Cohort 1: Critical ITT) | Day 22 | The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity |
| Percentage of Participants Who Recover (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Day 22 | Percentage of Participants Who Recover (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use) at Day 22 |
| Percentage of Participants Who Recover (Phase 3 Cohort 1: Critical ITT) | Day 22 | Percentage of Participants Who Recover (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use) at Day 22 |
| Percentage of Participants Who Die (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Up to Day 29 and Day 60 | Percentage of Participants who die through Day 29 and Day 60 |
| Percentage of Participants Who Die (Phase 3 Cohort 1: Critical ITT) | Up to Day 29 and Day 60 | Percentage of Participants who die through Day 29 and Day 60 |
| Percentage of Participants Alive Not Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | At Day 22 | Percentage of participants alive not receiving mechanical ventilation or ECMO at Day 22 (Phase 3 Cohort 1) |
| Percentage of Participants With at Least a 2-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | At Day 22 | Percentage of participants with at least a 2-point improvement in clinical status from baseline to Day 22 using the 7-point ordinal scale. The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity |
| Percentage of Participants Alive Not Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical ITT) | At Day 22 | Percentage of participants alive not receiving mechanical ventilation or ECMO at Day 22 (Phase 3 Cohort 1) |
| Percentage of Participants With at Least a 2-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT) | At Day 22 | Percentage of participants with at least a 2-point improvement in clinical status from baseline to Day 22 using the 7-point ordinal scale. The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity |
| Time to Recovery (Phase 3 Cohort 1: Critical ITT) | Up to day 29 | Phase 3 Cohort 1 Time to Recovery (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use) |
| Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Up to day 29 | The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity |
| Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT) | Up to day 29 | The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity |
| Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 2) | Up to day 29 | The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity |
| Time to at Least 2-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1) | Up to day 29 | The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity |
| Time to at Least 2-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT) | Up to day 29 | The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity |
| Percentage of Participants Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Day 22 | — |
| Percentage of Participants Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical ITT) | Day 22 | — |
| Percentage of Patients Discharged and Alive (Phase 3 Cohort 1) | At Day 22 | Percentage of Patients Discharged and Alive at Day 22 |
| Percentage of Participants Discharged and Alive at Day 22 (Phase 3 Cohort 1: Critical ITT) | At Day 22 | Percentage of Participants Discharged and Alive at Day 22 |
| Time to Recovery (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Up to day 29 | Phase 3 Cohort 1 Time to Recovery (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use) |
| Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Days 1, 4, 15 and 29 | — |
| Time to Recovery (Phase 3 Cohort 2) | Up to day 29 | Time to Recovery (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use) |
| Time to Death (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Up to day 60 | Phase 3 Cohort 1 Time to Death (All-Cause Mortality) |
| Time to Death (Phase 3 Cohort 1: Critical ITT) | Up to day 60 | Time to Death (All-Cause Mortality) |
| Time to Death (Phase 3 Cohort 2) | Up to day 60 | Time to Death (All-Cause Mortality) |
| Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Days 8, 15, 22 and 29 | Number of Ventilator-Free days up to Day 29 (Phase 3 Cohort 1) |
| Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical ITT) | Days 8, 15, 22 and 29 | Number of Ventilator-Free days up to Day 29 (Phase 3 Cohort 1) |
| Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1) | Days 8, 15, 22 and 29 | Number of days of hospitalization among survivors (Phase 3 Cohort 1) |
| Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1: Critical ITT) | Days 8, 15, 22 and 29 | Number of days of hospitalization among survivors (Phase 3 Cohort 1: Critical ITT population) |
| Number of Participants With Any Serious Adverse Event | Up to day 60 | — |
| Number of Participants With Grade 4 Neutropenia (ANC <500/mm3) | Up to day 60 | Grade 4 Neutropenia defined as Absolute Neutrophil Count (ANC) of less than 500 per cubic millimeter(mm3) |
| Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection | Up to day 60 | — |
| Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection | Up to day 60 | — |
| Number of Participants With Grade >=2 Infusion Related Reactions | Up to day 60 | — |
| Number of Participants With Grade >=2 Hypersensitivity Reactions | Up to day 60 | — |
| Number of Participants With Gastrointestinal Perforation | Up to day 60 | — |
| Mean Observed Leukocyte Values Across Study Days (Phase 2) | Days 1, 4, 15 and 29 | — |
| Mean Observed Leukocyte Values Across Study Days (Phase 3) | Days 1, 4, 15 and 29 | — |
| Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 2) | Days 1, 4, 15 and 29 | — |
| Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Days 1, 4, 15 and 29 | — |
| Mean Observed Platelet Count Across Study Days (Phase 2) | Days 1, 4, 15 and 29 | — |
| Mean Observed Platelet Count Across Study Days (Phase 3) | Days 1, 4, 15 and 29 | — |
| Mean Observed Total Bilirubin Values Across Study Days (Phase 2) | Days 1, 4, 15 and 29 | — |
| Mean Observed Total Bilirubin Across Study Days (Phase 3) | Days 1, 4, 15 and 29 | — |
| Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 2) | Days 1, 4, 15 and 29 | — |
| Mean Observed Hemoglobin Values Across Study Days (Phase 2) | Days 1, 4, 15 and 29 | — |
| Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Days 1, 4, 15 and 29 | — |
| Mean Observed Creatinine Values Across Study Days (Phase 2) | Days 1, 4, 15 and 29 | — |
Countries
United States
Participant flow
Pre-assignment details
Of 1946 participants screened, 1912 were randomized and 1861 were treated. 51 randomized participants were never treated: 26 withdrew consent, 14 investigator decision, 9 deaths, and 3 other.
Participants by arm
| Arm | Count |
|---|---|
| Phase 2: Placebo Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment | 90 |
| Phase 2: Sarilumab 200mg IV Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment | 187 |
| Phase 2: Sarilumab 400mg IV Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment | 180 |
| Phase 3 Cohort 1: Placebo - Critical Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU) | 170 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Critical Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU) | 242 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Critical Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU) | 338 |
| Phase 3 Cohort 1: Placebo - Severe Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device) | 70 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device) | 140 |
| Phase 3 Cohort 1 :Sarilumab 400mg IV - Severe Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device) | 137 |
| Phase 3 Cohort 1: Placebo - MSOD Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD) \[vasopressors, extracorporeal life support, or renal replacement therapy\] | 46 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD) \[vasopressors, extracorporeal life support, or renal replacement therapy\] | 95 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD) \[vasopressors, extracorporeal life support, or renal replacement therapy\] | 92 |
| Phase 3 Cohort 1: Placebo - Immunocompromised Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment | 8 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment | 12 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment | 15 |
| Phase 3 Cohort 2: Placebo Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19 | 15 |
| Phase 3 Cohort 2: Sarilumab 800mg IV Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19 | 16 |
| Phase 3 Cohort 3: Placebo Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline | 6 |
| Phase 3 Cohort 3: Sarilumab 800mg IV Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline | 2 |
| Total | 1,861 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 24 | 60 | 49 | 59 | 70 | 114 | 9 | 12 | 21 | 16 | 40 | 40 | 3 | 4 | 6 | 4 | 3 | 1 | 0 |
| Overall Study | Lost to Follow-up | 5 | 10 | 6 | 8 | 12 | 13 | 9 | 16 | 14 | 0 | 2 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 2 | 2 | 2 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Phase 2: Placebo | Phase 2: Sarilumab 200mg IV | Phase 2: Sarilumab 400mg IV | Phase 3 Cohort 1: Placebo - Critical | Phase 3 Cohort 1: Sarilumab 200mg IV - Critical | Phase 3 Cohort 1: Sarilumab 400mg IV - Critical | Phase 3 Cohort 1: Placebo - Severe | Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Phase 3 Cohort 1 :Sarilumab 400mg IV - Severe | Phase 3 Cohort 1: Placebo - MSOD | Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Phase 3 Cohort 1: Placebo - Immunocompromised | Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Phase 3 Cohort 2: Placebo | Phase 3 Cohort 2: Sarilumab 800mg IV | Phase 3 Cohort 3: Placebo | Phase 3 Cohort 3: Sarilumab 800mg IV | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 60.3 Years STANDARD_DEVIATION 13.4 | 57.1 Years STANDARD_DEVIATION 14.6 | 56.3 Years STANDARD_DEVIATION 14.7 | 60.1 Years STANDARD_DEVIATION 15 | 58.5 Years STANDARD_DEVIATION 13.7 | 61.8 Years STANDARD_DEVIATION 14.2 | 61.2 Years STANDARD_DEVIATION 13.9 | 61.3 Years STANDARD_DEVIATION 15.1 | 62.2 Years STANDARD_DEVIATION 15.3 | 59.9 Years STANDARD_DEVIATION 13.7 | 59.1 Years STANDARD_DEVIATION 12.4 | 61.1 Years STANDARD_DEVIATION 15.1 | 58.3 Years STANDARD_DEVIATION 11.9 | 57.7 Years STANDARD_DEVIATION 7 | 65.2 Years STANDARD_DEVIATION 8 | 48.6 Years STANDARD_DEVIATION 15.3 | 52.9 Years STANDARD_DEVIATION 14.7 | 61.5 Years STANDARD_DEVIATION 9.1 | 66.0 Years STANDARD_DEVIATION 7.1 | 59.7 Years STANDARD_DEVIATION 14.4 |
| CRP levels | 192.537 milligrams per Liter (mg/L) STANDARD_DEVIATION 122.295 | 191.997 milligrams per Liter (mg/L) STANDARD_DEVIATION 124.583 | 195.037 milligrams per Liter (mg/L) STANDARD_DEVIATION 119.274 | 167.476 milligrams per Liter (mg/L) STANDARD_DEVIATION 115.02 | 187.573 milligrams per Liter (mg/L) STANDARD_DEVIATION 108.085 | 179.085 milligrams per Liter (mg/L) STANDARD_DEVIATION 103.837 | 111.933 milligrams per Liter (mg/L) STANDARD_DEVIATION 81.789 | 127.811 milligrams per Liter (mg/L) STANDARD_DEVIATION 116.058 | 129.355 milligrams per Liter (mg/L) STANDARD_DEVIATION 136.734 | 205.978 milligrams per Liter (mg/L) STANDARD_DEVIATION 118.459 | 235.395 milligrams per Liter (mg/L) STANDARD_DEVIATION 280.665 | 232.924 milligrams per Liter (mg/L) STANDARD_DEVIATION 128.435 | 141.207 milligrams per Liter (mg/L) STANDARD_DEVIATION 71.915 | 203.356 milligrams per Liter (mg/L) STANDARD_DEVIATION 118.998 | 185.740 milligrams per Liter (mg/L) STANDARD_DEVIATION 91.237 | 226.846 milligrams per Liter (mg/L) STANDARD_DEVIATION 112.047 | 212.920 milligrams per Liter (mg/L) STANDARD_DEVIATION 107.702 | 177.334 milligrams per Liter (mg/L) STANDARD_DEVIATION 79.49 | 258.081 milligrams per Liter (mg/L) STANDARD_DEVIATION 200.704 | 180.010 milligrams per Liter (mg/L) STANDARD_DEVIATION 131.909 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 54 Participants | 40 Participants | 59 Participants | 77 Participants | 115 Participants | 19 Participants | 30 Participants | 30 Participants | 12 Participants | 27 Participants | 21 Participants | 1 Participants | 3 Participants | 4 Participants | 5 Participants | 10 Participants | 2 Participants | 1 Participants | 526 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants | 98 Participants | 105 Participants | 87 Participants | 119 Participants | 163 Participants | 40 Participants | 80 Participants | 88 Participants | 26 Participants | 46 Participants | 47 Participants | 5 Participants | 7 Participants | 10 Participants | 5 Participants | 6 Participants | 3 Participants | 0 Participants | 994 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants | 35 Participants | 35 Participants | 24 Participants | 46 Participants | 60 Participants | 11 Participants | 30 Participants | 19 Participants | 8 Participants | 22 Participants | 24 Participants | 2 Participants | 2 Participants | 1 Participants | 5 Participants | 0 Participants | 1 Participants | 1 Participants | 341 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 20 Participants | 21 Participants | 13 Participants | 10 Participants | 8 Participants | 2 Participants | 6 Participants | 13 Participants | 5 Participants | 3 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 113 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 32 Participants | 31 Participants | 23 Participants | 39 Participants | 65 Participants | 10 Participants | 35 Participants | 25 Participants | 8 Participants | 23 Participants | 23 Participants | 2 Participants | 2 Participants | 9 Participants | 3 Participants | 3 Participants | 2 Participants | 0 Participants | 350 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 27 Participants | 65 Participants | 63 Participants | 59 Participants | 102 Participants | 137 Participants | 29 Participants | 51 Participants | 49 Participants | 21 Participants | 40 Participants | 41 Participants | 3 Participants | 6 Participants | 3 Participants | 5 Participants | 5 Participants | 2 Participants | 1 Participants | 709 Participants |
| Race (NIH/OMB) White | 39 Participants | 70 Participants | 64 Participants | 74 Participants | 89 Participants | 127 Participants | 28 Participants | 45 Participants | 49 Participants | 11 Participants | 29 Participants | 25 Participants | 3 Participants | 3 Participants | 3 Participants | 7 Participants | 8 Participants | 2 Participants | 1 Participants | 677 Participants |
| Sex: Female, Male Female | 21 Participants | 63 Participants | 42 Participants | 59 Participants | 67 Participants | 111 Participants | 25 Participants | 59 Participants | 51 Participants | 21 Participants | 41 Participants | 34 Participants | 4 Participants | 3 Participants | 4 Participants | 4 Participants | 5 Participants | 3 Participants | 0 Participants | 617 Participants |
| Sex: Female, Male Male | 69 Participants | 124 Participants | 138 Participants | 111 Participants | 175 Participants | 227 Participants | 45 Participants | 81 Participants | 86 Participants | 25 Participants | 54 Participants | 58 Participants | 4 Participants | 9 Participants | 11 Participants | 11 Participants | 11 Participants | 3 Participants | 2 Participants | 1244 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 24 / 90 | 60 / 187 | 49 / 180 | 59 / 170 | 70 / 242 | 114 / 338 | 9 / 70 | 12 / 140 | 21 / 137 | 16 / 46 | 40 / 95 | 40 / 92 | 3 / 8 | 4 / 12 | 6 / 15 | 4 / 15 | 3 / 16 | 1 / 6 | 0 / 2 |
| other Total, other adverse events | 20 / 90 | 48 / 187 | 44 / 180 | 24 / 170 | 57 / 242 | 83 / 338 | 0 / 70 | 0 / 140 | 8 / 137 | 17 / 46 | 23 / 95 | 15 / 92 | 3 / 8 | 5 / 12 | 6 / 15 | 5 / 15 | 7 / 16 | 1 / 6 | 2 / 2 |
| serious Total, serious adverse events | 39 / 90 | 90 / 187 | 84 / 180 | 89 / 170 | 119 / 242 | 183 / 338 | 11 / 70 | 23 / 140 | 30 / 137 | 27 / 46 | 67 / 95 | 58 / 92 | 3 / 8 | 6 / 12 | 9 / 15 | 10 / 15 | 5 / 16 | 1 / 6 | 1 / 2 |
Outcome results
Primary
Percentage of Participants With at Least 1-point Improvement in Clinical Status Using the 7-point Ordinal Scale in Participants With COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 2)
The ordinal scale is an assessment of the clinical status of a participant The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Time frame: Day 22
Population: Phase 3 Cohort 2 ITT participants receiving mechanical ventilation at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: Placebo | Percentage of Participants With at Least 1-point Improvement in Clinical Status Using the 7-point Ordinal Scale in Participants With COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 2) | 60.0 Percentage of participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants With at Least 1-point Improvement in Clinical Status Using the 7-point Ordinal Scale in Participants With COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 2) | 68.8 Percentage of participants |
p-value: 0.732895% CI: [-26.2, 36.8]Cochran-Mantel-Haenszel
Primary
Percentage of Participants With at Least a 1-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale in Participants With Critical COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 1)
The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Time frame: Day 22
Population: Phase 3 Cohort 1 Intention-to-treat (ITT) participants with a disease severity of critical and mechanical ventilation at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: Placebo | Percentage of Participants With at Least a 1-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale in Participants With Critical COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 1) | 35.5 Percentage of participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants With at Least a 1-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale in Participants With Critical COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 1) | 43.3 Percentage of participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants With at Least a 1-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale in Participants With Critical COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 1) | 43.2 Percentage of participants |
p-value: 0.370795% CI: [-8.4, 21.7]Cochran-Mantel-Haenszel
p-value: 0.326195% CI: [-7.4, 21.3]Cochran-Mantel-Haenszel
Primary
Percent Change From Baseline in CRP Levels at Day 4 in Participants With Serum IL-6 Level Greater Than the ULN (Phase 2)
Percent Change from Baseline in C-Reactive Protein (CRP) Levels at Day 4 in Participants with Serum Interleukin 6 (IL-6) Level Greater than the Upper Limit of Normal (ULN) Least Squares (LS) means estimate of percent change from baseline at Day 4 (raw scale) for each treatment group is based on the Analysis of Covariance (ANCOVA) model. It is defined as anti-log of the estimate of dependent variable minus 1, i.e., (exp\[ln(CRP at day 4/Baseline CRP)\]-1. Negative numbers imply improvement in CRP.
Time frame: Baseline and Day 4
Population: Phase 2 mITT population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of the study drug and have high baseline IL-6 levels.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Placebo | Percent Change From Baseline in CRP Levels at Day 4 in Participants With Serum IL-6 Level Greater Than the ULN (Phase 2) | -0.20 Percent Change | Standard Error 0.077 |
| Phase 2: Sarilumab 200mg IV | Percent Change From Baseline in CRP Levels at Day 4 in Participants With Serum IL-6 Level Greater Than the ULN (Phase 2) | -0.77 Percent Change | Standard Error 0.018 |
| Phase 2: Sarilumab 400mg IV | Percent Change From Baseline in CRP Levels at Day 4 in Participants With Serum IL-6 Level Greater Than the ULN (Phase 2) | -0.78 Percent Change | Standard Error 0.017 |
p-value: <0.000195% CI: [-1.456, -1.035]ANCOVA
p-value: <0.000195% CI: [-1.511, -1.09]ANCOVA
Secondary
Change From Baseline in NEWS2 Scoring System (Phase 2)
NEWS2 was used to standardize assessment of acute-illness severity, track clinical condition of participants and to alert clinical teams to participant deterioration. NEWS2 score was based on 7 clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0, 1, 2, and 3 was allocated to each parameter except supplemental oxygen (a score of 0 or 1 was allocated) and level of consciousness (a score of 0 or 3 was allocated), where 0 = normal health condition to 3 = worst health condition; higher score indicated more severity. All scores were summed to get an aggregate score. Aggregate NEWS2 score ranged from 0 to 19, with higher scores meaning more severity/higher risk: low risk (score 0 to 4); low to medium risk (score of 3 in any individual parameter); medium risk (score 5 to 6); high risk (score 7 to 19).
Time frame: Days 3, 5, 8, 11, 15 and 29
Population: Phase 2 ITT population with NEWS2 score reported at baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Change From Baseline in NEWS2 Scoring System (Phase 2) | Day 3 | 0.46 scores on a scale | Standard Deviation 2.29 |
| Phase 2: Placebo | Change From Baseline in NEWS2 Scoring System (Phase 2) | Day 5 | 0.36 scores on a scale | Standard Deviation 3.18 |
| Phase 2: Placebo | Change From Baseline in NEWS2 Scoring System (Phase 2) | Day 8 | -0.17 scores on a scale | Standard Deviation 3.05 |
| Phase 2: Placebo | Change From Baseline in NEWS2 Scoring System (Phase 2) | Day 11 | 0.00 scores on a scale | Standard Deviation 3.53 |
| Phase 2: Placebo | Change From Baseline in NEWS2 Scoring System (Phase 2) | Day 15 | -0.40 scores on a scale | Standard Deviation 3.55 |
| Phase 2: Placebo | Change From Baseline in NEWS2 Scoring System (Phase 2) | Day 29 | -0.67 scores on a scale | Standard Deviation 4.12 |
| Phase 2: Sarilumab 200mg IV | Change From Baseline in NEWS2 Scoring System (Phase 2) | Day 29 | -1.12 scores on a scale | Standard Deviation 4.23 |
| Phase 2: Sarilumab 200mg IV | Change From Baseline in NEWS2 Scoring System (Phase 2) | Day 3 | 0.14 scores on a scale | Standard Deviation 2.69 |
| Phase 2: Sarilumab 200mg IV | Change From Baseline in NEWS2 Scoring System (Phase 2) | Day 11 | -0.27 scores on a scale | Standard Deviation 3.65 |
| Phase 2: Sarilumab 200mg IV | Change From Baseline in NEWS2 Scoring System (Phase 2) | Day 15 | -0.45 scores on a scale | Standard Deviation 3.91 |
| Phase 2: Sarilumab 200mg IV | Change From Baseline in NEWS2 Scoring System (Phase 2) | Day 5 | 0.00 scores on a scale | Standard Deviation 2.98 |
| Phase 2: Sarilumab 200mg IV | Change From Baseline in NEWS2 Scoring System (Phase 2) | Day 8 | -0.22 scores on a scale | Standard Deviation 3.33 |
| Phase 2: Sarilumab 400mg IV | Change From Baseline in NEWS2 Scoring System (Phase 2) | Day 5 | 0.03 scores on a scale | Standard Deviation 3.26 |
| Phase 2: Sarilumab 400mg IV | Change From Baseline in NEWS2 Scoring System (Phase 2) | Day 8 | -0.31 scores on a scale | Standard Deviation 3.65 |
| Phase 2: Sarilumab 400mg IV | Change From Baseline in NEWS2 Scoring System (Phase 2) | Day 29 | -1.34 scores on a scale | Standard Deviation 4.75 |
| Phase 2: Sarilumab 400mg IV | Change From Baseline in NEWS2 Scoring System (Phase 2) | Day 11 | -0.29 scores on a scale | Standard Deviation 4.29 |
| Phase 2: Sarilumab 400mg IV | Change From Baseline in NEWS2 Scoring System (Phase 2) | Day 3 | 0.03 scores on a scale | Standard Deviation 3 |
| Phase 2: Sarilumab 400mg IV | Change From Baseline in NEWS2 Scoring System (Phase 2) | Day 15 | -0.48 scores on a scale | Standard Deviation 4.5 |
Secondary
Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 2)
Time frame: Days 1, 4, 15 and 29
Population: Phase 2 Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 2) | Day 1 (Baseline) | 47.93 International Units/Liter (IU/L) | Standard Deviation 34.75 |
| Phase 2: Placebo | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 2) | Day 4 | 54.34 International Units/Liter (IU/L) | Standard Deviation 42.15 |
| Phase 2: Placebo | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 2) | Day 15 | 55.00 International Units/Liter (IU/L) | Standard Deviation 37.75 |
| Phase 2: Placebo | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 2) | Day 29 | 94.30 International Units/Liter (IU/L) | Standard Deviation 112.36 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 2) | Day 29 | 58.63 International Units/Liter (IU/L) | Standard Deviation 48.92 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 2) | Day 1 (Baseline) | 50.25 International Units/Liter (IU/L) | Standard Deviation 36.69 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 2) | Day 15 | 106.17 International Units/Liter (IU/L) | Standard Deviation 282.61 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 2) | Day 4 | 86.08 International Units/Liter (IU/L) | Standard Deviation 148.46 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 2) | Day 29 | 64.82 International Units/Liter (IU/L) | Standard Deviation 78.9 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 2) | Day 4 | 74.20 International Units/Liter (IU/L) | Standard Deviation 78.45 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 2) | Day 15 | 121.58 International Units/Liter (IU/L) | Standard Deviation 507.41 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 2) | Day 1 (Baseline) | 48.25 International Units/Liter (IU/L) | Standard Deviation 30.38 |
Secondary
Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3)
Time frame: Days 1, 4, 15 and 29
Population: Phase 3 population. Only those participants with data available at the specified time points were analyzed. Phase 3 Cohort 3 data was not summarized due to insufficient sample size
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 71.09 International Units/Liter (IU/L) | Standard Deviation 71.11 |
| Phase 2: Placebo | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 73.45 International Units/Liter (IU/L) | Standard Deviation 139.06 |
| Phase 2: Placebo | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 66.71 International Units/Liter (IU/L) | Standard Deviation 107.24 |
| Phase 2: Placebo | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 51.69 International Units/Liter (IU/L) | Standard Deviation 37.36 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 86.04 International Units/Liter (IU/L) | Standard Deviation 155.72 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 79.98 International Units/Liter (IU/L) | Standard Deviation 131.21 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 51.08 International Units/Liter (IU/L) | Standard Deviation 35.87 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 72.32 International Units/Liter (IU/L) | Standard Deviation 60.25 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 155.63 International Units/Liter (IU/L) | Standard Deviation 759.34 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 93.82 International Units/Liter (IU/L) | Standard Deviation 155.98 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 74.62 International Units/Liter (IU/L) | Standard Deviation 77.09 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 52.15 International Units/Liter (IU/L) | Standard Deviation 36.66 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 46.69 International Units/Liter (IU/L) | Standard Deviation 34.09 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 60.00 International Units/Liter (IU/L) | Standard Deviation 36.37 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 59.38 International Units/Liter (IU/L) | Standard Deviation 51.04 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 52.60 International Units/Liter (IU/L) | Standard Deviation 48.06 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 68.69 International Units/Liter (IU/L) | Standard Deviation 51.45 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 54.22 International Units/Liter (IU/L) | Standard Deviation 42.27 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 97.73 International Units/Liter (IU/L) | Standard Deviation 205.87 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 127.30 International Units/Liter (IU/L) | Standard Deviation 173.38 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 101.00 International Units/Liter (IU/L) | Standard Deviation 156.42 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 49.43 International Units/Liter (IU/L) | Standard Deviation 39.98 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 86.13 International Units/Liter (IU/L) | Standard Deviation 146.92 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 88.17 International Units/Liter (IU/L) | Standard Deviation 127.32 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 62.11 International Units/Liter (IU/L) | Standard Deviation 42.15 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 45.00 International Units/Liter (IU/L) | Standard Deviation 35.07 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 46.24 International Units/Liter (IU/L) | Standard Deviation 48.87 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 52.22 International Units/Liter (IU/L) | Standard Deviation 52.86 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 69.75 International Units/Liter (IU/L) | Standard Deviation 102.66 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 46.85 International Units/Liter (IU/L) | Standard Deviation 28.14 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 64.80 International Units/Liter (IU/L) | Standard Deviation 68.11 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 59.13 International Units/Liter (IU/L) | Standard Deviation 96.74 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 98.31 International Units/Liter (IU/L) | Standard Deviation 163.08 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 41.75 International Units/Liter (IU/L) | Standard Deviation 29.42 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 84.68 International Units/Liter (IU/L) | Standard Deviation 152.72 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 48.51 International Units/Liter (IU/L) | Standard Deviation 39.44 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 40.86 International Units/Liter (IU/L) | Standard Deviation 26.62 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 257.25 International Units/Liter (IU/L) | Standard Deviation 454.57 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 17.00 International Units/Liter (IU/L) | Standard Deviation 0 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 33.50 International Units/Liter (IU/L) | Standard Deviation 18.45 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 39.00 International Units/Liter (IU/L) | Standard Deviation 0 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 43.00 International Units/Liter (IU/L) | Standard Deviation 31.81 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 45.17 International Units/Liter (IU/L) | Standard Deviation 23.35 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 66.14 International Units/Liter (IU/L) | Standard Deviation 51.89 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 36.00 International Units/Liter (IU/L) | Standard Deviation 32.99 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 38.50 International Units/Liter (IU/L) | Standard Deviation 45.66 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 47.57 International Units/Liter (IU/L) | Standard Deviation 53.53 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 22.27 International Units/Liter (IU/L) | Standard Deviation 25.57 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 46.77 International Units/Liter (IU/L) | Standard Deviation 31.49 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 45.83 International Units/Liter (IU/L) | Standard Deviation 24.52 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 62.27 International Units/Liter (IU/L) | Standard Deviation 33.29 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 25.50 International Units/Liter (IU/L) | Standard Deviation 0.71 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 58.33 International Units/Liter (IU/L) | Standard Deviation 33.66 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 45.33 International Units/Liter (IU/L) | Standard Deviation 40.77 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 85.75 International Units/Liter (IU/L) | Standard Deviation 104.56 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 53.06 International Units/Liter (IU/L) | Standard Deviation 44.57 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 103.67 International Units/Liter (IU/L) | Standard Deviation 174.35 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 24.33 International Units/Liter (IU/L) | Standard Deviation 7.51 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 103.33 International Units/Liter (IU/L) | Standard Deviation 153.15 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 48.00 International Units/Liter (IU/L) | Standard Deviation 12.73 |
| Phase 3 Cohort 2: Placebo | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 33.50 International Units/Liter (IU/L) | Standard Deviation 30.41 |
| Phase 3 Cohort 2: Placebo | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 14.00 International Units/Liter (IU/L) | Standard Deviation 4.24 |
| Phase 3 Cohort 2: Placebo | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 32.00 International Units/Liter (IU/L) | Standard Deviation 28.28 |
| Phase 3 Cohort 2: Placebo | Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 83.50 International Units/Liter (IU/L) | Standard Deviation 85.56 |
Secondary
Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 2)
Time frame: Days 1, 4, 15 and 29
Population: Phase 2 Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 2) | Day 1 (Baseline) | 58.58 International Units/Liter (IU/L) | Standard Deviation 32.4 |
| Phase 2: Placebo | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 2) | Day 4 | 62.52 International Units/Liter (IU/L) | Standard Deviation 61.41 |
| Phase 2: Placebo | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 2) | Day 15 | 42.12 International Units/Liter (IU/L) | Standard Deviation 25.17 |
| Phase 2: Placebo | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 2) | Day 29 | 76.00 International Units/Liter (IU/L) | Standard Deviation 82.78 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 2) | Day 29 | 40.69 International Units/Liter (IU/L) | Standard Deviation 35.7 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 2) | Day 1 (Baseline) | 57.88 International Units/Liter (IU/L) | Standard Deviation 33.35 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 2) | Day 15 | 188.65 International Units/Liter (IU/L) | Standard Deviation 941.96 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 2) | Day 4 | 90.01 International Units/Liter (IU/L) | Standard Deviation 127.42 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 2) | Day 29 | 100.05 International Units/Liter (IU/L) | Standard Deviation 337.72 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 2) | Day 4 | 78.34 International Units/Liter (IU/L) | Standard Deviation 63.75 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 2) | Day 15 | 88.96 International Units/Liter (IU/L) | Standard Deviation 329.04 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 2) | Day 1 (Baseline) | 60.39 International Units/Liter (IU/L) | Standard Deviation 36.85 |
Secondary
Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3)
Time frame: Days 1, 4, 15 and 29
Population: Phase 3 population. Only those participants with data available at the specified time points were analyzed. Phase 3 Cohort 3 data was not summarized due to insufficient sample size
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 60.21 IU/L | Standard Deviation 74.93 |
| Phase 2: Placebo | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 52.76 IU/L | Standard Deviation 102.66 |
| Phase 2: Placebo | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 62.95 IU/L | Standard Deviation 131.49 |
| Phase 2: Placebo | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 58.54 IU/L | Standard Deviation 33.67 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 72.27 IU/L | Standard Deviation 232.21 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 54.73 IU/L | Standard Deviation 35.99 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 163.83 IU/L | Standard Deviation 817.08 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 69.30 IU/L | Standard Deviation 65.1 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 60.61 IU/L | Standard Deviation 39.15 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 363.69 IU/L | Standard Deviation 2565.77 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 78.29 IU/L | Standard Deviation 108.57 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 75.08 IU/L | Standard Deviation 162.6 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 38.73 IU/L | Standard Deviation 20.81 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 80.33 IU/L | Standard Deviation 65.9 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 51.54 IU/L | Standard Deviation 28.35 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 52.79 IU/L | Standard Deviation 39.9 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 58.58 IU/L | Standard Deviation 45.19 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 66.47 IU/L | Standard Deviation 63.95 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 347.60 IU/L | Standard Deviation 982.89 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 73.42 IU/L | Standard Deviation 152.57 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 126.70 IU/L | Standard Deviation 312.36 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 47.80 IU/L | Standard Deviation 29.38 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 72.17 IU/L | Standard Deviation 86.39 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 76.77 IU/L | Standard Deviation 178.97 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 35.24 IU/L | Standard Deviation 21.51 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 65.39 IU/L | Standard Deviation 52.27 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 61.13 IU/L | Standard Deviation 38.23 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 50.00 IU/L | Standard Deviation 37.36 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 77.66 IU/L | Standard Deviation 163.34 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 94.76 IU/L | Standard Deviation 136.93 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 49.89 IU/L | Standard Deviation 46.5 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 40.07 IU/L | Standard Deviation 25.67 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 98.84 IU/L | Standard Deviation 276.99 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 124.83 IU/L | Standard Deviation 270.78 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 57.68 IU/L | Standard Deviation 36.02 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 38.19 IU/L | Standard Deviation 29.82 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 58.00 IU/L | Standard Deviation 69.65 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 25.00 IU/L | Standard Deviation 0 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 47.00 IU/L | Standard Deviation 37.44 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 128.25 IU/L | Standard Deviation 180.12 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 51.33 IU/L | Standard Deviation 33.72 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 47.36 IU/L | Standard Deviation 24.52 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 45.29 IU/L | Standard Deviation 26.3 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 20.00 IU/L | Standard Deviation 0 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 52.29 IU/L | Standard Deviation 43.1 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 35.47 IU/L | Standard Deviation 22.96 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 52.93 IU/L | Standard Deviation 48.68 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 31.20 IU/L | Standard Deviation 16.69 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 25.50 IU/L | Standard Deviation 13.44 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 76.73 IU/L | Standard Deviation 35.24 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 33.17 IU/L | Standard Deviation 9.68 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 58.77 IU/L | Standard Deviation 42.03 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 58.33 IU/L | Standard Deviation 27.48 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 64.08 IU/L | Standard Deviation 58.97 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 75.88 IU/L | Standard Deviation 51.15 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 46.67 IU/L | Standard Deviation 39.87 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 114.00 IU/L | Standard Deviation 134.17 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 40.00 IU/L | Standard Deviation 41.87 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 74.50 IU/L | Standard Deviation 65.31 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 69.00 IU/L | Standard Deviation 57.98 |
| Phase 3 Cohort 2: Placebo | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 15 | 15.00 IU/L | Standard Deviation 4.24 |
| Phase 3 Cohort 2: Placebo | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 1 (Baseline) | 36.50 IU/L | Standard Deviation 3.54 |
| Phase 3 Cohort 2: Placebo | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 4 | 32.50 IU/L | Standard Deviation 19.09 |
| Phase 3 Cohort 2: Placebo | Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3) | Day 29 | 46.00 IU/L | Standard Deviation 42.43 |
Secondary
Mean Observed Creatinine Values Across Study Days (Phase 2)
Time frame: Days 1, 4, 15 and 29
Population: Phase 2 population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Mean Observed Creatinine Values Across Study Days (Phase 2) | Day 1 (Baseline) | 129.81 micromole/liter (umol/L) | Standard Deviation 142.13 |
| Phase 2: Placebo | Mean Observed Creatinine Values Across Study Days (Phase 2) | Day 4 | 153.12 micromole/liter (umol/L) | Standard Deviation 184.77 |
| Phase 2: Placebo | Mean Observed Creatinine Values Across Study Days (Phase 2) | Day 15 | 188.56 micromole/liter (umol/L) | Standard Deviation 260.81 |
| Phase 2: Placebo | Mean Observed Creatinine Values Across Study Days (Phase 2) | Day 29 | 147.52 micromole/liter (umol/L) | Standard Deviation 138.14 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Creatinine Values Across Study Days (Phase 2) | Day 29 | 138.02 micromole/liter (umol/L) | Standard Deviation 121.95 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Creatinine Values Across Study Days (Phase 2) | Day 1 (Baseline) | 137.20 micromole/liter (umol/L) | Standard Deviation 148.58 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Creatinine Values Across Study Days (Phase 2) | Day 15 | 168.74 micromole/liter (umol/L) | Standard Deviation 201.28 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Creatinine Values Across Study Days (Phase 2) | Day 4 | 151.86 micromole/liter (umol/L) | Standard Deviation 163.45 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Creatinine Values Across Study Days (Phase 2) | Day 29 | 118.56 micromole/liter (umol/L) | Standard Deviation 133.25 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Creatinine Values Across Study Days (Phase 2) | Day 4 | 164.62 micromole/liter (umol/L) | Standard Deviation 246.69 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Creatinine Values Across Study Days (Phase 2) | Day 15 | 155.23 micromole/liter (umol/L) | Standard Deviation 163.5 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Creatinine Values Across Study Days (Phase 2) | Day 1 (Baseline) | 158.18 micromole/liter (umol/L) | Standard Deviation 242.13 |
Secondary
Mean Observed Creatinine Values Across Study Days (Phase 3)
Time frame: Days 1, 4, 15 and 29
Population: Phase 3 population. Only those participants with data available at the specified time points were analyzed. Phase 3 Cohort 3 data was not summarized due to insufficient sample size
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 15 | 151.06 umol/L | Standard Deviation 175.53 |
| Phase 2: Placebo | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 4 | 133.77 umol/L | Standard Deviation 144.1 |
| Phase 2: Placebo | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 29 | 133.14 umol/L | Standard Deviation 140.37 |
| Phase 2: Placebo | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 1 (Baseline) | 122.64 umol/L | Standard Deviation 145.57 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 29 | 124.97 umol/L | Standard Deviation 124.62 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 15 | 136.98 umol/L | Standard Deviation 149.03 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 1 (Baseline) | 141.97 umol/L | Standard Deviation 187.4 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 4 | 129.08 umol/L | Standard Deviation 145.08 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 29 | 100.02 umol/L | Standard Deviation 107.1 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 15 | 120.96 umol/L | Standard Deviation 134.39 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 4 | 128.56 umol/L | Standard Deviation 127.48 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 1 (Baseline) | 121.75 umol/L | Standard Deviation 132.43 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 1 (Baseline) | 109.14 umol/L | Standard Deviation 196.52 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 29 | 122.88 umol/L | Standard Deviation 161.56 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 4 | 93.23 umol/L | Standard Deviation 151.97 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 15 | 151.11 umol/L | Standard Deviation 284.59 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 4 | 101.45 umol/L | Standard Deviation 129.88 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 1 (Baseline) | 174.92 umol/L | Standard Deviation 802.76 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 15 | 175.09 umol/L | Standard Deviation 243.54 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 29 | 205.17 umol/L | Standard Deviation 269.33 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 15 | 111.99 umol/L | Standard Deviation 97.29 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 1 (Baseline) | 111.63 umol/L | Standard Deviation 168.83 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 4 | 113.30 umol/L | Standard Deviation 152.19 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 29 | 143.62 umol/L | Standard Deviation 98.5 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 15 | 160.94 umol/L | Standard Deviation 198.07 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 1 (Baseline) | 187.93 umol/L | Standard Deviation 232.11 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 29 | 128.74 umol/L | Standard Deviation 191.15 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 4 | 176.80 umol/L | Standard Deviation 160.17 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 4 | 314.53 umol/L | Standard Deviation 352.59 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 29 | 125.21 umol/L | Standard Deviation 128.22 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 15 | 179.87 umol/L | Standard Deviation 183.06 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 1 (Baseline) | 308.63 umol/L | Standard Deviation 308.42 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 15 | 170.10 umol/L | Standard Deviation 198.2 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 1 (Baseline) | 280.83 umol/L | Standard Deviation 280.3 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 4 | 281.92 umol/L | Standard Deviation 310.48 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 29 | 197.65 umol/L | Standard Deviation 655.38 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 4 | 267.96 umol/L | Standard Deviation 479.59 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 15 | 142.32 umol/L | Standard Deviation 115.06 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 29 | 80.44 umol/L | Standard Deviation 0 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 1 (Baseline) | 259.01 umol/L | Standard Deviation 401.63 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 29 | 116.69 umol/L | Standard Deviation 32.2 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 1 (Baseline) | 265.36 umol/L | Standard Deviation 396.16 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 4 | 205.38 umol/L | Standard Deviation 249.38 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 15 | 137.46 umol/L | Standard Deviation 99.29 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 29 | 195.01 umol/L | Standard Deviation 108.79 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 4 | 395.09 umol/L | Standard Deviation 246.34 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 15 | 270.39 umol/L | Standard Deviation 176.43 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 1 (Baseline) | 401.87 umol/L | Standard Deviation 294.63 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 1 (Baseline) | 103.19 umol/L | Standard Deviation 74.6 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 15 | 116.96 umol/L | Standard Deviation 92.34 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 4 | 121.40 umol/L | Standard Deviation 84.33 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 29 | 55.69 umol/L | Standard Deviation 15.14 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 29 | 78.30 umol/L | Standard Deviation 40.12 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 1 (Baseline) | 78.79 umol/L | Standard Deviation 30.71 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 15 | 86.06 umol/L | Standard Deviation 64.78 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 4 | 99.28 umol/L | Standard Deviation 96.74 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 4 | 83.24 umol/L | Standard Deviation 62.6 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 15 | 136.49 umol/L | Standard Deviation 110.96 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 1 (Baseline) | 108.73 umol/L | Standard Deviation 92.72 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 29 | 65.86 umol/L | Standard Deviation 11.88 |
| Phase 3 Cohort 2: Placebo | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 1 (Baseline) | 497.25 umol/L | Standard Deviation 621.96 |
| Phase 3 Cohort 2: Placebo | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 15 | 311.61 umol/L | Standard Deviation 396.93 |
| Phase 3 Cohort 2: Placebo | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 4 | 458.80 umol/L | Standard Deviation 576.33 |
| Phase 3 Cohort 2: Placebo | Mean Observed Creatinine Values Across Study Days (Phase 3) | Day 29 | 276.25 umol/L | Standard Deviation 346.92 |
Secondary
Mean Observed Hemoglobin Values Across Study Days (Phase 2)
Time frame: Days 1, 4, 15 and 29
Population: Phase 2 population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Mean Observed Hemoglobin Values Across Study Days (Phase 2) | Day 1 (Baseline) | 122.53 grams/Liter (g/L) | Standard Deviation 20.65 |
| Phase 2: Placebo | Mean Observed Hemoglobin Values Across Study Days (Phase 2) | Day 4 | 120.30 grams/Liter (g/L) | Standard Deviation 28.23 |
| Phase 2: Placebo | Mean Observed Hemoglobin Values Across Study Days (Phase 2) | Day 15 | 100.04 grams/Liter (g/L) | Standard Deviation 22.39 |
| Phase 2: Placebo | Mean Observed Hemoglobin Values Across Study Days (Phase 2) | Day 29 | 90.48 grams/Liter (g/L) | Standard Deviation 15.3 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Hemoglobin Values Across Study Days (Phase 2) | Day 29 | 96.00 grams/Liter (g/L) | Standard Deviation 21.36 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Hemoglobin Values Across Study Days (Phase 2) | Day 1 (Baseline) | 122.19 grams/Liter (g/L) | Standard Deviation 19.75 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Hemoglobin Values Across Study Days (Phase 2) | Day 15 | 104.11 grams/Liter (g/L) | Standard Deviation 21.88 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Hemoglobin Values Across Study Days (Phase 2) | Day 4 | 122.79 grams/Liter (g/L) | Standard Deviation 20.44 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Hemoglobin Values Across Study Days (Phase 2) | Day 29 | 98.20 grams/Liter (g/L) | Standard Deviation 19.2 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Hemoglobin Values Across Study Days (Phase 2) | Day 4 | 122.61 grams/Liter (g/L) | Standard Deviation 20.83 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Hemoglobin Values Across Study Days (Phase 2) | Day 15 | 105.85 grams/Liter (g/L) | Standard Deviation 22.67 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Hemoglobin Values Across Study Days (Phase 2) | Day 1 (Baseline) | 122.75 grams/Liter (g/L) | Standard Deviation 20.27 |
Secondary
Mean Observed Hemoglobin Values Across Study Days (Phase 3)
Time frame: Days 1, 4, 15 and 29
Population: Phase 3 population. Only those participants with data available at the specified time points were analyzed. Phase 3 Cohort 3 data was not summarized due to insufficient sample size
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 15 | 99.66 grams/Liter (g/L) | Standard Deviation 20 |
| Phase 2: Placebo | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 4 | 112.90 grams/Liter (g/L) | Standard Deviation 20.72 |
| Phase 2: Placebo | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 29 | 84.31 grams/Liter (g/L) | Standard Deviation 15.05 |
| Phase 2: Placebo | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 1 (Baseline) | 117.70 grams/Liter (g/L) | Standard Deviation 19.85 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 29 | 91.50 grams/Liter (g/L) | Standard Deviation 18.08 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 15 | 104.70 grams/Liter (g/L) | Standard Deviation 22.93 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 1 (Baseline) | 121.25 grams/Liter (g/L) | Standard Deviation 20.39 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 4 | 121.03 grams/Liter (g/L) | Standard Deviation 20.83 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 29 | 96.28 grams/Liter (g/L) | Standard Deviation 19.5 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 15 | 107.87 grams/Liter (g/L) | Standard Deviation 23.48 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 4 | 120.57 grams/Liter (g/L) | Standard Deviation 21.82 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 1 (Baseline) | 121.06 grams/Liter (g/L) | Standard Deviation 19.97 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 1 (Baseline) | 127.64 grams/Liter (g/L) | Standard Deviation 15.27 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 29 | 86.67 grams/Liter (g/L) | Standard Deviation 17.67 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 4 | 123.58 grams/Liter (g/L) | Standard Deviation 16.89 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 15 | 112.15 grams/Liter (g/L) | Standard Deviation 21.36 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 4 | 125.70 grams/Liter (g/L) | Standard Deviation 20.59 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 1 (Baseline) | 124.18 grams/Liter (g/L) | Standard Deviation 20.59 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 15 | 106.27 grams/Liter (g/L) | Standard Deviation 20.25 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 29 | 99.58 grams/Liter (g/L) | Standard Deviation 22.48 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 15 | 113.43 grams/Liter (g/L) | Standard Deviation 27.11 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 1 (Baseline) | 124.76 grams/Liter (g/L) | Standard Deviation 20.64 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 4 | 125.61 grams/Liter (g/L) | Standard Deviation 20.74 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 29 | 88.92 grams/Liter (g/L) | Standard Deviation 22.72 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 15 | 91.16 grams/Liter (g/L) | Standard Deviation 15.85 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 1 (Baseline) | 114.59 grams/Liter (g/L) | Standard Deviation 19.03 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 29 | 85.23 grams/Liter (g/L) | Standard Deviation 10.88 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 4 | 101.36 grams/Liter (g/L) | Standard Deviation 16.9 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 4 | 106.55 grams/Liter (g/L) | Standard Deviation 21.22 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 29 | 88.74 grams/Liter (g/L) | Standard Deviation 13.27 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 15 | 95.21 grams/Liter (g/L) | Standard Deviation 18.3 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 1 (Baseline) | 110.40 grams/Liter (g/L) | Standard Deviation 22.34 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 15 | 90.88 grams/Liter (g/L) | Standard Deviation 18.37 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 1 (Baseline) | 104.19 grams/Liter (g/L) | Standard Deviation 19.4 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 4 | 102.46 grams/Liter (g/L) | Standard Deviation 20.43 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 29 | 88.44 grams/Liter (g/L) | Standard Deviation 15.13 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 4 | 114.13 grams/Liter (g/L) | Standard Deviation 15.57 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 15 | 106.75 grams/Liter (g/L) | Standard Deviation 28.94 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 29 | 135.00 grams/Liter (g/L) | Standard Deviation 0 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 1 (Baseline) | 121.88 grams/Liter (g/L) | Standard Deviation 24 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 29 | 96.00 grams/Liter (g/L) | Standard Deviation 11.27 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 1 (Baseline) | 120.55 grams/Liter (g/L) | Standard Deviation 18.93 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 4 | 118.25 grams/Liter (g/L) | Standard Deviation 21.64 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 15 | 111.00 grams/Liter (g/L) | Standard Deviation 21.87 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 29 | 85.20 grams/Liter (g/L) | Standard Deviation 13.68 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 4 | 97.13 grams/Liter (g/L) | Standard Deviation 22.68 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 15 | 91.86 grams/Liter (g/L) | Standard Deviation 19.15 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 1 (Baseline) | 99.00 grams/Liter (g/L) | Standard Deviation 22.83 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 1 (Baseline) | 111.20 grams/Liter (g/L) | Standard Deviation 19.01 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 15 | 92.85 grams/Liter (g/L) | Standard Deviation 16.8 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 4 | 103.73 grams/Liter (g/L) | Standard Deviation 19.49 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 29 | 99.40 grams/Liter (g/L) | Standard Deviation 23.03 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 29 | 106.29 grams/Liter (g/L) | Standard Deviation 12.59 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 1 (Baseline) | 115.75 grams/Liter (g/L) | Standard Deviation 21.51 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 15 | 109.43 grams/Liter (g/L) | Standard Deviation 15.54 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 4 | 114.56 grams/Liter (g/L) | Standard Deviation 17 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 4 | 115.33 grams/Liter (g/L) | Standard Deviation 16.15 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 15 | 103.40 grams/Liter (g/L) | Standard Deviation 20.88 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 1 (Baseline) | 122.00 grams/Liter (g/L) | Standard Deviation 17.16 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 29 | 98.50 grams/Liter (g/L) | Standard Deviation 38.89 |
| Phase 3 Cohort 2: Placebo | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 1 (Baseline) | 111.50 grams/Liter (g/L) | Standard Deviation 33.23 |
| Phase 3 Cohort 2: Placebo | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 15 | 101.50 grams/Liter (g/L) | Standard Deviation 14.85 |
| Phase 3 Cohort 2: Placebo | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 4 | 113.50 grams/Liter (g/L) | Standard Deviation 38.89 |
| Phase 3 Cohort 2: Placebo | Mean Observed Hemoglobin Values Across Study Days (Phase 3) | Day 29 | 82.50 grams/Liter (g/L) | Standard Deviation 6.36 |
Secondary
Mean Observed Leukocyte Values Across Study Days (Phase 2)
Time frame: Days 1, 4, 15 and 29
Population: Phase 2 population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Mean Observed Leukocyte Values Across Study Days (Phase 2) | Day 1 | 8.95 10^9 cells/liter(L) | Standard Deviation 3.73 |
| Phase 2: Placebo | Mean Observed Leukocyte Values Across Study Days (Phase 2) | Day 4 | 10.75 10^9 cells/liter(L) | Standard Deviation 5.54 |
| Phase 2: Placebo | Mean Observed Leukocyte Values Across Study Days (Phase 2) | Day 15 | 12.44 10^9 cells/liter(L) | Standard Deviation 5.94 |
| Phase 2: Placebo | Mean Observed Leukocyte Values Across Study Days (Phase 2) | Day 29 | 12.06 10^9 cells/liter(L) | Standard Deviation 6.73 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Leukocyte Values Across Study Days (Phase 2) | Day 29 | 11.20 10^9 cells/liter(L) | Standard Deviation 5.81 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Leukocyte Values Across Study Days (Phase 2) | Day 1 | 9.41 10^9 cells/liter(L) | Standard Deviation 4.68 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Leukocyte Values Across Study Days (Phase 2) | Day 15 | 13.10 10^9 cells/liter(L) | Standard Deviation 7.17 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Leukocyte Values Across Study Days (Phase 2) | Day 4 | 9.00 10^9 cells/liter(L) | Standard Deviation 6.61 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Leukocyte Values Across Study Days (Phase 2) | Day 29 | 12.48 10^9 cells/liter(L) | Standard Deviation 6.9 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Leukocyte Values Across Study Days (Phase 2) | Day 4 | 9.47 10^9 cells/liter(L) | Standard Deviation 6.91 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Leukocyte Values Across Study Days (Phase 2) | Day 15 | 12.10 10^9 cells/liter(L) | Standard Deviation 7.78 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Leukocyte Values Across Study Days (Phase 2) | Day 1 | 10.28 10^9 cells/liter(L) | Standard Deviation 6.47 |
Secondary
Mean Observed Leukocyte Values Across Study Days (Phase 3)
Time frame: Days 1, 4, 15 and 29
Population: Phase 3 population. Only those participants with data available at the specified time points were analyzed. Phase 3 Cohort 3 data was not summarized due to insufficient sample size.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 15 | 12.03 10^9 cells/liter(L) | Standard Deviation 4.68 |
| Phase 2: Placebo | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 4 | 12.11 10^9 cells/liter(L) | Standard Deviation 5.49 |
| Phase 2: Placebo | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 29 | 11.90 10^9 cells/liter(L) | Standard Deviation 6 |
| Phase 2: Placebo | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 1 (Baseline) | 10.18 10^9 cells/liter(L) | Standard Deviation 4.57 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 29 | 12.17 10^9 cells/liter(L) | Standard Deviation 7.45 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 15 | 11.26 10^9 cells/liter(L) | Standard Deviation 6.79 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 1 (Baseline) | 10.51 10^9 cells/liter(L) | Standard Deviation 4.83 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 4 | 9.47 10^9 cells/liter(L) | Standard Deviation 5.77 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 29 | 31.35 10^9 cells/liter(L) | Standard Deviation 194.41 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 15 | 10.47 10^9 cells/liter(L) | Standard Deviation 6.28 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 4 | 9.19 10^9 cells/liter(L) | Standard Deviation 5.82 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 1 (Baseline) | 10.52 10^9 cells/liter(L) | Standard Deviation 4.442 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 1 (Baseline) | 7.83 10^9 cells/liter(L) | Standard Deviation 2.97 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 29 | 7.81 10^9 cells/liter(L) | Standard Deviation 2.66 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 4 | 7.93 10^9 cells/liter(L) | Standard Deviation 2.87 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 15 | 10.58 10^9 cells/liter(L) | Standard Deviation 5.86 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 4 | 6.76 10^9 cells/liter(L) | Standard Deviation 3.92 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 1 (Baseline) | 8.16 10^9 cells/liter(L) | Standard Deviation 3.42 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 15 | 9.68 10^9 cells/liter(L) | Standard Deviation 4.88 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 29 | 11.56 10^9 cells/liter(L) | Standard Deviation 6.67 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 15 | 11.18 10^9 cells/liter(L) | Standard Deviation 10.52 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 1 (Baseline) | 8.38 10^9 cells/liter(L) | Standard Deviation 4.06 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 4 | 6.89 10^9 cells/liter(L) | Standard Deviation 5.1 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 29 | 11.72 10^9 cells/liter(L) | Standard Deviation 6.28 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 15 | 13.97 10^9 cells/liter(L) | Standard Deviation 5.57 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 1 (Baseline) | 12.01 10^9 cells/liter(L) | Standard Deviation 5.57 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 29 | 10.22 10^9 cells/liter(L) | Standard Deviation 3.62 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 4 | 13.53 10^9 cells/liter(L) | Standard Deviation 7.44 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 4 | 11.62 10^9 cells/liter(L) | Standard Deviation 7.05 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 29 | 11.15 10^9 cells/liter(L) | Standard Deviation 6.84 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 15 | 12.73 10^9 cells/liter(L) | Standard Deviation 7.25 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 1 (Baseline) | 12.98 10^9 cells/liter(L) | Standard Deviation 5.72 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 15 | 11.90 10^9 cells/liter(L) | Standard Deviation 8.88 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 1 (Baseline) | 12.35 10^9 cells/liter(L) | Standard Deviation 5.78 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 4 | 11.25 10^9 cells/liter(L) | Standard Deviation 8.42 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 29 | 10.50 10^9 cells/liter(L) | Standard Deviation 6.44 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 4 | 13.48 10^9 cells/liter(L) | Standard Deviation 10.88 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 15 | 22.45 10^9 cells/liter(L) | Standard Deviation 17.05 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 29 | 18.30 10^9 cells/liter(L) | Standard Deviation 0 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 1 (Baseline) | 14.26 10^9 cells/liter(L) | Standard Deviation 9.99 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 29 | 9.52 10^9 cells/liter(L) | Standard Deviation 5.47 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 1 (Baseline) | 9.13 10^9 cells/liter(L) | Standard Deviation 5.112 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 4 | 6.44 10^9 cells/liter(L) | Standard Deviation 2.68 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 15 | 8.12 10^9 cells/liter(L) | Standard Deviation 2.75 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 29 | 14.10 10^9 cells/liter(L) | Standard Deviation 11.02 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 4 | 6.50 10^9 cells/liter(L) | Standard Deviation 6.36 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 15 | 12.84 10^9 cells/liter(L) | Standard Deviation 7.21 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 1 (Baseline) | 7.20 10^9 cells/liter(L) | Standard Deviation 5.28 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 1 (Baseline) | 11.52 10^9 cells/liter(L) | Standard Deviation 3.55 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 15 | 11.70 10^9 cells/liter(L) | Standard Deviation 4.81 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 4 | 12.15 10^9 cells/liter(L) | Standard Deviation 4.87 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 29 | 11.22 10^9 cells/liter(L) | Standard Deviation 8.67 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 29 | 7.43 10^9 cells/liter(L) | Standard Deviation 2.57 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 1 (Baseline) | 12.13 10^9 cells/liter(L) | Standard Deviation 5.27 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 15 | 10.68 10^9 cells/liter(L) | Standard Deviation 10.76 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 4 | 8.30 10^9 cells/liter(L) | Standard Deviation 3.87 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 4 | 9.96 10^9 cells/liter(L) | Standard Deviation 2.92 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 15 | 14.45 10^9 cells/liter(L) | Standard Deviation 8.12 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 1 (Baseline) | 8.80 10^9 cells/liter(L) | Standard Deviation 2.14 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 29 | 28.44 10^9 cells/liter(L) | Standard Deviation 22.96 |
| Phase 3 Cohort 2: Placebo | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 1 (Baseline) | 4.80 10^9 cells/liter(L) | Standard Deviation 1.84 |
| Phase 3 Cohort 2: Placebo | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 15 | 16.40 10^9 cells/liter(L) | Standard Deviation 1.84 |
| Phase 3 Cohort 2: Placebo | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 4 | 4.70 10^9 cells/liter(L) | Standard Deviation 3.54 |
| Phase 3 Cohort 2: Placebo | Mean Observed Leukocyte Values Across Study Days (Phase 3) | Day 29 | 7.50 10^9 cells/liter(L) | Standard Deviation 5.09 |
Secondary
Mean Observed Platelet Count Across Study Days (Phase 2)
Time frame: Days 1, 4, 15 and 29
Population: Phase 2 population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Mean Observed Platelet Count Across Study Days (Phase 2) | Day 1 (Baseline) | 241.03 10^9 platelets/liter(L) | Standard Deviation 102.22 |
| Phase 2: Placebo | Mean Observed Platelet Count Across Study Days (Phase 2) | Day 4 | 314.86 10^9 platelets/liter(L) | Standard Deviation 129.8 |
| Phase 2: Placebo | Mean Observed Platelet Count Across Study Days (Phase 2) | Day 15 | 351.89 10^9 platelets/liter(L) | Standard Deviation 155.08 |
| Phase 2: Placebo | Mean Observed Platelet Count Across Study Days (Phase 2) | Day 29 | 313.12 10^9 platelets/liter(L) | Standard Deviation 148.66 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Platelet Count Across Study Days (Phase 2) | Day 29 | 306.87 10^9 platelets/liter(L) | Standard Deviation 119.1 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Platelet Count Across Study Days (Phase 2) | Day 1 (Baseline) | 249.40 10^9 platelets/liter(L) | Standard Deviation 100.55 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Platelet Count Across Study Days (Phase 2) | Day 15 | 264.03 10^9 platelets/liter(L) | Standard Deviation 116.22 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Platelet Count Across Study Days (Phase 2) | Day 4 | 304.94 10^9 platelets/liter(L) | Standard Deviation 117.17 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Platelet Count Across Study Days (Phase 2) | Day 29 | 312.14 10^9 platelets/liter(L) | Standard Deviation 147.07 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Platelet Count Across Study Days (Phase 2) | Day 4 | 319.89 10^9 platelets/liter(L) | Standard Deviation 116.8 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Platelet Count Across Study Days (Phase 2) | Day 15 | 257.88 10^9 platelets/liter(L) | Standard Deviation 118.01 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Platelet Count Across Study Days (Phase 2) | Day 1 (Baseline) | 261.50 10^9 platelets/liter(L) | Standard Deviation 94.51 |
Secondary
Mean Observed Platelet Count Across Study Days (Phase 3)
Time frame: Days 1, 4, 15 and 29
Population: Phase 3 population. Only those participants with data available at the specified time points were analyzed. Phase 3 Cohort 3 data was not summarized due to insufficient sample size
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 15 | 315.38 10^9 platelets/liter(L) | Standard Deviation 143.62 |
| Phase 2: Placebo | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 4 | 328.20 10^9 platelets/liter(L) | Standard Deviation 137.22 |
| Phase 2: Placebo | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 29 | 284.02 10^9 platelets/liter(L) | Standard Deviation 143.38 |
| Phase 2: Placebo | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 1 (Baseline) | 285.56 10^9 platelets/liter(L) | Standard Deviation 120.77 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 29 | 270.88 10^9 platelets/liter(L) | Standard Deviation 102.72 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 15 | 230.44 10^9 platelets/liter(L) | Standard Deviation 100.71 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 1 (Baseline) | 278.60 10^9 platelets/liter(L) | Standard Deviation 112.15 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 4 | 318.16 10^9 platelets/liter(L) | Standard Deviation 129.76 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 29 | 248.60 10^9 platelets/liter(L) | Standard Deviation 139.26 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 15 | 222.62 10^9 platelets/liter(L) | Standard Deviation 100.21 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 4 | 311.42 10^9 platelets/liter(L) | Standard Deviation 136.44 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 1 (Baseline) | 278.40 10^9 platelets/liter(L) | Standard Deviation 120.16 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 1 (Baseline) | 251.03 10^9 platelets/liter(L) | Standard Deviation 109.74 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 29 | 264.67 10^9 platelets/liter(L) | Standard Deviation 147.97 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 4 | 324.57 10^9 platelets/liter(L) | Standard Deviation 154.49 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 15 | 271.71 10^9 platelets/liter(L) | Standard Deviation 124.32 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 4 | 348.96 10^9 platelets/liter(L) | Standard Deviation 135.13 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 1 (Baseline) | 271.70 10^9 platelets/liter(L) | Standard Deviation 109.63 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 15 | 242.40 10^9 platelets/liter(L) | Standard Deviation 82.25 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 29 | 238.67 10^9 platelets/liter(L) | Standard Deviation 125.15 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 15 | 223.14 10^9 platelets/liter(L) | Standard Deviation 102.57 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 1 (Baseline) | 259.06 10^9 platelets/liter(L) | Standard Deviation 115.47 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 4 | 330.84 10^9 platelets/liter(L) | Standard Deviation 154.22 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 29 | 182.58 10^9 platelets/liter(L) | Standard Deviation 107.29 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 15 | 312.81 10^9 platelets/liter(L) | Standard Deviation 155.88 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 1 (Baseline) | 244.11 10^9 platelets/liter(L) | Standard Deviation 103.1 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 29 | 332.73 10^9 platelets/liter(L) | Standard Deviation 156.61 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 4 | 276.70 10^9 platelets/liter(L) | Standard Deviation 111.39 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 4 | 275.84 10^9 platelets/liter(L) | Standard Deviation 116.7 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 29 | 310.52 10^9 platelets/liter(L) | Standard Deviation 155.05 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 15 | 232.97 10^9 platelets/liter(L) | Standard Deviation 115.44 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 1 (Baseline) | 251.85 10^9 platelets/liter(L) | Standard Deviation 105.45 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 15 | 226.89 10^9 platelets/liter(L) | Standard Deviation 110.91 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 1 (Baseline) | 258.37 10^9 platelets/liter(L) | Standard Deviation 100.32 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 4 | 268.18 10^9 platelets/liter(L) | Standard Deviation 116.49 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 29 | 279.31 10^9 platelets/liter(L) | Standard Deviation 124.43 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 4 | 244.88 10^9 platelets/liter(L) | Standard Deviation 73.27 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 15 | 219.25 10^9 platelets/liter(L) | Standard Deviation 77.89 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 29 | 267.00 10^9 platelets/liter(L) | Standard Deviation 0 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 1 (Baseline) | 233.00 10^9 platelets/liter(L) | Standard Deviation 74.04 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 29 | 281.00 10^9 platelets/liter(L) | Standard Deviation 130.09 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 1 (Baseline) | 221.64 10^9 platelets/liter(L) | Standard Deviation 84.86 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 4 | 261.00 10^9 platelets/liter(L) | Standard Deviation 109.9 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 15 | 203.63 10^9 platelets/liter(L) | Standard Deviation 47.37 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 29 | 181.25 10^9 platelets/liter(L) | Standard Deviation 53.01 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 4 | 225.47 10^9 platelets/liter(L) | Standard Deviation 75.84 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 15 | 133.14 10^9 platelets/liter(L) | Standard Deviation 59.74 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 1 (Baseline) | 190.33 10^9 platelets/liter(L) | Standard Deviation 77.23 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 1 (Baseline) | 228.40 10^9 platelets/liter(L) | Standard Deviation 121.12 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 15 | 275.69 10^9 platelets/liter(L) | Standard Deviation 150.11 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 4 | 267.80 10^9 platelets/liter(L) | Standard Deviation 132.29 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 29 | 265.00 10^9 platelets/liter(L) | Standard Deviation 70.67 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 29 | 235.71 10^9 platelets/liter(L) | Standard Deviation 100.19 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 1 (Baseline) | 278.31 10^9 platelets/liter(L) | Standard Deviation 130.65 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 15 | 209.00 10^9 platelets/liter(L) | Standard Deviation 92.41 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 4 | 318.25 10^9 platelets/liter(L) | Standard Deviation 134.09 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 4 | 421.17 10^9 platelets/liter(L) | Standard Deviation 135.03 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 15 | 306.60 10^9 platelets/liter(L) | Standard Deviation 108.91 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 1 (Baseline) | 298.50 10^9 platelets/liter(L) | Standard Deviation 114.86 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 29 | 272.00 10^9 platelets/liter(L) | Standard Deviation 26.87 |
| Phase 3 Cohort 2: Placebo | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 1 (Baseline) | 197.00 10^9 platelets/liter(L) | Standard Deviation 22.63 |
| Phase 3 Cohort 2: Placebo | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 15 | 259.00 10^9 platelets/liter(L) | Standard Deviation 39.6 |
| Phase 3 Cohort 2: Placebo | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 4 | 294.00 10^9 platelets/liter(L) | Standard Deviation 127.28 |
| Phase 3 Cohort 2: Placebo | Mean Observed Platelet Count Across Study Days (Phase 3) | Day 29 | 373.00 10^9 platelets/liter(L) | Standard Deviation 367.7 |
Secondary
Mean Observed Total Bilirubin Across Study Days (Phase 3)
Time frame: Days 1, 4, 15 and 29
Population: Phase 3 population. Only those participants with data available at the specified time points were analyzed. Phase 3 Cohort 3 data was not summarized due to insufficient sample size
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 15 | 16.47 umol/L | Standard Deviation 37.13 |
| Phase 2: Placebo | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 1 (Baseline) | 11.79 umol/L | Standard Deviation 7.66 |
| Phase 2: Placebo | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 4 | 13.11 umol/L | Standard Deviation 13.11 |
| Phase 2: Placebo | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 29 | 11.66 umol/L | Standard Deviation 11 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 29 | 11.74 umol/L | Standard Deviation 13.86 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 15 | 11.66 umol/L | Standard Deviation 8.09 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 1 (Baseline) | 12.02 umol/L | Standard Deviation 7.82 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 4 | 10.10 umol/L | Standard Deviation 6.39 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 15 | 15.60 umol/L | Standard Deviation 48.78 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 29 | 19.24 umol/L | Standard Deviation 38.66 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 1 (Baseline) | 12.99 umol/L | Standard Deviation 14.2 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 4 | 10.21 umol/L | Standard Deviation 8.61 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 15 | 8.66 umol/L | Standard Deviation 2.54 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 1 (Baseline) | 9.09 umol/L | Standard Deviation 4.17 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 4 | 9.53 umol/L | Standard Deviation 4.67 |
| Phase 3 Cohort 1: Placebo - Critical | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 29 | 9.69 umol/L | Standard Deviation 0.99 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 4 | 8.45 umol/L | Standard Deviation 5.43 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 15 | 11.07 umol/L | Standard Deviation 7.15 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 29 | 25.48 umol/L | Standard Deviation 38.28 |
| Phase 3 Cohort 1: 200mg IV - Critical | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 1 (Baseline) | 9.93 umol/L | Standard Deviation 5.27 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 1 (Baseline) | 10.12 umol/L | Standard Deviation 5.95 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 29 | 31.19 umol/L | Standard Deviation 71.38 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 15 | 19.37 umol/L | Standard Deviation 47.14 |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 4 | 8.38 umol/L | Standard Deviation 4.16 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 1 (Baseline) | 10.94 umol/L | Standard Deviation 8.57 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 15 | 13.20 umol/L | Standard Deviation 11.02 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 4 | 14.57 umol/L | Standard Deviation 14.93 |
| Phase 3 Cohort 1: Placebo - Severe | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 29 | 9.69 umol/L | Standard Deviation 9.13 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 29 | 9.44 umol/L | Standard Deviation 9.44 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 4 | 10.94 umol/L | Standard Deviation 10.45 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 15 | 10.69 umol/L | Standard Deviation 7.93 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 1 (Baseline) | 16.89 umol/L | Standard Deviation 21.77 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 4 | 13.98 umol/L | Standard Deviation 11 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 1 (Baseline) | 16.56 umol/L | Standard Deviation 13.46 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 15 | 14.26 umol/L | Standard Deviation 18.85 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 29 | 10.54 umol/L | Standard Deviation 8.19 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 1 (Baseline) | 6.27 umol/L | Standard Deviation 2.57 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 4 | 7.98 umol/L | Standard Deviation 6.18 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 15 | 19.24 umol/L | Standard Deviation 10.76 |
| Phase 3 Cohort 1: Placebo - MSOD | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 29 | 13.68 umol/L | Standard Deviation 0 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 15 | 16.37 umol/L | Standard Deviation 24.6 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 4 | 10.26 umol/L | Standard Deviation 8.12 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 29 | 3.42 umol/L | Standard Deviation 0 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 1 (Baseline) | 10.10 umol/L | Standard Deviation 9.9 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 4 | 6.96 umol/L | Standard Deviation 3.11 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 29 | 8.89 umol/L | Standard Deviation 3.71 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 15 | 8.55 umol/L | Standard Deviation 2.61 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 1 (Baseline) | 7.30 umol/L | Standard Deviation 4.77 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 1 (Baseline) | 10.79 umol/L | Standard Deviation 7.47 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 15 | 23.09 umol/L | Standard Deviation 45.49 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 29 | 4.27 umol/L | Standard Deviation 1.21 |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 4 | 12.43 umol/L | Standard Deviation 5.19 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 1 (Baseline) | 9.92 umol/L | Standard Deviation 5.93 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 29 | 6.56 umol/L | Standard Deviation 2.52 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 15 | 10.97 umol/L | Standard Deviation 3.53 |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 4 | 7.70 umol/L | Standard Deviation 5.15 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 4 | 11.40 umol/L | Standard Deviation 4.55 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 1 (Baseline) | 9.98 umol/L | Standard Deviation 1.68 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 29 | 13.68 umol/L | Standard Deviation 14.51 |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 15 | 10.26 umol/L | Standard Deviation 4.52 |
| Phase 3 Cohort 2: Placebo | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 29 | 7.70 umol/L | Standard Deviation 3.63 |
| Phase 3 Cohort 2: Placebo | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 15 | 11.97 umol/L | Standard Deviation 2.42 |
| Phase 3 Cohort 2: Placebo | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 4 | 9.41 umol/L | Standard Deviation 3.63 |
| Phase 3 Cohort 2: Placebo | Mean Observed Total Bilirubin Across Study Days (Phase 3) | Day 1 (Baseline) | 9.41 umol/L | Standard Deviation 1.21 |
Secondary
Mean Observed Total Bilirubin Values Across Study Days (Phase 2)
Time frame: Days 1, 4, 15 and 29
Population: Phase 2 Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Mean Observed Total Bilirubin Values Across Study Days (Phase 2) | Day 1 (Baseline) | 12.07 micromole/liter (umol/L) | Standard Deviation 14.2 |
| Phase 2: Placebo | Mean Observed Total Bilirubin Values Across Study Days (Phase 2) | Day 4 | 12.44 micromole/liter (umol/L) | Standard Deviation 10.9 |
| Phase 2: Placebo | Mean Observed Total Bilirubin Values Across Study Days (Phase 2) | Day 15 | 13.75 micromole/liter (umol/L) | Standard Deviation 17.63 |
| Phase 2: Placebo | Mean Observed Total Bilirubin Values Across Study Days (Phase 2) | Day 29 | 14.00 micromole/liter (umol/L) | Standard Deviation 19.84 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Total Bilirubin Values Across Study Days (Phase 2) | Day 29 | 7.87 micromole/liter (umol/L) | Standard Deviation 3.44 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Total Bilirubin Values Across Study Days (Phase 2) | Day 1 (Baseline) | 11.96 micromole/liter (umol/L) | Standard Deviation 13.59 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Total Bilirubin Values Across Study Days (Phase 2) | Day 15 | 12.43 micromole/liter (umol/L) | Standard Deviation 8.69 |
| Phase 2: Sarilumab 200mg IV | Mean Observed Total Bilirubin Values Across Study Days (Phase 2) | Day 4 | 11.87 micromole/liter (umol/L) | Standard Deviation 17.12 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Total Bilirubin Values Across Study Days (Phase 2) | Day 29 | 11.40 micromole/liter (umol/L) | Standard Deviation 12.23 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Total Bilirubin Values Across Study Days (Phase 2) | Day 4 | 9.89 micromole/liter (umol/L) | Standard Deviation 11.1 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Total Bilirubin Values Across Study Days (Phase 2) | Day 15 | 14.16 micromole/liter (umol/L) | Standard Deviation 21.94 |
| Phase 2: Sarilumab 400mg IV | Mean Observed Total Bilirubin Values Across Study Days (Phase 2) | Day 1 (Baseline) | 12.24 micromole/liter (umol/L) | Standard Deviation 15.77 |
Secondary
Number of Days in an Intensive Care Unit (ICU) in Participants Who Were Not in ICU at Baseline (Phase 2)
Time frame: Up to Day 29
Population: Phase 2 ITT population participants who were not in ICU at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Placebo | Number of Days in an Intensive Care Unit (ICU) in Participants Who Were Not in ICU at Baseline (Phase 2) | 13.6 Days | Standard Deviation 11 |
| Phase 2: Sarilumab 200mg IV | Number of Days in an Intensive Care Unit (ICU) in Participants Who Were Not in ICU at Baseline (Phase 2) | 11.4 Days | Standard Deviation 10.5 |
| Phase 2: Sarilumab 400mg IV | Number of Days in an Intensive Care Unit (ICU) in Participants Who Were Not in ICU at Baseline (Phase 2) | 13.8 Days | Standard Deviation 15.5 |
Secondary
Number of Days of Hospitalization Among Survivors (Phase 2)
Time frame: Up to day 29
Population: Phase 2 ITT population participants with a hospital discharge date on or before Day 29
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Number of Days of Hospitalization Among Survivors (Phase 2) | Up to Day 8 | 7.3 days | Standard Deviation 1.3 |
| Phase 2: Placebo | Number of Days of Hospitalization Among Survivors (Phase 2) | Up to Day 15 | 13.7 days | Standard Deviation 2 |
| Phase 2: Placebo | Number of Days of Hospitalization Among Survivors (Phase 2) | Up to Day 22 | 21.3 days | Standard Deviation 1.8 |
| Phase 2: Placebo | Number of Days of Hospitalization Among Survivors (Phase 2) | Up to Day 29 | 27.3 days | Standard Deviation 2.5 |
| Phase 2: Sarilumab 200mg IV | Number of Days of Hospitalization Among Survivors (Phase 2) | Up to Day 29 | 27.5 days | Standard Deviation 2.2 |
| Phase 2: Sarilumab 200mg IV | Number of Days of Hospitalization Among Survivors (Phase 2) | Up to Day 8 | 7.3 days | Standard Deviation 1.3 |
| Phase 2: Sarilumab 200mg IV | Number of Days of Hospitalization Among Survivors (Phase 2) | Up to Day 22 | 21.2 days | Standard Deviation 1.7 |
| Phase 2: Sarilumab 200mg IV | Number of Days of Hospitalization Among Survivors (Phase 2) | Up to Day 15 | 13.5 days | Standard Deviation 2.2 |
| Phase 2: Sarilumab 400mg IV | Number of Days of Hospitalization Among Survivors (Phase 2) | Up to Day 29 | 28.4 days | Standard Deviation 1.4 |
| Phase 2: Sarilumab 400mg IV | Number of Days of Hospitalization Among Survivors (Phase 2) | Up to Day 15 | 13.5 days | Standard Deviation 2.2 |
| Phase 2: Sarilumab 400mg IV | Number of Days of Hospitalization Among Survivors (Phase 2) | Up to Day 22 | 21.6 days | Standard Deviation 1.1 |
| Phase 2: Sarilumab 400mg IV | Number of Days of Hospitalization Among Survivors (Phase 2) | Up to Day 8 | 7.2 days | Standard Deviation 1.5 |
Secondary
Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1)
Number of days of hospitalization among survivors (Phase 3 Cohort 1)
Time frame: Days 8, 15, 22 and 29
Population: Phase 3 Cohort 1: Critical population receiving mechanical ventilation at baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1) | Hospitalized up to Day 8 | 7.7 days | Standard Deviation 0.9 |
| Phase 2: Placebo | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1) | Hospitalized up to Day 15 | 14.5 days | Standard Deviation 1.5 |
| Phase 2: Placebo | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1) | Hospitalized up to Day 22 | 20.7 days | Standard Deviation 2.3 |
| Phase 2: Placebo | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1) | Hospitalized up to Day 29 | 28.3 days | Standard Deviation 1.8 |
| Phase 2: Sarilumab 200mg IV | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1) | Hospitalized up to Day 29 | 28.5 days | Standard Deviation 1.4 |
| Phase 2: Sarilumab 200mg IV | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1) | Hospitalized up to Day 8 | 7.8 days | Standard Deviation 0.6 |
| Phase 2: Sarilumab 200mg IV | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1) | Hospitalized up to Day 22 | 21.6 days | Standard Deviation 1.3 |
| Phase 2: Sarilumab 200mg IV | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1) | Hospitalized up to Day 15 | 14.4 days | Standard Deviation 1.5 |
| Phase 2: Sarilumab 400mg IV | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1) | Hospitalized up to Day 29 | 28.2 days | Standard Deviation 1.6 |
| Phase 2: Sarilumab 400mg IV | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1) | Hospitalized up to Day 15 | 14.5 days | Standard Deviation 1.3 |
| Phase 2: Sarilumab 400mg IV | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1) | Hospitalized up to Day 22 | 21.1 days | Standard Deviation 1.7 |
| Phase 2: Sarilumab 400mg IV | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1) | Hospitalized up to Day 8 | 8.0 days | Standard Deviation 0.2 |
Comparison: Hospitalized up to Day 8p-value: 0.366295% CI: [-0.2, 0.5]t-test, 2 sided
Comparison: Hospitalized up to Day 8p-value: 0.08295% CI: [0, 0.6]t-test, 2 sided
Comparison: Hospitalized up to Day 15p-value: 0.698495% CI: [-0.9, 0.6]t-test, 2 sided
Comparison: Hospitalized up to Day 15p-value: 0.983395% CI: [-0.6, 0.6]t-test, 2 sided
Comparison: Hospitalized up to Day 22p-value: 0.143695% CI: [-0.3, 2]t-test, 2 sided
Comparison: Hospitalized up to Day 22p-value: 0.41995% CI: [-0.6, 1.4]t-test, 2 sided
Comparison: Hospitalized up to Day 29p-value: 0.65295% CI: [-0.7, 1.2]t-test, 2 sided
Comparison: Hospitalized up to Day 29p-value: 0.80195% CI: [-1.1, 0.9]t-test, 2 sided
Secondary
Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1: Critical ITT)
Number of days of hospitalization among survivors (Phase 3 Cohort 1: Critical ITT population)
Time frame: Days 8, 15, 22 and 29
Population: Phase 3 Cohort 1: Critical ITT population participants with a hospital discharge date on or before Day 29
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1: Critical ITT) | Hospitalized up to Day 8 | 7.5 days | Standard Deviation 1.2 |
| Phase 2: Placebo | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1: Critical ITT) | Hospitalized up to Day 15 | 13.7 days | Standard Deviation 2 |
| Phase 2: Placebo | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1: Critical ITT) | Hospitalized up to Day 22 | 20.8 days | Standard Deviation 2 |
| Phase 2: Placebo | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1: Critical ITT) | Hospitalized up to Day 29 | 28.4 days | Standard Deviation 1.4 |
| Phase 2: Sarilumab 200mg IV | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1: Critical ITT) | Hospitalized up to Day 29 | 28.2 days | Standard Deviation 1.8 |
| Phase 2: Sarilumab 200mg IV | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1: Critical ITT) | Hospitalized up to Day 8 | 7.4 days | Standard Deviation 1.3 |
| Phase 2: Sarilumab 200mg IV | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1: Critical ITT) | Hospitalized up to Day 22 | 21.1 days | Standard Deviation 1.8 |
| Phase 2: Sarilumab 200mg IV | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1: Critical ITT) | Hospitalized up to Day 15 | 13.8 days | Standard Deviation 1.9 |
| Phase 2: Sarilumab 400mg IV | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1: Critical ITT) | Hospitalized up to Day 29 | 28.1 days | Standard Deviation 1.8 |
| Phase 2: Sarilumab 400mg IV | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1: Critical ITT) | Hospitalized up to Day 15 | 13.8 days | Standard Deviation 2 |
| Phase 2: Sarilumab 400mg IV | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1: Critical ITT) | Hospitalized up to Day 22 | 21.2 days | Standard Deviation 1.7 |
| Phase 2: Sarilumab 400mg IV | Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1: Critical ITT) | Hospitalized up to Day 8 | 7.6 days | Standard Deviation 1.1 |
Comparison: Hospitalized up to Day 8p-value: 0.372495% CI: [-0.4, 0.2]t-test, 2 sided
Comparison: Hospitalized up to Day 8p-value: 0.703495% CI: [-0.2, 0.3]t-test, 2 sided
Comparison: Hospitalized up to Day 15p-value: 0.584195% CI: [-0.4, 0.7]t-test, 2 sided
Comparison: Hospitalized up to Day 15p-value: 0.664895% CI: [-0.4, 0.6]t-test, 2 sided
Comparison: Hospitalized up to Day 22p-value: 0.462495% CI: [-0.4, 1]t-test, 2 sided
Comparison: Hospitalized up to Day 22p-value: 0.254695% CI: [-0.3, 1]t-test, 2 sided
Comparison: Hospitalized up to Day 29p-value: 0.531295% CI: [-1, 0.5]t-test, 2 sided
Comparison: Hospitalized up to Day 29p-value: 0.303995% CI: [-1.1, 0.3]t-test, 2 sided
Secondary
Number of Days of Resting Respiratory Rate >24 Breaths/Min (Phase 2)
Time frame: Up to day 29
Population: Phase 2 ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Placebo | Number of Days of Resting Respiratory Rate >24 Breaths/Min (Phase 2) | 9.2 Days | Standard Deviation 10.29 |
| Phase 2: Sarilumab 200mg IV | Number of Days of Resting Respiratory Rate >24 Breaths/Min (Phase 2) | 7.3 Days | Standard Deviation 8.21 |
| Phase 2: Sarilumab 400mg IV | Number of Days of Resting Respiratory Rate >24 Breaths/Min (Phase 2) | 8.2 Days | Standard Deviation 7.99 |
Secondary
Number of Days of Supplemental Oxygen Use (Phase 2)
Time frame: Up to day 29
Population: Phase 2 ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Placebo | Number of Days of Supplemental Oxygen Use (Phase 2) | 17.7 days | Standard Deviation 14.15 |
| Phase 2: Sarilumab 200mg IV | Number of Days of Supplemental Oxygen Use (Phase 2) | 14.1 days | Standard Deviation 11.92 |
| Phase 2: Sarilumab 400mg IV | Number of Days of Supplemental Oxygen Use (Phase 2) | 16.2 days | Standard Deviation 14.02 |
Secondary
Number of Days With Fever (Phase 2)
Defined as ≥38°C (oral), ≥38.4°C (rectal or tympanic) or ≥37.6°C (temporal or axillary)
Time frame: Up to Day 29
Population: Phase 2 ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Placebo | Number of Days With Fever (Phase 2) | 6.3 Days | Standard Deviation 5.92 |
| Phase 2: Sarilumab 200mg IV | Number of Days With Fever (Phase 2) | 4.2 Days | Standard Deviation 4.37 |
| Phase 2: Sarilumab 400mg IV | Number of Days With Fever (Phase 2) | 5.8 Days | Standard Deviation 7.49 |
Secondary
Number of Days With Hypoxemia (Phase 2)
Time frame: Up to day 29
Population: Phase 2 ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Placebo | Number of Days With Hypoxemia (Phase 2) | 18.1 Days | Standard Deviation 14.16 |
| Phase 2: Sarilumab 200mg IV | Number of Days With Hypoxemia (Phase 2) | 14.5 Days | Standard Deviation 11.96 |
| Phase 2: Sarilumab 400mg IV | Number of Days With Hypoxemia (Phase 2) | 16.4 Days | Standard Deviation 13.94 |
Secondary
Number of Deaths Due to Any Cause
Number of deaths due to any cause (All-Cause Mortality)
Time frame: Up to day 60
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: Placebo | Number of Deaths Due to Any Cause | 24 deaths |
| Phase 2: Sarilumab 200mg IV | Number of Deaths Due to Any Cause | 60 deaths |
| Phase 2: Sarilumab 400mg IV | Number of Deaths Due to Any Cause | 49 deaths |
| Phase 3 Cohort 1: Placebo - Critical | Number of Deaths Due to Any Cause | 59 deaths |
| Phase 3 Cohort 1: 200mg IV - Critical | Number of Deaths Due to Any Cause | 70 deaths |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Number of Deaths Due to Any Cause | 114 deaths |
| Phase 3 Cohort 1: Placebo - Severe | Number of Deaths Due to Any Cause | 9 deaths |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Number of Deaths Due to Any Cause | 12 deaths |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Number of Deaths Due to Any Cause | 21 deaths |
| Phase 3 Cohort 1: Placebo - MSOD | Number of Deaths Due to Any Cause | 16 deaths |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Number of Deaths Due to Any Cause | 40 deaths |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Number of Deaths Due to Any Cause | 40 deaths |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Number of Deaths Due to Any Cause | 3 deaths |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Number of Deaths Due to Any Cause | 4 deaths |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Number of Deaths Due to Any Cause | 6 deaths |
| Phase 3 Cohort 2: Placebo | Number of Deaths Due to Any Cause | 4 deaths |
| Phase 3 Cohort 2: Sarilumab 800 mg IV | Number of Deaths Due to Any Cause | 3 deaths |
| Phase 3 Cohort 3: Placebo | Number of Deaths Due to Any Cause | 1 deaths |
| Phase 3 Cohort 3: Sarilumab 800 mg IV | Number of Deaths Due to Any Cause | 0 deaths |
Secondary
Number of Participants Who Initiated Mechanical Ventilation After Baseline (Phase 2)
Time frame: Up to Day 29
Population: Phase 2 ITT population not on Invasive mechanical ventilation or ECMO at baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2: Placebo | Number of Participants Who Initiated Mechanical Ventilation After Baseline (Phase 2) | Disease Severity: Critical | 13 Participants |
| Phase 2: Placebo | Number of Participants Who Initiated Mechanical Ventilation After Baseline (Phase 2) | Disease Severity: Severe | 2 Participants |
| Phase 2: Placebo | Number of Participants Who Initiated Mechanical Ventilation After Baseline (Phase 2) | Disease Severity: MSOD | 0 Participants |
| Phase 2: Sarilumab 200mg IV | Number of Participants Who Initiated Mechanical Ventilation After Baseline (Phase 2) | Disease Severity: Critical | 14 Participants |
| Phase 2: Sarilumab 200mg IV | Number of Participants Who Initiated Mechanical Ventilation After Baseline (Phase 2) | Disease Severity: Severe | 4 Participants |
| Phase 2: Sarilumab 200mg IV | Number of Participants Who Initiated Mechanical Ventilation After Baseline (Phase 2) | Disease Severity: MSOD | 0 Participants |
| Phase 2: Sarilumab 400mg IV | Number of Participants Who Initiated Mechanical Ventilation After Baseline (Phase 2) | Disease Severity: Severe | 9 Participants |
| Phase 2: Sarilumab 400mg IV | Number of Participants Who Initiated Mechanical Ventilation After Baseline (Phase 2) | Disease Severity: MSOD | 0 Participants |
| Phase 2: Sarilumab 400mg IV | Number of Participants Who Initiated Mechanical Ventilation After Baseline (Phase 2) | Disease Severity: Critical | 11 Participants |
Secondary
Number of Participants With Any Serious Adverse Event
Time frame: Up to day 60
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 2: Placebo | Number of Participants With Any Serious Adverse Event | 39 Participants |
| Phase 2: Sarilumab 200mg IV | Number of Participants With Any Serious Adverse Event | 90 Participants |
| Phase 2: Sarilumab 400mg IV | Number of Participants With Any Serious Adverse Event | 84 Participants |
| Phase 3 Cohort 1: Placebo - Critical | Number of Participants With Any Serious Adverse Event | 89 Participants |
| Phase 3 Cohort 1: 200mg IV - Critical | Number of Participants With Any Serious Adverse Event | 119 Participants |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Number of Participants With Any Serious Adverse Event | 183 Participants |
| Phase 3 Cohort 1: Placebo - Severe | Number of Participants With Any Serious Adverse Event | 11 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Number of Participants With Any Serious Adverse Event | 23 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Number of Participants With Any Serious Adverse Event | 30 Participants |
| Phase 3 Cohort 1: Placebo - MSOD | Number of Participants With Any Serious Adverse Event | 27 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Number of Participants With Any Serious Adverse Event | 67 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Number of Participants With Any Serious Adverse Event | 58 Participants |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Number of Participants With Any Serious Adverse Event | 3 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Number of Participants With Any Serious Adverse Event | 6 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Number of Participants With Any Serious Adverse Event | 9 Participants |
| Phase 3 Cohort 2: Placebo | Number of Participants With Any Serious Adverse Event | 10 Participants |
| Phase 3 Cohort 2: Sarilumab 800 mg IV | Number of Participants With Any Serious Adverse Event | 5 Participants |
| Phase 3 Cohort 3: Placebo | Number of Participants With Any Serious Adverse Event | 1 Participants |
| Phase 3 Cohort 3: Sarilumab 800 mg IV | Number of Participants With Any Serious Adverse Event | 1 Participants |
Secondary
Number of Participants With Gastrointestinal Perforation
Time frame: Up to day 60
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 2: Placebo | Number of Participants With Gastrointestinal Perforation | 0 Participants |
| Phase 2: Sarilumab 200mg IV | Number of Participants With Gastrointestinal Perforation | 1 Participants |
| Phase 2: Sarilumab 400mg IV | Number of Participants With Gastrointestinal Perforation | 0 Participants |
| Phase 3 Cohort 1: Placebo - Critical | Number of Participants With Gastrointestinal Perforation | 0 Participants |
| Phase 3 Cohort 1: 200mg IV - Critical | Number of Participants With Gastrointestinal Perforation | 1 Participants |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Number of Participants With Gastrointestinal Perforation | 0 Participants |
| Phase 3 Cohort 1: Placebo - Severe | Number of Participants With Gastrointestinal Perforation | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Number of Participants With Gastrointestinal Perforation | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Number of Participants With Gastrointestinal Perforation | 0 Participants |
| Phase 3 Cohort 1: Placebo - MSOD | Number of Participants With Gastrointestinal Perforation | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Number of Participants With Gastrointestinal Perforation | 1 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Number of Participants With Gastrointestinal Perforation | 0 Participants |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Number of Participants With Gastrointestinal Perforation | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Number of Participants With Gastrointestinal Perforation | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Number of Participants With Gastrointestinal Perforation | 0 Participants |
| Phase 3 Cohort 2: Placebo | Number of Participants With Gastrointestinal Perforation | 0 Participants |
| Phase 3 Cohort 2: Sarilumab 800 mg IV | Number of Participants With Gastrointestinal Perforation | 0 Participants |
| Phase 3 Cohort 3: Placebo | Number of Participants With Gastrointestinal Perforation | 0 Participants |
| Phase 3 Cohort 3: Sarilumab 800 mg IV | Number of Participants With Gastrointestinal Perforation | 0 Participants |
Secondary
Number of Participants With Grade >=2 Hypersensitivity Reactions
Time frame: Up to day 60
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 2: Placebo | Number of Participants With Grade >=2 Hypersensitivity Reactions | 0 Participants |
| Phase 2: Sarilumab 200mg IV | Number of Participants With Grade >=2 Hypersensitivity Reactions | 0 Participants |
| Phase 2: Sarilumab 400mg IV | Number of Participants With Grade >=2 Hypersensitivity Reactions | 0 Participants |
| Phase 3 Cohort 1: Placebo - Critical | Number of Participants With Grade >=2 Hypersensitivity Reactions | 1 Participants |
| Phase 3 Cohort 1: 200mg IV - Critical | Number of Participants With Grade >=2 Hypersensitivity Reactions | 1 Participants |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Number of Participants With Grade >=2 Hypersensitivity Reactions | 0 Participants |
| Phase 3 Cohort 1: Placebo - Severe | Number of Participants With Grade >=2 Hypersensitivity Reactions | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Number of Participants With Grade >=2 Hypersensitivity Reactions | 1 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Number of Participants With Grade >=2 Hypersensitivity Reactions | 0 Participants |
| Phase 3 Cohort 1: Placebo - MSOD | Number of Participants With Grade >=2 Hypersensitivity Reactions | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Number of Participants With Grade >=2 Hypersensitivity Reactions | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Number of Participants With Grade >=2 Hypersensitivity Reactions | 0 Participants |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Number of Participants With Grade >=2 Hypersensitivity Reactions | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Number of Participants With Grade >=2 Hypersensitivity Reactions | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Number of Participants With Grade >=2 Hypersensitivity Reactions | 0 Participants |
| Phase 3 Cohort 2: Placebo | Number of Participants With Grade >=2 Hypersensitivity Reactions | 0 Participants |
| Phase 3 Cohort 2: Sarilumab 800 mg IV | Number of Participants With Grade >=2 Hypersensitivity Reactions | 0 Participants |
| Phase 3 Cohort 3: Placebo | Number of Participants With Grade >=2 Hypersensitivity Reactions | 0 Participants |
| Phase 3 Cohort 3: Sarilumab 800 mg IV | Number of Participants With Grade >=2 Hypersensitivity Reactions | 0 Participants |
Secondary
Number of Participants With Grade >=2 Infusion Related Reactions
Time frame: Up to day 60
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 2: Placebo | Number of Participants With Grade >=2 Infusion Related Reactions | 0 Participants |
| Phase 2: Sarilumab 200mg IV | Number of Participants With Grade >=2 Infusion Related Reactions | 0 Participants |
| Phase 2: Sarilumab 400mg IV | Number of Participants With Grade >=2 Infusion Related Reactions | 1 Participants |
| Phase 3 Cohort 1: Placebo - Critical | Number of Participants With Grade >=2 Infusion Related Reactions | 1 Participants |
| Phase 3 Cohort 1: 200mg IV - Critical | Number of Participants With Grade >=2 Infusion Related Reactions | 2 Participants |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Number of Participants With Grade >=2 Infusion Related Reactions | 6 Participants |
| Phase 3 Cohort 1: Placebo - Severe | Number of Participants With Grade >=2 Infusion Related Reactions | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Number of Participants With Grade >=2 Infusion Related Reactions | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Number of Participants With Grade >=2 Infusion Related Reactions | 2 Participants |
| Phase 3 Cohort 1: Placebo - MSOD | Number of Participants With Grade >=2 Infusion Related Reactions | 1 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Number of Participants With Grade >=2 Infusion Related Reactions | 2 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Number of Participants With Grade >=2 Infusion Related Reactions | 2 Participants |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Number of Participants With Grade >=2 Infusion Related Reactions | 1 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Number of Participants With Grade >=2 Infusion Related Reactions | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Number of Participants With Grade >=2 Infusion Related Reactions | 0 Participants |
| Phase 3 Cohort 2: Placebo | Number of Participants With Grade >=2 Infusion Related Reactions | 1 Participants |
| Phase 3 Cohort 2: Sarilumab 800 mg IV | Number of Participants With Grade >=2 Infusion Related Reactions | 0 Participants |
| Phase 3 Cohort 3: Placebo | Number of Participants With Grade >=2 Infusion Related Reactions | 0 Participants |
| Phase 3 Cohort 3: Sarilumab 800 mg IV | Number of Participants With Grade >=2 Infusion Related Reactions | 1 Participants |
Secondary
Number of Participants With Grade 4 Neutropenia (ANC <500/mm3)
Grade 4 Neutropenia defined as Absolute Neutrophil Count (ANC) of less than 500 per cubic millimeter(mm3)
Time frame: Up to day 60
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 2: Placebo | Number of Participants With Grade 4 Neutropenia (ANC <500/mm3) | 0 Participants |
| Phase 2: Sarilumab 200mg IV | Number of Participants With Grade 4 Neutropenia (ANC <500/mm3) | 1 Participants |
| Phase 2: Sarilumab 400mg IV | Number of Participants With Grade 4 Neutropenia (ANC <500/mm3) | 1 Participants |
| Phase 3 Cohort 1: Placebo - Critical | Number of Participants With Grade 4 Neutropenia (ANC <500/mm3) | 0 Participants |
| Phase 3 Cohort 1: 200mg IV - Critical | Number of Participants With Grade 4 Neutropenia (ANC <500/mm3) | 2 Participants |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Number of Participants With Grade 4 Neutropenia (ANC <500/mm3) | 1 Participants |
| Phase 3 Cohort 1: Placebo - Severe | Number of Participants With Grade 4 Neutropenia (ANC <500/mm3) | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Number of Participants With Grade 4 Neutropenia (ANC <500/mm3) | 1 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Number of Participants With Grade 4 Neutropenia (ANC <500/mm3) | 2 Participants |
| Phase 3 Cohort 1: Placebo - MSOD | Number of Participants With Grade 4 Neutropenia (ANC <500/mm3) | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Number of Participants With Grade 4 Neutropenia (ANC <500/mm3) | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Number of Participants With Grade 4 Neutropenia (ANC <500/mm3) | 2 Participants |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Number of Participants With Grade 4 Neutropenia (ANC <500/mm3) | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Number of Participants With Grade 4 Neutropenia (ANC <500/mm3) | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Number of Participants With Grade 4 Neutropenia (ANC <500/mm3) | 1 Participants |
| Phase 3 Cohort 2: Placebo | Number of Participants With Grade 4 Neutropenia (ANC <500/mm3) | 0 Participants |
| Phase 3 Cohort 2: Sarilumab 800 mg IV | Number of Participants With Grade 4 Neutropenia (ANC <500/mm3) | 1 Participants |
| Phase 3 Cohort 3: Placebo | Number of Participants With Grade 4 Neutropenia (ANC <500/mm3) | 0 Participants |
| Phase 3 Cohort 3: Sarilumab 800 mg IV | Number of Participants With Grade 4 Neutropenia (ANC <500/mm3) | 0 Participants |
Secondary
Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection
Time frame: Up to day 60
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 2: Placebo | Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection | 0 Participants |
| Phase 2: Sarilumab 200mg IV | Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection | 0 Participants |
| Phase 2: Sarilumab 400mg IV | Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection | 0 Participants |
| Phase 3 Cohort 1: Placebo - Critical | Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection | 0 Participants |
| Phase 3 Cohort 1: 200mg IV - Critical | Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection | 0 Participants |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection | 0 Participants |
| Phase 3 Cohort 1: Placebo - Severe | Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection | 0 Participants |
| Phase 3 Cohort 1: Placebo - MSOD | Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection | 0 Participants |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection | 0 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection | 0 Participants |
| Phase 3 Cohort 2: Placebo | Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection | 0 Participants |
| Phase 3 Cohort 2: Sarilumab 800 mg IV | Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection | 0 Participants |
| Phase 3 Cohort 3: Placebo | Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection | 0 Participants |
| Phase 3 Cohort 3: Sarilumab 800 mg IV | Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection | 0 Participants |
Secondary
Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection
Time frame: Up to day 60
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 2: Placebo | Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection | 14 Participants |
| Phase 2: Sarilumab 200mg IV | Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection | 17 Participants |
| Phase 2: Sarilumab 400mg IV | Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection | 25 Participants |
| Phase 3 Cohort 1: Placebo - Critical | Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection | 36 Participants |
| Phase 3 Cohort 1: 200mg IV - Critical | Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection | 53 Participants |
| Phase 3 Cohort 1:Sarilumab 400mg IV - Critical | Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection | 72 Participants |
| Phase 3 Cohort 1: Placebo - Severe | Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection | 2 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Severe | Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection | 2 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Severe | Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection | 10 Participants |
| Phase 3 Cohort 1: Placebo - MSOD | Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection | 16 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD | Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection | 30 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD | Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection | 28 Participants |
| Phase 3 Cohort 1: Placebo - Immunocompromised | Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection | 1 Participants |
| Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised | Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection | 4 Participants |
| Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised | Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection | 3 Participants |
| Phase 3 Cohort 2: Placebo | Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection | 3 Participants |
| Phase 3 Cohort 2: Sarilumab 800 mg IV | Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection | 4 Participants |
| Phase 3 Cohort 3: Placebo | Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection | 1 Participants |
| Phase 3 Cohort 3: Sarilumab 800 mg IV | Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection | 1 Participants |
Secondary
Number of Ventilator Free Days (Phase 2)
Summary of Ventilator-free days during study in Participants using Invasive Mechanical Ventilation at Baseline
Time frame: Up to Day 22
Population: Phase 2 ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Number of Ventilator Free Days (Phase 2) | Disease Severity: Critical | 8.9 Days | Standard Deviation 9.6 |
| Phase 2: Placebo | Number of Ventilator Free Days (Phase 2) | Disease Severity: Severe | 19.9 Days | Standard Deviation 4.2 |
| Phase 2: Placebo | Number of Ventilator Free Days (Phase 2) | Disease Severity: MSOD | 4.5 Days | Standard Deviation 5.5 |
| Phase 2: Sarilumab 200mg IV | Number of Ventilator Free Days (Phase 2) | Disease Severity: Critical | 7.6 Days | Standard Deviation 8.5 |
| Phase 2: Sarilumab 200mg IV | Number of Ventilator Free Days (Phase 2) | Disease Severity: Severe | 19.7 Days | Standard Deviation 4.7 |
| Phase 2: Sarilumab 200mg IV | Number of Ventilator Free Days (Phase 2) | Disease Severity: MSOD | 4.6 Days | Standard Deviation 6.5 |
| Phase 2: Sarilumab 400mg IV | Number of Ventilator Free Days (Phase 2) | Disease Severity: Severe | 15.5 Days | Standard Deviation 9.1 |
| Phase 2: Sarilumab 400mg IV | Number of Ventilator Free Days (Phase 2) | Disease Severity: MSOD | 3.3 Days | Standard Deviation 5.1 |
| Phase 2: Sarilumab 400mg IV | Number of Ventilator Free Days (Phase 2) | Disease Severity: Critical | 10.9 Days | Standard Deviation 9.3 |
Secondary
Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical ITT)
Number of Ventilator-Free days up to Day 29 (Phase 3 Cohort 1)
Time frame: Days 8, 15, 22 and 29
Population: Phase 3 Cohort 1: Critical ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical ITT) | Ventilator-free days up to Day 8 | 3.6 days | Standard Deviation 3.3 |
| Phase 2: Placebo | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical ITT) | Ventilator-free days up to Day 15 | 7.2 days | Standard Deviation 6.5 |
| Phase 2: Placebo | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical ITT) | Ventilator-free days up to Day 22 | 11.1 days | Standard Deviation 9.7 |
| Phase 2: Placebo | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical ITT) | Ventilator-free days up to Day 29 | 15.3 days | Standard Deviation 12.8 |
| Phase 2: Sarilumab 200mg IV | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical ITT) | Ventilator-free days up to Day 29 | 15.5 days | Standard Deviation 12.4 |
| Phase 2: Sarilumab 200mg IV | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical ITT) | Ventilator-free days up to Day 8 | 3.5 days | Standard Deviation 3.3 |
| Phase 2: Sarilumab 200mg IV | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical ITT) | Ventilator-free days up to Day 22 | 11.3 days | Standard Deviation 9.4 |
| Phase 2: Sarilumab 200mg IV | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical ITT) | Ventilator-free days up to Day 15 | 7.2 days | Standard Deviation 6.4 |
| Phase 2: Sarilumab 400mg IV | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical ITT) | Ventilator-free days up to Day 29 | 13.9 days | Standard Deviation 12.5 |
| Phase 2: Sarilumab 400mg IV | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical ITT) | Ventilator-free days up to Day 15 | 6.4 days | Standard Deviation 6.4 |
| Phase 2: Sarilumab 400mg IV | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical ITT) | Ventilator-free days up to Day 22 | 9.9 days | Standard Deviation 9.4 |
| Phase 2: Sarilumab 400mg IV | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical ITT) | Ventilator-free days up to Day 8 | 3.2 days | Standard Deviation 3.3 |
Comparison: Ventilator-free days up to Day 8p-value: 0.56495% CI: [-0.8, 0.5]t-test, 2 sided
Comparison: Ventilator-free days up to Day 8p-value: 0.160295% CI: [-1, 0.2]t-test, 2 sided
Comparison: Ventilator-free days up to Day 15p-value: 0.914495% CI: [-1.3, 1.2]t-test, 2 sided
Comparison: Ventilator-free days up to Day 15p-value: 0.14595% CI: [-2.1, 0.3]t-test, 2 sided
Comparison: Ventilator-free days up to Day 22p-value: 0.837895% CI: [-1.7, 2.1]t-test, 2 sided
Comparison: Ventilator-free days up to Day 22p-value: 0.198895% CI: [-2.9, 0.6]t-test, 2 sided
Comparison: Ventilator-free days up to Day 29p-value: 0.855695% CI: [-2.2, 2.7]t-test, 2 sided
Comparison: Ventilator-free days up to Day 29p-value: 0.26395% CI: [-3.7, 1]t-test, 2 sided
Secondary
Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Number of Ventilator-Free days up to Day 29 (Phase 3 Cohort 1)
Time frame: Days 8, 15, 22 and 29
Population: Phase 3 Cohort 1: Critical population receiving mechanical ventilation at baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Placebo | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Ventilator-free days up to Day 8 | 0.6 days | Standard Deviation 1.4 |
| Phase 2: Placebo | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Ventilator-free days up to Day 15 | 2.2 days | Standard Deviation 4 |
| Phase 2: Placebo | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Ventilator-free days up to Day 22 | 4.3 days | Standard Deviation 6.8 |
| Phase 2: Placebo | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Ventilator-free days up to Day 29 | 6.9 days | Standard Deviation 9.9 |
| Phase 2: Sarilumab 200mg IV | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Ventilator-free days up to Day 29 | 8.7 days | Standard Deviation 10.4 |
| Phase 2: Sarilumab 200mg IV | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Ventilator-free days up to Day 8 | 0.8 days | Standard Deviation 1.7 |
| Phase 2: Sarilumab 200mg IV | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Ventilator-free days up to Day 22 | 5.5 days | Standard Deviation 7.3 |
| Phase 2: Sarilumab 200mg IV | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Ventilator-free days up to Day 15 | 2.8 days | Standard Deviation 4.4 |
| Phase 2: Sarilumab 400mg IV | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Ventilator-free days up to Day 29 | 8.0 days | Standard Deviation 9.6 |
| Phase 2: Sarilumab 400mg IV | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Ventilator-free days up to Day 15 | 2.2 days | Standard Deviation 3.7 |
| Phase 2: Sarilumab 400mg IV | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Ventilator-free days up to Day 22 | 4.8 days | Standard Deviation 6.6 |
| Phase 2: Sarilumab 400mg IV | Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Ventilator-free days up to Day 8 | 0.4 days | Standard Deviation 1.2 |
Comparison: Ventilator-free days up to Day 8p-value: 0.280495% CI: [-0.2, 0.8]t-test, 2 sided
Comparison: Ventilator-free days up to Day 8p-value: 0.502395% CI: [-0.5, 0.3]t-test, 2 sided
Comparison: Ventilator-free days up to Day 15p-value: 0.382195% CI: [-0.7, 1.9]t-test, 2 sided
Comparison: Ventilator-free days up to Day 15p-value: 0.973795% CI: [-1.2, 1.1]t-test, 2 sided
Comparison: Ventilator-free days up to Day 22p-value: 0.317995% CI: [-1.1, 3.4]t-test, 2 sided
Comparison: Ventilator-free days up to Day 22p-value: 0.630295% CI: [-1.5, 2.5]t-test, 2 sided
Comparison: Ventilator-free days up to Day 29p-value: 0.286295% CI: [-1.5, 5]t-test, 2 sided
Comparison: Ventilator-free days up to Day 29p-value: 0.450995% CI: [-1.8, 4.1]t-test, 2 sided
Secondary
Percentage of Participants Alive Not Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical ITT)
Percentage of participants alive not receiving mechanical ventilation or ECMO at Day 22 (Phase 3 Cohort 1)
Time frame: At Day 22
Population: Phase 3 Cohort 1: Critical ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: Placebo | Percentage of Participants Alive Not Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical ITT) | 58.8 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants Alive Not Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical ITT) | 63.6 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants Alive Not Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical ITT) | 55.9 Percentage of Participants |
p-value: 0.289695% CI: [-4.3, 14.7]Cochran-Mantel-Haenszel
p-value: 0.535595% CI: [-11.8, 6.2]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Alive Not Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Percentage of participants alive not receiving mechanical ventilation or ECMO at Day 22 (Phase 3 Cohort 1)
Time frame: At Day 22
Population: Phase 3 Cohort 1 - Critical population receiving mechanical ventilation at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: Placebo | Percentage of Participants Alive Not Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | 35.5 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants Alive Not Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | 46.2 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants Alive Not Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | 44.7 Percentage of Participants |
p-value: 0.220395% CI: [-6, 24.3]Cochran-Mantel-Haenszel
p-value: 0.248395% CI: [-6.1, 22.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Alive, Off Oxygen (Phase 2)
Time frame: At Day 29
Population: Phase 2 ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 2: Placebo | Percentage of Participants Alive, Off Oxygen (Phase 2) | Disease Severity: Critical | 40.9 percentage of participants |
| Phase 2: Placebo | Percentage of Participants Alive, Off Oxygen (Phase 2) | Disease Severity: Severe | 92.0 percentage of participants |
| Phase 2: Placebo | Percentage of Participants Alive, Off Oxygen (Phase 2) | Disease Severity: MSOD | 38.1 percentage of participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants Alive, Off Oxygen (Phase 2) | Disease Severity: Critical | 50.0 percentage of participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants Alive, Off Oxygen (Phase 2) | Disease Severity: Severe | 92.0 percentage of participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants Alive, Off Oxygen (Phase 2) | Disease Severity: MSOD | 39.5 percentage of participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants Alive, Off Oxygen (Phase 2) | Disease Severity: Severe | 70.6 percentage of participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants Alive, Off Oxygen (Phase 2) | Disease Severity: MSOD | 34.1 percentage of participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants Alive, Off Oxygen (Phase 2) | Disease Severity: Critical | 61.4 percentage of participants |
Comparison: Disease Severity: Severep-value: 1Chi-squared
Comparison: Disease Severity: Severep-value: 0.0353Chi-squared
Comparison: Disease Severity: Criticalp-value: 0.3187Chi-squared
Comparison: Disease Severity: Criticalp-value: 0.0261Chi-squared
Comparison: Disease Severity: MSODp-value: 0.9117Chi-squared
Comparison: Disease Severity: MSODp-value: 0.7584Chi-squared
Secondary
Percentage of Participants Discharged and Alive at Day 22 (Phase 3 Cohort 1: Critical ITT)
Percentage of Participants Discharged and Alive at Day 22
Time frame: At Day 22
Population: Phase 3 Cohort 1: Critical ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: Placebo | Percentage of Participants Discharged and Alive at Day 22 (Phase 3 Cohort 1: Critical ITT) | 47.6 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants Discharged and Alive at Day 22 (Phase 3 Cohort 1: Critical ITT) | 47.5 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants Discharged and Alive at Day 22 (Phase 3 Cohort 1: Critical ITT) | 42.6 Percentage of Participants |
p-value: 0.934395% CI: [-9.3, 10.1]Cochran-Mantel-Haenszel
p-value: 0.282295% CI: [-14.1, 4.1]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Percentage of participants in each clinical status category using the 7-point ordinal scale from Baseline (Day 1) up to Day 29. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: Phase 2 ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 7 | 92.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 7 | 40.9 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 1 | 33.3 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 2 | 40.9 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 4 | 9.5 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 3 | 9.1 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 4 | 4.5 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 4 | 50.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 3 | 4.8 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 2 | 27.3 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 7 | 31.8 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 2 | 8.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 2 | 59.1 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 2 | 66.7 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 4 | 13.6 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 3 | 9.1 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 4 | 31.8 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 7 | 4.8 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 2 | 36.4 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 1 | 18.2 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 4 | 72.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 2 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 7 | 25.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = Missing | 4.8 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 2 | 52.3 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 4 | 20.5 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 3 | 11.4 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 4 | 96.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 4 | 34.1 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 2 | 45.5 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 5 | 2.3 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 4 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 1 | 9.1 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 7 | 16.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 7 | 13.6 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 3 | 9.5 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 1 | 6.8 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 2 | 43.2 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 4 | 29.5 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 3 | 6.8 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 2 | 8.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 2 | 71.4 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 3 | 4.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 1 | 19.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 4 | 48.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 4 | 100 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 7 | 40.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 4 | 9.5 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 1 | 19.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 4 | 33.3 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 2 | 8.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 4 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 7 | 33.3 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 4 | 32.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 2 | 90.5 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 5 | 4.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 1 | 9.5 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 7 | 56.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 2 | 38.1 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 2 | 4.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = Missing | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 4 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 2 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 4 | 16.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 5 | 4.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 1 | 23.8 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 2 | 100 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 3 | 4.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 7 | 76.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 2 | 19.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 2 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 1 | 27.3 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 4 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 4 | 8.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 6 | 4.0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 2 | 100 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 2 | 4.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 2 | 6.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 6 | 2.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 7 | 14.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 4 | 6.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 1 | 9.6 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 1 | 25.6 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 2 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 3 | 2.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 4 | 94.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 5 | 4.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 3 | 6.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 4 | 88.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 5 | 2.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 3 | 8.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 4 | 66.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 5 | 4.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 1 | 2.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 2 | 4.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 3 | 8.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 4 | 34.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 5 | 6.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 7 | 46.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 1 | 2.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 2 | 4.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 3 | 6.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 4 | 14.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 7 | 74.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 1 | 4.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 2 | 2.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 3 | 2.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 7 | 86.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 1 | 4.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 2 | 2.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 4 | 2.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 7 | 92.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 2 | 64.9 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 3 | 6.4 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 4 | 28.7 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 1 | 3.2 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 2 | 71.3 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 3 | 6.4 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 4 | 19.1 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = Missing | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 2 | 64.9 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 3 | 8.5 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 4 | 14.9 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 7 | 2.1 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 1 | 20.2 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 2 | 50.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 3 | 5.3 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 4 | 16.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 5 | 1.1 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 7 | 7.4 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 1 | 21.3 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 2 | 41.5 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 3 | 6.4 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 4 | 11.7 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 5 | 2.1 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 7 | 17.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 1 | 27.7 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 2 | 24.5 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 3 | 3.2 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 4 | 19.1 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 5 | 3.2 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 6 | 1.1 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 7 | 21.3 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 1 | 37.2 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 2 | 7.4 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 3 | 2.1 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 4 | 4.3 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 5 | 2.1 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 7 | 46.8 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 2 | 100 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 4 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 1 | 4.7 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 2 | 95.3 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 4 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 1 | 9.3 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 2 | 88.4 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 4 | 2.3 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 1 | 14.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 2 | 69.8 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 4 | 14.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 5 | 2.3 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 2 | 46.5 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 3 | 4.7 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 4 | 11.6 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 5 | 4.7 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 6 | 2.3 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 7 | 4.7 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 1 | 34.9 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 2 | 34.9 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 3 | 2.3 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 4 | 2.3 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 5 | 7.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 7 | 18.6 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 1 | 41.9 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 2 | 14.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 3 | 2.3 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 4 | 2.3 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 5 | 7.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 6 | 4.7 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 7 | 27.9 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = Missing | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 7 | 56.8 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 3 | 5.9 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 3 | 4.9 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 2 | 100 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 4 | 2.0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 7 | 2.4 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 3 | 2.0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 2 | 13.7 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 4 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 2 | 7.8 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 1 | 17.6 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 1 | 31.7 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 7 | 68.6 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 1 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = Missing | 1.1 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 1 | 2.4 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 2 | 51.2 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 2 | 97.6 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 4 | 5.9 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 2 | 9.8 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 4 | 9.8 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 4 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 15 Ordinal Scale = 1 | 15.7 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 7 | 60.8 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 4 | 88.2 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 3 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 5 | 2.0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 5 | 2.0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 1 | 14.6 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 4 | 9.8 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 4 | 9.8 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 2 | 82.9 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 3 | 3.9 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 3 | 3.9 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 2 | 11.8 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 7 | 22.0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 4 | 2.4 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 11 Ordinal Scale = 1 | 11.8 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 7 | 43.1 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 2 | 7.8 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 4 | 29.4 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 5 | 9.8 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 5 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 3 | 5.9 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 1 | 19.5 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 2 | 19.6 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 1 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 2 | 75.6 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 7 | 11.8 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 1 | 26.8 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 8 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 6 | 2.0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 3 | 1.1 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 2 | 46.6 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 15 Ordinal Scale = 7 | 7.3 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 4 | 27.3 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 1 | 9.1 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 4 | 4.9 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 7 | 2.3 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 5 | 11.8 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 6 | 2.4 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 8 Ordinal Scale = 7 | 15.9 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 5 | 2.3 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 1 | 11.4 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 4 | 28.4 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 4 | 49.0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 2 | 37.5 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 3 | 9.1 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 3 | 2.3 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 2 | 53.4 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 4 | 19.3 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 5 Ordinal Scale = 1 | 4.5 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 3 | 3.9 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 5 | 2.3 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = Missing | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 1 | 39.0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 6 | 1.1 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 7 | 1.1 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 8 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 11 Ordinal Scale = 7 | 26.1 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 5 | 1.1 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 2 | 21.6 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 1 | 13.6 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 4 | 28.4 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 6 | 1.1 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 2 | 29.5 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 3 | 10.2 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 2 | 61.0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 3 | 1.1 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 2 | 56.8 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 7 | 3.9 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 4 | 14.8 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 1 | 1.1 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 5 | 1.1 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 7 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 15 Ordinal Scale = 7 | 38.6 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 29 Ordinal Scale = 2 | 14.6 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 1 | 25.0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 4 | 7.3 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 2 | 5.7 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 4 | 38.6 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 5 | 3.9 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 3 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 3 | 6.8 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 3 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 4 | 9.1 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 2 | 54.5 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: MSOD Day 11 Ordinal Scale = 5 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 5 | 3.4 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 1 Ordinal Scale = 1 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 3 Ordinal Scale = 4 | 72.5 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Critical Day 29 Ordinal Scale = 6 | 0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 29 Ordinal Scale = 7 | 70.6 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2) | Disease Severity: Severe Day 5 Ordinal Scale = 1 | 0 Percentage of Participants |
Secondary
Percentage of Participants Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical ITT)
Time frame: Day 22
Population: Phase 3 Cohort 1: Critical ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: Placebo | Percentage of Participants Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical ITT) | 17.1 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical ITT) | 15.7 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical ITT) | 17.5 Percentage of Participants |
p-value: 0.685895% CI: [-9.1, 5.6]Cochran-Mantel-Haenszel
p-value: 0.917395% CI: [-7, 7]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Time frame: Day 22
Population: Phase 3 Cohort 1: Critical population receiving mechanical ventilation at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: Placebo | Percentage of Participants Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | 25.8 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | 24.0 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | 23.5 Percentage of Participants |
p-value: 0.886495% CI: [-15.2, 12.1]Cochran-Mantel-Haenszel
p-value: 0.7595% CI: [-15.8, 10.1]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Die (Phase 3 Cohort 1: Critical ITT)
Percentage of Participants who die through Day 29 and Day 60
Time frame: Up to Day 29 and Day 60
Population: Phase 3 Cohort 1 Critical ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 2: Placebo | Percentage of Participants Who Die (Phase 3 Cohort 1: Critical ITT) | Through Day 29 | 25.3 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants Who Die (Phase 3 Cohort 1: Critical ITT) | Through Day 60 | 34.7 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants Who Die (Phase 3 Cohort 1: Critical ITT) | Through Day 29 | 24.8 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants Who Die (Phase 3 Cohort 1: Critical ITT) | Through Day 60 | 28.9 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants Who Die (Phase 3 Cohort 1: Critical ITT) | Through Day 29 | 30.5 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants Who Die (Phase 3 Cohort 1: Critical ITT) | Through Day 60 | 33.7 Percentage of Participants |
Comparison: Through Day 29p-value: 0.884495% CI: [-9.3, 7.7]Cochran-Mantel-Haenszel
Comparison: Through Day 29p-value: 0.224795% CI: [-3.3, 13]Cochran-Mantel-Haenszel
Comparison: Through Day 60p-value: 0.210295% CI: [-28.2, 2.3]Cochran-Mantel-Haenszel
Comparison: Through Day 60p-value: 0.829295% CI: [-26.4, 2.9]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Die (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Percentage of Participants who die through Day 29 and Day 60
Time frame: Up to Day 29 and Day 60
Population: Phase 3 Cohort 1 Critical population receiving mechanical ventilation at baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 2: Placebo | Percentage of Participants Who Die (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Through Day 29 | 41.9 Percentage of Participants |
| Phase 2: Placebo | Percentage of Participants Who Die (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Through Day 60 | 51.6 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants Who Die (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Through Day 29 | 33.7 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants Who Die (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Through Day 60 | 37.5 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants Who Die (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Through Day 29 | 36.4 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants Who Die (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | Through Day 60 | 39.4 Percentage of Participants |
Comparison: Through Day 29p-value: 0.321795% CI: [-22.8, 7.2]Cochran-Mantel-Haenszel
Comparison: Through Day 29p-value: 0.46395% CI: [-20.2, 8.7]Cochran-Mantel-Haenszel
Comparison: Through Day 60p-value: 0.097195% CI: [-28.2, 2.3]Cochran-Mantel-Haenszel
Comparison: Through Day 60p-value: 0.119395% CI: [-26.4, 2.9]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Recover (Phase 3 Cohort 1: Critical ITT)
Percentage of Participants Who Recover (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use) at Day 22
Time frame: Day 22
Population: Phase 3 Cohort 1 Critical ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: Placebo | Percentage of Participants Who Recover (Phase 3 Cohort 1: Critical ITT) | 50.0 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants Who Recover (Phase 3 Cohort 1: Critical ITT) | 49.6 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants Who Recover (Phase 3 Cohort 1: Critical ITT) | 45.3 Percentage of Participants |
p-value: 0.969695% CI: [-9.5, 9.9]Cochran-Mantel-Haenszel
p-value: 0.315295% CI: [-13.8, 4.4]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Recover (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Percentage of Participants Who Recover (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use) at Day 22
Time frame: Day 22
Population: Phase 3 Cohort 1 Critical population receiving mechanical ventilation at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: Placebo | Percentage of Participants Who Recover (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | 25.8 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants Who Recover (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | 30.8 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants Who Recover (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | 31.8 Percentage of Participants |
p-value: 0.477795% CI: [-9.4, 18.6]Cochran-Mantel-Haenszel
p-value: 0.420295% CI: [-8.4, 18.2]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least 1-point Improvement in Clinical Status Using the 7-point Ordinal Scale in Participants With Critical COVID-19 (Phase 3 Cohort 1: Critical ITT)
The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Time frame: Day 22
Population: Phase 3 Cohort 1 Critical ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: Placebo | Percentage of Participants With at Least 1-point Improvement in Clinical Status Using the 7-point Ordinal Scale in Participants With Critical COVID-19 (Phase 3 Cohort 1: Critical ITT) | 54.1 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants With at Least 1-point Improvement in Clinical Status Using the 7-point Ordinal Scale in Participants With Critical COVID-19 (Phase 3 Cohort 1: Critical ITT) | 56.6 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants With at Least 1-point Improvement in Clinical Status Using the 7-point Ordinal Scale in Participants With Critical COVID-19 (Phase 3 Cohort 1: Critical ITT) | 51.5 Percentage of Participants |
p-value: 0.585195% CI: [-7, 12.4]Cochran-Mantel-Haenszel
p-value: 0.576795% CI: [-11.7, 6.5]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least a 2-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT)
Percentage of participants with at least a 2-point improvement in clinical status from baseline to Day 22 using the 7-point ordinal scale. The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Time frame: At Day 22
Population: Phase 3 Cohort 1: Critical ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: Placebo | Percentage of Participants With at Least a 2-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT) | 52.4 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants With at Least a 2-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT) | 52.5 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants With at Least a 2-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT) | 47.6 Percentage of Participants |
p-value: 0.92195% CI: [-9.2, 10.2]Cochran-Mantel-Haenszel
p-value: 0.317495% CI: [-13.8, 4.5]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least a 2-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Percentage of participants with at least a 2-point improvement in clinical status from baseline to Day 22 using the 7-point ordinal scale. The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Time frame: At Day 22
Population: Phase 3 Cohort 1: Critical population receiving mechanical ventilation at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: Placebo | Percentage of Participants With at Least a 2-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | 33.9 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Participants With at Least a 2-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | 38.5 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Participants With at Least a 2-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | 40.2 Percentage of Participants |
p-value: 0.60295% CI: [-11.2, 18.5]Cochran-Mantel-Haenszel
p-value: 0.434295% CI: [-8.9, 19.5]Cochran-Mantel-Haenszel
Secondary
Percentage of Patients Discharged and Alive (Phase 3 Cohort 1)
Percentage of Patients Discharged and Alive at Day 22
Time frame: At Day 22
Population: Phase 3 Cohort 1: Critical population receiving mechanical ventilation at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: Placebo | Percentage of Patients Discharged and Alive (Phase 3 Cohort 1) | 22.6 Percentage of Participants |
| Phase 2: Sarilumab 200mg IV | Percentage of Patients Discharged and Alive (Phase 3 Cohort 1) | 26.9 Percentage of Participants |
| Phase 2: Sarilumab 400mg IV | Percentage of Patients Discharged and Alive (Phase 3 Cohort 1) | 26.5 Percentage of Participants |
p-value: 0.523995% CI: [-9.7, 17.3]Cochran-Mantel-Haenszel
p-value: 0.580995% CI: [-10, 15.6]Cochran-Mantel-Haenszel
Secondary
Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT)
The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Time frame: Up to day 29
Population: Phase 3 Cohort 1 Critical ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 2: Placebo | Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT) | 19.5 Days |
| Phase 2: Sarilumab 200mg IV | Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT) | 16.0 Days |
| Phase 2: Sarilumab 400mg IV | Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT) | 18.0 Days |
p-value: 0.183195% CI: [0.91, 1.52]Log Rank
p-value: 0.87795% CI: [0.82, 1.34]Log Rank
Secondary
Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Time frame: Up to day 29
Population: Phase 3 Cohort 1 Critical populations receiving mechanical ventilation at baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 2: Placebo | Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | NA Days |
| Phase 2: Sarilumab 200mg IV | Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | 27.0 Days |
| Phase 2: Sarilumab 400mg IV | Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | NA Days |
p-value: 0.070595% CI: [0.98, 2.66]Log Rank
p-value: 0.1895% CI: [0.92, 2.43]Log Rank
Secondary
Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 2)
The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Time frame: Up to day 29
Population: Phase 3 Cohort 2 Critical population receiving mechanical ventilation at baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 2: Placebo | Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 2) | 17.0 Days |
| Phase 2: Sarilumab 200mg IV | Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 2) | 15.0 Days |
p-value: 0.710395% CI: [0.35, 2.06]Log Rank
Secondary
Time to at Least 2-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1)
The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Time frame: Up to day 29
Population: Phase 3 Cohort 1: Critical population receiving mechanical ventilation at baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 2: Placebo | Time to at Least 2-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1) | NA days |
| Phase 2: Sarilumab 200mg IV | Time to at Least 2-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1) | NA days |
| Phase 2: Sarilumab 400mg IV | Time to at Least 2-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1) | NA days |
p-value: 0.151295% CI: [0.89, 2.43]Log Rank
p-value: 0.295295% CI: [0.85, 2.24]Log Rank
Secondary
Time to at Least 2-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT)
The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Time frame: Up to day 29
Population: Phase 3 Cohort 1: Critical ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 2: Placebo | Time to at Least 2-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT) | 22.0 days |
| Phase 2: Sarilumab 200mg IV | Time to at Least 2-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT) | 19.0 days |
| Phase 2: Sarilumab 400mg IV | Time to at Least 2-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT) | 23.0 days |
p-value: 0.229795% CI: [0.89, 1.5]Log Rank
p-value: 0.865195% CI: [0.79, 1.3]Log Rank
Secondary
Time to Death (Phase 3 Cohort 1: Critical ITT)
Time to Death (All-Cause Mortality)
Time frame: Up to day 60
Population: Phase 3 Cohort 1: Critical ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 2: Placebo | Time to Death (Phase 3 Cohort 1: Critical ITT) | NA days |
| Phase 2: Sarilumab 200mg IV | Time to Death (Phase 3 Cohort 1: Critical ITT) | NA days |
| Phase 2: Sarilumab 400mg IV | Time to Death (Phase 3 Cohort 1: Critical ITT) | NA days |
p-value: 0.19895% CI: [0.57, 1.14]Log Rank
p-value: 0.797395% CI: [0.73, 1.36]Log Rank
Secondary
Time to Death (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Phase 3 Cohort 1 Time to Death (All-Cause Mortality)
Time frame: Up to day 60
Population: Phase 3 Cohort 1 Critical population receiving mechanical ventilation at baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 2: Placebo | Time to Death (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | 41.0 days |
| Phase 2: Sarilumab 200mg IV | Time to Death (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | NA days |
| Phase 2: Sarilumab 400mg IV | Time to Death (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | NA days |
p-value: 0.084395% CI: [0.41, 1.03]Log Rank
p-value: 0.157695% CI: [0.44, 1.07]Log Rank
Secondary
Time to Death (Phase 3 Cohort 2)
Time to Death (All-Cause Mortality)
Time frame: Up to day 60
Population: Phase 3 Cohort 2 population receiving mechanical ventilation at baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 2: Placebo | Time to Death (Phase 3 Cohort 2) | NA days |
| Phase 2: Sarilumab 200mg IV | Time to Death (Phase 3 Cohort 2) | NA days |
p-value: 0.502395% CI: [0.13, 2.75]Log Rank
Secondary
Time to Discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and Maintained for 24 Hours (Phase 2)
NEWS2 was used to standardize assessment of acute-illness severity, track clinical condition of participants and to alert clinical teams to participant deterioration. NEWS2 score was based on 7 clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0, 1, 2, and 3 was allocated to each parameter except supplemental oxygen (a score of 0 or 1 was allocated) and level of consciousness (a score of 0 or 3 was allocated), where 0 = normal health condition to 3 = worst health condition; higher score indicated more severity. All scores were summed to get an aggregate score. Aggregate NEWS2 score ranged from 0 to 19, with higher scores meaning more severity/higher risk: low risk (score 0 to 4); low to medium risk (score of 3 in any individual parameter); medium risk (score 5 to 6); high risk (score 7 to 19).
Time frame: Up to day 29
Population: Phase 2 ITT population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 2: Placebo | Time to Discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and Maintained for 24 Hours (Phase 2) | Disease Severity: Critical | NA Days |
| Phase 2: Placebo | Time to Discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and Maintained for 24 Hours (Phase 2) | Disease Severity: Severe | 6.0 Days |
| Phase 2: Placebo | Time to Discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and Maintained for 24 Hours (Phase 2) | Disease Severity: MSOD | NA Days |
| Phase 2: Sarilumab 200mg IV | Time to Discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and Maintained for 24 Hours (Phase 2) | Disease Severity: Critical | 25.0 Days |
| Phase 2: Sarilumab 200mg IV | Time to Discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and Maintained for 24 Hours (Phase 2) | Disease Severity: Severe | 6.0 Days |
| Phase 2: Sarilumab 200mg IV | Time to Discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and Maintained for 24 Hours (Phase 2) | Disease Severity: MSOD | NA Days |
| Phase 2: Sarilumab 400mg IV | Time to Discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and Maintained for 24 Hours (Phase 2) | Disease Severity: Severe | 6.0 Days |
| Phase 2: Sarilumab 400mg IV | Time to Discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and Maintained for 24 Hours (Phase 2) | Disease Severity: MSOD | NA Days |
| Phase 2: Sarilumab 400mg IV | Time to Discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and Maintained for 24 Hours (Phase 2) | Disease Severity: Critical | 15.0 Days |
Comparison: Disease Severity: Severep-value: 0.698795% CI: [0.59, 1.59]Log Rank
Comparison: Disease Severity: Severep-value: 0.045395% CI: [0.39, 1.09]Log Rank
Comparison: Disease Severity: Criticalp-value: 0.973495% CI: [0.73, 2.09]Log Rank
Comparison: Disease Severity: Criticalp-value: 0.00495% CI: [1.14, 3.2]Log Rank
Comparison: Disease Severity: MSODp-value: 0.955195% CI: [0.43, 2.17]Log Rank
Comparison: Disease Severity: MSODp-value: 0.872295% CI: [0.42, 2.1]Log Rank
Secondary
Time to Improvement (2 Points) in Clinical Status Assessment in Severe or Critical Patients With All Serum IL-6 Levels (Phase 2)
Time to improvement (2 points) in clinical status assessment on the 7-point ordinal scale in severe or critical participants with all serum IL-6 levels. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Time frame: Up to Day 29
Population: Phase 2 Severe and Critical ITT population. The intention-to-treat (ITT) population includes all randomized patients who received at least one dose of the study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 2: Placebo | Time to Improvement (2 Points) in Clinical Status Assessment in Severe or Critical Patients With All Serum IL-6 Levels (Phase 2) | 15.0 Days |
| Phase 2: Sarilumab 200mg IV | Time to Improvement (2 Points) in Clinical Status Assessment in Severe or Critical Patients With All Serum IL-6 Levels (Phase 2) | 14.0 Days |
| Phase 2: Sarilumab 400mg IV | Time to Improvement (2 Points) in Clinical Status Assessment in Severe or Critical Patients With All Serum IL-6 Levels (Phase 2) | 13.0 Days |
p-value: 0.362295% CI: [0.83, 1.7]Log Rank
p-value: 0.580295% CI: [0.79, 1.63]Log Rank
Secondary
Time to Improvement (2 Points) in Clinical Status Assessment in Severe or Critical Patients With Serum IL-6 Levels Greater Than the Upper Limit of Normal (Phase 2)
Time to improvement (2 points) in clinical status assessment on the 7-point ordinal scale in severe or critical participants with serum IL-6 levels greater than the upper limit of normal (ULN). The ordinal scale is an assessment of the clinical status of a patient. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Time frame: Up to Day 29
Population: Phase 2 mITT population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of the study drug and have high baseline IL-6 levels.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 2: Placebo | Time to Improvement (2 Points) in Clinical Status Assessment in Severe or Critical Patients With Serum IL-6 Levels Greater Than the Upper Limit of Normal (Phase 2) | 16.0 Days |
| Phase 2: Sarilumab 200mg IV | Time to Improvement (2 Points) in Clinical Status Assessment in Severe or Critical Patients With Serum IL-6 Levels Greater Than the Upper Limit of Normal (Phase 2) | 15.0 Days |
| Phase 2: Sarilumab 400mg IV | Time to Improvement (2 Points) in Clinical Status Assessment in Severe or Critical Patients With Serum IL-6 Levels Greater Than the Upper Limit of Normal (Phase 2) | 14.0 Days |
p-value: 0.568795% CI: [0.76, 1.66]Log Rank
p-value: 0.701495% CI: [0.74, 1.62]Log Rank
Secondary
Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2)
Time to Improvement defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
Time frame: Up to day 29
Population: Phase 2 ITT population with IL-6 measurement reported at baseline
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 2: Placebo | Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2) | Severe Participants Baseline IL-6 >= 67.11pg/mL (median) | 6.5 Days |
| Phase 2: Placebo | Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2) | Critical Participants Baseline IL-6 < 131.90pg/mL (median) | 7.0 Days |
| Phase 2: Placebo | Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2) | MSOD / Immunocompromised Participants Baseline IL-6 >= 254.95pg/mL (median) | 24.0 Days |
| Phase 2: Placebo | Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2) | MSOD / Immunocompromised Participants Baseline IL-6 < 254.95pg/mL (median) | 14.0 Days |
| Phase 2: Placebo | Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2) | Critical Participants Baseline IL-6 >= 131.90pg/mL (median) | 15.0 Days |
| Phase 2: Placebo | Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2) | Severe Participants Baseline IL-6 < 67.11pg/mL (median) | 8.0 Days |
| Phase 2: Sarilumab 200mg IV | Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2) | Severe Participants Baseline IL-6 < 67.11pg/mL (median) | 5.0 Days |
| Phase 2: Sarilumab 200mg IV | Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2) | Severe Participants Baseline IL-6 >= 67.11pg/mL (median) | 8.5 Days |
| Phase 2: Sarilumab 200mg IV | Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2) | Critical Participants Baseline IL-6 < 131.90pg/mL (median) | 17.0 Days |
| Phase 2: Sarilumab 200mg IV | Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2) | Critical Participants Baseline IL-6 >= 131.90pg/mL (median) | NA Days |
| Phase 2: Sarilumab 200mg IV | Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2) | MSOD / Immunocompromised Participants Baseline IL-6 < 254.95pg/mL (median) | NA Days |
| Phase 2: Sarilumab 200mg IV | Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2) | MSOD / Immunocompromised Participants Baseline IL-6 >= 254.95pg/mL (median) | NA Days |
| Phase 2: Sarilumab 400mg IV | Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2) | Severe Participants Baseline IL-6 >= 67.11pg/mL (median) | NA Days |
| Phase 2: Sarilumab 400mg IV | Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2) | MSOD / Immunocompromised Participants Baseline IL-6 >= 254.95pg/mL (median) | 19.0 Days |
| Phase 2: Sarilumab 400mg IV | Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2) | MSOD / Immunocompromised Participants Baseline IL-6 < 254.95pg/mL (median) | 24.0 Days |
| Phase 2: Sarilumab 400mg IV | Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2) | Critical Participants Baseline IL-6 < 131.90pg/mL (median) | 8.5 Days |
| Phase 2: Sarilumab 400mg IV | Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2) | Severe Participants Baseline IL-6 < 67.11pg/mL (median) | 7.5 Days |
| Phase 2: Sarilumab 400mg IV | Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2) | Critical Participants Baseline IL-6 >= 131.90pg/mL (median) | 14.0 Days |
Comparison: Disease Severity: Severe Baseline IL-6 \< 67.11 pg/mL (median)p-value: 0.38995% CI: [0.52, 2.79]Log Rank
Comparison: Disease Severity: Severe Baseline IL-6 \>= 67.11pg/mL (median)p-value: 0.783895% CI: [0.3, 1.41]Log Rank
Comparison: Disease Severity: Severe Baseline IL-6 \< 67.11 pg/mL (median)p-value: 0.23795% CI: [0.28, 1.65]Log Rank
Comparison: Disease Severity: Severe Baseline IL-6 \>= 67.11pg/mL (median)p-value: 0.000495% CI: [0.1, 0.59]Log Rank
Comparison: Disease Severity: Critical Baseline IL-6 \< 131.90 pg/mL (median)p-value: 0.17495% CI: [0.37, 1.32]Log Rank
Comparison: Disease Severity: Critical Baseline IL-6 \>= 131.90 pg/mL (median)p-value: 0.366495% CI: [0.38, 1.66]Log Rank
Comparison: Disease Severity: Critical Baseline IL-6 \< 131.90 pg/mL (median)p-value: 0.731895% CI: [0.53, 1.87]Log Rank
Comparison: Disease Severity: Critical Baseline IL-6 \>= 131.90 pg/mL (median)p-value: 0.415595% CI: [0.59, 2.37]Log Rank
Comparison: Disease Severity: MSOD Baseline IL-6 \< 254.95 pg/mL (median)p-value: 0.626295% CI: [0.23, 2.45]Log Rank
Comparison: Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (median)p-value: 0.55395% CI: [0.21, 2.3]Log Rank
Comparison: Disease Severity: MSOD Baseline IL-6 \< 254.95 pg/mL (median)p-value: 0.877595% CI: [0.25, 2.85]Log Rank
Comparison: Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (median)p-value: 0.748595% CI: [0.41, 2.99]Log Rank
Secondary
Time to Improvement in Oxygenation for at Least 48 Hours (Phase 2)
Improvement in oxygenation defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
Time frame: Up to day 29
Population: Phase 2 ITT population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 2: Placebo | Time to Improvement in Oxygenation for at Least 48 Hours (Phase 2) | Disease Severity: Severe | 7.0 Days |
| Phase 2: Placebo | Time to Improvement in Oxygenation for at Least 48 Hours (Phase 2) | Disease Severity: MSOD | 20.0 Days |
| Phase 2: Placebo | Time to Improvement in Oxygenation for at Least 48 Hours (Phase 2) | Disease Severity: Critical | 10.5 Days |
| Phase 2: Sarilumab 200mg IV | Time to Improvement in Oxygenation for at Least 48 Hours (Phase 2) | Disease Severity: Severe | 6.0 Days |
| Phase 2: Sarilumab 200mg IV | Time to Improvement in Oxygenation for at Least 48 Hours (Phase 2) | Disease Severity: MSOD | NA Days |
| Phase 2: Sarilumab 200mg IV | Time to Improvement in Oxygenation for at Least 48 Hours (Phase 2) | Disease Severity: Critical | 20.0 Days |
| Phase 2: Sarilumab 400mg IV | Time to Improvement in Oxygenation for at Least 48 Hours (Phase 2) | Disease Severity: MSOD | 19.0 Days |
| Phase 2: Sarilumab 400mg IV | Time to Improvement in Oxygenation for at Least 48 Hours (Phase 2) | Disease Severity: Critical | 11.0 Days |
| Phase 2: Sarilumab 400mg IV | Time to Improvement in Oxygenation for at Least 48 Hours (Phase 2) | Disease Severity: Severe | 11.0 Days |
Comparison: Disease Severity: Severep-value: 0.903295% CI: [0.52, 1.47]Log Rank
Comparison: Disease Severity: Severep-value: 0.005295% CI: [0.29, 0.88]Log Rank
Comparison: Disease Severity: Criticalp-value: 0.116895% CI: [0.48, 1.21]Log Rank
Comparison: Disease Severity: Criticalp-value: 0.375395% CI: [0.69, 1.72]Log Rank
Comparison: Disease Severity: MSODp-value: 0.495695% CI: [0.4, 1.66]Log Rank
Comparison: Disease Severity: MSODp-value: 0.843995% CI: [0.5, 2.02]Log Rank
Secondary
Time to Recovery (Phase 3 Cohort 1: Critical ITT)
Phase 3 Cohort 1 Time to Recovery (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use)
Time frame: Up to day 29
Population: Phase 3 Cohort 1: Critical ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 2: Placebo | Time to Recovery (Phase 3 Cohort 1: Critical ITT) | 25.5 days |
| Phase 2: Sarilumab 200mg IV | Time to Recovery (Phase 3 Cohort 1: Critical ITT) | 23.0 days |
| Phase 2: Sarilumab 400mg IV | Time to Recovery (Phase 3 Cohort 1: Critical ITT) | 27.0 days |
p-value: 0.467495% CI: [0.84, 1.43]Log Rank
p-value: 0.850395% CI: [0.77, 1.28]Log Rank
Secondary
Time to Recovery (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Phase 3 Cohort 1 Time to Recovery (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use)
Time frame: Up to day 29
Population: Phase 3 Cohort 1 Critical population receiving mechanical ventilation at baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 2: Placebo | Time to Recovery (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | NA days |
| Phase 2: Sarilumab 200mg IV | Time to Recovery (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | NA days |
| Phase 2: Sarilumab 400mg IV | Time to Recovery (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline) | NA days |
p-value: 0.451995% CI: [0.75, 2.18]Log Rank
p-value: 0.281895% CI: [0.81, 2.24]Log Rank
Secondary
Time to Recovery (Phase 3 Cohort 2)
Time to Recovery (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use)
Time frame: Up to day 29
Population: Phase 3 Cohort 2 population receiving mechanical ventilation at baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 2: Placebo | Time to Recovery (Phase 3 Cohort 2) | 23.0 days |
| Phase 2: Sarilumab 200mg IV | Time to Recovery (Phase 3 Cohort 2) | 22.0 days |
p-value: 0.615695% CI: [0.31, 2.02]Log Rank
Secondary
Time to Resolution of Fever and Improvement in Oxygenation for at Least 48 Hours (Phase 2)
Resolution of fever defined as postbaseline body temperature \<37.2°C (oral), or \<37.6°C (rectal or tympanic) or \<36.8°C (temporal or axillary) Improvement in oxygenation defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
Time frame: Up to day 29
Population: Phase 2 ITT population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 2: Placebo | Time to Resolution of Fever and Improvement in Oxygenation for at Least 48 Hours (Phase 2) | Disease Severity: Severe | 7.0 Days |
| Phase 2: Placebo | Time to Resolution of Fever and Improvement in Oxygenation for at Least 48 Hours (Phase 2) | Disease Severity: Critical | 15.0 Days |
| Phase 2: Placebo | Time to Resolution of Fever and Improvement in Oxygenation for at Least 48 Hours (Phase 2) | Disease Severity: MSOD | 20.0 Days |
| Phase 2: Sarilumab 200mg IV | Time to Resolution of Fever and Improvement in Oxygenation for at Least 48 Hours (Phase 2) | Disease Severity: MSOD | NA Days |
| Phase 2: Sarilumab 200mg IV | Time to Resolution of Fever and Improvement in Oxygenation for at Least 48 Hours (Phase 2) | Disease Severity: Critical | 22.0 Days |
| Phase 2: Sarilumab 200mg IV | Time to Resolution of Fever and Improvement in Oxygenation for at Least 48 Hours (Phase 2) | Disease Severity: Severe | 4.0 Days |
| Phase 2: Sarilumab 400mg IV | Time to Resolution of Fever and Improvement in Oxygenation for at Least 48 Hours (Phase 2) | Disease Severity: MSOD | 24.0 Days |
| Phase 2: Sarilumab 400mg IV | Time to Resolution of Fever and Improvement in Oxygenation for at Least 48 Hours (Phase 2) | Disease Severity: Critical | 8.5 Days |
| Phase 2: Sarilumab 400mg IV | Time to Resolution of Fever and Improvement in Oxygenation for at Least 48 Hours (Phase 2) | Disease Severity: Severe | 6.0 Days |
Comparison: Disease Severity: Severep-value: 0.455695% CI: [0.63, 1.79]Log Rank
Comparison: Disease Severity: Severep-value: 0.024895% CI: [0.35, 1.04]Log Rank
Comparison: Disease Severity: Criticalp-value: 0.684295% CI: [0.62, 1.67]Log Rank
Comparison: Disease Severity: Criticalp-value: 0.067195% CI: [0.89, 2.32]Log Rank
Comparison: Disease Severity: MSODp-value: 0.614695% CI: [0.41, 1.74]Log Rank
Comparison: Disease Severity: MSODp-value: 0.97395% CI: [0.48, 1.99]Log Rank
Secondary
Time to Resolution of Fever for at Least 48 Hours Without Antipyretics by Clinical Severity (Phase 2)
Resolution of fever is defined as body temperature \<=36.8 C (axilla or temporal) or\<= 37.2 C (oral) or \<37.6 C (rectal or tympanic) for at least 48 hours without antipyretics or until discharge. Resolution of fever is defined only in participants with presence of fever at baseline.
Time frame: Up to day 29
Population: Phase 2 ITT population with presence of fever at baseline
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 2: Placebo | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics by Clinical Severity (Phase 2) | Disease Severity: Critical | NA Days |
| Phase 2: Placebo | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics by Clinical Severity (Phase 2) | Disease Severity: Severe | 7.0 Days |
| Phase 2: Placebo | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics by Clinical Severity (Phase 2) | Disease Severity: Multisystem Organ Dysfunction | NA Days |
| Phase 2: Sarilumab 200mg IV | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics by Clinical Severity (Phase 2) | Disease Severity: Critical | 29.0 Days |
| Phase 2: Sarilumab 200mg IV | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics by Clinical Severity (Phase 2) | Disease Severity: Severe | 5.0 Days |
| Phase 2: Sarilumab 200mg IV | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics by Clinical Severity (Phase 2) | Disease Severity: Multisystem Organ Dysfunction | NA Days |
| Phase 2: Sarilumab 400mg IV | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics by Clinical Severity (Phase 2) | Disease Severity: Severe | 6.0 Days |
| Phase 2: Sarilumab 400mg IV | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics by Clinical Severity (Phase 2) | Disease Severity: Multisystem Organ Dysfunction | NA Days |
| Phase 2: Sarilumab 400mg IV | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics by Clinical Severity (Phase 2) | Disease Severity: Critical | 20.5 Days |
Comparison: Disease Severity: Severep-value: 0.315195% CI: [0.66, 2.43]Log Rank
Comparison: Disease Severity: Severep-value: 0.188495% CI: [0.39, 1.41]Log Rank
Comparison: Disease Severity: Criticalp-value: 0.435695% CI: [0.76, 3.4]Log Rank
Comparison: Disease Severity: Criticalp-value: 0.037195% CI: [1.01, 4.4]Log Rank
Comparison: Disease Severity: MSODp-value: 0.892395% CI: [0.32, 3.05]Log Rank
Comparison: Disease Severity: MSODp-value: 0.69495% CI: [0.25, 2.71]Log Rank
Secondary
Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2)
Resolution of fever is defined as body temperature \<=36.8 C (axilla or temporal) or\<= 37.2 C (oral) or \<37.6 C (rectal or tympanic) for at least 48 hours without antipyretics or until discharge, by baseline IL-6 levels. Resolution of fever is defined only in participants with presence of fever at baseline.
Time frame: Up to Day 29
Population: Phase 2 ITT population with presence of fever and IL-6 measurement reported at baseline
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 2: Placebo | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2) | Disease Severity: Severe Baseline IL-6 < 87.04 picograms per milliliter (pg/mL) Median | 8.5 Days |
| Phase 2: Placebo | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2) | Disease Severity: Severe Baseline IL-6 >= 87.04pg/mL (Median) | 5.0 Days |
| Phase 2: Placebo | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2) | Disease Severity: Critical Baseline IL-6 < 166.68pg/mL (Median) | 14.0 Days |
| Phase 2: Placebo | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2) | Disease Severity: MSOD Baseline IL-6 <254.95 pg/mL (Median) | NA Days |
| Phase 2: Placebo | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2) | Disease Severity: Critical Baseline IL-6 >= 166.68pg/mL (Median) | NA Days |
| Phase 2: Placebo | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2) | Disease Severity: MSOD Baseline IL-6 >= 254.95 pg/mL (Median) | NA Days |
| Phase 2: Sarilumab 200mg IV | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2) | Disease Severity: Critical Baseline IL-6 >= 166.68pg/mL (Median) | NA Days |
| Phase 2: Sarilumab 200mg IV | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2) | Disease Severity: Severe Baseline IL-6 < 87.04 picograms per milliliter (pg/mL) Median | 5.0 Days |
| Phase 2: Sarilumab 200mg IV | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2) | Disease Severity: Critical Baseline IL-6 < 166.68pg/mL (Median) | 16.5 Days |
| Phase 2: Sarilumab 200mg IV | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2) | Disease Severity: MSOD Baseline IL-6 >= 254.95 pg/mL (Median) | NA Days |
| Phase 2: Sarilumab 200mg IV | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2) | Disease Severity: Severe Baseline IL-6 >= 87.04pg/mL (Median) | 8.0 Days |
| Phase 2: Sarilumab 200mg IV | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2) | Disease Severity: MSOD Baseline IL-6 <254.95 pg/mL (Median) | NA Days |
| Phase 2: Sarilumab 400mg IV | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2) | Disease Severity: Severe Baseline IL-6 >= 87.04pg/mL (Median) | NA Days |
| Phase 2: Sarilumab 400mg IV | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2) | Disease Severity: Critical Baseline IL-6 >= 166.68pg/mL (Median) | 25.0 Days |
| Phase 2: Sarilumab 400mg IV | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2) | Disease Severity: MSOD Baseline IL-6 <254.95 pg/mL (Median) | NA Days |
| Phase 2: Sarilumab 400mg IV | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2) | Disease Severity: MSOD Baseline IL-6 >= 254.95 pg/mL (Median) | NA Days |
| Phase 2: Sarilumab 400mg IV | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2) | Disease Severity: Critical Baseline IL-6 < 166.68pg/mL (Median) | 17.0 Days |
| Phase 2: Sarilumab 400mg IV | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2) | Disease Severity: Severe Baseline IL-6 < 87.04 picograms per milliliter (pg/mL) Median | 5.0 Days |
Comparison: Disease Severity: Severe Baseline IL-6 \< 87.04 pg/mL (median)p-value: 0.083295% CI: [0.81, 5.65]Log Rank
Comparison: Disease Severity: Severe Baseline IL-6 \< 87.04 pg/mL (median)p-value: 0.136995% CI: [0.77, 4.8]Log Rank
Comparison: Disease Severity: Severe Baseline IL-6 \>= 87.04 pg/mL (median)p-value: 0.963695% CI: [0.28, 1.95]Log Rank
Comparison: Disease Severity: Severe Baseline IL-6 \>= 87.04 pg/mL (median)p-value: 0.003895% CI: [0.08, 0.74]Log Rank
Comparison: Disease Severity: Critical Baseline IL-6 \< 166.68pg/mL (Median)p-value: 0.73895% CI: [0.47, 3.13]Log Rank
Comparison: Disease Severity: Critical Baseline IL-6 \<166.68pg/mL (Median)p-value: 0.734295% CI: [0.48, 3.05]Log Rank
Comparison: Disease Severity: Critical Baseline IL-6 \>= 166.68pg/mL (Median)p-value: 0.193495% CI: [0.79, 16.17]Log Rank
Comparison: Disease Severity: Critical Baseline IL-6 \>= 166.68pg/mL (Median)p-value: 0.015995% CI: [1.19, 23.94]Log Rank
Comparison: Disease Severity: MSOD Baseline IL-6 \<254.95 pg/mL (Median)p-value: 0.628195% CI: [0.13, 8.75]Log Rank
Comparison: Disease Severity: MSOD Baseline IL-6 \<254.95 pg/mL (Median)p-value: 0.497195% CI: [0.06, 6.13]Log Rank
Comparison: Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (Median)p-value: 0.29995% CI: [0.03, 2.86]Log Rank
Comparison: Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (Median)p-value: 0.93695% CI: [0.22, 4.41]Log Rank
Secondary
Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, in Patients With Documented Fever at Baseline (Phase 2)
Time to resolution of fever for at least 48 hours without antipyretics or until discharge, whichever is sooner, in patients with documented fever ≥38°C (oral), ≥38.4°C (rectal or tympanic), or ≥37.6°C (temporal or axillary) at Baseline. Resolution of fever is defined as postbaseline body temperature \<37.2°C (oral), or \<37.6°C (rectal or tympanic) or \<36.8°C (temporal or axillary).
Time frame: Up to Day 29
Population: Phase 2 ITT population with presence of fever at baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 2: Placebo | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, in Patients With Documented Fever at Baseline (Phase 2) | 17.0 Days |
| Phase 2: Sarilumab 200mg IV | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, in Patients With Documented Fever at Baseline (Phase 2) | 18.0 Days |
| Phase 2: Sarilumab 400mg IV | Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, in Patients With Documented Fever at Baseline (Phase 2) | 18.0 Days |
p-value: 0.23495% CI: [0.83, 2.02]Log Rank
p-value: 0.694995% CI: [0.74, 1.79]Log Rank
Secondary
Time to Saturation ≥94% on Room Air (Phase 2)
Time frame: Up to day 29
Population: Phase 2 ITT population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 2: Placebo | Time to Saturation ≥94% on Room Air (Phase 2) | Disease Severity: Critical | NA Days |
| Phase 2: Placebo | Time to Saturation ≥94% on Room Air (Phase 2) | Disease Severity: Severe | NA Days |
| Phase 2: Placebo | Time to Saturation ≥94% on Room Air (Phase 2) | Disease Severity: MSOD | 5.0 Days |
| Phase 2: Sarilumab 200mg IV | Time to Saturation ≥94% on Room Air (Phase 2) | Disease Severity: Critical | NA Days |
| Phase 2: Sarilumab 200mg IV | Time to Saturation ≥94% on Room Air (Phase 2) | Disease Severity: Severe | NA Days |
| Phase 2: Sarilumab 200mg IV | Time to Saturation ≥94% on Room Air (Phase 2) | Disease Severity: MSOD | NA Days |
| Phase 2: Sarilumab 400mg IV | Time to Saturation ≥94% on Room Air (Phase 2) | Disease Severity: Severe | NA Days |
| Phase 2: Sarilumab 400mg IV | Time to Saturation ≥94% on Room Air (Phase 2) | Disease Severity: MSOD | NA Days |
| Phase 2: Sarilumab 400mg IV | Time to Saturation ≥94% on Room Air (Phase 2) | Disease Severity: Critical | NA Days |
Comparison: Disease Severity: Severep-value: 0.038595% CI: [0.11, 0.94]Log Rank
Comparison: Disease Severity: Severep-value: 0.078295% CI: [0.14, 1.05]Log Rank
Comparison: Disease Severity: Criticalp-value: 0.243695% CI: [0.7, 2.14]Log Rank
Comparison: Disease Severity: Criticalp-value: 0.322395% CI: [0.46, 1.51]Log Rank
Comparison: Disease Severity: MSODp-value: 0.46795% CI: [0.36, 1.52]Log Rank
Comparison: Disease Severity: MSODp-value: 0.372895% CI: [0.35, 1.47]Log Rank