SARS-CoV-2
Conditions
Brief summary
Hyper-inflammation, caused by a cytokine storm resulting from an exaggerated response of the immune system in the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is considered to represent one of the most important negative prognostic factors in patients infected with sSARS-CoV-2. The objective of this study is to investigate new treatment options to reduce the number of patients requiring mechanical ventilation. This is intended to address the most urgent need to preserve the access to intensive care unit support to the lowest possible number of patients and may potentially reduce mortality.
Detailed description
This is an open label, controlled, parallel group, 3-arm, multicenter study to assess the efficacy and safety of Emapalumab or Anakinra, versus standard of care (SoC). Patients between 30 and 80 years will be eligible to participate in the study. The study is planned to consist of three groups, each comprising 18 patients. Treatment will be randomized to either Emapalumab+SoC, Anakinra+SoC or only SoC for two weeks. Follow-up visit or phone calls will be made 4 and 8 weeks after end of treatment period.
Interventions
BIOLOGICALEmapalumab
I.v. infusion every third day
BIOLOGICALAnakinra
Daily i.v. infusion
Sponsors
Swedish Orphan Biovitrum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent provided by the patient, or by the patient's legally authorized representative(s), as applicable. 2. Documented presence of SARS-CoV-2 infection as per hospital routine. 3. Age \> 18 to \< 85 years at the time of screening. 4. Presence of respiratory distress, defined as: 1. PaO2/FiO2 \< 300 mm Hg and \>200 mm Hg or 2. Respiratory Rate (RR) ≥30 breaths/min or 3. SpO2 \< 93 percent in air at rest. Note: Patients given continous positive airway pressure (CPAP) ventilator support are eligible for inclusion. Presence of hyperinflammation defined as: 1. Lymphocyte counts: * \< 1000 cells/µL, in patients who have not received systemic glucocorticoids for at least 2 days prior to the assessment of the lymphocyte count * \< 1200 cells/µL, in patients who have received systemic glucocorticoids for at least 2 days prior to the assessment of the lymphocyte count and 2. One of the following three criteria: i. Ferritin \> 500ng/mL ii. LDH \> 300 U/L iii. D-Dimers \> 1000 ng/mL
Exclusion criteria
1. Patients in mechanical ventilation or with modified early warning score (MEWS) \>4 with evidence of moderate or above ARDS (Berlin definition, namely with PaO2/FiO2 \>100, but \<200 mm Hg) or severe respiratory insufficiency or evidence of rapid worsening (respiratory distress requiring mechanical ventilation or presence of shock or presence of concomitant organ failure requiring ICU admission). Note: For the evaluation of patient eligibility, temperature will not be considered in the calculation of the total MEWS score since presence of fever is a hallmark of SARS-CoV-2 infection 2. Impairment of cardiac function defined as poorly controlled heart diseases, such as New York heart association (NYHA) class II (mild) and above, cardiac insufficiency, unstable angina pectoris, myocardial infarction within 1 year before enrollment, supraventricular or ventricular arrhythmia need treatment or intervention. 3. Severe renal dysfunction (estimated glomerular filtration rate ≤ 30 mL/min/1.73 m2) or receive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis. 4. Uncontrolled hypertension (seated systolic blood pressure \>180 mmHg, or diastolic blood pressure \>110mmHg) . 5. Administration of plasma from convalescent patients who recovered from SARS-CoV-2 infection. 6. Clinical suspicion of latent tuberculosis. 7. History of hypersensitivity or allergy to any component of the study drug. 8. Pregnant women. 9. Existence of any life-threatening co-morbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion. 10. Enrollment in another concurrent clinical interventional study, or intake of an investigational drug within three months or 5 half-lives prior to inclusion in this study, if considered interfering with this study objectives as assessed by the Investigator. 11. Foreseeable inability to cooperate with given instructions or study procedures. 12. Clinical suspicion of active mycobacteria, histoplasma capsulatum, herpes zoster, salmonella, and shigella Infections. 13. Patients with liver dysfunction defined as AST or ALT \> 5 × ULN
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Success | Up to Day 15 | Defined as the number of patients not requiring invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in D-dimers | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Number of Participants Requiring Mechanical Ventilation | Date of randomization to date of mechanical ventilation, up to 15 Days | Measured in number of participants |
| Change From Baseline in Modified Early Warning System Score | Baseline, Day 15 | The full (unabbreviated) scale name is Modified Early Warning system score (MEWS score) Measured in total score Total score is the sum of 5 categorized components (blood pressure, heart rate, respiratory rate, temperature and alert/voice/pain/unresponsive score) that are assigned a score between 0 and 2 or 0 and 3. MEWS total score range is 0 to 14. Higher score= worse outcome |
| Change From Baseline in Ferritin | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2) | Baseline, 3 assessments every Days 4, 7, 10, 13 and 15 | Measured in percent (%) |
| Change From Baseline in Oxygen Supplementation | Baseline, Days 4, 7, 10, 13 and 15. | Measured in l/min |
| Change From Baseline in Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2) | Baseline, Day 15 | Measured in mmHg |
| Number of Participants With Changes in High-resolution Computed Tomography (CT) Scan of the Chest | Screening, Day 15 | Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done |
| Overall Survival | Weeks 6 and 10 | Confirmation of death |
| Number of Patients With Hospital Discharge | Until discharge up to Week 10 | Measured in number of patients |
| Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Change of Potassium in Hemogasanalysis From Baseline | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Change of Sodium in Hemogasanalysis From Baseline | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Change of Chloride in Hemogasanalysis From Baseline | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Change From Baseline in Lactate Dehydrogenase (LDH) | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Change of Hemoglobin in Hemogasanalysis From Baseline | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Change From Baseline in White Blood Cells With Differential Counts | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Change From Baseline in Red Blood Counts | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Change From Baseline in Hemoglobin | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Change From Baseline in Platelet Count | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Change From Baseline in Fibrinogen | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Change From Baseline in Complement Factors C3/C4 | Day 15 | Measured in local units |
| Change From Baseline in Prothrombin Time | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Change From Baseline in Cardiac Troponin | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Change From Baseline in Aspartate Aminotransferase (AST) | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Change From Baseline in Alanine Aminotransferase (ALT) | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Change From Baseline in Total Bilirubin Levels | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Change From Baseline in C-Reactive Protein | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Change From Baseline in Creatinine | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
| Change of Lactic Acid in Hemogasanalysis From Baseline | Baseline, Days 4, 7, 10, 13 and 15 | Measured in local units |
Countries
Italy, United States
Participant flow
Pre-assignment details
Patients were screened within 72h prior to the first IMP administration. A total of 54 patients were planned to be randomized. A total of 16 patients were randomized and analyzed.
Participants by arm
| Arm | Count |
|---|---|
| Emapalumab Emapalumab i.v. infusion every 3rd day for a total 5 infusions. Day 1: 6mg/kg. Days 4, 7, 10 and 13: 3 mg/kg
Emapalumab: I.v. infusion every third day | 5 |
| Anakinra Anakinra i.v. infusion four times daily for 15 days. 400 mg/day in total, divided into 4 doses given every 6 hours
Anakinra: Daily i.v. infusion | 5 |
| Standard of Care Standard of care according to local practice | 6 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Death | 1 | 1 | 0 |
| Overall Study | Lack of Efficacy | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Standard of Care | Anakinra | Emapalumab |
|---|---|---|---|---|
| Age, Continuous | 63.3 years STANDARD_DEVIATION 12.3 | 62.5 years STANDARD_DEVIATION 62.5 | 62.4 years STANDARD_DEVIATION 11.1 | 65.0 years STANDARD_DEVIATION 14.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 5 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Fraction of Inspired oxygen (FiO2) (%) | 56.3 % of inspired oxygen STANDARD_DEVIATION 27.4 | 53.2 % of inspired oxygen STANDARD_DEVIATION 22.4 | 54.8 % of inspired oxygen STANDARD_DEVIATION 37.1 | 61.8 % of inspired oxygen STANDARD_DEVIATION 29.9 |
| Height (cm) | 171 cm STANDARD_DEVIATION 9.5 | 172.3 cm STANDARD_DEVIATION 14.4 | 170.2 cm STANDARD_DEVIATION 4.4 | 170.8 cm STANDARD_DEVIATION 10.9 |
| Hospitalization | 16 Participants | 6 Participants | 5 Participants | 5 Participants |
| Oxygen levels (mmHg) | 85.2 mmHg STANDARD_DEVIATION 27.7 | 78.6 mmHg STANDARD_DEVIATION 20.5 | 78.5 mmHg STANDARD_DEVIATION 21 | 103.0 mmHg STANDARD_DEVIATION 38.2 |
| Region of Enrollment Italy | 16 participants | 6 participants | 5 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 14 Participants | 6 Participants | 4 Participants | 4 Participants |
| Symptom duration (days) | 3.6 days STANDARD_DEVIATION 4 | 5.3 days STANDARD_DEVIATION 4.8 | 1.0 days STANDARD_DEVIATION 0 | 4.0 days STANDARD_DEVIATION 4.2 |
| Weight (kg) | 79.7 kg STANDARD_DEVIATION 13 | 83.0 kg STANDARD_DEVIATION 12.8 | 79.4 kg STANDARD_DEVIATION 13.4 | 77.4 kg STANDARD_DEVIATION 15 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 5 | 1 / 5 | 0 / 6 |
| other Total, other adverse events | 1 / 5 | 1 / 5 | 1 / 6 |
| serious Total, serious adverse events | 2 / 5 | 1 / 5 | 0 / 6 |
Outcome results
Primary
Number of Participants With Treatment Success
Defined as the number of patients not requiring invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)
Time frame: Up to Day 15
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Emapalumab | Number of Participants With Treatment Success | 3 Participants |
| Anakinra | Number of Participants With Treatment Success | 4 Participants |
| Standard of Care | Number of Participants With Treatment Success | 5 Participants |
Secondary
Change From Baseline in Alanine Aminotransferase (ALT)
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Day 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change From Baseline in Alanine Aminotransferase (ALT) | Change from Baseline D13 | -111.0 U/L | Standard Deviation 293.3 |
| Emapalumab | Change From Baseline in Alanine Aminotransferase (ALT) | Change from Baseline D10 | -107.8 U/L | Standard Deviation 258.3 |
| Emapalumab | Change From Baseline in Alanine Aminotransferase (ALT) | Change from Baseline D4 | -74.8 U/L | Standard Deviation 152.9 |
| Emapalumab | Change From Baseline in Alanine Aminotransferase (ALT) | Change from Baseline D7 | -97.5 U/L | Standard Deviation 237.1 |
| Emapalumab | Change From Baseline in Alanine Aminotransferase (ALT) | Change from Baseline at D15 | -90.6 U/L | Standard Deviation 260.7 |
| Anakinra | Change From Baseline in Alanine Aminotransferase (ALT) | Change from Baseline D10 | 5.0 U/L | Standard Deviation 54.5 |
| Anakinra | Change From Baseline in Alanine Aminotransferase (ALT) | Change from Baseline D4 | 2.6 U/L | Standard Deviation 38.8 |
| Anakinra | Change From Baseline in Alanine Aminotransferase (ALT) | Change from Baseline D7 | 16.6 U/L | Standard Deviation 66.9 |
| Anakinra | Change From Baseline in Alanine Aminotransferase (ALT) | Change from Baseline D13 | -4.8 U/L | Standard Deviation 51.9 |
| Anakinra | Change From Baseline in Alanine Aminotransferase (ALT) | Change from Baseline at D15 | -5.8 U/L | Standard Deviation 53.2 |
| Standard of Care | Change From Baseline in Alanine Aminotransferase (ALT) | Change from Baseline at D15 | -121.8 U/L | Standard Deviation 309.1 |
| Standard of Care | Change From Baseline in Alanine Aminotransferase (ALT) | Change from Baseline D13 | -119.2 U/L | Standard Deviation 352.2 |
| Standard of Care | Change From Baseline in Alanine Aminotransferase (ALT) | Change from Baseline D4 | -23.6 U/L | Standard Deviation 148.8 |
| Standard of Care | Change From Baseline in Alanine Aminotransferase (ALT) | Change from Baseline D10 | -107.0 U/L | Standard Deviation 350 |
| Standard of Care | Change From Baseline in Alanine Aminotransferase (ALT) | Change from Baseline D7 | -62.0 U/L | Standard Deviation 251.3 |
Secondary
Change From Baseline in Aspartate Aminotransferase (AST)
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Day 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change From Baseline in Aspartate Aminotransferase (AST) | Change from Baseline at D13 | -44.0 U/L | Standard Deviation 119.3 |
| Emapalumab | Change From Baseline in Aspartate Aminotransferase (AST) | Change from Baseline at D10 | -53.3 U/L | Standard Deviation 108.6 |
| Emapalumab | Change From Baseline in Aspartate Aminotransferase (AST) | Change from baseline at D4 | -46.0 U/L | Standard Deviation 79.8 |
| Emapalumab | Change From Baseline in Aspartate Aminotransferase (AST) | Change from Baseline at D7 | -52.8 U/L | Standard Deviation 107 |
| Emapalumab | Change From Baseline in Aspartate Aminotransferase (AST) | Change from baseline at D15 | -35.4 U/L | Standard Deviation 105.3 |
| Anakinra | Change From Baseline in Aspartate Aminotransferase (AST) | Change from Baseline at D10 | -27.8 U/L | Standard Deviation 32.9 |
| Anakinra | Change From Baseline in Aspartate Aminotransferase (AST) | Change from baseline at D4 | -19.2 U/L | Standard Deviation 32 |
| Anakinra | Change From Baseline in Aspartate Aminotransferase (AST) | Change from Baseline at D7 | -27.6 U/L | Standard Deviation 36.8 |
| Anakinra | Change From Baseline in Aspartate Aminotransferase (AST) | Change from Baseline at D13 | -25.2 U/L | Standard Deviation 28.9 |
| Anakinra | Change From Baseline in Aspartate Aminotransferase (AST) | Change from baseline at D15 | -25.8 U/L | Standard Deviation 28.3 |
| Standard of Care | Change From Baseline in Aspartate Aminotransferase (AST) | Change from baseline at D15 | -77.7 U/L | Standard Deviation 151 |
| Standard of Care | Change From Baseline in Aspartate Aminotransferase (AST) | Change from Baseline at D13 | -83.6 U/L | Standard Deviation 163.2 |
| Standard of Care | Change From Baseline in Aspartate Aminotransferase (AST) | Change from baseline at D4 | -63.2 U/L | Standard Deviation 146 |
| Standard of Care | Change From Baseline in Aspartate Aminotransferase (AST) | Change from Baseline at D10 | -79.8 U/L | Standard Deviation 170.6 |
| Standard of Care | Change From Baseline in Aspartate Aminotransferase (AST) | Change from Baseline at D7 | -65.4 U/L | Standard Deviation 171.1 |
Secondary
Change From Baseline in Cardiac Troponin
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Day 15 Data not available for the whole population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change From Baseline in Cardiac Troponin | Change from Baseline at D7 | -0.022 ug/L | — |
| Emapalumab | Change From Baseline in Cardiac Troponin | Change from Baseline at D13 | -0.021 ug/L | — |
| Emapalumab | Change From Baseline in Cardiac Troponin | Change from Baseline at D10 | -0.022 ug/L | — |
| Emapalumab | Change From Baseline in Cardiac Troponin | Change from Baseline at D15 | -0.022 ug/L | — |
| Emapalumab | Change From Baseline in Cardiac Troponin | Change from Baseline at D4 | -0.017 ug/L | — |
| Standard of Care | Change From Baseline in Cardiac Troponin | Change from Baseline at D15 | -0.001 ug/L | Standard Deviation 0.001 |
| Standard of Care | Change From Baseline in Cardiac Troponin | Change from Baseline at D4 | 0.002 ug/L | Standard Deviation 0.002 |
| Standard of Care | Change From Baseline in Cardiac Troponin | Change from Baseline at D7 | 0.001 ug/L | Standard Deviation 0.001 |
| Standard of Care | Change From Baseline in Cardiac Troponin | Change from Baseline at D10 | -0.001 ug/L | Standard Deviation 0.001 |
| Standard of Care | Change From Baseline in Cardiac Troponin | Change from Baseline at D13 | -0.001 ug/L | Standard Deviation 0.001 |
Secondary
Change From Baseline in Complement Factors C3/C4
Measured in local units
Time frame: Day 15
Population: Change from baseline at Day 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change From Baseline in Complement Factors C3/C4 | C3 | 0.054 g/L | Standard Deviation 0.094 |
| Emapalumab | Change From Baseline in Complement Factors C3/C4 | C4 | 0.024 g/L | Standard Deviation 0.043 |
| Anakinra | Change From Baseline in Complement Factors C3/C4 | C3 | -0.068 g/L | Standard Deviation 0.222 |
| Anakinra | Change From Baseline in Complement Factors C3/C4 | C4 | -0.108 g/L | Standard Deviation 0.08 |
| Standard of Care | Change From Baseline in Complement Factors C3/C4 | C3 | -0.020 g/L | Standard Deviation 0.581 |
| Standard of Care | Change From Baseline in Complement Factors C3/C4 | C4 | -0.007 g/L | Standard Deviation 0.192 |
Secondary
Change From Baseline in C-Reactive Protein
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Day 15. Data not available for the whole population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change From Baseline in C-Reactive Protein | Change from Baseline D13 | -60.50 mg/L | Standard Deviation 106.66 |
| Emapalumab | Change From Baseline in C-Reactive Protein | Change from Baseline D10 | -60.05 mg/L | Standard Deviation 106.21 |
| Emapalumab | Change From Baseline in C-Reactive Protein | Change from Baseline D4 | -53.73 mg/L | Standard Deviation 98.88 |
| Emapalumab | Change From Baseline in C-Reactive Protein | Change from Baseline D7 | -63.65 mg/L | Standard Deviation 101.74 |
| Emapalumab | Change From Baseline in C-Reactive Protein | Change from Baseline D15 | -38.96 mg/L | Standard Deviation 103.48 |
| Anakinra | Change From Baseline in C-Reactive Protein | Change from Baseline D10 | -20.70 mg/L | Standard Deviation 30.57 |
| Anakinra | Change From Baseline in C-Reactive Protein | Change from Baseline D4 | -20.66 mg/L | Standard Deviation 22.29 |
| Anakinra | Change From Baseline in C-Reactive Protein | Change from Baseline D7 | -19.20 mg/L | Standard Deviation 30.95 |
| Anakinra | Change From Baseline in C-Reactive Protein | Change from Baseline D13 | -8.26 mg/L | Standard Deviation 50.51 |
| Anakinra | Change From Baseline in C-Reactive Protein | Change from Baseline D15 | -8.32 mg/L | Standard Deviation 50.53 |
| Standard of Care | Change From Baseline in C-Reactive Protein | Change from Baseline D15 | -15.26 mg/L | Standard Deviation 12.71 |
| Standard of Care | Change From Baseline in C-Reactive Protein | Change from Baseline D13 | -16.33 mg/L | Standard Deviation 14.27 |
| Standard of Care | Change From Baseline in C-Reactive Protein | Change from Baseline D4 | -12.65 mg/L | Standard Deviation 12.81 |
| Standard of Care | Change From Baseline in C-Reactive Protein | Change from Baseline D10 | -14.60 mg/L | Standard Deviation 15.72 |
| Standard of Care | Change From Baseline in C-Reactive Protein | Change from Baseline D7 | -10.98 mg/L | Standard Deviation 19.57 |
Secondary
Change From Baseline in Creatinine
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Day 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change From Baseline in Creatinine | Change from Baseline D13 | -5.304 umol/L | Standard Deviation 20.171 |
| Emapalumab | Change From Baseline in Creatinine | Change from Baseline D10 | -7.514 umol/L | Standard Deviation 14.481 |
| Emapalumab | Change From Baseline in Creatinine | Change from Baseline D4 | -6.542 umol/L | Standard Deviation 9.43 |
| Emapalumab | Change From Baseline in Creatinine | Change from Baseline D7 | -8.840 umol/L | Standard Deviation 14.454 |
| Emapalumab | Change From Baseline in Creatinine | Change from Baseline D15 | -9.901 umol/L | Standard Deviation 19.281 |
| Anakinra | Change From Baseline in Creatinine | Change from Baseline D10 | 0.000 umol/L | Standard Deviation 5.83 |
| Anakinra | Change From Baseline in Creatinine | Change from Baseline D4 | 1.414 umol/L | Standard Deviation 8.516 |
| Anakinra | Change From Baseline in Creatinine | Change from Baseline D7 | 0.530 umol/L | Standard Deviation 6.893 |
| Anakinra | Change From Baseline in Creatinine | Change from Baseline D13 | 0.000 umol/L | Standard Deviation 8.928 |
| Anakinra | Change From Baseline in Creatinine | Change from Baseline D15 | -0.354 umol/L | Standard Deviation 9.756 |
| Standard of Care | Change From Baseline in Creatinine | Change from Baseline D15 | -5.746 umol/L | Standard Deviation 24.292 |
| Standard of Care | Change From Baseline in Creatinine | Change from Baseline D13 | -1.945 umol/L | Standard Deviation 3.088 |
| Standard of Care | Change From Baseline in Creatinine | Change from Baseline D4 | -6.041 umol/L | Standard Deviation 8.148 |
| Standard of Care | Change From Baseline in Creatinine | Change from Baseline D10 | -0.530 umol/L | Standard Deviation 5.506 |
| Standard of Care | Change From Baseline in Creatinine | Change from Baseline D7 | 0.000 umol/L | Standard Deviation 6.156 |
Secondary
Change From Baseline in D-dimers
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Days 4, 7, 10, 13 and 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change From Baseline in D-dimers | Change from Baseline at D4 | -0.19 nmol/L | Standard Deviation 0.34 |
| Emapalumab | Change From Baseline in D-dimers | Change from Baseline at D13 | -7.99 nmol/L | Standard Deviation 13.4 |
| Emapalumab | Change From Baseline in D-dimers | Change from Baseline at D10 | -10.07 nmol/L | Standard Deviation 18.16 |
| Emapalumab | Change From Baseline in D-dimers | Change from Baseline at D15 | -6.84 nmol/L | Standard Deviation 12.67 |
| Emapalumab | Change From Baseline in D-dimers | Change from Baseline at D7 | -7.37 nmol/L | Standard Deviation 13.84 |
| Anakinra | Change From Baseline in D-dimers | Change from Baseline at D13 | 6.84 nmol/L | Standard Deviation 19.39 |
| Anakinra | Change From Baseline in D-dimers | Change from Baseline at D4 | 5.13 nmol/L | Standard Deviation 14.73 |
| Anakinra | Change From Baseline in D-dimers | Change from Baseline at D7 | 6.78 nmol/L | Standard Deviation 19.41 |
| Anakinra | Change From Baseline in D-dimers | Change from Baseline at D10 | 4.66 nmol/L | Standard Deviation 12.82 |
| Anakinra | Change From Baseline in D-dimers | Change from Baseline at D15 | 6.64 nmol/L | Standard Deviation 19.51 |
| Standard of Care | Change From Baseline in D-dimers | Change from Baseline at D7 | -4.30 nmol/L | Standard Deviation 1.96 |
| Standard of Care | Change From Baseline in D-dimers | Change from Baseline at D13 | -5.67 nmol/L | Standard Deviation 7.11 |
| Standard of Care | Change From Baseline in D-dimers | Change from Baseline at D4 | -2.05 nmol/L | Standard Deviation 1.65 |
| Standard of Care | Change From Baseline in D-dimers | Change from Baseline at D15 | -5.55 nmol/L | Standard Deviation 6.45 |
| Standard of Care | Change From Baseline in D-dimers | Change from Baseline at D10 | -7.18 nmol/L | Standard Deviation 5.96 |
Secondary
Change From Baseline in Ferritin
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Days 4, 7, 10, 13 and 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change From Baseline in Ferritin | Change from Baseline at D13 | -823.1 pmol/L | Standard Deviation 2792.5 |
| Emapalumab | Change From Baseline in Ferritin | Change from Baselind at D10 | -527.5 pmol/L | Standard Deviation 3086.3 |
| Emapalumab | Change From Baseline in Ferritin | Change from Baseline at D4 | -380.8 pmol/L | Standard Deviation 3026.3 |
| Emapalumab | Change From Baseline in Ferritin | Change from Baselind at D7 | 60.5 pmol/L | Standard Deviation 2503.4 |
| Emapalumab | Change From Baseline in Ferritin | Change from baseline at D15 | -506.6 pmol/L | Standard Deviation 2518.2 |
| Anakinra | Change From Baseline in Ferritin | Change from Baselind at D10 | -2066.8 pmol/L | Standard Deviation 3342.9 |
| Anakinra | Change From Baseline in Ferritin | Change from Baseline at D4 | -2864.2 pmol/L | Standard Deviation 3789.3 |
| Anakinra | Change From Baseline in Ferritin | Change from Baselind at D7 | -2179.6 pmol/L | Standard Deviation 3108.3 |
| Anakinra | Change From Baseline in Ferritin | Change from Baseline at D13 | -1931.1 pmol/L | Standard Deviation 3601.8 |
| Anakinra | Change From Baseline in Ferritin | Change from baseline at D15 | -2045.2 pmol/L | Standard Deviation 3627.7 |
| Standard of Care | Change From Baseline in Ferritin | Change from baseline at D15 | -842.6 pmol/L | Standard Deviation 1020 |
| Standard of Care | Change From Baseline in Ferritin | Change from Baseline at D13 | -1260.6 pmol/L | Standard Deviation 781.7 |
| Standard of Care | Change From Baseline in Ferritin | Change from Baseline at D4 | -770.2 pmol/L | Standard Deviation 1093 |
| Standard of Care | Change From Baseline in Ferritin | Change from Baselind at D10 | -1295.0 pmol/L | Standard Deviation 359.8 |
| Standard of Care | Change From Baseline in Ferritin | Change from Baselind at D7 | -1103.3 pmol/L | Standard Deviation 168.4 |
Secondary
Change From Baseline in Fibrinogen
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Days 4, 7, 10, 13 and 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change From Baseline in Fibrinogen | Change from baseline at D13 | -2.587 umol/L | Standard Deviation 9.308 |
| Emapalumab | Change From Baseline in Fibrinogen | Change from baseline at D10 | -3.535 umol/L | Standard Deviation 8.998 |
| Emapalumab | Change From Baseline in Fibrinogen | Change from baseline at D4 | -1.435 umol/L | Standard Deviation 3.137 |
| Emapalumab | Change From Baseline in Fibrinogen | Change from baseline at D7 | -3.925 umol/L | Standard Deviation 6.113 |
| Emapalumab | Change From Baseline in Fibrinogen | Change from baseline at D15 | -0.588 umol/L | Standard Deviation 9.21 |
| Anakinra | Change From Baseline in Fibrinogen | Change from baseline at D10 | -4.980 umol/L | Standard Deviation 2.625 |
| Anakinra | Change From Baseline in Fibrinogen | Change from baseline at D4 | -2.434 umol/L | Standard Deviation 1.83 |
| Anakinra | Change From Baseline in Fibrinogen | Change from baseline at D7 | -4.898 umol/L | Standard Deviation 2.61 |
| Anakinra | Change From Baseline in Fibrinogen | Change from baseline at D13 | -6.227 umol/L | Standard Deviation 2.627 |
| Anakinra | Change From Baseline in Fibrinogen | Change from baseline at D15 | -6.380 umol/L | Standard Deviation 2.357 |
| Standard of Care | Change From Baseline in Fibrinogen | Change from baseline at D15 | -4.596 umol/L | Standard Deviation 5.624 |
| Standard of Care | Change From Baseline in Fibrinogen | Change from baseline at D13 | -5.479 umol/L | Standard Deviation 5.027 |
| Standard of Care | Change From Baseline in Fibrinogen | Change from baseline at D4 | -0.088 umol/L | Standard Deviation 4.582 |
| Standard of Care | Change From Baseline in Fibrinogen | Change from baseline at D10 | -5.562 umol/L | Standard Deviation 5.089 |
| Standard of Care | Change From Baseline in Fibrinogen | Change from baseline at D7 | -1.147 umol/L | Standard Deviation 7.883 |
Secondary
Change From Baseline in Hemoglobin
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Days 4, 7, 10, 13 and 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change From Baseline in Hemoglobin | Change from baseline at D13 | -10.8 g/L | Standard Deviation 36.8 |
| Emapalumab | Change From Baseline in Hemoglobin | Change from baseline at D10 | -11.3 g/L | Standard Deviation 24.5 |
| Emapalumab | Change From Baseline in Hemoglobin | Change from baseline at D4 | -6.2 g/L | Standard Deviation 14.6 |
| Emapalumab | Change From Baseline in Hemoglobin | Change from baseline at D7 | -9.3 g/L | Standard Deviation 21.3 |
| Emapalumab | Change From Baseline in Hemoglobin | Change from baseline at D15 | -14.0 g/L | Standard Deviation 28.8 |
| Anakinra | Change From Baseline in Hemoglobin | Change from baseline at D10 | 6.6 g/L | Standard Deviation 11.9 |
| Anakinra | Change From Baseline in Hemoglobin | Change from baseline at D4 | 0.8 g/L | Standard Deviation 7 |
| Anakinra | Change From Baseline in Hemoglobin | Change from baseline at D7 | 0.8 g/L | Standard Deviation 13.1 |
| Anakinra | Change From Baseline in Hemoglobin | Change from baseline at D13 | 2.8 g/L | Standard Deviation 13.6 |
| Anakinra | Change From Baseline in Hemoglobin | Change from baseline at D15 | 0.00 g/L | Standard Deviation 15.6 |
| Standard of Care | Change From Baseline in Hemoglobin | Change from baseline at D15 | -3.7 g/L | Standard Deviation 16.9 |
| Standard of Care | Change From Baseline in Hemoglobin | Change from baseline at D13 | -8.2 g/L | Standard Deviation 17.3 |
| Standard of Care | Change From Baseline in Hemoglobin | Change from baseline at D4 | -3.5 g/L | Standard Deviation 9.1 |
| Standard of Care | Change From Baseline in Hemoglobin | Change from baseline at D10 | -8.0 g/L | Standard Deviation 16 |
| Standard of Care | Change From Baseline in Hemoglobin | Change from baseline at D7 | -6.2 g/L | Standard Deviation 10.7 |
Secondary
Change From Baseline in Lactate Dehydrogenase (LDH)
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Days 4, 7, 10, 13 and 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at D15 | -163.6 U/L | Standard Deviation 252.4 |
| Emapalumab | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at D10 | -184.3 U/L | Standard Deviation 200.2 |
| Emapalumab | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at D7 | -164.3 U/L | Standard Deviation 267.4 |
| Emapalumab | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at D13 | -185.3 U/L | Standard Deviation 260.9 |
| Emapalumab | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at D4 | -128.3 U/L | Standard Deviation 160.9 |
| Anakinra | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at D13 | -2.6 U/L | Standard Deviation 264.4 |
| Anakinra | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at D15 | -20.6 U/L | Standard Deviation 274.8 |
| Anakinra | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at D4 | -31.8 U/L | Standard Deviation 13 |
| Anakinra | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at D7 | -16.8 U/L | Standard Deviation 162.9 |
| Anakinra | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at D10 | -60.4 U/L | Standard Deviation 76.4 |
| Standard of Care | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at D4 | -70.4 U/L | Standard Deviation 85.5 |
| Standard of Care | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at D15 | -158.4 U/L | Standard Deviation 108.3 |
| Standard of Care | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at D10 | -143.5 U/L | Standard Deviation 128.7 |
| Standard of Care | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at D13 | -155.0 U/L | Standard Deviation 121 |
| Standard of Care | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at D7 | -96.0 U/L | Standard Deviation 107.3 |
Secondary
Change From Baseline in Modified Early Warning System Score
The full (unabbreviated) scale name is Modified Early Warning system score (MEWS score) Measured in total score Total score is the sum of 5 categorized components (blood pressure, heart rate, respiratory rate, temperature and alert/voice/pain/unresponsive score) that are assigned a score between 0 and 2 or 0 and 3. MEWS total score range is 0 to 14. Higher score= worse outcome
Time frame: Baseline, Day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emapalumab | Change From Baseline in Modified Early Warning System Score | -1.00 scores on a scale | Standard Deviation 0 |
| Anakinra | Change From Baseline in Modified Early Warning System Score | 0.00 scores on a scale | Standard Deviation 0.82 |
| Standard of Care | Change From Baseline in Modified Early Warning System Score | -0.75 scores on a scale | Standard Deviation 0.96 |
Secondary
Change From Baseline in Oxygen Supplementation
Measured in l/min
Time frame: Baseline, Days 4, 7, 10, 13 and 15.
Population: Change from baseline at Days 4, 7, 10, 13 and 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change From Baseline in Oxygen Supplementation | Change from baseline at D13 | -4.3 L/min | Standard Deviation 8.1 |
| Emapalumab | Change From Baseline in Oxygen Supplementation | Change from baseline at D10 | -3.3 L/min | Standard Deviation 6.9 |
| Emapalumab | Change From Baseline in Oxygen Supplementation | Change from baseline at D4 | 0.0 L/min | Standard Deviation 0 |
| Emapalumab | Change From Baseline in Oxygen Supplementation | Change from baseline at D7 | -1.0 L/min | Standard Deviation 5.8 |
| Emapalumab | Change From Baseline in Oxygen Supplementation | Change from baseline at D15 | -3.6 L/min | Standard Deviation 9.3 |
| Anakinra | Change From Baseline in Oxygen Supplementation | Change from baseline at D10 | -2.3 L/min | Standard Deviation 6.2 |
| Anakinra | Change From Baseline in Oxygen Supplementation | Change from baseline at D4 | 2.8 L/min | Standard Deviation 5.5 |
| Anakinra | Change From Baseline in Oxygen Supplementation | Change from baseline at D7 | -1.8 L/min | Standard Deviation 4.8 |
| Anakinra | Change From Baseline in Oxygen Supplementation | Change from baseline at D13 | -3.3 L/min | Standard Deviation 7.8 |
| Anakinra | Change From Baseline in Oxygen Supplementation | Change from baseline at D15 | -4.3 L/min | Standard Deviation 7.9 |
| Standard of Care | Change From Baseline in Oxygen Supplementation | Change from baseline at D15 | -15.3 L/min | Standard Deviation 19.3 |
| Standard of Care | Change From Baseline in Oxygen Supplementation | Change from baseline at D13 | -20.0 L/min | Standard Deviation 17 |
| Standard of Care | Change From Baseline in Oxygen Supplementation | Change from baseline at D4 | -0.2 L/min | Standard Deviation 9.5 |
| Standard of Care | Change From Baseline in Oxygen Supplementation | Change from baseline at D10 | -17.8 L/min | Standard Deviation 18.2 |
| Standard of Care | Change From Baseline in Oxygen Supplementation | Change from baseline at D7 | -7.8 L/min | Standard Deviation 9.1 |
Secondary
Change From Baseline in Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2)
Measured in mmHg
Time frame: Baseline, Day 15
Population: Change from baseline at Day 15 Data not available for the whole population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emapalumab | Change From Baseline in Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2) | 28.98 mmHg | Standard Deviation 106.66 |
| Anakinra | Change From Baseline in Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2) | 51.19 mmHg | — |
| Standard of Care | Change From Baseline in Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2) | 156.72 mmHg | Standard Deviation 113.53 |
Secondary
Change From Baseline in Platelet Count
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Day 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change From Baseline in Platelet Count | Change from baseline at D13 | -32.0 10^9 cells /L | Standard Deviation 126.5 |
| Emapalumab | Change From Baseline in Platelet Count | Change from baseline at D10 | -3.8 10^9 cells /L | Standard Deviation 142.5 |
| Emapalumab | Change From Baseline in Platelet Count | Change from baseline at D4 | 29.0 10^9 cells /L | Standard Deviation 77.2 |
| Emapalumab | Change From Baseline in Platelet Count | Change from baseline at D7 | 19.8 10^9 cells /L | Standard Deviation 116.6 |
| Emapalumab | Change From Baseline in Platelet Count | Change from baseline at D15 | -37.6 10^9 cells /L | Standard Deviation 129 |
| Anakinra | Change From Baseline in Platelet Count | Change from baseline at D10 | 129.8 10^9 cells /L | Standard Deviation 223.9 |
| Anakinra | Change From Baseline in Platelet Count | Change from baseline at D4 | 85.4 10^9 cells /L | Standard Deviation 76.7 |
| Anakinra | Change From Baseline in Platelet Count | Change from baseline at D7 | 140.4 10^9 cells /L | Standard Deviation 191.8 |
| Anakinra | Change From Baseline in Platelet Count | Change from baseline at D13 | 80.8 10^9 cells /L | Standard Deviation 213.2 |
| Anakinra | Change From Baseline in Platelet Count | Change from baseline at D15 | 41.2 10^9 cells /L | Standard Deviation 169.3 |
| Standard of Care | Change From Baseline in Platelet Count | Change from baseline at D15 | -67.2 10^9 cells /L | Standard Deviation 158.1 |
| Standard of Care | Change From Baseline in Platelet Count | Change from baseline at D13 | -53.8 10^9 cells /L | Standard Deviation 191.9 |
| Standard of Care | Change From Baseline in Platelet Count | Change from baseline at D4 | 9.8 10^9 cells /L | Standard Deviation 153.7 |
| Standard of Care | Change From Baseline in Platelet Count | Change from baseline at D10 | 9.0 10^9 cells /L | Standard Deviation 232.8 |
| Standard of Care | Change From Baseline in Platelet Count | Change from baseline at D7 | 47.4 10^9 cells /L | Standard Deviation 232.9 |
Secondary
Change From Baseline in Prothrombin Time
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Day 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change From Baseline in Prothrombin Time | Change from Baseline at D13 | -2.250 sec | Standard Deviation 0.354 |
| Emapalumab | Change From Baseline in Prothrombin Time | Change from Baseline at D10 | -1.003 sec | Standard Deviation 0.895 |
| Emapalumab | Change From Baseline in Prothrombin Time | Change from baseline at D4 | -0.867 sec | Standard Deviation 0.058 |
| Emapalumab | Change From Baseline in Prothrombin Time | Change from baseline at D7 | -1.250 sec | Standard Deviation 0.071 |
| Emapalumab | Change From Baseline in Prothrombin Time | Change from baseline at D15 | -1.278 sec | Standard Deviation 1.087 |
| Anakinra | Change From Baseline in Prothrombin Time | Change from Baseline at D10 | -0.150 sec | Standard Deviation 0.919 |
| Anakinra | Change From Baseline in Prothrombin Time | Change from baseline at D4 | 0750 sec | Standard Deviation 0.071 |
| Anakinra | Change From Baseline in Prothrombin Time | Change from baseline at D7 | 0.300 sec | Standard Deviation 0.283 |
| Anakinra | Change From Baseline in Prothrombin Time | Change from Baseline at D13 | 0.050 sec | Standard Deviation 0.495 |
| Anakinra | Change From Baseline in Prothrombin Time | Change from baseline at D15 | -0.150 sec | Standard Deviation 0.778 |
| Standard of Care | Change From Baseline in Prothrombin Time | Change from baseline at D15 | -0.800 sec | Standard Deviation 1.697 |
| Standard of Care | Change From Baseline in Prothrombin Time | Change from Baseline at D13 | -1.600 sec | — |
| Standard of Care | Change From Baseline in Prothrombin Time | Change from baseline at D4 | -0.550 sec | Standard Deviation 1.344 |
| Standard of Care | Change From Baseline in Prothrombin Time | Change from Baseline at D10 | -1.700 sec | — |
| Standard of Care | Change From Baseline in Prothrombin Time | Change from baseline at D7 | -2.100 sec | — |
Secondary
Change From Baseline in Red Blood Counts
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Days 4, 7, 10, 13 and 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change From Baseline in Red Blood Counts | Change from baseline at D13 | -0.350 10^12 cells/L | Standard Deviation 1.254 |
| Emapalumab | Change From Baseline in Red Blood Counts | Change from baseline at D10 | -0.415 10^12 cells/L | Standard Deviation 0.875 |
| Emapalumab | Change From Baseline in Red Blood Counts | Change from baseline at D4 | -0.260 10^12 cells/L | Standard Deviation 0.47 |
| Emapalumab | Change From Baseline in Red Blood Counts | Change from baseline at D7 | -0.385 10^12 cells/L | Standard Deviation 0.732 |
| Emapalumab | Change From Baseline in Red Blood Counts | Change from baseline at D15 | -0.510 10^12 cells/L | Standard Deviation 0.969 |
| Anakinra | Change From Baseline in Red Blood Counts | Change from baseline at D10 | 0.220 10^12 cells/L | Standard Deviation 0.435 |
| Anakinra | Change From Baseline in Red Blood Counts | Change from baseline at D4 | -0.022 10^12 cells/L | Standard Deviation 0.351 |
| Anakinra | Change From Baseline in Red Blood Counts | Change from baseline at D7 | 0.016 10^12 cells/L | Standard Deviation 0.422 |
| Anakinra | Change From Baseline in Red Blood Counts | Change from baseline at D13 | 0.106 10^12 cells/L | Standard Deviation 0.395 |
| Anakinra | Change From Baseline in Red Blood Counts | Change from baseline at D15 | 0.004 10^12 cells/L | Standard Deviation 0.531 |
| Standard of Care | Change From Baseline in Red Blood Counts | Change from baseline at D15 | -0.163 10^12 cells/L | Standard Deviation 0.571 |
| Standard of Care | Change From Baseline in Red Blood Counts | Change from baseline at D13 | -0.275 10^12 cells/L | Standard Deviation 0.564 |
| Standard of Care | Change From Baseline in Red Blood Counts | Change from baseline at D4 | -0.108 10^12 cells/L | Standard Deviation 0.359 |
| Standard of Care | Change From Baseline in Red Blood Counts | Change from baseline at D10 | -0.262 10^12 cells/L | Standard Deviation 0.549 |
| Standard of Care | Change From Baseline in Red Blood Counts | Change from baseline at D7 | -0.196 10^12 cells/L | Standard Deviation 0.465 |
Secondary
Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2)
Measured in percent (%)
Time frame: Baseline, 3 assessments every Days 4, 7, 10, 13 and 15
Population: Change from baseline at Days 4, 7, 10, 13 and 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2) | Change from baseline at D13 | 1.358 SpO2% | Standard Deviation 2.14 |
| Emapalumab | Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2) | Change from baseline at D10 | 0.625 SpO2% | Standard Deviation 3.523 |
| Emapalumab | Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2) | Change from baseline at D4 | -0.667 SpO2% | Standard Deviation 3.598 |
| Emapalumab | Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2) | Change from baseline at D7 | 0.867 SpO2% | Standard Deviation 2.923 |
| Emapalumab | Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2) | Change from baseline at D15 | -1.640 SpO2% | Standard Deviation 3.383 |
| Anakinra | Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2) | Change from baseline at D10 | 0.267 SpO2% | Standard Deviation 1.754 |
| Anakinra | Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2) | Change from baseline at D4 | 0.267 SpO2% | Standard Deviation 2.06 |
| Anakinra | Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2) | Change from baseline at D7 | 0.667 SpO2% | Standard Deviation 1.748 |
| Anakinra | Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2) | Change from baseline at D13 | -2.233 SpO2% | Standard Deviation 6.098 |
| Anakinra | Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2) | Change from baseline at D15 | -2.400 SpO2% | Standard Deviation 5.771 |
| Standard of Care | Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2) | Change from baseline at D15 | 2.944 SpO2% | Standard Deviation 2.84 |
| Standard of Care | Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2) | Change from baseline at D13 | 1.600 SpO2% | Standard Deviation 3.639 |
| Standard of Care | Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2) | Change from baseline at D4 | 0.722 SpO2% | Standard Deviation 2.603 |
| Standard of Care | Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2) | Change from baseline at D10 | 2.333 SpO2% | Standard Deviation 3.528 |
| Standard of Care | Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2) | Change from baseline at D7 | 2.000 SpO2% | Standard Deviation 2.415 |
Secondary
Change From Baseline in Total Bilirubin Levels
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Day 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change From Baseline in Total Bilirubin Levels | Change from Baseline at D15 | -3.523 umol/L | Standard Deviation 4.473 |
| Emapalumab | Change From Baseline in Total Bilirubin Levels | Change from Baseline D10 | -0.385 umol/L | Standard Deviation 4.598 |
| Emapalumab | Change From Baseline in Total Bilirubin Levels | Change from Baseline D7 | -1.496 umol/L | Standard Deviation 4.011 |
| Emapalumab | Change From Baseline in Total Bilirubin Levels | Change from Baseline at D4 | -0.171 umol/L | Standard Deviation 3.519 |
| Emapalumab | Change From Baseline in Total Bilirubin Levels | Change from Baseline D13 | -1.710 umol/L | Standard Deviation 4.413 |
| Anakinra | Change From Baseline in Total Bilirubin Levels | Change from Baseline at D4 | -1.129 umol/L | Standard Deviation 12.314 |
| Anakinra | Change From Baseline in Total Bilirubin Levels | Change from Baseline at D15 | 14.125 umol/L | Standard Deviation 29.771 |
| Anakinra | Change From Baseline in Total Bilirubin Levels | Change from Baseline D13 | 13.885 umol/L | Standard Deviation 30.276 |
| Anakinra | Change From Baseline in Total Bilirubin Levels | Change from Baseline D10 | 4.685 umol/L | Standard Deviation 21.108 |
| Anakinra | Change From Baseline in Total Bilirubin Levels | Change from Baseline D7 | -0.376 umol/L | Standard Deviation 15.492 |
| Standard of Care | Change From Baseline in Total Bilirubin Levels | Change from Baseline at D15 | -0.057 umol/L | Standard Deviation 9.046 |
| Standard of Care | Change From Baseline in Total Bilirubin Levels | Change from Baseline D10 | 0.787 umol/L | Standard Deviation 11.931 |
| Standard of Care | Change From Baseline in Total Bilirubin Levels | Change from Baseline at D4 | 0.376 umol/L | Standard Deviation 2.6 |
| Standard of Care | Change From Baseline in Total Bilirubin Levels | Change from Baseline D13 | 3.591 umol/L | Standard Deviation 14.146 |
| Standard of Care | Change From Baseline in Total Bilirubin Levels | Change from Baseline D7 | 0.684 umol/L | Standard Deviation 9.922 |
Secondary
Change From Baseline in White Blood Cells With Differential Counts
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Days 4, 7, 10, 13 and 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change From Baseline in White Blood Cells With Differential Counts | Change from baseline at D13 | 1.548 10^9 cells /L | Standard Deviation 5.265 |
| Emapalumab | Change From Baseline in White Blood Cells With Differential Counts | Change from baseline at D10 | 2.728 10^9 cells /L | Standard Deviation 1.867 |
| Emapalumab | Change From Baseline in White Blood Cells With Differential Counts | Change from baseline at D4 | 1.000 10^9 cells /L | Standard Deviation 4.408 |
| Emapalumab | Change From Baseline in White Blood Cells With Differential Counts | Change from baseline at D7 | 0.340 10^9 cells /L | Standard Deviation 2.623 |
| Emapalumab | Change From Baseline in White Blood Cells With Differential Counts | Change from baseline at D15 | 1.686 10^9 cells /L | Standard Deviation 4.395 |
| Anakinra | Change From Baseline in White Blood Cells With Differential Counts | Change from baseline at D10 | 4.796 10^9 cells /L | Standard Deviation 3.091 |
| Anakinra | Change From Baseline in White Blood Cells With Differential Counts | Change from baseline at D4 | 0.294 10^9 cells /L | Standard Deviation 0.886 |
| Anakinra | Change From Baseline in White Blood Cells With Differential Counts | Change from baseline at D7 | 2.812 10^9 cells /L | Standard Deviation 2.953 |
| Anakinra | Change From Baseline in White Blood Cells With Differential Counts | Change from baseline at D13 | 1.588 10^9 cells /L | Standard Deviation 2.653 |
| Anakinra | Change From Baseline in White Blood Cells With Differential Counts | Change from baseline at D15 | 1.070 10^9 cells /L | Standard Deviation 2.42 |
| Standard of Care | Change From Baseline in White Blood Cells With Differential Counts | Change from baseline at D15 | 1.878 10^9 cells /L | Standard Deviation 4.788 |
| Standard of Care | Change From Baseline in White Blood Cells With Differential Counts | Change from baseline at D13 | -0.318 10^9 cells /L | Standard Deviation 4.079 |
| Standard of Care | Change From Baseline in White Blood Cells With Differential Counts | Change from baseline at D4 | 0.332 10^9 cells /L | Standard Deviation 3.009 |
| Standard of Care | Change From Baseline in White Blood Cells With Differential Counts | Change from baseline at D10 | 0.806 10^9 cells /L | Standard Deviation 3.643 |
| Standard of Care | Change From Baseline in White Blood Cells With Differential Counts | Change from baseline at D7 | 1.738 10^9 cells /L | Standard Deviation 4.165 |
Secondary
Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Days 4, 7, 10, 13 and 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline | Change from baseline at D13 | 0.30 mmHg | Standard Deviation 9.48 |
| Emapalumab | Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline | Change from baseline at D10 | 2.33 mmHg | Standard Deviation 6.03 |
| Emapalumab | Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline | Change from baseline at D4 | 0.00 mmHg | Standard Deviation 7.21 |
| Emapalumab | Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline | Change from baseline at D7 | -0.33 mmHg | Standard Deviation 9.45 |
| Emapalumab | Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline | Change from baseline at D15 | 0.77 mmHg | Standard Deviation 8.33 |
| Anakinra | Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline | Change from baseline at D10 | 3.67 mmHg | Standard Deviation 8.08 |
| Anakinra | Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline | Change from baseline at D4 | -1.00 mmHg | Standard Deviation 3.46 |
| Anakinra | Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline | Change from baseline at D7 | 1.00 mmHg | Standard Deviation 1.41 |
| Anakinra | Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline | Change from baseline at D13 | 6.50 mmHg | Standard Deviation 3.54 |
| Anakinra | Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline | Change from baseline at D15 | 3.75 mmHg | Standard Deviation 5.74 |
| Standard of Care | Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline | Change from baseline at D15 | 4.00 mmHg | Standard Deviation 5.1 |
| Standard of Care | Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline | Change from baseline at D13 | 0.25 mmHg | Standard Deviation 4.11 |
| Standard of Care | Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline | Change from baseline at D4 | 2.00 mmHg | Standard Deviation 5.77 |
| Standard of Care | Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline | Change from baseline at D10 | 4.20 mmHg | Standard Deviation 5.12 |
| Standard of Care | Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline | Change from baseline at D7 | 5.46 mmHg | Standard Deviation 5.68 |
Secondary
Change of Chloride in Hemogasanalysis From Baseline
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Days 4, 7, 10, 13 and 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change of Chloride in Hemogasanalysis From Baseline | Change from baseline at D13 | -1.0 mmol/L | — |
| Emapalumab | Change of Chloride in Hemogasanalysis From Baseline | Change from baseline at D10 | 0.0 mmol/L | Standard Deviation 2.8 |
| Emapalumab | Change of Chloride in Hemogasanalysis From Baseline | Change from baseline at D4 | 2.0 mmol/L | Standard Deviation 5.7 |
| Emapalumab | Change of Chloride in Hemogasanalysis From Baseline | Change from baseline at D7 | 0.5 mmol/L | Standard Deviation 0.7 |
| Emapalumab | Change of Chloride in Hemogasanalysis From Baseline | Change from baseline at D15 | 2.0 mmol/L | Standard Deviation 4.2 |
| Anakinra | Change of Chloride in Hemogasanalysis From Baseline | Change from baseline at D10 | -4.5 mmol/L | Standard Deviation 3.5 |
| Anakinra | Change of Chloride in Hemogasanalysis From Baseline | Change from baseline at D4 | -0.5 mmol/L | Standard Deviation 2.1 |
| Anakinra | Change of Chloride in Hemogasanalysis From Baseline | Change from baseline at D7 | -4.0 mmol/L | — |
| Anakinra | Change of Chloride in Hemogasanalysis From Baseline | Change from baseline at D13 | -4.0 mmol/L | — |
| Anakinra | Change of Chloride in Hemogasanalysis From Baseline | Change from baseline at D15 | -2.0 mmol/L | Standard Deviation 3 |
| Standard of Care | Change of Chloride in Hemogasanalysis From Baseline | Change from baseline at D15 | 3.0 mmol/L | Standard Deviation 2.8 |
| Standard of Care | Change of Chloride in Hemogasanalysis From Baseline | Change from baseline at D13 | 3.0 mmol/L | — |
| Standard of Care | Change of Chloride in Hemogasanalysis From Baseline | Change from baseline at D4 | 1.5 mmol/L | Standard Deviation 2.1 |
| Standard of Care | Change of Chloride in Hemogasanalysis From Baseline | Change from baseline at D10 | 4.0 mmol/L | Standard Deviation 1.4 |
| Standard of Care | Change of Chloride in Hemogasanalysis From Baseline | Change from baseline at D7 | 2.5 mmol/L | Standard Deviation 0.7 |
Secondary
Change of Hemoglobin in Hemogasanalysis From Baseline
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Days 4, 7, 10, 13 and 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change of Hemoglobin in Hemogasanalysis From Baseline | Change from baseline at D13 | -73.0 g/L | — |
| Emapalumab | Change of Hemoglobin in Hemogasanalysis From Baseline | Change from baseline at D10 | -34.0 g/L | Standard Deviation 62.2 |
| Emapalumab | Change of Hemoglobin in Hemogasanalysis From Baseline | Change from baseline at D4 | -34.0 g/L | Standard Deviation 46.7 |
| Emapalumab | Change of Hemoglobin in Hemogasanalysis From Baseline | Change from baseline at D7 | -41.0 g/L | Standard Deviation 65.1 |
| Emapalumab | Change of Hemoglobin in Hemogasanalysis From Baseline | Change from baseline at D15 | -38.0 g/L | Standard Deviation 49.5 |
| Anakinra | Change of Hemoglobin in Hemogasanalysis From Baseline | Change from baseline at D10 | 7.5 g/L | Standard Deviation 6.4 |
| Anakinra | Change of Hemoglobin in Hemogasanalysis From Baseline | Change from baseline at D4 | -15.5 g/L | Standard Deviation 10.6 |
| Anakinra | Change of Hemoglobin in Hemogasanalysis From Baseline | Change from baseline at D7 | 3.0 g/L | — |
| Anakinra | Change of Hemoglobin in Hemogasanalysis From Baseline | Change from baseline at D13 | 2.0 g/L | — |
| Anakinra | Change of Hemoglobin in Hemogasanalysis From Baseline | Change from baseline at D15 | -3.0 g/L | Standard Deviation 18 |
| Standard of Care | Change of Hemoglobin in Hemogasanalysis From Baseline | Change from baseline at D15 | -4.0 g/L | Standard Deviation 15.9 |
| Standard of Care | Change of Hemoglobin in Hemogasanalysis From Baseline | Change from baseline at D13 | -6.5 g/L | Standard Deviation 20.5 |
| Standard of Care | Change of Hemoglobin in Hemogasanalysis From Baseline | Change from baseline at D4 | 8.0 g/L | Standard Deviation 2.8 |
| Standard of Care | Change of Hemoglobin in Hemogasanalysis From Baseline | Change from baseline at D10 | -1.7 g/L | Standard Deviation 9.5 |
| Standard of Care | Change of Hemoglobin in Hemogasanalysis From Baseline | Change from baseline at D7 | 6.7 g/L | Standard Deviation 1.5 |
Secondary
Change of Lactic Acid in Hemogasanalysis From Baseline
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Days 4, 7, 10, 13 and 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change of Lactic Acid in Hemogasanalysis From Baseline | Change from baseline at D15 | 0.00 mmol/L | — |
| Emapalumab | Change of Lactic Acid in Hemogasanalysis From Baseline | Change from baseline at D4 | 0.20 mmol/L | — |
| Emapalumab | Change of Lactic Acid in Hemogasanalysis From Baseline | Change from baseline at D10 | 0.90 mmol/L | — |
| Emapalumab | Change of Lactic Acid in Hemogasanalysis From Baseline | Change from baseline at D7 | 0.70 mmol/L | — |
| Anakinra | Change of Lactic Acid in Hemogasanalysis From Baseline | Change from baseline at D10 | 1.20 mmol/L | Standard Deviation 0.17 |
| Anakinra | Change of Lactic Acid in Hemogasanalysis From Baseline | Change from baseline at D4 | 0.00 mmol/L | Standard Deviation 0.28 |
| Anakinra | Change of Lactic Acid in Hemogasanalysis From Baseline | Change from baseline at D7 | 1.80 mmol/L | — |
| Anakinra | Change of Lactic Acid in Hemogasanalysis From Baseline | Change from baseline at D13 | 0.10 mmol/L | — |
| Anakinra | Change of Lactic Acid in Hemogasanalysis From Baseline | Change from baseline at D15 | 1.27 mmol/L | Standard Deviation 1.16 |
| Standard of Care | Change of Lactic Acid in Hemogasanalysis From Baseline | Change from baseline at D15 | -0.05 mmol/L | Standard Deviation 0.07 |
| Standard of Care | Change of Lactic Acid in Hemogasanalysis From Baseline | Change from baseline at D13 | 0.20 mmol/L | — |
| Standard of Care | Change of Lactic Acid in Hemogasanalysis From Baseline | Change from baseline at D4 | -0.45 mmol/L | Standard Deviation 1.2 |
| Standard of Care | Change of Lactic Acid in Hemogasanalysis From Baseline | Change from baseline at D7 | 0.00 mmol/L | Standard Deviation 0.85 |
| Standard of Care | Change of Lactic Acid in Hemogasanalysis From Baseline | Change from baseline at D10 | -0.50 mmol/L | Standard Deviation 0.28 |
Secondary
Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Days 4, 7, 10, 13 and 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline | Change from baseline at D13 | 18.00 mmHg | Standard Deviation 84.85 |
| Emapalumab | Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline | Change from baseline at D10 | 4.00 mmHg | Standard Deviation 37.36 |
| Emapalumab | Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline | Change from baseline at D4 | 19.33 mmHg | Standard Deviation 44.28 |
| Emapalumab | Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline | Change from baseline at D7 | 19.33 mmHg | Standard Deviation 36.56 |
| Emapalumab | Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline | Change from baseline at D15 | 17.57 mmHg | Standard Deviation 61.05 |
| Anakinra | Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline | Change from baseline at D10 | -1.33 mmHg | Standard Deviation 11.93 |
| Anakinra | Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline | Change from baseline at D4 | 40.67 mmHg | Standard Deviation 34.78 |
| Anakinra | Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline | Change from baseline at D7 | 18.50 mmHg | Standard Deviation 13.44 |
| Anakinra | Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline | Change from baseline at D13 | -12.00 mmHg | Standard Deviation 5.66 |
| Anakinra | Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline | Change from baseline at D15 | 8.75 mmHg | Standard Deviation 47.84 |
| Standard of Care | Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline | Change from baseline at D15 | 8.80 mmHg | Standard Deviation 21.37 |
| Standard of Care | Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline | Change from baseline at D13 | 24.25 mmHg | Standard Deviation 36.04 |
| Standard of Care | Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline | Change from baseline at D4 | 5.75 mmHg | Standard Deviation 16.92 |
| Standard of Care | Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline | Change from baseline at D10 | 4.00 mmHg | Standard Deviation 43.73 |
| Standard of Care | Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline | Change from baseline at D7 | 23.64 mmHg | Standard Deviation 35.04 |
Secondary
Change of Potassium in Hemogasanalysis From Baseline
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Days 4, 7, 10, 13 and 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change of Potassium in Hemogasanalysis From Baseline | Change from baseline at D13 | -0.50 mmol/L | — |
| Emapalumab | Change of Potassium in Hemogasanalysis From Baseline | Change from baseline at D10 | 0.25 mmol/L | Standard Deviation 0.92 |
| Emapalumab | Change of Potassium in Hemogasanalysis From Baseline | Change from baseline at D4 | 0.55 mmol/L | Standard Deviation 0.92 |
| Emapalumab | Change of Potassium in Hemogasanalysis From Baseline | Change from baseline at D7 | 0.45 mmol/L | Standard Deviation 1.2 |
| Emapalumab | Change of Potassium in Hemogasanalysis From Baseline | Change from baseline at D15 | 0.00 mmol/L | Standard Deviation 0.71 |
| Anakinra | Change of Potassium in Hemogasanalysis From Baseline | Change from baseline at D10 | 0.25 mmol/L | Standard Deviation 0.49 |
| Anakinra | Change of Potassium in Hemogasanalysis From Baseline | Change from baseline at D4 | -0.35 mmol/L | Standard Deviation 0.49 |
| Anakinra | Change of Potassium in Hemogasanalysis From Baseline | Change from baseline at D7 | 0.40 mmol/L | — |
| Anakinra | Change of Potassium in Hemogasanalysis From Baseline | Change from baseline at D13 | 0.10 mmol/L | — |
| Anakinra | Change of Potassium in Hemogasanalysis From Baseline | Change from baseline at D15 | 0.03 mmol/L | Standard Deviation 0.75 |
| Standard of Care | Change of Potassium in Hemogasanalysis From Baseline | Change from baseline at D15 | 0.17 mmol/L | Standard Deviation 0.47 |
| Standard of Care | Change of Potassium in Hemogasanalysis From Baseline | Change from baseline at D13 | 0.10 mmol/L | Standard Deviation 0.85 |
| Standard of Care | Change of Potassium in Hemogasanalysis From Baseline | Change from baseline at D4 | 0.45 mmol/L | Standard Deviation 1.34 |
| Standard of Care | Change of Potassium in Hemogasanalysis From Baseline | Change from baseline at D10 | 0.43 mmol/L | Standard Deviation 1.22 |
| Standard of Care | Change of Potassium in Hemogasanalysis From Baseline | Change from baseline at D7 | 0.53 mmol/L | Standard Deviation 0.93 |
Secondary
Change of Sodium in Hemogasanalysis From Baseline
Measured in local units
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Population: Change from baseline at Days 4, 7, 10, 13 and 15 Data not available for all patients at all timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emapalumab | Change of Sodium in Hemogasanalysis From Baseline | Change from baseline at D13 | -2.0 mmol/L | — |
| Emapalumab | Change of Sodium in Hemogasanalysis From Baseline | Change from baseline at D10 | 2.0 mmol/L | Standard Deviation 4.2 |
| Emapalumab | Change of Sodium in Hemogasanalysis From Baseline | Change from baseline at D4 | 3.0 mmol/L | Standard Deviation 5.7 |
| Emapalumab | Change of Sodium in Hemogasanalysis From Baseline | Change from baseline at D7 | 1.0 mmol/L | Standard Deviation 1.4 |
| Emapalumab | Change of Sodium in Hemogasanalysis From Baseline | Change from Baseline at D15 | 2.5 mmol/L | Standard Deviation 6.4 |
| Anakinra | Change of Sodium in Hemogasanalysis From Baseline | Change from baseline at D10 | -3.0 mmol/L | Standard Deviation 7.1 |
| Anakinra | Change of Sodium in Hemogasanalysis From Baseline | Change from baseline at D4 | -0.5 mmol/L | Standard Deviation 2.1 |
| Anakinra | Change of Sodium in Hemogasanalysis From Baseline | Change from baseline at D7 | -5.0 mmol/L | — |
| Anakinra | Change of Sodium in Hemogasanalysis From Baseline | Change from baseline at D13 | -6.0 mmol/L | — |
| Anakinra | Change of Sodium in Hemogasanalysis From Baseline | Change from Baseline at D15 | 0.0 mmol/L | Standard Deviation 2.6 |
| Standard of Care | Change of Sodium in Hemogasanalysis From Baseline | Change from Baseline at D15 | 0.7 mmol/L | Standard Deviation 2.1 |
| Standard of Care | Change of Sodium in Hemogasanalysis From Baseline | Change from baseline at D13 | -1.0 mmol/L | Standard Deviation 1.4 |
| Standard of Care | Change of Sodium in Hemogasanalysis From Baseline | Change from baseline at D4 | -4.5 mmol/L | Standard Deviation 2.1 |
| Standard of Care | Change of Sodium in Hemogasanalysis From Baseline | Change from baseline at D10 | 1.3 mmol/L | Standard Deviation 1.2 |
| Standard of Care | Change of Sodium in Hemogasanalysis From Baseline | Change from baseline at D7 | 0.3 mmol/L | Standard Deviation 4 |
Secondary
Number of Participants Requiring Mechanical Ventilation
Measured in number of participants
Time frame: Date of randomization to date of mechanical ventilation, up to 15 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Emapalumab | Number of Participants Requiring Mechanical Ventilation | 1 Participants |
| Anakinra | Number of Participants Requiring Mechanical Ventilation | 1 Participants |
| Standard of Care | Number of Participants Requiring Mechanical Ventilation | 1 Participants |
Secondary
Number of Participants With Changes in High-resolution Computed Tomography (CT) Scan of the Chest
Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done
Time frame: Screening, Day 15
Population: Data not available for all patients
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Emapalumab | Number of Participants With Changes in High-resolution Computed Tomography (CT) Scan of the Chest | Abnormal (NC) | 1 Participants |
| Emapalumab | Number of Participants With Changes in High-resolution Computed Tomography (CT) Scan of the Chest | Normal | 0 Participants |
| Emapalumab | Number of Participants With Changes in High-resolution Computed Tomography (CT) Scan of the Chest | Abnormal (CS) | 3 Participants |
| Anakinra | Number of Participants With Changes in High-resolution Computed Tomography (CT) Scan of the Chest | Abnormal (NC) | 3 Participants |
| Anakinra | Number of Participants With Changes in High-resolution Computed Tomography (CT) Scan of the Chest | Abnormal (CS) | 1 Participants |
| Anakinra | Number of Participants With Changes in High-resolution Computed Tomography (CT) Scan of the Chest | Normal | 0 Participants |
| Standard of Care | Number of Participants With Changes in High-resolution Computed Tomography (CT) Scan of the Chest | Normal | 1 Participants |
| Standard of Care | Number of Participants With Changes in High-resolution Computed Tomography (CT) Scan of the Chest | Abnormal (CS) | 2 Participants |
| Standard of Care | Number of Participants With Changes in High-resolution Computed Tomography (CT) Scan of the Chest | Abnormal (NC) | 1 Participants |
Secondary
Number of Patients With Hospital Discharge
Measured in number of patients
Time frame: Until discharge up to Week 10
Population: Hospital discharge
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Emapalumab | Number of Patients With Hospital Discharge | Hospital Discharge | 3 Participants |
| Emapalumab | Number of Patients With Hospital Discharge | Terminated prior to discharge | 2 Participants |
| Anakinra | Number of Patients With Hospital Discharge | Hospital Discharge | 4 Participants |
| Anakinra | Number of Patients With Hospital Discharge | Terminated prior to discharge | 1 Participants |
| Standard of Care | Number of Patients With Hospital Discharge | Hospital Discharge | 5 Participants |
| Standard of Care | Number of Patients With Hospital Discharge | Terminated prior to discharge | 1 Participants |
Secondary
Overall Survival
Confirmation of death
Time frame: Weeks 6 and 10
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Emapalumab | Overall Survival | 2 Participants |
| Anakinra | Overall Survival | 1 Participants |
| Standard of Care | Overall Survival | 0 Participants |