Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19

A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients With COVID-19

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04426695

Enrollment

2252

Registered

2020-06-11

Start date

2020-06-10

Completion date

2021-10-22

Last updated

2023-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), coronavirus, acute respiratory distress syndrome

Brief summary

The primary objectives are: Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) * To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 * To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation Phase 1/2 (Cohort 1) * To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation * To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo

Interventions

DRUGREGN10933+REGN10987 combination therapy

Administered intravenously (IV) single dose

DRUGPlacebo

Placebo IV Single Dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Phase 1/Phase 2/Phase 3

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal \[OP\], or saliva) ≤72 hours prior to randomization and no alternative explanation for current clinical condition. A historical record of positive result from test conducted ≤72 hours prior to randomization is acceptable. * Has symptoms consistent with COVID-19, as determined by investigator, with onset ≤10 days before randomization * Hospitalized for ≤72 hours with at least 1 of the following at randomization; patients meeting more than one criterion will be categorized in the most severely affected category: 1. Cohort 1A: With COVID-19 symptoms but not requiring supplemental oxygen 2. Cohort 1: Maintains O2 saturation \>93% on low-flow oxygen as defined in the protocol 3. Cohort 2: High-intensity oxygen therapy without mechanical ventilation as defined in the protocol 4. Cohort 3: On mechanical ventilation Key

Exclusion criteria

* Phase 1 Only: Patients maintaining O2 saturation \>94% on room air * In the opinion of the investigator, unlikely to survive for \>48 hours from screening * Receiving extracorporeal membrane oxygenation (ECMO) * Has new-onset stroke or seizure disorder during hospitalization * Initiated on renal replacement therapy due to COVID-19 NOTE: Other protocol defined inclusion /

Design outcomes

Primary

Measure	Time frame	Description
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS	Day 1 to Day 7	Time-weighted average daily change from Day 1 to Day 7 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS	Day 6 to Day 29	Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on high viral load mFAS were reported.
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Seronegative mFAS	Day 6 to Day 29	Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on seronegative mFAS were reported.
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Overall mFAS	Day 6 to Day 29	Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on overall FAS were reported.
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS	Day 1 to Day 29	Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on high viral load mFAS were reported.
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS	Day 1 to Day 29	Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on seronegative mFAS were reported.
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS	Day 1 to Day 29	Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on overall mFAS were reported.
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Treatment-Emergent Serious Adverse Events	Up to Day 169	Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the observation period.
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4	Up to Day 4	Infusion-related reactions are defined as any relevant adverse event that occurs during the infusion or up to day 4. The severity of adverse events (including test findings classified as adverse events) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29	Up to Day 29	Hypersensitivity reactions are defined as any relevant adverse event that occurs during the infusion or up to study day 29. The severity of adverse events (including test findings classified as adverse events) were graded according to NCI-CTCAE.
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS	Up to Day 29	Cumulative incidence percentage was estimated using Kaplan-Meier method.
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS	Up to Day 29	Cumulative incidence percentage was estimated using Kaplan-Meier method.

Secondary

Measure	Time frame	Description
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	by Day 29	Number of participants with cumulative incidence of mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS	by Day 29	Percentage of participants with cumulative incidence of mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	by Day 29	Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS	by Day 29	Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS	Up to Day 56	Time to discharge from hospital based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS	Up to Day 56	Time to discharge from hospital based on Seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.
Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Treatment-Emergent Serious Adverse Events	Up to Day 169	—
Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4	Up to Day 4	—
Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29	Up to Day 29	—
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS	by Day 29	Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS	Day 6 to Day 29	Percentage of participants who died from Day 6 through Day 29 in phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS	Day 1 to Day 29	Percentage of participants who died from Day 1 through Day 29 in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS	by Day 29	Percentage of participants who were discharged in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported.
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS	Up to Day 29	Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) by Day 29 were reported. Readmission to hospital was based on investigator report.
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS	Up to Day 29	Percentage of participants with cumulative incidence of death in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) up to Day 29 from randomization were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS	by Day 29	Percentage of participants with cumulative incidence of mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS	by Day 29	Percentage of participants with cumulative incidence of death or mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS	Up to Day 56	Time to discharge from hospital up to Day 56 was reported.
Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS	Day 1 to Day 11	TWA change from baseline in viral load up to Day 11 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 11, was measured by RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.
Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29	Day 1 to Day 29	TWA change from baseline in viral load up to Day 29 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 29, was measured by quantitative RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.
Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Days 3, 5, 7, 9, 11, 13, 15, 22 and 29	Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.
Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Days 3, 5, 7, 9, 11, 13, 15, 22 and 29	Percent change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	by Day 29	Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS	Day 6 to Day 29	Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS	Day 1 to Day 29	Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS	by Day 29	Percentage of participants who were discharged in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS	Up to Day 29	Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) over time were reported. Readmission to hospital was based on investigator report.
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS	Up to Day 29	Cumulative Incidence of Death Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS	Up to Day 29	Cumulative Incidence of Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	by Day 29	Percentage of participants who went on mechanical ventilation by Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS	Up to Day 56	Time to Discharge in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.
Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Up to Day 29	Time-weighted average daily change over time up to Day 29 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Days 3, 5, 7, 9, 11, 13, 15, 22 and 29	Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.
Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on Seronegative mFAS	Through Day 29	—
Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	Through Day 29	—
Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28)	Up to Day 28	—
Concentration at the End of Infusion (Ceoi)	Day 1	—
Concentration at Day 28 (C28)	Day 28	—
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933	Through Day 169	—
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987	Through Day 169	—
Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933	Through Day 57	—
Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987	Through Day 57	—
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS	Up to Day 29	Cumulative Incidence of Death or Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS	by Day 29	Percentage of participants who went on mechanical ventilation at Day 29 based on Seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS	Day 6 to Day 29	Percentage of participants who died from Day 6 through Day 29 based on high viral load mFAS were reported.
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS	Day 6 to Day 29	Percentage of participants who died from Day 6 through Day 29 Based on seronegative mFAS in pooled analysis phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS	Day 1 to Day 29	Percentage of participants who died from Day 1 through Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS	Day 1 to Day 29	Percentage of participants who died from Day 1 through Day 29 based on seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS	by Day 29	Percentage of participants who were discharged by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS	by Day 29	Percentage of participants who were discharged by Day 29 based on seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS	Up to Day 29	Percentage of participants who died or were readmitted to hospital over time based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)were reported. Readmission to hospital was based on investigator report.
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS	by Day 29	Percentage of participants who died or were readmitted to hospital at Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Readmission to hospital was based on investigator report.
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS	by Day 29	Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS	by Day 29	Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A)were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

Countries

Brazil, Chile, Mexico, Moldova, Romania, United States

Participant flow

Pre-assignment details

A total of 2324 participants were screened and 2203 participants randomized and treated, 49 participants were randomized but not treated, and 72 discontinued at the screening phase. Reasons for discontinuation at screening phase: 54 - Screen Failure, 10 - Subject Decision, 1- Sponsor Request, 7- Other.

Participants by arm

Arm	Count
Phase 1: Cohort 1 (Placebo) Participants with O2 saturation \> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 1 (Cohort 1)	18
Phase 1: Cohort 1 (R10933+R10987 2400 mg IV) Participants with O2 saturation \> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 1 (Cohort 1)	18
Phase 1: Cohort 1 (R10933+R10987 8000 mg IV) Participants with O2 saturation \> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 1 (Cohort 1)	20
Phase 2: Cohort 1 (Placebo) Participants with O2 saturation \> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1)	204
Phase 2: Cohort 1 (R10933+R10987 2400 mg IV) Participants with O2 saturation \> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1)	206
Phase 2: Cohort 1 (R10933+R10987 8000 mg IV) Participants with O2 saturation \> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1)	205
Phase 3: Cohort 1 (Placebo) Participants with O2 saturation \> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1).	247
Phase 3: Cohort 1 (R10933+R10987 2400 mg IV) Phase 1: Cohort 1 (R10933+R10987 2400 mg IV)Edit Participants with O2 saturation \> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1.	246
Phase 3: Cohort 1 (R10933+R10987 8000 mg IV) Participants with O2 saturation \> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 3 (Cohort 1)	246
Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1A).	198
Phase 2: Cohort 1A (R10933+R10987 2400 mg IV) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).	202
Phase 2: Cohort 1A (R10933+R10987 8000 mg IV) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).	197
Phase 2: Cohort 2 (Placebo) Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 2).	51
Phase 2: Cohort 2 (R10933+R10987 2400 mg IV) Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).	56
Phase 2: Cohort 2 (R10933+R10987 8000 mg IV) Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).	54
Phase 2: Cohort 3 (Placebo) Participants on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 3).	12
Phase 2: Cohort 3 (R10933+R10987 2400 mg IV) Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	12
Phase 2: Cohort 3 (R10933+R10987 8000 mg IV) Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	11
Total	2,203

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008	FG009	FG010	FG011	FG012	FG013	FG014	FG015	FG016	FG017
Overall Study	Adverse Event	0	0	0	0	0	0	0	1	0	0	1	1	0	0	0	0	0	0
Overall Study	Death	2	0	1	27	25	21	42	23	37	14	8	7	13	25	19	7	8	4
Overall Study	Lost to Follow-up	2	4	1	19	10	14	5	14	10	11	12	6	2	2	2	0	0	0
Overall Study	Participant Decision	1	2	2	12	18	22	13	13	10	15	16	17	2	1	2	0	0	0
Overall Study	Physician Decision	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0
Overall Study	Randomized but Never Treated	3	1	0	4	5	5	4	6	6	3	3	6	1	2	0	0	0	0
Overall Study	Sponsor Request	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0

Baseline characteristics

Characteristic	Phase 1: Cohort 1 (R10933+R10987 2400 mg IV)	Phase 1: Cohort 1 (R10933+R10987 8000 mg IV)	Phase 2: Cohort 1 (Placebo)	Phase 2: Cohort 1 (R10933+R10987 2400 mg IV)	Phase 2: Cohort 1 (R10933+R10987 8000 mg IV)	Phase 3: Cohort 1 (Placebo)	Phase 3: Cohort 1 (R10933+R10987 2400 mg IV)	Phase 3: Cohort 1 (R10933+R10987 8000 mg IV)	Phase 2: Cohort 1A (Placebo)	Phase 1: Cohort 1 (Placebo)	Phase 2: Cohort 1A (R10933+R10987 2400 mg IV)	Phase 2: Cohort 1A (R10933+R10987 8000 mg IV)	Phase 2: Cohort 2 (Placebo)	Phase 2: Cohort 2 (R10933+R10987 2400 mg IV)	Phase 2: Cohort 2 (R10933+R10987 8000 mg IV)	Phase 2: Cohort 3 (Placebo)	Phase 2: Cohort 3 (R10933+R10987 2400 mg IV)	Phase 2: Cohort 3 (R10933+R10987 8000 mg IV)	Total
Age, Customized Age: 18- <40 years	1 Participants	2 Participants	26 Participants	16 Participants	17 Participants	29 Participants	28 Participants	14 Participants	22 Participants	1 Participants	20 Participants	20 Participants	4 Participants	4 Participants	6 Participants	0 Participants	1 Participants	1 Participants	212 Participants
Age, Customized Age: 40- <65 years	8 Participants	10 Participants	82 Participants	99 Participants	96 Participants	105 Participants	119 Participants	127 Participants	82 Participants	9 Participants	101 Participants	91 Participants	30 Participants	23 Participants	24 Participants	6 Participants	4 Participants	5 Participants	1021 Participants
Age, Customized Age: >=65 years	9 Participants	8 Participants	96 Participants	91 Participants	92 Participants	113 Participants	99 Participants	105 Participants	94 Participants	8 Participants	81 Participants	86 Participants	17 Participants	29 Participants	24 Participants	6 Participants	7 Participants	5 Participants	970 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants	10 Participants	49 Participants	50 Participants	52 Participants	92 Participants	94 Participants	82 Participants	38 Participants	12 Participants	53 Participants	40 Participants	13 Participants	22 Participants	18 Participants	6 Participants	5 Participants	4 Participants	647 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants	10 Participants	144 Participants	148 Participants	146 Participants	146 Participants	140 Participants	155 Participants	148 Participants	6 Participants	138 Participants	143 Participants	35 Participants	33 Participants	30 Participants	6 Participants	7 Participants	7 Participants	1453 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	11 Participants	8 Participants	7 Participants	9 Participants	12 Participants	9 Participants	12 Participants	0 Participants	11 Participants	14 Participants	3 Participants	1 Participants	6 Participants	0 Participants	0 Participants	0 Participants	103 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	9 Participants	9 Participants	13 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	36 Participants
Race (NIH/OMB) Asian	2 Participants	0 Participants	6 Participants	7 Participants	6 Participants	6 Participants	10 Participants	9 Participants	11 Participants	0 Participants	8 Participants	6 Participants	2 Participants	2 Participants	1 Participants	1 Participants	1 Participants	0 Participants	78 Participants
Race (NIH/OMB) Black or African American	2 Participants	8 Participants	34 Participants	21 Participants	33 Participants	26 Participants	32 Participants	25 Participants	27 Participants	3 Participants	32 Participants	25 Participants	7 Participants	6 Participants	9 Participants	1 Participants	1 Participants	3 Participants	295 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	2 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	10 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants	1 Participants	25 Participants	30 Participants	29 Participants	47 Participants	43 Participants	40 Participants	49 Participants	3 Participants	46 Participants	34 Participants	7 Participants	8 Participants	8 Participants	1 Participants	1 Participants	3 Participants	378 Participants
Race (NIH/OMB) White	11 Participants	11 Participants	136 Participants	146 Participants	134 Participants	159 Participants	151 Participants	158 Participants	111 Participants	12 Participants	116 Participants	131 Participants	33 Participants	39 Participants	36 Participants	8 Participants	9 Participants	5 Participants	1406 Participants
Sex: Female, Male Female	8 Participants	10 Participants	90 Participants	98 Participants	98 Participants	113 Participants	112 Participants	115 Participants	91 Participants	8 Participants	87 Participants	89 Participants	17 Participants	20 Participants	20 Participants	8 Participants	4 Participants	2 Participants	990 Participants
Sex: Female, Male Male	10 Participants	10 Participants	114 Participants	108 Participants	107 Participants	134 Participants	134 Participants	131 Participants	107 Participants	10 Participants	115 Participants	108 Participants	34 Participants	36 Participants	34 Participants	4 Participants	8 Participants	9 Participants	1213 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk	EG012 affected / at risk	EG013 affected / at risk	EG014 affected / at risk	EG015 affected / at risk	EG016 affected / at risk	EG017 affected / at risk
deaths Total, all-cause mortality	2 / 18	0 / 18	1 / 20	15 / 198	8 / 202	7 / 197	28 / 204	25 / 206	21 / 205	13 / 51	25 / 56	19 / 54	7 / 12	8 / 12	4 / 11	42 / 247	24 / 246	37 / 246
other Total, other adverse events	0 / 18	0 / 18	1 / 20	0 / 198	0 / 202	0 / 197	0 / 204	0 / 206	0 / 205	0 / 51	0 / 56	0 / 54	0 / 12	1 / 12	1 / 11	0 / 247	1 / 246	2 / 246
serious Total, serious adverse events	3 / 18	3 / 18	2 / 20	43 / 198	29 / 202	32 / 197	63 / 204	47 / 206	47 / 205	20 / 51	31 / 56	26 / 54	9 / 12	11 / 12	5 / 11	65 / 247	56 / 246	69 / 246

Outcome results

Primary

Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS

Cumulative incidence percentage was estimated using Kaplan-Meier method.

Time frame: Up to Day 29

Population: High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 \[Cohort 1\] and Phase 2 \[Cohort 1\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS	20.7 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS	18.9 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS	11.6 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS	15.3 Cumulative Incidence Percentage

Primary

Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS

Cumulative incidence percentage was estimated using Kaplan-Meier method.

Time frame: Up to Day 29

Population: Seronegative modified full analysis set (mFAS) was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 \[Cohort 1\] and Phase 2 \[Cohort 1\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS	23.0 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS	15.1 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS	20.3 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS	17.6 Cumulative Incidence Percentage

Primary

Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29

Hypersensitivity reactions are defined as any relevant adverse event that occurs during the infusion or up to study day 29. The severity of adverse events (including test findings classified as adverse events) were graded according to NCI-CTCAE.

Time frame: Up to Day 29

Population: The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29	1 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29	2 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29	2 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29	4 Participants

Primary

Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4

Infusion-related reactions are defined as any relevant adverse event that occurs during the infusion or up to day 4. The severity of adverse events (including test findings classified as adverse events) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).

Time frame: Up to Day 4

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4	3 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4	2 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4	6 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4	8 Participants

Primary

Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Treatment-Emergent Serious Adverse Events

Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the observation period.

Time frame: Up to Day 169

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Treatment-Emergent Serious Adverse Events	54 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Treatment-Emergent Serious Adverse Events	45 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Treatment-Emergent Serious Adverse Events	47 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Treatment-Emergent Serious Adverse Events	92 Participants

Primary

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS

Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on high viral load mFAS were reported.

Time frame: Day 1 to Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \> 10\^6 copies per mL. Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS	18.8 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS	10.0 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS	14.4 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS	12.2 Percentage of Participants

p-value: 0.0092Cochran-Mantel-Haenszel

p-value: 0.221Cochran-Mantel-Haenszel

Comparison: To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.p-value: 0.0249Cochran-Mantel-Haenszel

Primary

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS

Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on overall mFAS were reported.

Time frame: Day 1 to Day 29

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS	14.8 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS	7.9 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS	12.6 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS	10.2 Percentage of Participants

p-value: 0.0023Cochran-Mantel-Haenszel

p-value: 0.3544Cochran-Mantel-Haenszel

Primary

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS

Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on seronegative mFAS were reported.

Time frame: Day 1 to Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS	19.4 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS	8.1 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS	12.2 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS	10.3 Percentage of Participants

p-value: 0.0045Cochran-Mantel-Haenszel

p-value: 0.0714Cochran-Mantel-Haenszel

Primary

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS

Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on high viral load mFAS were reported.

Time frame: Day 6 to Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS	13.3 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS	7.3 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS	12.4 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS	9.9 Percentage of Participants

p-value: 0.0431Cochran-Mantel-Haenszel

p-value: 0.7975Cochran-Mantel-Haenszel

Primary

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Overall mFAS

Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on overall FAS were reported.

Time frame: Day 6 to Day 29

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Overall mFAS	10.6 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Overall mFAS	5.4 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Overall mFAS	10.7 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Overall mFAS	8.1 Percentage of Participants

p-value: 0.0085Cochran-Mantel-Haenszel

p-value: 0.9902Cochran-Mantel-Haenszel

Primary

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Seronegative mFAS

Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on seronegative mFAS were reported.

Time frame: Day 6 to Day 29

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Seronegative mFAS	15.0 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Seronegative mFAS	4.9 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Seronegative mFAS	10.6 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Seronegative mFAS	7.9 Percentage of Participants

p-value: 0.0039Cochran-Mantel-Haenszel

p-value: 0.2415Cochran-Mantel-Haenszel

Primary

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS

Time-weighted average daily change from Day 1 to Day 7 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.

Time frame: Day 1 to Day 7

Population: The seronegative modified full analysis set (mFAS) was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS	-1.03 log10 copies/milliliter (mL)	Standard Error 0.1
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS	-1.28 log10 copies/milliliter (mL)	Standard Error 0.09
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS	-1.34 log10 copies/milliliter (mL)	Standard Error 0.09
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS	-1.31 log10 copies/milliliter (mL)	Standard Error 0.06

p-value: 0.066395% CI: [-0.51, 0.02]ANCOVA

p-value: 0.020495% CI: [-0.57, 0.05]ANCOVA

Secondary

Concentration at Day 28 (C28)

Time frame: Day 28

Population: Participants who received any study drug of casirivimab and imdevimab and who had at least 1 non-missing drug concentration measurement following the first dose of study drug

Arm	Measure	Group	Value (MEAN)	Dispersion
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Concentration at Day 28 (C28)	C28 of Casirivimab	50.7 mg/L	Standard Deviation 19.5
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Concentration at Day 28 (C28)	C28 of Imdevimab	36.1 mg/L	Standard Deviation 16.1
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Concentration at Day 28 (C28)	C28 of Imdevimab	131 mg/L	Standard Deviation 84.1
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Concentration at Day 28 (C28)	C28 of Casirivimab	166 mg/L	Standard Deviation 108
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Concentration at Day 28 (C28)	C28 of Casirivimab	64.8 mg/L	Standard Deviation 35.9
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Concentration at Day 28 (C28)	C28 of Imdevimab	54.7 mg/L	Standard Deviation 37.6
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Concentration at Day 28 (C28)	C28 of Imdevimab	150 mg/L	Standard Deviation 62.9
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Concentration at Day 28 (C28)	C28 of Casirivimab	174 mg/L	Standard Deviation 65.1
Phase 2: Cohort 1A (Placebo)	Concentration at Day 28 (C28)	C28 of Casirivimab	50.0 mg/L	Standard Deviation 20.4
Phase 2: Cohort 1A (Placebo)	Concentration at Day 28 (C28)	C28 of Imdevimab	39.8 mg/L	Standard Deviation 18.9
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Concentration at Day 28 (C28)	C28 of Casirivimab	144 mg/L	Standard Deviation 89.8
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Concentration at Day 28 (C28)	C28 of Imdevimab	113 mg/L	Standard Deviation 68.8
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Concentration at Day 28 (C28)	C28 of Casirivimab	26.4 mg/L	Standard Deviation 18.5
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Concentration at Day 28 (C28)	C28 of Imdevimab	18.7 mg/L	Standard Deviation 14.7
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Concentration at Day 28 (C28)	C28 of Imdevimab	60.0 mg/L	Standard Deviation 53.9
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Concentration at Day 28 (C28)	C28 of Casirivimab	79.4 mg/L	Standard Deviation 61.4
Phase 2 (Cohort 3): R10933+R10987 2400mg IV	Concentration at Day 28 (C28)	C28 of Imdevimab	5.25 mg/L	Standard Deviation 4.12
Phase 2 (Cohort 3): R10933+R10987 2400mg IV	Concentration at Day 28 (C28)	C28 of Casirivimab	9.06 mg/L	Standard Deviation 2.64
Phase 2 (Cohort 3): R10933+R10987 8000mg IV	Concentration at Day 28 (C28)	C28 of Casirivimab	67.8 mg/L	Standard Deviation 31.1
Phase 2 (Cohort 3): R10933+R10987 8000mg IV	Concentration at Day 28 (C28)	C28 of Imdevimab	52.4 mg/L	Standard Deviation 24.7
Phase 3 (Cohort 1): R10933+R10987 2400mg IV	Concentration at Day 28 (C28)	C28 of Casirivimab	49.1 mg/L	Standard Deviation 40.4
Phase 3 (Cohort 1): R10933+R10987 2400mg IV	Concentration at Day 28 (C28)	C28 of Imdevimab	40.8 mg/L	Standard Deviation 48.3
Phase 3 (Cohort 1): R10933+R10987 8000mg IV	Concentration at Day 28 (C28)	C28 of Casirivimab	140 mg/L	Standard Deviation 66.1
Phase 3 (Cohort 1): R10933+R10987 8000mg IV	Concentration at Day 28 (C28)	C28 of Imdevimab	114 mg/L	Standard Deviation 62.6

Secondary

Concentration at the End of Infusion (Ceoi)

Time frame: Day 1

Population: Participants who received any study drug of casirivimab and imdevimab

Arm	Measure	Group	Value (MEAN)	Dispersion
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Concentration at the End of Infusion (Ceoi)	Ceoi of Imdevimab	243 milligrams per liter (mg/L)	Standard Deviation 117
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Concentration at the End of Infusion (Ceoi)	Ceoi of Casirivimab	231 milligrams per liter (mg/L)	Standard Deviation 110
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Concentration at the End of Infusion (Ceoi)	Ceoi of Imdevimab	795 milligrams per liter (mg/L)	Standard Deviation 371
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Concentration at the End of Infusion (Ceoi)	Ceoi of Casirivimab	776 milligrams per liter (mg/L)	Standard Deviation 372
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Concentration at the End of Infusion (Ceoi)	Ceoi of Imdevimab	283 milligrams per liter (mg/L)	Standard Deviation 127
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Concentration at the End of Infusion (Ceoi)	Ceoi of Casirivimab	272 milligrams per liter (mg/L)	Standard Deviation 124
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Concentration at the End of Infusion (Ceoi)	Ceoi of Imdevimab	868 milligrams per liter (mg/L)	Standard Deviation 298
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Concentration at the End of Infusion (Ceoi)	Ceoi of Casirivimab	847 milligrams per liter (mg/L)	Standard Deviation 300
Phase 2: Cohort 1A (Placebo)	Concentration at the End of Infusion (Ceoi)	Ceoi of Imdevimab	300 milligrams per liter (mg/L)	Standard Deviation 87.3
Phase 2: Cohort 1A (Placebo)	Concentration at the End of Infusion (Ceoi)	Ceoi of Casirivimab	288 milligrams per liter (mg/L)	Standard Deviation 86.8
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Concentration at the End of Infusion (Ceoi)	Ceoi of Casirivimab	848 milligrams per liter (mg/L)	Standard Deviation 261
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Concentration at the End of Infusion (Ceoi)	Ceoi of Imdevimab	880 milligrams per liter (mg/L)	Standard Deviation 268
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Concentration at the End of Infusion (Ceoi)	Ceoi of Imdevimab	302 milligrams per liter (mg/L)	Standard Deviation 94
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Concentration at the End of Infusion (Ceoi)	Ceoi of Casirivimab	286 milligrams per liter (mg/L)	Standard Deviation 93.5
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Concentration at the End of Infusion (Ceoi)	Ceoi of Casirivimab	921 milligrams per liter (mg/L)	Standard Deviation 262
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Concentration at the End of Infusion (Ceoi)	Ceoi of Imdevimab	946 milligrams per liter (mg/L)	Standard Deviation 244
Phase 2 (Cohort 3): R10933+R10987 2400mg IV	Concentration at the End of Infusion (Ceoi)	Ceoi of Imdevimab	290 milligrams per liter (mg/L)	Standard Deviation 81.7
Phase 2 (Cohort 3): R10933+R10987 2400mg IV	Concentration at the End of Infusion (Ceoi)	Ceoi of Casirivimab	284 milligrams per liter (mg/L)	Standard Deviation 69.3
Phase 2 (Cohort 3): R10933+R10987 8000mg IV	Concentration at the End of Infusion (Ceoi)	Ceoi of Casirivimab	708 milligrams per liter (mg/L)	Standard Deviation 128
Phase 2 (Cohort 3): R10933+R10987 8000mg IV	Concentration at the End of Infusion (Ceoi)	Ceoi of Imdevimab	738 milligrams per liter (mg/L)	Standard Deviation 124
Phase 3 (Cohort 1): R10933+R10987 2400mg IV	Concentration at the End of Infusion (Ceoi)	Ceoi of Casirivimab	307 milligrams per liter (mg/L)	Standard Deviation 153
Phase 3 (Cohort 1): R10933+R10987 2400mg IV	Concentration at the End of Infusion (Ceoi)	Ceoi of Imdevimab	312 milligrams per liter (mg/L)	Standard Deviation 157
Phase 3 (Cohort 1): R10933+R10987 8000mg IV	Concentration at the End of Infusion (Ceoi)	Ceoi of Casirivimab	908 milligrams per liter (mg/L)	Standard Deviation 338
Phase 3 (Cohort 1): R10933+R10987 8000mg IV	Concentration at the End of Infusion (Ceoi)	Ceoi of Imdevimab	945 milligrams per liter (mg/L)	Standard Deviation 351

Secondary

Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933

Time frame: Through Day 169

Population: ADA analysis set includes all treated participants from all phases/cohorts who received any amount of study drug and had at least one non-missing antibody variables result following the first dose of study drug or placebo.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933	489 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933	471 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933	484 Participants

Secondary

Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987

Time frame: Through Day 169

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987	467 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987	444 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987	463 Participants

Secondary

Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933

Time frame: Through Day 57

Population: NAb analysis set includes all Phase 2/3 treated participants who received any study drug, had at least one non-missing antibody result following the first dose of study drug, and either tested negative at all ADA sampling times or tested positive for ADA with at least one non-missing NAb result after first dose of the study drug.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933	Anti-drug Antibody (ADA) Negative	489 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933	Neutralizing antibody (NAb) Positive	1 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933	Anti-drug Antibody (ADA) Negative	471 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933	Neutralizing antibody (NAb) Positive	1 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933	Anti-drug Antibody (ADA) Negative	484 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933	Neutralizing antibody (NAb) Positive	1 Participants

Secondary

Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987

Time frame: Through Day 57

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987	Anti-drug Antibody (ADA) Negative	467 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987	Neutralizing antibody (NAb) Positive	9 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987	Anti-drug Antibody (ADA) Negative	444 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987	Neutralizing antibody (NAb) Positive	10 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987	Anti-drug Antibody (ADA) Negative	463 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987	Neutralizing antibody (NAb) Positive	4 Participants

Secondary

Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS

Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.

Time frame: Days 3, 5, 7, 9, 11, 13, 15, 22 and 29

Population: Seronegative modified full analysis set (mFAS) = all participants in mFAS with documented seroneg status at baseline. Number of Participants Analyzed = participants with measurements at baseline. Number Analyzed = participants with measurements at both baseline and specific study day. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected/reported for Phase 1 \[Cohort 1\] and Phase 2 \[Cohort 1\].

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 15	-4.60 log10 copies/milliliter (mL)	Standard Error 0.39
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 13	-3.04 log10 copies/milliliter (mL)	Standard Error 0.38
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 29	-6.01 log10 copies/milliliter (mL)	Standard Error 0.32
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 9	-2.68 log10 copies/milliliter (mL)	Standard Error 0.34
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 7	-1.62 log10 copies/milliliter (mL)	Standard Error 0.3
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 5	-1.18 log10 copies/milliliter (mL)	Standard Error 0.26
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 22	-5.89 log10 copies/milliliter (mL)	Standard Error 0.37
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 11	-3.55 log10 copies/milliliter (mL)	Standard Error 0.39
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 3	-0.66 log10 copies/milliliter (mL)	Standard Error 0.22
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 11	-3.74 log10 copies/milliliter (mL)	Standard Error 0.38
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 15	-4.67 log10 copies/milliliter (mL)	Standard Error 0.35
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 13	-5.01 log10 copies/milliliter (mL)	Standard Error 0.35
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 5	-2.08 log10 copies/milliliter (mL)	Standard Error 0.26
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 3	-0.81 log10 copies/milliliter (mL)	Standard Error 0.21
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 7	-2.76 log10 copies/milliliter (mL)	Standard Error 0.27
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 29	-6.04 log10 copies/milliliter (mL)	Standard Error 0.27
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 22	-5.21 log10 copies/milliliter (mL)	Standard Error 0.31
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 9	-3.24 log10 copies/milliliter (mL)	Standard Error 0.31
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 11	-3.94 log10 copies/milliliter (mL)	Standard Error 0.37
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 3	-1.08 log10 copies/milliliter (mL)	Standard Error 0.23
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 5	-2.28 log10 copies/milliliter (mL)	Standard Error 0.27
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 7	-2.56 log10 copies/milliliter (mL)	Standard Error 0.29
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 9	-3.16 log10 copies/milliliter (mL)	Standard Error 0.32
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 13	-4.25 log10 copies/milliliter (mL)	Standard Error 0.39
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 15	-5.01 log10 copies/milliliter (mL)	Standard Error 0.36
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 22	-5.25 log10 copies/milliliter (mL)	Standard Error 0.32
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 29	-6.16 log10 copies/milliliter (mL)	Standard Error 0.28
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 15	-4.84 log10 copies/milliliter (mL)	Standard Error 0.25
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 9	-3.20 log10 copies/milliliter (mL)	Standard Error 0.22
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 7	-2.67 log10 copies/milliliter (mL)	Standard Error 0.2
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 29	-6.10 log10 copies/milliliter (mL)	Standard Error 0.2
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 22	-5.23 log10 copies/milliliter (mL)	Standard Error 0.22
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 5	-2.18 log10 copies/milliliter (mL)	Standard Error 0.19
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 13	-4.68 log10 copies/milliliter (mL)	Standard Error 0.26
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 11	-3.87 log10 copies/milliliter (mL)	Standard Error 0.26
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 3	-0.94 log10 copies/milliliter (mL)	Standard Error 0.16

Secondary

Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

Time frame: Through Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 \[Cohort 1\] and Phase 2 \[Cohort 1\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	23.1 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	23.4 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	13.8 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	18.5 Percentage of Participants

Secondary

Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Time frame: Through Day 29

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on Seronegative mFAS	26.9 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on Seronegative mFAS	17.7 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on Seronegative mFAS	22.0 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on Seronegative mFAS	19.8 Percentage of Participants

Secondary

Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS

Time-weighted average daily change over time up to Day 29 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.

Time frame: Up to Day 29

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 15	-1.50 log10 copies/milliliter (mL)	Standard Error 0.19
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 13	-1.33 log10 copies/milliliter (mL)	Standard Error 0.18
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 29	-2.35 log10 copies/milliliter (mL)	Standard Error 0.24
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 9	-0.93 log10 copies/milliliter (mL)	Standard Error 0.16
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 7	-0.70 log10 copies/milliliter (mL)	Standard Error 0.14
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 5	-0.55 log10 copies/milliliter (mL)	Standard Error 0.14
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 22	-1.89 log10 copies/milliliter (mL)	Standard Error 0.22
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 11	-1.12 log10 copies/milliliter (mL)	Standard Error 0.16
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 3	-0.33 log10 copies/milliliter (mL)	Standard Error 0.11
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 11	-1.72 log10 copies/milliliter (mL)	Standard Error 0.16
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 15	-2.19 log10 copies/milliliter (mL)	Standard Error 0.18
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 13	-1.96 log10 copies/milliliter (mL)	Standard Error 0.17
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 5	-0.86 log10 copies/milliliter (mL)	Standard Error 0.14
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 3	-0.40 log10 copies/milliliter (mL)	Standard Error 0.11
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 7	-1.23 log10 copies/milliliter (mL)	Standard Error 0.14
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 29	-2.98 log10 copies/milliliter (mL)	Standard Error 0.23
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 22	-2.62 log10 copies/milliliter (mL)	Standard Error 0.21
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 9	-1.47 log10 copies/milliliter (mL)	Standard Error 0.15
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 11	-1.78 log10 copies/milliliter (mL)	Standard Error 0.17
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 3	-0.60 log10 copies/milliliter (mL)	Standard Error 0.12
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 5	-0.92 log10 copies/milliliter (mL)	Standard Error 0.14
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 7	-1.23 log10 copies/milliliter (mL)	Standard Error 0.14
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 9	-1.58 log10 copies/milliliter (mL)	Standard Error 0.16
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 13	-1.95 log10 copies/milliliter (mL)	Standard Error 0.18
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 15	-2.16 log10 copies/milliliter (mL)	Standard Error 0.19
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 22	-2.64 log10 copies/milliliter (mL)	Standard Error 0.22
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 29	-2.95 log10 copies/milliliter (mL)	Standard Error 0.24
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 15	-2.18 log10 copies/milliliter (mL)	Standard Error 0.13
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 9	-1.52 log10 copies/milliliter (mL)	Standard Error 0.11
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 7	-1.23 log10 copies/milliliter (mL)	Standard Error 0.1
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 29	-2.97 log10 copies/milliliter (mL)	Standard Error 0.17
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 22	-2.63 log10 copies/milliliter (mL)	Standard Error 0.15
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 5	-0.89 log10 copies/milliliter (mL)	Standard Error 0.1
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 13	-1.96 log10 copies/milliliter (mL)	Standard Error 0.12
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 11	-1.75 log10 copies/milliliter (mL)	Standard Error 0.12
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS	Time-weighted average change from baseline from Day 1 to Day 3	-0.50 log10 copies/milliliter (mL)	Standard Error 0.08

Secondary

Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28)

Time frame: Up to Day 28

Population: Participants in Phase 1 (Cohort 1) who received any study drug of casirivimab and imdevimab and who had at least 1 non-missing drug concentration measurement following the first dose of study drug

Arm	Measure	Group	Value (MEAN)	Dispersion
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28)	AUC0-28 of Casirivimab	3026 day*mg/L	Standard Deviation 719
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28)	AUC0-28 of Imdevimab	2582 day*mg/L	Standard Deviation 581
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28)	AUC0-28 of Casirivimab	9678 day*mg/L	Standard Deviation 3362
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28)	AUC0-28 of Imdevimab	8680 day*mg/L	Standard Deviation 2930

Secondary

Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time

Time frame: Days 3, 5, 7, 9, 11, 13, 15, 22 and 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Number of Participants Analyzed = participants with measurements at baseline. Number Analyzed = participants with measurements for both baseline and the specific study day. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 22	-5.29 log10 copies/mL	Standard Error 0.3
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 9	-2.56 log10 copies/mL	Standard Error 0.32
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 15	-4.42 log10 copies/mL	Standard Error 0.32
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 13	-3.76 log10 copies/mL	Standard Error 0.35
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 29	-5.90 log10 copies/mL	Standard Error 0.24
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 5	-1.97 log10 copies/mL	Standard Error 0.27
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 11	-3.22 log10 copies/mL	Standard Error 0.35
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 7	-1.97 log10 copies/mL	Standard Error 0.3
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 3	-1.10 log10 copies/mL	Standard Error 0.22
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 7	-2.92 log10 copies/mL	Standard Error 0.26
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 3	-0.90 log10 copies/mL	Standard Error 0.19
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 9	-3.89 log10 copies/mL	Standard Error 0.27
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 22	-5.74 log10 copies/mL	Standard Error 0.24
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 11	-4.23 log10 copies/mL	Standard Error 0.29
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 29	-6.46 log10 copies/mL	Standard Error 0.18
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 5	-2.28 log10 copies/mL	Standard Error 0.23
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 13	-5.18 log10 copies/mL	Standard Error 0.3
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 15	-5.41 log10 copies/mL	Standard Error 0.28
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 7	-3.22 log10 copies/mL	Standard Error 0.25
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 13	-5.00 log10 copies/mL	Standard Error 0.29
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 29	-6.60 log10 copies/mL	Standard Error 0.18
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 5	-1.91 log10 copies/mL	Standard Error 0.25
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 3	-0.93 log10 copies/mL	Standard Error 0.19
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 22	-5.95 log10 copies/mL	Standard Error 0.24
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 9	-4.16 log10 copies/mL	Standard Error 0.27
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 15	-5.25 log10 copies/mL	Standard Error 0.27
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 11	-4.57 log10 copies/mL	Standard Error 0.3
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 9	-4.03 log10 copies/mL	Standard Error 0.19
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 7	-3.09 log10 copies/mL	Standard Error 0.18
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 11	-4.41 log10 copies/mL	Standard Error 0.21
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 22	-5.85 log10 copies/mL	Standard Error 0.17
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 5	-2.11 log10 copies/mL	Standard Error 0.17
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 29	-6.54 log10 copies/mL	Standard Error 0.13
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 15	-5.34 log10 copies/mL	Standard Error 0.19
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 3	-0.92 log10 copies/mL	Standard Error 0.14
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 13	-5.10 log10 copies/mL	Standard Error 0.21
Phase 2: Cohort 1A (Placebo)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 11	-3.88 log10 copies/mL	Standard Error 0.32
Phase 2: Cohort 1A (Placebo)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 3	-0.85 log10 copies/mL	Standard Error 0.21
Phase 2: Cohort 1A (Placebo)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 5	-1.55 log10 copies/mL	Standard Error 0.25
Phase 2: Cohort 1A (Placebo)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 7	-2.29 log10 copies/mL	Standard Error 0.26
Phase 2: Cohort 1A (Placebo)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 9	-2.90 log10 copies/mL	Standard Error 0.28
Phase 2: Cohort 1A (Placebo)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 13	-4.22 log10 copies/mL	Standard Error 0.31
Phase 2: Cohort 1A (Placebo)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 15	-4.14 log10 copies/mL	Standard Error 0.28
Phase 2: Cohort 1A (Placebo)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 22	-5.37 log10 copies/mL	Standard Error 0.3
Phase 2: Cohort 1A (Placebo)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 29	-5.77 log10 copies/mL	Standard Error 0.27
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 5	-2.21 log10 copies/mL	Standard Error 0.26
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 3	-1.03 log10 copies/mL	Standard Error 0.2
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 15	-5.03 log10 copies/mL	Standard Error 0.27
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 7	-3.06 log10 copies/mL	Standard Error 0.25
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 9	-3.75 log10 copies/mL	Standard Error 0.26
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 29	-6.34 log10 copies/mL	Standard Error 0.26
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 11	-4.76 log10 copies/mL	Standard Error 0.3
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 22	-5.75 log10 copies/mL	Standard Error 0.29
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 13	-4.56 log10 copies/mL	Standard Error 0.29
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 22	-5.77 log10 copies/mL	Standard Error 0.25
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 3	-1.41 log10 copies/mL	Standard Error 0.19
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 11	-4.34 log10 copies/mL	Standard Error 0.27
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 15	-5.23 log10 copies/mL	Standard Error 0.25
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 9	-3.85 log10 copies/mL	Standard Error 0.24
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 7	-3.49 log10 copies/mL	Standard Error 0.24
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 5	-2.24 log10 copies/mL	Standard Error 0.24
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 29	-6.36 log10 copies/mL	Standard Error 0.23
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 13	-5.05 log10 copies/mL	Standard Error 0.27
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 29	-6.35 log10 copies/mL	Standard Error 0.17
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 13	-4.82 log10 copies/mL	Standard Error 0.2
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 9	-3.80 log10 copies/mL	Standard Error 0.18
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 7	-3.27 log10 copies/mL	Standard Error 0.17
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 15	-5.14 log10 copies/mL	Standard Error 0.18
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 5	-2.21 log10 copies/mL	Standard Error 0.18
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 22	-5.75 log10 copies/mL	Standard Error 0.19
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 3	-1.23 log10 copies/mL	Standard Error 0.14
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Change at Day 11	-4.52 log10 copies/mL	Standard Error 0.2

Comparison: Difference vs. Placebo by Day 29p-value: 0.0623MMRM

Comparison: Difference vs. Placebo by Day 29p-value: 0.0203MMRM

Comparison: Difference vs. Placebo by Day 29p-value: 0.0193MMRM

Comparison: Difference vs. Placebo by Day 29p-value: 0.1206MMRM

Comparison: Difference vs. Placebo by Day 29p-value: 0.0911MMRM

Comparison: Difference vs. Placebo by Day 29p-value: 0.0645MMRM

Secondary

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Percentage of participants with cumulative incidence of death or mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

Time frame: by Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS	30.4 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS	12.7 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS	21.2 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS	17.0 Cumulative Incidence Percentage
Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS	11.8 Cumulative Incidence Percentage
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS	4.7 Cumulative Incidence Percentage
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS	5.9 Cumulative Incidence Percentage
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS	5.4 Cumulative Incidence Percentage

Secondary

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS

Cumulative Incidence of Death or Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

Time frame: Up to Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS	27.2 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS	15.0 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS	24.4 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS	19.5 Cumulative Incidence Percentage
Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS	9.1 Cumulative Incidence Percentage
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS	4.1 Cumulative Incidence Percentage
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS	5.3 Cumulative Incidence Percentage
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS	4.8 Cumulative Incidence Percentage

Secondary

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS

Cumulative Incidence of Death Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

Time frame: Up to Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS	21.1 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS	11.2 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS	17.9 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS	14.3 Cumulative Incidence Percentage
Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS	7.2 Cumulative Incidence Percentage
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS	3.1 Cumulative Incidence Percentage
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS	5.3 Cumulative Incidence Percentage
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS	4.3 Cumulative Incidence Percentage

Secondary

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS

Percentage of participants with cumulative incidence of death in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) up to Day 29 from randomization were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

Time frame: Up to Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS	23.6 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS	7.8 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS	11.4 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS	9.6 Cumulative Incidence Percentage
Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS	9.6 Cumulative Incidence Percentage
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS	3.6 Cumulative Incidence Percentage
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS	5.9 Cumulative Incidence Percentage
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS	4.8 Cumulative Incidence Percentage

Secondary

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Percentage of participants with cumulative incidence of mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

Time frame: by Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS	18.2 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS	8.9 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS	17.6 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS	13.4 Cumulative Incidence Percentage
Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS	4.7 Cumulative Incidence Percentage
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS	3.5 Cumulative Incidence Percentage
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS	0.0 Cumulative Incidence Percentage
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS	1.7 Cumulative Incidence Percentage

Secondary

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS

Cumulative Incidence of Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

Time frame: Up to Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS	18.1 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS	8.8 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS	18.0 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS	13.1 Cumulative Incidence Percentage
Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS	4.0 Cumulative Incidence Percentage
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS	3.1 Cumulative Incidence Percentage
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS	0.0 Cumulative Incidence Percentage
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS	1.5 Cumulative Incidence Percentage

Secondary

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS

Percentage of participants who died from Day 1 through Day 29 in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.

Time frame: Day 1 to Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS	22.9 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS	7.5 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS	11.0 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS	9.3 Percentage of Participants
Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS	8.9 Percentage of Participants
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS	3.3 Percentage of Participants
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS	5.7 Percentage of Participants
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS	4.5 Percentage of Participants

p-value: 0.0147Cochran-Mantel-Haenszel

p-value: 0.0669Cochran-Mantel-Haenszel

p-value: 0.0094Cochran-Mantel-Haenszel

p-value: 0.1306Cochran-Mantel-Haenszel

p-value: 0.3576Cochran-Mantel-Haenszel

p-value: 0.1476Cochran-Mantel-Haenszel

Secondary

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS

Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.

Time frame: Day 1 to Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS	20.6 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS	10.9 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS	16.9 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS	13.8 Percentage of Participants
Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS	6.8 Percentage of Participants
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS	2.9 Percentage of Participants
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS	5.1 Percentage of Participants
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS	4.1 Percentage of Participants

p-value: 0.0389Cochran-Mantel-Haenszel

p-value: 0.5208Cochran-Mantel-Haenszel

p-value: 0.1079Cochran-Mantel-Haenszel

p-value: 0.3315Cochran-Mantel-Haenszel

p-value: 0.5797Cochran-Mantel-Haenszel

p-value: 0.3036Cochran-Mantel-Haenszel

Secondary

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS

Percentage of participants who died from Day 6 through Day 29 in phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.

Time frame: Day 6 to Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS	19.4 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS	6.3 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS	10.0 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS	8.2 Percentage of Participants
Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS	9.3 Percentage of Participants
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS	3.4 Percentage of Participants
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS	5.0 Percentage of Participants
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS	4.2 Percentage of Participants

p-value: 0.0223Cochran-Mantel-Haenszel

p-value: 0.1256Cochran-Mantel-Haenszel

p-value: 0.023Cochran-Mantel-Haenszel

p-value: 0.1298Cochran-Mantel-Haenszel

p-value: 0.2642Cochran-Mantel-Haenszel

p-value: 0.097Cochran-Mantel-Haenszel

Secondary

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS

Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.

Time frame: Day 6 to Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS	18.0 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS	10.2 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS	15.7 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS	12.8 Percentage of Participants
Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS	7.0 Percentage of Participants
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS	3.1 Percentage of Participants
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS	4.4 Percentage of Participants
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS	3.8 Percentage of Participants

p-value: 0.0811Cochran-Mantel-Haenszel

p-value: 0.6701Cochran-Mantel-Haenszel

p-value: 0.2006Cochran-Mantel-Haenszel

p-value: 0.3313Cochran-Mantel-Haenszel

p-value: 0.5542Cochran-Mantel-Haenszel

p-value: 0.2214Cochran-Mantel-Haenszel

Secondary

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS

Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) by Day 29 were reported. Readmission to hospital was based on investigator report.

Time frame: Up to Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS	27.1 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS	13.8 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS	14.6 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS	14.2 Percentage of Participants
Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS	22.2 Percentage of Participants
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS	9.8 Percentage of Participants
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS	11.3 Percentage of Participants
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS	10.6 Percentage of Participants

p-value: 0.0388Cochran-Mantel-Haenszel

p-value: 0.0092Cochran-Mantel-Haenszel

p-value: 0.05Cochran-Mantel-Haenszel

p-value: 0.0663Cochran-Mantel-Haenszel

p-value: 0.0229Cochran-Mantel-Haenszel

p-value: 0.0208Cochran-Mantel-Haenszel

Secondary

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS

Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) over time were reported. Readmission to hospital was based on investigator report.

Time frame: Up to Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS	24.6 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS	18.6 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS	22.9 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS	20.6 Percentage of Participants
Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS	16.5 Percentage of Participants
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS	10.8 Percentage of Participants
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS	11.9 Percentage of Participants
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS	11.4 Percentage of Participants

p-value: 0.2635Cochran-Mantel-Haenszel

p-value: 0.8013Cochran-Mantel-Haenszel

p-value: 0.416Cochran-Mantel-Haenszel

p-value: 0.2194Cochran-Mantel-Haenszel

p-value: 0.324Cochran-Mantel-Haenszel

p-value: 0.1981Cochran-Mantel-Haenszel

Secondary

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.

Time frame: by Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	17.5 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	8.5 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	16.9 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	12.6 Percentage of Participants
Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	3.9 Percentage of Participants
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	2.9 Percentage of Participants
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	0.0 Percentage of Participants
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	1.4 Percentage of Participants

p-value: 0.0481Cochran-Mantel-Haenszel

p-value: 0.988Cochran-Mantel-Haenszel

p-value: 0.2498Cochran-Mantel-Haenszel

p-value: 1Cochran-Mantel-Haenszel

p-value: 0.0457Cochran-Mantel-Haenszel

p-value: 0.2153Cochran-Mantel-Haenszel

Secondary

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.

Time frame: by Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS	17.1 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS	8.8 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS	17.1 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS	13.0 Percentage of Participants
Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS	4.4 Percentage of Participants
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS	3.3 Percentage of Participants
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS	0.0 Percentage of Participants
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS	1.5 Percentage of Participants

p-value: 0.2162Cochran-Mantel-Haenszel

p-value: 0.8783Cochran-Mantel-Haenszel

p-value: 0.5583Cochran-Mantel-Haenszel

p-value: 0.7189Cochran-Mantel-Haenszel

p-value: 0.0429Cochran-Mantel-Haenszel

p-value: 0.2103Cochran-Mantel-Haenszel

Secondary

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS

Percentage of participants who were discharged in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.

Time frame: by Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS	72.2 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS	83.7 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS	78.8 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS	81.4 Percentage of Participants
Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS	90.3 Percentage of Participants
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS	96.1 Percentage of Participants
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS	94.9 Percentage of Participants
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS	95.5 Percentage of Participants

p-value: 0.0364Cochran-Mantel-Haenszel

p-value: 0.2795Cochran-Mantel-Haenszel

p-value: 0.0588Cochran-Mantel-Haenszel

p-value: 0.0364Cochran-Mantel-Haenszel

p-value: 0.2795Cochran-Mantel-Haenszel

p-value: 0.0588Cochran-Mantel-Haenszel

Secondary

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS

Percentage of participants who were discharged in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported.

Time frame: by Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS	70.0 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS	85.0 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS	84.1 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS	84.6 Percentage of Participants
Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS	90.0 Percentage of Participants
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS	94.6 Percentage of Participants
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS	94.3 Percentage of Participants
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS	94.4 Percentage of Participants

p-value: 0.0481Cochran-Mantel-Haenszel

p-value: 0.0535Cochran-Mantel-Haenszel

p-value: 0.0199Cochran-Mantel-Haenszel

p-value: 0.2784Cochran-Mantel-Haenszel

p-value: 0.251Cochran-Mantel-Haenszel

p-value: 0.1702Cochran-Mantel-Haenszel

Secondary

Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time

Percent change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.

Time frame: Days 3, 5, 7, 9, 11, 13, 15, 22 and 29

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 22	-100.00 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 9	-99.72 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 15	-100.00 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 13	-99.98 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 29	-100.00 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 5	-98.92 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 11	-99.94 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 7	-98.92 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 3	-92.04 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 7	-99.88 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 3	-87.52 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 9	-99.99 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 22	-100.00 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 11	-99.99 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 29	-100.00 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 5	-99.48 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 13	-100.00 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 15	-100.00 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 7	-99.94 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 13	-100.00 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 29	-100.00 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 5	-98.76 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 3	-88.15 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 22	-100.00 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 9	-99.99 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 15	-100.00 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 11	-100.00 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 9	-99.99 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 7	-99.92 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 11	-100.00 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 22	-100.00 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 5	-99.23 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 29	-100.00 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 15	-100.00 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 3	-87.94 Percent Change
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 13	-100.00 Percent Change
Phase 2: Cohort 1A (Placebo)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 11	-99.99 Percent Change
Phase 2: Cohort 1A (Placebo)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 3	-85.92 Percent Change
Phase 2: Cohort 1A (Placebo)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 5	-97.18 Percent Change
Phase 2: Cohort 1A (Placebo)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 7	-99.49 Percent Change
Phase 2: Cohort 1A (Placebo)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 9	-99.87 Percent Change
Phase 2: Cohort 1A (Placebo)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 13	-99.99 Percent Change
Phase 2: Cohort 1A (Placebo)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 15	-99.99 Percent Change
Phase 2: Cohort 1A (Placebo)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 22	-100.00 Percent Change
Phase 2: Cohort 1A (Placebo)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 29	-100.00 Percent Change
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 5	-99.38 Percent Change
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 3	-90.65 Percent Change
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 15	-100.00 Percent Change
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 7	-99.91 Percent Change
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 9	-99.98 Percent Change
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 29	-100.00 Percent Change
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 11	-100.00 Percent Change
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 22	-100.00 Percent Change
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 13	-100.00 Percent Change
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 22	-100.00 Percent Change
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 3	-96.15 Percent Change
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 11	-100.00 Percent Change
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 15	-100.00 Percent Change
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 9	-99.99 Percent Change
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 7	-99.97 Percent Change
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 5	-99.42 Percent Change
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 29	-100.00 Percent Change
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 13	-100.00 Percent Change
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 29	-100.00 Percent Change
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 13	-100.00 Percent Change
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 9	-99.98 Percent Change
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 7	-99.95 Percent Change
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 15	-100.00 Percent Change
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 5	-99.39 Percent Change
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 22	-100.00 Percent Change
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 3	-94.15 Percent Change
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time	Percent change at Day 11	-100.00 Percent Change

Comparison: Percent Difference vs. Placebo at Day 29p-value: 0.0623MMRM

Comparison: Percent Difference vs. Placebo at Day 29p-value: 0.0203MMRM

Comparison: Percent Difference vs. Placebo at Day 29p-value: 0.0193MMRM

Comparison: Percent Difference vs. Placebo at Day 29p-value: 0.1206MMRM

Comparison: Percent Difference vs. Placebo at Day 29p-value: 0.0911MMRM

Comparison: Percent Difference vs. Placebo at Day 29p-value: 0.0645MMRM

Secondary

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS

Time to Discharge in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.

Time frame: Up to Day 56

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (MEDIAN)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS	7.0 days
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS	7.0 days
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS	7.0 days
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS	7.0 days
Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS	4.0 days
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS	3.0 days
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS	3.0 days
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS	3.0 days

Secondary

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS

Time to discharge from hospital up to Day 56 was reported.

Time frame: Up to Day 56

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (MEDIAN)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS	8.5 Days
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS	5.0 Days
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS	6.0 Days
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS	6.0 Days
Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS	4.0 Days
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS	3.0 Days
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS	3.0 Days
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS	3.0 Days

p-value: 0.037stratified log-rank test

p-value: 0.1596stratified log-rank test

p-value: 0.0444stratified log-rank test

p-value: 0.1802stratified log-rank test

p-value: 0.0407stratified log-rank test

p-value: 0.0523stratified log-rank test

Secondary

Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS

TWA change from baseline in viral load up to Day 11 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 11, was measured by RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.

Time frame: Day 1 to Day 11

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS	-1.52 log10 copies/mL	Standard Error 0.17
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS	-2.03 log10 copies/mL	Standard Error 0.15
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS	-1.95 log10 copies/mL	Standard Error 0.15
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS	-2.00 log10 copies/mL	Standard Error 0.1
Phase 2: Cohort 1A (Placebo)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS	-1.28 log10 copies/mL	Standard Error 0.14
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS	-1.88 log10 copies/mL	Standard Error 0.14
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS	-2.01 log10 copies/mL	Standard Error 0.14
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS	-1.95 log10 copies/mL	Standard Error 0.1

p-value: 0.0245ANCOVA

p-value: 0.0554ANCOVA

p-value: 0.0179ANCOVA

p-value: 0.0035ANCOVA

p-value: 0.0003ANCOVA

p-value: 0.0002ANCOVA

Secondary

Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29

TWA change from baseline in viral load up to Day 29 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 29, was measured by quantitative RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.

Time frame: Day 1 to Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29	-2.72 log10 copies/mL	Standard Error 0.22
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29	-3.68 log10 copies/mL	Standard Error 0.2
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29	-3.69 log10 copies/mL	Standard Error 0.2
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29	-3.69 log10 copies/mL	Standard Error 0.14
Phase 2: Cohort 1A (Placebo)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29	-2.66 log10 copies/mL	Standard Error 0.21
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29	-3.31 log10 copies/mL	Standard Error 0.21
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29	-3.58 log10 copies/mL	Standard Error 0.2
Phase 2 (Cohort 1A): Combined R10933+R10987 IV	Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29	-3.45 log10 copies/mL	Standard Error 0.14

p-value: 0.0013ANCOVA

p-value: 0.001ANCOVA

p-value: 0.0002ANCOVA

p-value: 0.025ANCOVA

p-value: 0.0012ANCOVA

p-value: 0.0014ANCOVA

Secondary

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS

Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

Time frame: by Day 29

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS	14.9 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS	7.7 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS	11.7 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS	9.7 Cumulative Incidence Percentage

Secondary

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS

Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A)were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

Time frame: by Day 29

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS	15.8 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS	5.6 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS	8.4 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS	7.0 Cumulative Incidence Percentage

Secondary

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

Time frame: by Day 29

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	19.1 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	10.2 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	15.0 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	12.7 Cumulative Incidence Percentage

Secondary

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

Time frame: by Day 29

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS	20.1 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS	8.4 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS	12.7 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS	10.7 Cumulative Incidence Percentage

Secondary

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

Number of participants with cumulative incidence of mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

Time frame: by Day 29

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	11.8 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	6.3 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	9.1 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	7.7 Cumulative Incidence Percentage

Secondary

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Percentage of participants with cumulative incidence of mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

Time frame: by Day 29

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS	10.6 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS	6.0 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS	7.9 Cumulative Incidence Percentage
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS	7.0 Cumulative Incidence Percentage

Secondary

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS

Percentage of participants who died from Day 1 through Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.

Time frame: Day 1 to Day 29

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS	14.4 Percentage of participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS	7.4 Percentage of participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS	11.0 Percentage of participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS	9.2 Percentage of participants

p-value: 0.0174Cochran-Mantel-Haenszel

p-value: 0.29Cochran-Mantel-Haenszel

p-value: 0.0454Cochran-Mantel-Haenszel

Secondary

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS

Percentage of participants who died from Day 1 through Day 29 based on seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.

Time frame: Day 1 to Day 29

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS	15.0 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS	5.2 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS	8.0 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS	6.7 Percentage of Participants

p-value: 0.004Cochran-Mantel-Haenszel

p-value: 0.0413Cochran-Mantel-Haenszel

p-value: 0.0032Cochran-Mantel-Haenszel

Secondary

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS

Percentage of participants who died from Day 6 through Day 29 based on high viral load mFAS were reported.

Time frame: Day 6 to Day 29

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS	13.1 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS	7.1 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS	10.1 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS	8.6 Percentage of Participants

p-value: 0.0383Cochran-Mantel-Haenszel

p-value: 0.3296Cochran-Mantel-Haenszel

p-value: 0.0766Cochran-Mantel-Haenszel

Secondary

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS

Percentage of participants who died from Day 6 through Day 29 Based on seronegative mFAS in pooled analysis phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.

Time frame: Day 6 to Day 29

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS	13.7 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS	4.8 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS	7.2 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS	6.0 Percentage of Participants

p-value: 0.007Cochran-Mantel-Haenszel

p-value: 0.0507Cochran-Mantel-Haenszel

p-value: 0.0051Cochran-Mantel-Haenszel

Secondary

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS

Percentage of participants who died or were readmitted to hospital at Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Readmission to hospital was based on investigator report.

Time frame: by Day 29

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS	24.4 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS	11.6 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS	12.8 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS	12.2 Percentage of Participants

p-value: 0.00024Cochran-Mantel-Haenszel

p-value: 0.0054Cochran-Mantel-Haenszel

p-value: 0.0005Cochran-Mantel-Haenszel

Secondary

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS

Percentage of participants who died or were readmitted to hospital over time based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)were reported. Readmission to hospital was based on investigator report.

Time frame: Up to Day 29

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS	21.0 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS	15.2 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS	17.4 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS	16.3 Percentage of Participants

p-value: 0.1032Cochran-Mantel-Haenszel

p-value: 0.335Cochran-Mantel-Haenszel

p-value: 0.1314Cochran-Mantel-Haenszel

Secondary

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

Percentage of participants who went on mechanical ventilation by Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.

Time frame: by Day 29

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	11.4 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	6.1 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	8.5 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS	7.3 Percentage of Participants

p-value: 0.0575Cochran-Mantel-Haenszel

p-value: 0.3133Cochran-Mantel-Haenszel

p-value: 0.0849Cochran-Mantel-Haenszel

Secondary

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Percentage of participants who went on mechanical ventilation at Day 29 based on Seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.

Time frame: by Day 29

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS	10.0 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS	5.8 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS	7.4 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS	6.7 Percentage of Participants

p-value: 0.2167Cochran-Mantel-Haenszel

p-value: 0.4123Cochran-Mantel-Haenszel

p-value: 0.2206Cochran-Mantel-Haenszel

Secondary

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS

Percentage of participants who were discharged by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.

Time frame: by Day 29

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS	80.3 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS	89.2 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS	86.9 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS	88.0 Percentage of Participants

p-value: 0.0105Cochran-Mantel-Haenszel

p-value: 0.0622Cochran-Mantel-Haenszel

p-value: 0.0088Cochran-Mantel-Haenszel

Secondary

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS

Percentage of participants who were discharged by Day 29 based on seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.

Time frame: by Day 29

Arm	Measure	Value (NUMBER)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS	81.3 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS	90.1 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS	89.9 Percentage of Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS	90.0 Percentage of Participants

p-value: 0.0275Cochran-Mantel-Haenszel

p-value: 0.0223Cochran-Mantel-Haenszel

p-value: 0.0072Cochran-Mantel-Haenszel

Secondary

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS

Time to discharge from hospital based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.

Time frame: Up to Day 56

Arm	Measure	Value (MEDIAN)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS	5.0 Days
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS	4.0 Days
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS	4.0 Days
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS	4.0 Days

p-value: 0.0533Log Rank

p-value: 0.0411Log Rank

p-value: 0.0229Log Rank

Secondary

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS

Time to discharge from hospital based on Seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.

Time frame: Up to Day 56

Arm	Measure	Value (MEDIAN)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS	4.5 Days
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS	4.0 Days
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS	4.0 Days
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS	4.0 Days

p-value: 0.0218Stratified Log Rank Test

p-value: 0.0156Stratified Log Rank Test

p-value: 0.0067Stratified Log Rank Test

Secondary

Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29

Time frame: Up to Day 29

Population: all FAS participants. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29	2 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29	5 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29	7 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29	12 Participants

Secondary

Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4

Time frame: Up to Day 4

Population: all FAS participants. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4	6 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4	11 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4	15 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4	26 Participants

Secondary

Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Treatment-Emergent Serious Adverse Events

Time frame: Up to Day 169

Population: all FAS participants. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo	Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Treatment-Emergent Serious Adverse Events	203 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)	Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Treatment-Emergent Serious Adverse Events	177 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)	Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Treatment-Emergent Serious Adverse Events	181 Participants
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV	Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Treatment-Emergent Serious Adverse Events	358 Participants

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026

Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Intervention model description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS

Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS

Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29

Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4

Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Treatment-Emergent Serious Adverse Events

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Overall mFAS

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Seronegative mFAS

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS

Concentration at Day 28 (C28)

Concentration at the End of Infusion (Ceoi)

Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933

Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987

Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933

Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987

Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS

Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS

Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28)

Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS

Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS

Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS

Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS