Coronavirus Disease 2019
Conditions
Keywords
COVID-19, Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)
Brief summary
The study will evaluate the safety and efficacy of orally-administered M5049 in Coronavirus disease 2019 (COVID-19) pneumonia participants who are hospitalized but not on mechanical ventilation.
Interventions
DRUGM5049
Participants received M5049 50 milligram (mg) orally twice daily for 14 days.
DRUGPlacebo
Participants received placebo tablets matched to M5049 daily for 14 days.
Sponsors
Merck KGaA, Darmstadt, Germany
EMD Serono Research & Development Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participant provides signed informed consent prior to the initiation of any study assessments * Has laboratory-confirmed SARS-CoV-2 Infection as determined by nucleic acid amplification test, polymerase chain reaction, antigen test or other commercial or public health assay (based on locally acceptable accepted guidelines) in a sample collected less than (\<)10 days prior to randomization * Has chest imaging consistent with COVID-19 pneumonia (as per locally accepted guidelines) If chest imaging is not available during Screening, please discuss with Medical Monitor or designee regarding evidence of probable COVID-19 pneumonia for study participant eligibility * Not on mechanical ventilation or ECMO * Has an SpO2 less than (\<) 94 percent in room air And able to maintain a partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) greater than or equal to (\>=) 150 (Or equivalent SpO2/FiO2 \>=190) with a maximum FiO2 0.4 if participant is on chronic low oxygen therapy (less than or equal to 2 Liter), assess their current baseline oxygen requirements for eligibility * Requires hospitalization * Other protocol defined inclusion criteria may apply
Exclusion criteria
* Any condition that could interfere with the study objectives, conduct or evaluation in the opinion of the Investigator or Sponsor or designee * Significantly uncontrolled medical illness (eg, cardiovascular disease, hypertension, diabetes mellitus, obstructive lung disease, neurological associated with seizures (example: cerebrovascular accident/stroke, acute brain infection, traumatic brain injury, progressive brain disease, congenital brain disease or neuropsychiatric disorder) * Known active infection other than COVID-19 * Pregnancy or Breastfeeding * Other protocol defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Recovery | Day 1 through Day 28 | Time to recovery was defined as the time from first dose (Day 1) to first occurrence of World Health Organization (WHO) 9-point ordinal scale 3 or less. The scoring is assessed with the following ordinal scale: 0. Uninfected: no clinical or virological evidence of infection; 1. Ambulatory: no limitation of activities; 2. Ambulatory: limitation of activities; 3. Hospitalized, mild disease: hospitalized, no oxygen therapy; 4. Hospitalized, mild disease: oxygen by mask or nasal prongs; 5. Hospitalized, severe disease: noninvasive ventilation or high-flow oxygen; 6. Hospitalized, severe disease: intubation and mechanical ventilation; 7. Hospitalized, severe disease: ventilation plus additional organ support for example: vasopressors or Extracorporeal membrane oxygenation (ECMO); 8. Death. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interests (AESIs), TEAEs Leading to Treatment Discontinuation and Serious TEAEs (SAEs) According to NCI-CTCAE Version 5.0 | Day 1 through Day 60 | Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on treatment period. TEAEs included serious TEAEs and non-serious TEAEs. |
| Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters | Day 1 through Day 28 | Laboratory investigation included hematology and biochemistry. The number of participants with clinically significant changes from baseline in laboratory parameters were reported. Clinical significance was determined by the investigator. |
| Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Measurements | Day 1 through Day 28 | 12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semisupine position. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Intensive Care Unit (ICU) Admission | Day 1 through Day 28 | Time to ICU admission was defined as the time from first dose (Day 1) to the date/time of ICU admission, or death, whichever occurs first, in days. Event-free survival function for time to event (ICU admission or death) estimated via Kaplan-Meier method. |
| Time to Non-Invasive Mechanical Ventilation | Day 1 through Day 28 | Time to non-invasive mechanical ventilation was defined as the time from first dose (Day 1) to the date/time of clinical status \>= 5, in days. Event-free survival function for time to event (Non-invasive mechanical ventilation or death) estimated via Kaplan-Meier method. Clinical status was based on data collected on the 'Ordinal Scale for Clinical Status and is assessed with the following ordinal scale: 0. Uninfected: no clinical or virological evidence of infection; 1. Ambulatory: no limitation of activities; 2. Ambulatory: limitation of activities; 3. Hospitalized, mild disease: hospitalized, no oxygen therapy; 4. Hospitalized, mild disease: oxygen by mask or nasal prongs; 5. Hospitalized, severe disease: noninvasive ventilation or high-flow oxygen; 6. Hospitalized, severe disease: intubation and mechanical ventilation; 7. Hospitalized, severe disease: ventilation plus additional organ support for example: vasopressors, and ECMO; 8. Death |
| Time to Invasive Mechanical Ventilation | Day 1 through Day 28 | Time to invasive mechanical ventilation was defined as the time from first dose (Day 1) to the date/time of clinical status \>= 6, in days. Event-free survival function for time to event (invasive mechanical ventilation or death) estimated via Kaplan-Meier method. Clinical status was based on data collected on the 'Ordinal Scale for Clinical Status and is assessed with the following ordinal scale: 0. Uninfected: no clinical or virological evidence of infection; 1. Ambulatory: no limitation of activities; 2. Ambulatory: limitation of activities; 3. Hospitalized, mild disease: hospitalized, no oxygen therapy; 4. Hospitalized, mild disease: oxygen by mask or nasal prongs; 5. Hospitalized, severe disease: noninvasive ventilation or high-flow oxygen; 6. Hospitalized, severe disease: intubation and mechanical ventilation; 7. Hospitalized, severe disease: ventilation plus additional organ support for example: vasopressors, and ECMO; 8. Death. |
| Total Length of Stay in Intensive Care Unit (ICU) | Day 1 through Day 60 | Total days in the ICU was defined as the sum, for all ICU admissions, of the time from ICU admission to the date of ICU discharge, in days. |
| Total Length of Hospitalization Stay | Day 1 through Day 60 | Total days in the hospital was defined as the sum, for all hospitalization events, of the time from first dose to the date of hospital discharge in days. |
| Percentage of Participants Alive and Not Requiring Supplemental Oxygenation | Day 3, Day 7, Day 14, Day 21 and Day 28 | The percentage of participants who were alive and did not require supplemental oxygenation or ventilatory support (including noninvasive or mechanical ventilation and Extra Corporeal Membrane Oxygenation \[ECMO\]) reported. |
| Percent Change From Baseline in Inflammatory Biomarkers Over Time | Baseline, Day 3, Day7, Day 10, Day 14 and Day 28 | C-Reactive Protein, D-Dimer and Ferritin inflammatory biomarkers were analyzed for this study. Percent Change From Baseline in Inflammatory Biomarkers Over Time were reported here. |
| Percent Change From Baseline in Serum Cytokine Biomarkers | Baseline, Day 3, Day7, Day 14 and Day 28 | Interleukin 6 and Interleukin 8 serum cytokine biomarkers were analyzed. Percent Change From Baseline in Serum Cytokine Biomarkers were reported. |
| Percentage of Participants With Relapse | Day 5 through Day 60 | Relapse refers to rehospitalization due to worsening oxygenation, with either a positive result of any respiratory pathogenic nucleic acid test, or worsening lesions on chest imaging. |
| Percentage of Participants Who Are Re-Hospitalized | Day 5 through Day 60 | Percentage or participants who are re-hospitalized due to coronavirus disease 2019 (Covid-19) complications were reported. |
| Time to Hospital Discharge | Day 1 through Day 60 | The time to hospital discharge, defined as the time from first dose (Day 1) to the date of first hospitalization discharge, in days. |
| Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Baseline, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 14, Day 21, Day 28, Day 44, Day 60 | Clinical status was based on data collected on the 'Ordinal Scale for Clinical Status and is assessed with the following ordinal scale: 0. Uninfected: no clinical or virological evidence of infection; 1. Ambulatory: no limitation of activities; 2. Ambulatory: limitation of activities; 3. Hospitalized, mild disease: hospitalized, no oxygen therapy; 4. Hospitalized, mild disease: oxygen by mask or nasal prongs; 5. Hospitalized, severe disease: noninvasive ventilation or high-flow oxygen; 6. Hospitalized, severe disease: intubation and mechanical ventilation; 7. Hospitalized, severe disease: ventilation plus additional organ support for example: vasopressors or ECMO; 8. Death. |
| Time to Reach Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to 94 Percent for at Least 24 Hours in Room Air | Day 1 through Day 28 | SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 measured by pulse oximetry. The time to SPO2 greater than or equal to (\>=) 94 percent (%) sustained for at least 24 hours in room air is reported in days. |
| Percentage of Participants With All-Cause Mortality | Day 1 through Day 60 | Percentage of Participants who died for any reason reported. |
Countries
Brazil, Philippines, United States
Participant flow
Recruitment details
Overall, 200 participants were screened for this study. Of which, 149 participants were randomized into the study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received matched placebo tablets to M5049 daily for 14 days. | 49 |
| M5049 50 Milligram (mg) Participants received M5049 50 milligram (mg) orally twice daily for 14 days. | 54 |
| M5049 100 mg Participants received M5049 100 mg orally twice daily for 14 days. | 46 |
| Total | 149 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Death | 2 | 1 | 0 |
| Overall Study | Participant unable to attend Day 60 visit | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 1 |
Baseline characteristics
| Characteristic | Placebo | M5049 50 Milligram (mg) | M5049 100 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 48.4 Years STANDARD_DEVIATION 14.09 | 51.0 Years STANDARD_DEVIATION 12.25 | 49.2 Years STANDARD_DEVIATION 12.35 | 49.6 Years STANDARD_DEVIATION 12.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants | 38 Participants | 29 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 15 Participants | 15 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 16 Participants | 12 Participants | 41 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 4 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 7 Participants | 0 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 5 Participants | 13 Participants |
| Race (NIH/OMB) White | 22 Participants | 20 Participants | 25 Participants | 67 Participants |
| Sex: Female, Male Female | 18 Participants | 19 Participants | 14 Participants | 51 Participants |
| Sex: Female, Male Male | 31 Participants | 35 Participants | 32 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 49 | 1 / 54 | 0 / 46 |
| other Total, other adverse events | 12 / 49 | 15 / 54 | 10 / 46 |
| serious Total, serious adverse events | 9 / 49 | 5 / 54 | 1 / 46 |
Outcome results
Primary
Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Measurements
12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semisupine position. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.
Time frame: Day 1 through Day 28
Population: Safety analysis set included all participants who had received at least one dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Measurements | 1 Participants |
| M5049 50 Milligram (mg) | Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Measurements | 0 Participants |
| M5049 100 mg | Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Measurements | 0 Participants |
Primary
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters
Laboratory investigation included hematology and biochemistry. The number of participants with clinically significant changes from baseline in laboratory parameters were reported. Clinical significance was determined by the investigator.
Time frame: Day 1 through Day 28
Population: Safety analysis set included all participants who had received at least one dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters | 0 Participants |
| M5049 100 mg | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters | 0 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interests (AESIs), TEAEs Leading to Treatment Discontinuation and Serious TEAEs (SAEs) According to NCI-CTCAE Version 5.0
Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on treatment period. TEAEs included serious TEAEs and non-serious TEAEs.
Time frame: Day 1 through Day 60
Population: Safety analysis set included all participants who had received at least one dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interests (AESIs), TEAEs Leading to Treatment Discontinuation and Serious TEAEs (SAEs) According to NCI-CTCAE Version 5.0 | Participants with any TEAE | 28 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interests (AESIs), TEAEs Leading to Treatment Discontinuation and Serious TEAEs (SAEs) According to NCI-CTCAE Version 5.0 | Participants with any AESIs | 2 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interests (AESIs), TEAEs Leading to Treatment Discontinuation and Serious TEAEs (SAEs) According to NCI-CTCAE Version 5.0 | Participants with TEAEs leading to discontinuation | 4 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interests (AESIs), TEAEs Leading to Treatment Discontinuation and Serious TEAEs (SAEs) According to NCI-CTCAE Version 5.0 | Participants with Serious TEAEs | 9 Participants |
| M5049 50 Milligram (mg) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interests (AESIs), TEAEs Leading to Treatment Discontinuation and Serious TEAEs (SAEs) According to NCI-CTCAE Version 5.0 | Participants with Serious TEAEs | 5 Participants |
| M5049 50 Milligram (mg) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interests (AESIs), TEAEs Leading to Treatment Discontinuation and Serious TEAEs (SAEs) According to NCI-CTCAE Version 5.0 | Participants with any TEAE | 34 Participants |
| M5049 50 Milligram (mg) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interests (AESIs), TEAEs Leading to Treatment Discontinuation and Serious TEAEs (SAEs) According to NCI-CTCAE Version 5.0 | Participants with TEAEs leading to discontinuation | 4 Participants |
| M5049 50 Milligram (mg) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interests (AESIs), TEAEs Leading to Treatment Discontinuation and Serious TEAEs (SAEs) According to NCI-CTCAE Version 5.0 | Participants with any AESIs | 2 Participants |
| M5049 100 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interests (AESIs), TEAEs Leading to Treatment Discontinuation and Serious TEAEs (SAEs) According to NCI-CTCAE Version 5.0 | Participants with Serious TEAEs | 1 Participants |
| M5049 100 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interests (AESIs), TEAEs Leading to Treatment Discontinuation and Serious TEAEs (SAEs) According to NCI-CTCAE Version 5.0 | Participants with any AESIs | 0 Participants |
| M5049 100 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interests (AESIs), TEAEs Leading to Treatment Discontinuation and Serious TEAEs (SAEs) According to NCI-CTCAE Version 5.0 | Participants with TEAEs leading to discontinuation | 1 Participants |
| M5049 100 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interests (AESIs), TEAEs Leading to Treatment Discontinuation and Serious TEAEs (SAEs) According to NCI-CTCAE Version 5.0 | Participants with any TEAE | 26 Participants |
Primary
Time to Recovery
Time to recovery was defined as the time from first dose (Day 1) to first occurrence of World Health Organization (WHO) 9-point ordinal scale 3 or less. The scoring is assessed with the following ordinal scale: 0. Uninfected: no clinical or virological evidence of infection; 1. Ambulatory: no limitation of activities; 2. Ambulatory: limitation of activities; 3. Hospitalized, mild disease: hospitalized, no oxygen therapy; 4. Hospitalized, mild disease: oxygen by mask or nasal prongs; 5. Hospitalized, severe disease: noninvasive ventilation or high-flow oxygen; 6. Hospitalized, severe disease: intubation and mechanical ventilation; 7. Hospitalized, severe disease: ventilation plus additional organ support for example: vasopressors or Extracorporeal membrane oxygenation (ECMO); 8. Death.
Time frame: Day 1 through Day 28
Population: Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Recovery | 3.4 Days |
| M5049 50 Milligram (mg) | Time to Recovery | 3.7 Days |
| M5049 100 mg | Time to Recovery | 3.9 Days |
Secondary
Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale
Clinical status was based on data collected on the 'Ordinal Scale for Clinical Status and is assessed with the following ordinal scale: 0. Uninfected: no clinical or virological evidence of infection; 1. Ambulatory: no limitation of activities; 2. Ambulatory: limitation of activities; 3. Hospitalized, mild disease: hospitalized, no oxygen therapy; 4. Hospitalized, mild disease: oxygen by mask or nasal prongs; 5. Hospitalized, severe disease: noninvasive ventilation or high-flow oxygen; 6. Hospitalized, severe disease: intubation and mechanical ventilation; 7. Hospitalized, severe disease: ventilation plus additional organ support for example: vasopressors or ECMO; 8. Death.
Time frame: Baseline, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 14, Day 21, Day 28, Day 44, Day 60
Population: Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signified those participants who were evaluable for the specified category at given time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 44 | 2 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 10 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 3 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 60 | 18 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 7 | 4 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 3 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 60 | 24 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 21 | 1 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 3 | 1 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 60 | 3 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 10 | 5 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 3 | 4 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 60 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 10 | 1 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 3 | 29 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 60 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 21 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 3 | 12 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 60 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 14 | 2 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 3 | 1 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 60 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 7 | 10 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 3 | 2 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 60 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 21 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 3 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 60 | 2 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 14 | 26 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 2 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 2 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Baseline | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 7 | 11 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Baseline | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 21 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 2 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Baseline | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 10 | 8 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 2 | 3 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Baseline | 1 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 7 | 15 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 2 | 35 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Baseline | 48 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 21 | 1 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 2 | 9 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Baseline | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 14 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 2 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Baseline | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 7 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 2 | 1 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Baseline | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 21 | 2 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 2 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Baseline | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 14 | 5 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 5 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 28 | 14 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 10 | 16 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 5 | 2 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 28 | 24 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 14 | 1 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 5 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 28 | 5 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 10 | 2 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 5 | 6 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 28 | 2 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 10 | 5 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 5 | 11 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 28 | 1 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 14 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 5 | 13 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 28 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 14 | 7 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 5 | 4 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 28 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 7 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 5 | 9 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 28 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 14 | 2 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 5 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 28 | 2 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 10 | 1 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 4 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 44 | 17 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 7 | 2 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 4 | 1 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 44 | 23 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 21 | 8 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 4 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 44 | 4 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 10 | 5 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 4 | 5 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 44 | 2 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 7 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 4 | 17 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 44 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 21 | 22 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 4 | 14 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 44 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 14 | 5 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 4 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 44 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 7 | 5 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 4 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 44 | 0 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 21 | 9 Participants |
| Placebo | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 4 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 7 | 14 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 10 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 14 | 5 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 14 | 25 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 14 | 8 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 14 | 6 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 14 | 3 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 14 | 1 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 14 | 1 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 14 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 14 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 21 | 8 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 21 | 30 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 21 | 7 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 21 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 21 | 2 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 21 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 21 | 1 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 21 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 21 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 28 | 11 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 28 | 35 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 28 | 3 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 28 | 1 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 28 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 28 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 28 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 28 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 28 | 1 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 44 | 17 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 44 | 30 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 44 | 4 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 44 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 44 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 44 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 44 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 44 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 44 | 1 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 60 | 17 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 60 | 31 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 60 | 2 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 60 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 60 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 60 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 60 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 60 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 60 | 1 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Baseline | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Baseline | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Baseline | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Baseline | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Baseline | 52 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Baseline | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Baseline | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Baseline | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Baseline | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 2 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 2 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 2 | 1 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 2 | 12 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 2 | 39 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 2 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 2 | 1 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 2 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 2 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 3 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 3 | 2 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 3 | 3 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 3 | 9 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 3 | 36 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 3 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 3 | 1 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 3 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 3 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 4 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 4 | 1 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 4 | 1 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 4 | 16 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 4 | 22 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 4 | 1 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 4 | 1 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 4 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 4 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 5 | 1 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 5 | 6 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 5 | 5 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 5 | 18 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 5 | 14 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 5 | 3 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 5 | 1 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 5 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 5 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 7 | 1 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 7 | 16 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 7 | 9 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 7 | 5 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 7 | 2 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 7 | 1 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 7 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 7 | 0 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 10 | 2 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 10 | 21 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 10 | 4 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 10 | 10 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 10 | 2 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 10 | 2 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 10 | 1 Participants |
| M5049 50 Milligram (mg) | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 10 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 44 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 14 | 8 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 3 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 44 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 7 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 4 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 44 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 21 | 7 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 4 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 44 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 10 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 4 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 44 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 7 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 4 | 11 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 44 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 14 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 4 | 21 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 44 | 1 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 10 | 1 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 4 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 44 | 20 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 7 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 4 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 44 | 22 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 14 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 4 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 28 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 14 | 23 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 4 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 28 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 7 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 5 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 28 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 14 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 5 | 6 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 28 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 10 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 5 | 4 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 28 | 1 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 10 | 2 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 5 | 16 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 28 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 14 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 5 | 14 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 28 | 4 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 10 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 5 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 28 | 24 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 10 | 18 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 5 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 28 | 15 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 14 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 5 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 21 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 14 | 6 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Baseline | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Baseline | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 5 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 2 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Baseline | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 21 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 2 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Baseline | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 10 | 7 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 2 | 2 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Baseline | 44 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 7 | 1 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 2 | 13 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Baseline | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 21 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 2 | 30 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Baseline | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 14 | 7 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 2 | 1 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Baseline | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 7 | 15 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 2 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Baseline | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 21 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 2 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 60 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 10 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 8 at Day 2 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 60 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 7 | 8 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 3 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 60 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 21 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 3 | 1 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 60 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 21 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 3 | 2 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 60 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 7 | 11 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 3 | 14 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 60 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 21 | 1 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 3 | 26 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 2 at Day 60 | 1 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 3 at Day 10 | 7 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 5 at Day 3 | 1 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 60 | 22 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 4 at Day 7 | 7 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 6 at Day 3 | 0 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 0 at Day 60 | 22 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 1 at Day 21 | 35 Participants |
| M5049 100 mg | Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale | Participants with Scale 7 at Day 3 | 0 Participants |
Secondary
Percentage of Participants Alive and Not Requiring Supplemental Oxygenation
The percentage of participants who were alive and did not require supplemental oxygenation or ventilatory support (including noninvasive or mechanical ventilation and Extra Corporeal Membrane Oxygenation \[ECMO\]) reported.
Time frame: Day 3, Day 7, Day 14, Day 21 and Day 28
Population: Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signified those participants who were evaluable for the specified category at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Alive and Not Requiring Supplemental Oxygenation | At Day 21 | 93.0 Percentage of participants |
| Placebo | Percentage of Participants Alive and Not Requiring Supplemental Oxygenation | At Day 14 | 89.6 Percentage of participants |
| Placebo | Percentage of Participants Alive and Not Requiring Supplemental Oxygenation | At Day 3 | 30.6 Percentage of participants |
| Placebo | Percentage of Participants Alive and Not Requiring Supplemental Oxygenation | At Day 7 | 76.6 Percentage of participants |
| Placebo | Percentage of Participants Alive and Not Requiring Supplemental Oxygenation | At Day 28 | 93.8 Percentage of participants |
| M5049 50 Milligram (mg) | Percentage of Participants Alive and Not Requiring Supplemental Oxygenation | At Day 14 | 89.8 Percentage of participants |
| M5049 50 Milligram (mg) | Percentage of Participants Alive and Not Requiring Supplemental Oxygenation | At Day 3 | 27.5 Percentage of participants |
| M5049 50 Milligram (mg) | Percentage of Participants Alive and Not Requiring Supplemental Oxygenation | At Day 7 | 83.3 Percentage of participants |
| M5049 50 Milligram (mg) | Percentage of Participants Alive and Not Requiring Supplemental Oxygenation | At Day 21 | 93.8 Percentage of participants |
| M5049 50 Milligram (mg) | Percentage of Participants Alive and Not Requiring Supplemental Oxygenation | At Day 28 | 98.0 Percentage of participants |
| M5049 100 mg | Percentage of Participants Alive and Not Requiring Supplemental Oxygenation | At Day 28 | 97.7 Percentage of participants |
| M5049 100 mg | Percentage of Participants Alive and Not Requiring Supplemental Oxygenation | At Day 21 | 100.0 Percentage of participants |
| M5049 100 mg | Percentage of Participants Alive and Not Requiring Supplemental Oxygenation | At Day 3 | 38.6 Percentage of participants |
| M5049 100 mg | Percentage of Participants Alive and Not Requiring Supplemental Oxygenation | At Day 14 | 100.0 Percentage of participants |
| M5049 100 mg | Percentage of Participants Alive and Not Requiring Supplemental Oxygenation | At Day 7 | 83.3 Percentage of participants |
Secondary
Percentage of Participants Who Are Re-Hospitalized
Percentage or participants who are re-hospitalized due to coronavirus disease 2019 (Covid-19) complications were reported.
Time frame: Day 5 through Day 60
Population: Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Are Re-Hospitalized | 0.0 Percentage of participants |
| M5049 50 Milligram (mg) | Percentage of Participants Who Are Re-Hospitalized | 0.0 Percentage of participants |
| M5049 100 mg | Percentage of Participants Who Are Re-Hospitalized | 2.2 Percentage of participants |
Secondary
Percentage of Participants With All-Cause Mortality
Percentage of Participants who died for any reason reported.
Time frame: Day 1 through Day 60
Population: Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With All-Cause Mortality | 4.1 Percentage of participants |
| M5049 50 Milligram (mg) | Percentage of Participants With All-Cause Mortality | 1.9 Percentage of participants |
| M5049 100 mg | Percentage of Participants With All-Cause Mortality | 0.0 Percentage of participants |
Secondary
Percentage of Participants With Relapse
Relapse refers to rehospitalization due to worsening oxygenation, with either a positive result of any respiratory pathogenic nucleic acid test, or worsening lesions on chest imaging.
Time frame: Day 5 through Day 60
Population: Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Relapse | 0.0 Percentage of participants |
| M5049 50 Milligram (mg) | Percentage of Participants With Relapse | 0.0 Percentage of participants |
| M5049 100 mg | Percentage of Participants With Relapse | 0.0 Percentage of participants |
Secondary
Percent Change From Baseline in Inflammatory Biomarkers Over Time
C-Reactive Protein, D-Dimer and Ferritin inflammatory biomarkers were analyzed for this study. Percent Change From Baseline in Inflammatory Biomarkers Over Time were reported here.
Time frame: Baseline, Day 3, Day7, Day 10, Day 14 and Day 28
Population: Pharmacodynamics (PD) analysis set included all participants who received atleast 1 dose of study intervention, for whom atleast 1 postbaseline serum biomarker was obtained without any relevant protocol deviations or events that may have an influence on PD. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signified those participants who were evaluable for the specified category at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 3 in D-Dimer | 62.5 Percent change | Standard Deviation 150.19 |
| Placebo | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 10 in C-Reactive Protein | 10.5 Percent change | Standard Deviation 182.35 |
| Placebo | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 3 in Ferritin | 17.8 Percent change | Standard Deviation 83.23 |
| Placebo | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 7 in D-Dimer | 184.5 Percent change | Standard Deviation 517.94 |
| Placebo | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 7 in C-Reactive Protein | -48.1 Percent change | Standard Deviation 69.03 |
| Placebo | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 28 in D-Dimer | 893.4 Percent change | Standard Deviation 4731.82 |
| Placebo | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 10 in D-Dimer | 2004.2 Percent change | Standard Deviation 5139.01 |
| Placebo | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 10 in Ferritin | 21.4 Percent change | Standard Deviation 167 |
| Placebo | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 14 in D-Dimer | 1136.7 Percent change | Standard Deviation 6760.1 |
| Placebo | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 14 in C-Reactive Protein | -62.1 Percent change | Standard Deviation 39.95 |
| Placebo | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 28 in Ferritin | -61.3 Percent change | Standard Deviation 35.83 |
| Placebo | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 3 in C-Reactive Protein | -0.8 Percent change | Standard Deviation 113.57 |
| Placebo | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 28 in C-Reactive Protein | -62.0 Percent change | Standard Deviation 91.47 |
| Placebo | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 14 in Ferritin | -29.4 Percent change | Standard Deviation 117.71 |
| Placebo | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 7 in Ferritin | 11.1 Percent change | Standard Deviation 151.34 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 7 in Ferritin | -22.7 Percent change | Standard Deviation 40.53 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 3 in C-Reactive Protein | 48.2 Percent change | Standard Deviation 399.18 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 7 in C-Reactive Protein | -50.4 Percent change | Standard Deviation 133.43 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 10 in C-Reactive Protein | -58.2 Percent change | Standard Deviation 43.93 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 14 in C-Reactive Protein | 24.6 Percent change | Standard Deviation 543.06 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 28 in C-Reactive Protein | -27.0 Percent change | Standard Deviation 253.69 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 3 in D-Dimer | 2008.7 Percent change | Standard Deviation 11813.54 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 7 in D-Dimer | 35.4 Percent change | Standard Deviation 197.99 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 10 in D-Dimer | 62.6 Percent change | Standard Deviation 202.41 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 14 in D-Dimer | 0.7 Percent change | Standard Deviation 86.62 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 28 in D-Dimer | -5.9 Percent change | Standard Deviation 61.09 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 3 in Ferritin | 3.4 Percent change | Standard Deviation 43.05 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 10 in Ferritin | -25.4 Percent change | Standard Deviation 31.52 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 14 in Ferritin | -47.8 Percent change | Standard Deviation 31.56 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 28 in Ferritin | -62.3 Percent change | Standard Deviation 25.83 |
| M5049 100 mg | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 3 in D-Dimer | 2093.9 Percent change | Standard Deviation 11278.04 |
| M5049 100 mg | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 14 in Ferritin | -49.9 Percent change | Standard Deviation 18.54 |
| M5049 100 mg | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 3 in Ferritin | -7.2 Percent change | Standard Deviation 20.63 |
| M5049 100 mg | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 28 in C-Reactive Protein | -72.4 Percent change | Standard Deviation 45.01 |
| M5049 100 mg | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 14 in C-Reactive Protein | -51.2 Percent change | Standard Deviation 159.45 |
| M5049 100 mg | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 7 in Ferritin | -19.8 Percent change | Standard Deviation 27.64 |
| M5049 100 mg | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 10 in C-Reactive Protein | -68.3 Percent change | Standard Deviation 81.09 |
| M5049 100 mg | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 3 in C-Reactive Protein | -45.1 Percent change | Standard Deviation 59.64 |
| M5049 100 mg | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 10 in Ferritin | -39.7 Percent change | Standard Deviation 25.13 |
| M5049 100 mg | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 10 in D-Dimer | 171.3 Percent change | Standard Deviation 501.83 |
| M5049 100 mg | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 7 in C-Reactive Protein | -74.3 Percent change | Standard Deviation 32.19 |
| M5049 100 mg | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 14 in D-Dimer | 15.1 Percent change | Standard Deviation 100.97 |
| M5049 100 mg | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 7 in D-Dimer | 1922.7 Percent change | Standard Deviation 9449.18 |
| M5049 100 mg | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 28 in Ferritin | -63.2 Percent change | Standard Deviation 15.71 |
| M5049 100 mg | Percent Change From Baseline in Inflammatory Biomarkers Over Time | Percent change at Day 28 in D-Dimer | 1371.6 Percent change | Standard Deviation 6985.2 |
Secondary
Percent Change From Baseline in Serum Cytokine Biomarkers
Interleukin 6 and Interleukin 8 serum cytokine biomarkers were analyzed. Percent Change From Baseline in Serum Cytokine Biomarkers were reported.
Time frame: Baseline, Day 3, Day7, Day 14 and Day 28
Population: PD analysis set included all participants who received at least 1 dose of study intervention, for whom at least 1 postbaseline serum biomarker was obtained without any relevant protocol deviations or events that may have an influence on PD. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signified those participants who were evaluable for the specified category at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 3 in Interleukin 6 | 51.2 Percent change | Standard Deviation 257.64 |
| Placebo | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 7 in Interleukin 6 | 35.2 Percent change | Standard Deviation 167.99 |
| Placebo | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 14 in Interleukin 6 | 20.2 Percent change | Standard Deviation 164.19 |
| Placebo | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 28 in Interleukin 6 | -21.0 Percent change | Standard Deviation 41.33 |
| Placebo | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 3 in Interleukin 8 | 42.5 Percent change | Standard Deviation 165.56 |
| Placebo | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 7 in Interleukin 8 | 923.4 Percent change | Standard Deviation 4432.63 |
| Placebo | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 14 in Interleukin 8 | 408.9 Percent change | Standard Deviation 1776.87 |
| Placebo | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 28 in Interleukin 8 | -4.3 Percent change | Standard Deviation 90.29 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 14 in Interleukin 6 | 55.2 Percent change | Standard Deviation 476.42 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 14 in Interleukin 8 | 35.4 Percent change | Standard Deviation 147.85 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 28 in Interleukin 6 | -27.3 Percent change | Standard Deviation 37.78 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 3 in Interleukin 8 | 2.0 Percent change | Standard Deviation 77.66 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 7 in Interleukin 8 | 60.2 Percent change | Standard Deviation 253.12 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 3 in Interleukin 6 | -17.8 Percent change | Standard Deviation 38.95 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 7 in Interleukin 6 | 1.1 Percent change | Standard Deviation 159.45 |
| M5049 50 Milligram (mg) | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 28 in Interleukin 8 | -13.0 Percent change | Standard Deviation 59 |
| M5049 100 mg | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 14 in Interleukin 6 | 275.1 Percent change | Standard Deviation 1745.5 |
| M5049 100 mg | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 7 in Interleukin 6 | -25.5 Percent change | Standard Deviation 42.41 |
| M5049 100 mg | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 3 in Interleukin 6 | 1722.3 Percent change | Standard Deviation 10240.47 |
| M5049 100 mg | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 28 in Interleukin 6 | -30.1 Percent change | Standard Deviation 36.93 |
| M5049 100 mg | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 14 in Interleukin 8 | 283.5 Percent change | Standard Deviation 1616.08 |
| M5049 100 mg | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 7 in Interleukin 8 | 28.5 Percent change | Standard Deviation 113.48 |
| M5049 100 mg | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 3 in Interleukin 8 | 126.6 Percent change | Standard Deviation 574.74 |
| M5049 100 mg | Percent Change From Baseline in Serum Cytokine Biomarkers | Percent change at Day 28 in Interleukin 8 | -1.8 Percent change | Standard Deviation 123.62 |
Secondary
Time to Hospital Discharge
The time to hospital discharge, defined as the time from first dose (Day 1) to the date of first hospitalization discharge, in days.
Time frame: Day 1 through Day 60
Population: Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Hospital Discharge | 5.1 Days |
| M5049 50 Milligram (mg) | Time to Hospital Discharge | 5.1 Days |
| M5049 100 mg | Time to Hospital Discharge | 4.7 Days |
Secondary
Time to Intensive Care Unit (ICU) Admission
Time to ICU admission was defined as the time from first dose (Day 1) to the date/time of ICU admission, or death, whichever occurs first, in days. Event-free survival function for time to event (ICU admission or death) estimated via Kaplan-Meier method.
Time frame: Day 1 through Day 28
Population: Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Intensive Care Unit (ICU) Admission | NA Days |
| M5049 50 Milligram (mg) | Time to Intensive Care Unit (ICU) Admission | NA Days |
| M5049 100 mg | Time to Intensive Care Unit (ICU) Admission | NA Days |
Secondary
Time to Invasive Mechanical Ventilation
Time to invasive mechanical ventilation was defined as the time from first dose (Day 1) to the date/time of clinical status \>= 6, in days. Event-free survival function for time to event (invasive mechanical ventilation or death) estimated via Kaplan-Meier method. Clinical status was based on data collected on the 'Ordinal Scale for Clinical Status and is assessed with the following ordinal scale: 0. Uninfected: no clinical or virological evidence of infection; 1. Ambulatory: no limitation of activities; 2. Ambulatory: limitation of activities; 3. Hospitalized, mild disease: hospitalized, no oxygen therapy; 4. Hospitalized, mild disease: oxygen by mask or nasal prongs; 5. Hospitalized, severe disease: noninvasive ventilation or high-flow oxygen; 6. Hospitalized, severe disease: intubation and mechanical ventilation; 7. Hospitalized, severe disease: ventilation plus additional organ support for example: vasopressors, and ECMO; 8. Death.
Time frame: Day 1 through Day 28
Population: Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Invasive Mechanical Ventilation | NA Days |
| M5049 50 Milligram (mg) | Time to Invasive Mechanical Ventilation | NA Days |
| M5049 100 mg | Time to Invasive Mechanical Ventilation | NA Days |
Secondary
Time to Non-Invasive Mechanical Ventilation
Time to non-invasive mechanical ventilation was defined as the time from first dose (Day 1) to the date/time of clinical status \>= 5, in days. Event-free survival function for time to event (Non-invasive mechanical ventilation or death) estimated via Kaplan-Meier method. Clinical status was based on data collected on the 'Ordinal Scale for Clinical Status and is assessed with the following ordinal scale: 0. Uninfected: no clinical or virological evidence of infection; 1. Ambulatory: no limitation of activities; 2. Ambulatory: limitation of activities; 3. Hospitalized, mild disease: hospitalized, no oxygen therapy; 4. Hospitalized, mild disease: oxygen by mask or nasal prongs; 5. Hospitalized, severe disease: noninvasive ventilation or high-flow oxygen; 6. Hospitalized, severe disease: intubation and mechanical ventilation; 7. Hospitalized, severe disease: ventilation plus additional organ support for example: vasopressors, and ECMO; 8. Death
Time frame: Day 1 through Day 28
Population: Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Non-Invasive Mechanical Ventilation | NA Days |
| M5049 50 Milligram (mg) | Time to Non-Invasive Mechanical Ventilation | NA Days |
| M5049 100 mg | Time to Non-Invasive Mechanical Ventilation | NA Days |
Secondary
Time to Reach Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to 94 Percent for at Least 24 Hours in Room Air
SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 measured by pulse oximetry. The time to SPO2 greater than or equal to (\>=) 94 percent (%) sustained for at least 24 hours in room air is reported in days.
Time frame: Day 1 through Day 28
Population: Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Reach Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to 94 Percent for at Least 24 Hours in Room Air | 4.7 Days |
| M5049 50 Milligram (mg) | Time to Reach Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to 94 Percent for at Least 24 Hours in Room Air | 4.8 Days |
| M5049 100 mg | Time to Reach Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to 94 Percent for at Least 24 Hours in Room Air | 5.0 Days |
Secondary
Total Length of Hospitalization Stay
Total days in the hospital was defined as the sum, for all hospitalization events, of the time from first dose to the date of hospital discharge in days.
Time frame: Day 1 through Day 60
Population: Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Total Length of Hospitalization Stay | 7.0 Days |
| M5049 50 Milligram (mg) | Total Length of Hospitalization Stay | 6.0 Days |
| M5049 100 mg | Total Length of Hospitalization Stay | 6.0 Days |
Secondary
Total Length of Stay in Intensive Care Unit (ICU)
Total days in the ICU was defined as the sum, for all ICU admissions, of the time from ICU admission to the date of ICU discharge, in days.
Time frame: Day 1 through Day 60
Population: Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Total Length of Stay in Intensive Care Unit (ICU) | 7.1 Days |
| M5049 50 Milligram (mg) | Total Length of Stay in Intensive Care Unit (ICU) | 10.2 Days |
| M5049 100 mg | Total Length of Stay in Intensive Care Unit (ICU) | 3.7 Days |