Efficacy and Safety of Molnupiravir (MK-4482) in Hospital... | NCT04575584

NCT04575584

ID	Type	Description
MK-4482-001	Other Identifier	Merck
PHRR201210-003189	Registry Identifier	PHRR
jRCT2031200404	Registry Identifier	jRCT
2020-003367-26	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part 1: Molnupiravir 200 mg	Experimental	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Drug: Molnupiravir
Part 1: Molnupiravir 400 mg	Experimental	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Drug: Molnupiravir
Part 1: Molnupiravir 800 mg	Experimental	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Drug: Molnupiravir
Part 1: Placebo	Placebo Comparator	Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Drug: Placebo
Part 2: Molnupiravir	Experimental	Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Drug: Molnupiravir
Part 2: Placebo	Placebo Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Molnupiravir	Drug	Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time-to-sustained Recovery	The median time to sustained recovery is reported. Sustained recovery is defined as 1) the participant is alive and not hospitalized; or 2) the participant is alive and medically ready for discharge as determined by the investigator.	Up to 29 days
Number of Participants With an Adverse Event (AE)	The number of participants with at least 1 AE is presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	Up to 19 days (during treatment and 14-day follow-up)
Number of Participants Who Discontinued Study Intervention Due to an AE	The number of participants discontinuing from study treatment due to an AE is presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	Up to 5 days

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With All-cause Mortality	The number of participants with all-cause mortality through Day 29 is presented. All-cause mortality is defined as death due to any cause. Any participants with an unknown survival status at Day 29 were imputed as deceased.	Up to 29 days
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has documentation of polymerase chain reaction (PCR)-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with sample collection ≤ 10 days prior to the day of randomization. PCR is the preferred method; however other diagnostic methods are allowed if authorized by use in the country
Had initial onset of signs/symptoms attributable to COVID-19 for ≤10 days prior to the day of randomization and ≥1 sign/symptom attributable to COVID-19 present at randomization
Requires medical care in the hospital for ongoing clinical manifestations of COVID-19 (not just for public health or quarantine purposes)
Has mild, moderate, or severe COVID-19
Is willing and able to take oral medication
Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: Refrain from donating sperm; and either abstain from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception
Females are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP); or is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) for 28 days from the start of study intervention; a WOCBP must have a negative highly sensitive pregnancy test (serum test is required) within 24 hours before the first dose of study intervention

Exclusion Criteria:

Has critical COVID-19 with any of the following: respiratory failure (including endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (flow rates >20L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, or extracorporeal membrane oxygenation (ECMO))
Is on dialysis or has reduced estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m^2 by the Modification of Diet in Renal Disease (MDRD) equation
Has any of the following conditions: human immunodeficiency virus (HIV) with a recent viral load >50 copies/mL or cluster of differentiation 4 (CD4) <200 cell/mm^3; chemotherapy required within 6 weeks before randomization; a neutrophilic granulocyte absolute count <500/mm^3; autologous or allogeneic hematopoietic stem cell transplant recipient
Has history of Hepatitis B or Hepatitis C infection with any of the following: 1) cirrhosis 2) end-stage liver disease 3) hepatocellular carcinoma 4) aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal at screening
Has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis
Is taking or is anticipated to require any prohibited therapies
Is unwilling to abstain from participating in another interventional clinical trial through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics
Is anticipated to require transfer to a non-study hospital within 72 hours
Has a baseline heart rate of < 50 beats per minute at rest
Has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization
Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: participants who are not expected to survive longer than 48 hours after randomization or participants who are expected to require mechanical ventilation within 48 hours after randomization or participants with a recent history of mechanical ventilation or participants with conditions that could limit gastrointestinal absorption of capsule contents

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Kaiser Foundation Hospital - South Bay ( Site 1832)		Harbor City	California	90710	United States

PubMed Identifier	Type	Citation	Retractions
38319178	Result	Arribas JR, Bhagani S, Lobo SM, Khaertynova I, Mateu L, Fishchuk R, Park WY, Hussein K, Kim SW, Ghosn J, Brown ML, Zhang Y, Gao W, Assaid C, Grobler JA, Strizki J, Vesnesky M, Paschke A, Butterton JR, De Anda C. Randomized Trial of Molnupiravir or Placebo in Patients Hospitalized with Covid-19. NEJM Evid. 2022 Feb;1(2):EVIDoa2100044. doi: 10.1056/EVIDoa2100044. Epub 2021 Dec 16.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
FG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 17, 2020

Arm/Group Information

ID	Title	Description
BG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
BG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
BG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
BG003	Part 1: Placebo	Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
BG004	Part 2: Molnupiravir	Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
BG005	Part 2: Placebo	Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
BG006	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time-to-sustained Recovery

The median time to sustained recovery is reported. Sustained recovery is defined as 1) the participant is alive and not hospitalized; or 2) the participant is alive and medically ready for discharge as determined by the investigator.

All randomized participants in Part 1 who received ≥1 dose of study drug are included.

Posted

Median

95% Confidence Interval

days

Up to 29 days

ID	Title	Description
OG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG003	Part 1: Placebo	Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG004	Part 2: Molnupiravir	Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
OG005	Part 2: Placebo	Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)

Units	Counts
Participants	OG00073 OG00173 OG00272 OG003

Title

Denominators

Categories

Title	Measurements
	OG0009.0(7.0 to 10.0) OG0019.0(8.0 to 10.0) OG0029.0(8.0 to 11.0) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003		Log Rank		0.5620		Hazard Ratio (HR)	0.99			2-Sided	95	0.68	1.45			Based on Cox regression model with Efron's method of tie handling		Superiority
OG001 OG003		Log Rank

Primary

Number of Participants With an Adverse Event (AE)

The number of participants with at least 1 AE is presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

All randomized participants in Part 1 who received ≥1 dose of study drug are included.

Posted

Count of Participants

Participants

Up to 19 days (during treatment and 14-day follow-up)

ID	Title	Description
OG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG003	Part 1: Placebo	Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)

Primary

Number of Participants Who Discontinued Study Intervention Due to an AE

The number of participants discontinuing from study treatment due to an AE is presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

All randomized participants in Part 1 who received ≥1 dose of study drug are included.

Posted

Count of Participants

Participants

Up to 5 days

ID	Title	Description
OG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG003	Part 1: Placebo	Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)

Secondary

Number of Participants With All-cause Mortality

The number of participants with all-cause mortality through Day 29 is presented. All-cause mortality is defined as death due to any cause. Any participants with an unknown survival status at Day 29 were imputed as deceased.

All randomized participants in Part 1 who received ≥1 dose of study drug are included.

Posted

Count of Participants

Participants

Up to 29 days

ID	Title	Description
OG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG003	Part 1: Placebo	Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)

Secondary

Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3

Pulmonary score is a score on an ordinal scale which focuses on respiratory sequalae based on oxygen requirements using 7 mutually exclusive categories. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.

All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.

Posted

Count of Participants

Participants

Day 3

ID	Title	Description
OG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG003

Secondary

Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5])

All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.

Posted

Count of Participants

Participants

EOT (Day 5)

ID	Title	Description
OG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG003

Secondary

Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10

All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.

Posted

Count of Participants

Participants

Day 10

ID	Title	Description
OG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG003

Secondary

Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15

All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.

Posted

Count of Participants

Participants

Day 15

ID	Title	Description
OG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG003

Secondary

Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29

All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.

Posted

Count of Participants

Participants

Day 29

ID	Title	Description
OG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG003

Secondary

Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3

Pulmonary+ score is a score on an ordinal scale which is a 7-category assessment that captures the range of disease severity in hospitalized participants, including coagulation-related complications and respiratory dysfunction. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.

All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.

Posted

Count of Participants

Participants

Day 3

ID	Title	Description
OG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

Secondary

Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5)

All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.

Posted

Count of Participants

Participants

EOT (Day 5)

ID	Title	Description
OG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

Secondary

Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10

All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.

Posted

Count of Participants

Participants

Day 10

ID	Title	Description
OG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

Secondary

Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15

All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.

Posted

Count of Participants

Participants

Day 15

ID	Title	Description
OG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

Secondary

Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29

All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.

Posted

Count of Participants

Participants

Day 29

ID	Title	Description
OG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

Secondary

Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score

The National Early Warning Score (Royal College of Physicians, 2012) assesses a participant's degree of illness as assessed by clinical risk prediction categories based on a set of vital sign measurements. There are 7 physiological parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0 to 3 was allocated to each parameter except supplemental oxygen use (score of 0 [no] or 2 [yes]) and level of consciousness (score of 0 or 3 with 0 = normal health condition and 3 = worst health condition). All scores were summed to get an aggregate score. Aggregate NEWS score ranged from 0 to 19, with higher scores meaning more severity/higher risk: low risk (score 0 to 4); low to medium risk (score of 3 in any individual parameter); medium risk (score 5 to 6); high risk (score 7 to 19). The number of participants at each aggregate risk category is presented.

All randomized participants in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.

Posted

Count of Participants

Participants

EOT (Day 5)

ID	Title	Description
OG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

Secondary

Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3

The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented.

All randomized participants in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.

Posted

Count of Participants

Participants

Day 3

ID	Title	Description
OG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG003	Part 1: Placebo

Secondary

Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5)

All randomized participants in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.

Posted

Count of Participants

Participants

EOT (Day 5)

ID	Title	Description
OG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG003	Part 1: Placebo

Secondary

Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10

All randomized participants in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.

Posted

Count of Participants

Participants

Day 10

ID	Title	Description
OG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG003	Part 1: Placebo

Secondary

Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15

All randomized participants in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.

Posted

Count of Participants

Participants

Day 15

ID	Title	Description
OG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG003	Part 1: Placebo

Secondary

Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29

All randomized participants in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.

Posted

Count of Participants

Participants

Day 29

ID	Title	Description
OG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
OG003	Part 1: Placebo

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 1: Molnupiravir 200 mg	200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	6	75	11	73	11	73
EG001	Part 1: Molnupiravir 400 mg	400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	4	75	9	73	11	73
EG002	Part 1: Molnupiravir 800 mg	800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	7	76	13	72	7	72
EG003	Part 1: Placebo	Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	2	78	12	75	13	75
EG004	Part 2: Molnupiravir	Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	0	0	0	0	0	0
EG005	Part 2: Placebo	Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	0	0	0	0	0	0

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0011 events1 affected73 at risk EG0020 events0 affected72 at risk EG0030 events0 affected75 at risk EG0040 at risk EG0050 at risk
Cardiac arrest	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0011 events1 affected73 at risk EG0020 events0 affected72 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0010 events0 affected73 at risk EG0020 events0 affected72 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected73 at risk EG0010 events0 affected73 at risk EG0020 events0 affected72 at risk EG003
Physical deconditioning	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0010 events0 affected73 at risk EG0021 events1 affected72 at risk EG003
Cholestasis	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0010 events0 affected73 at risk EG0021 events1 affected72 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected73 at risk EG0010 events0 affected73 at risk EG0020 events0 affected72 at risk EG003
COVID-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0007 events7 affected73 at risk EG0014 events4 affected73 at risk EG0025 events5 affected72 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0011 events1 affected73 at risk EG0023 events3 affected72 at risk EG003
Peritonitis bacterial	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected73 at risk EG0010 events0 affected73 at risk EG0020 events0 affected72 at risk EG003
Pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0011 events1 affected73 at risk EG0022 events2 affected72 at risk EG003
Pulmonary sepsis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0010 events0 affected73 at risk EG0020 events0 affected72 at risk EG003
Septic shock	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0011 events1 affected73 at risk EG0021 events1 affected72 at risk EG003
Urinary tract infection enterococcal	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0010 events0 affected73 at risk EG0021 events1 affected72 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected73 at risk EG0010 events0 affected73 at risk EG0020 events0 affected72 at risk EG003
Transaminases increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0011 events1 affected73 at risk EG0021 events1 affected72 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0010 events0 affected73 at risk EG0021 events1 affected72 at risk EG003
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0011 events1 affected73 at risk EG0020 events0 affected72 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0011 events1 affected73 at risk EG0020 events0 affected72 at risk EG003
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0011 events1 affected73 at risk EG0020 events0 affected72 at risk EG003
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0010 events0 affected73 at risk EG0020 events0 affected72 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected73 at risk EG0010 events0 affected73 at risk EG0021 events1 affected72 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0010 events0 affected73 at risk EG0021 events1 affected72 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected73 at risk EG0011 events1 affected73 at risk EG0021 events1 affected72 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected73 at risk EG0010 events0 affected73 at risk EG0022 events2 affected72 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0010 events0 affected73 at risk EG0020 events0 affected72 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected73 at risk EG0010 events0 affected73 at risk EG0020 events0 affected72 at risk EG003
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected73 at risk EG0010 events0 affected73 at risk EG0020 events0 affected72 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected73 at risk EG0010 events0 affected73 at risk EG0020 events0 affected72 at risk EG003
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0011 events1 affected73 at risk EG0020 events0 affected72 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected73 at risk EG0014 events4 affected73 at risk EG0023 events3 affected72 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0010 events0 affected73 at risk EG0020 events0 affected72 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected73 at risk EG0010 events0 affected73 at risk EG0020 events0 affected72 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0010 events0 affected73 at risk EG0021 events1 affected72 at risk EG003
Hypotension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected73 at risk EG0010 events0 affected73 at risk EG0020 events0 affected72 at risk EG003
Shock	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected73 at risk EG0011 events1 affected73 at risk EG0020 events0 affected72 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected73 at risk EG0010 events0 affected73 at risk EG0022 events2 affected72 at risk EG003

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D018352	Coronavirus Infections
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0005 events5 affected73 at risk EG0012 events2 affected73 at risk EG0020 events0 affected72 at risk EG0035 events5 affected75 at risk EG0040 at risk EG0050 at risk
Alanine aminotransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected73 at risk EG0015 events5 affected73 at risk EG0027 events7 affected72 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected73 at risk EG0015 events5 affected73 at risk EG0026 events5 affected72 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected73 at risk EG0015 events5 affected73 at risk EG0020 events0 affected72 at risk EG003