Trial Outcomes & Findings for Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001) (NCT NCT04575584)

NCT ID: NCT04575584

Last Updated: 2023-01-17

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 304 participants
• Primary outcome timeframe: Up to 29 days
• Results posted on: 2023-01-17

Participant Flow

Participants were enrolled at 86 study centers in 15 countries.

Participant milestones

Measure	Part 1: Molnupiravir 200 mg 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Study STARTED	75	75	76	78	0	0
Overall Study Treated	73	73	72	75	0	0
Overall Study COMPLETED	61	60	63	70	0	0
Overall Study NOT COMPLETED	14	15	13	8	0	0

Reasons for withdrawal

Measure	Part 1: Molnupiravir 200 mg 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Study Death	6	4	6	2	0	0
Overall Study Lost to Follow-up	1	1	1	1	0	0
Overall Study Physician Decision	0	1	1	1	0	0
Overall Study Withdrawal by Subject	7	9	5	3	0	0
Overall Study Not recorded	0	0	0	1	0	0

Baseline Characteristics

Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001)

Baseline characteristics by cohort

Measure	Part 1: Molnupiravir 200 mg n=75 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=75 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=76 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=78 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Total n=304 Participants Total of all reporting groups
Age, Continuous	56.9 years STANDARD_DEVIATION 14.2 • n=5 Participants	57.0 years STANDARD_DEVIATION 14.0 • n=7 Participants	56.8 years STANDARD_DEVIATION 13.7 • n=5 Participants	57.1 years STANDARD_DEVIATION 14.2 • n=4 Participants	—	—	57.0 years STANDARD_DEVIATION 14.0 • n=115 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	34 Participants n=7 Participants	32 Participants n=5 Participants	34 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	132 Participants n=115 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	41 Participants n=7 Participants	44 Participants n=5 Participants	44 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	172 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants	32 Participants n=7 Participants	28 Participants n=5 Participants	27 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	114 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants	42 Participants n=7 Participants	46 Participants n=5 Participants	49 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	184 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	6 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	6 Participants n=115 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	23 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	18 Participants n=115 Participants
Race (NIH/OMB) White	58 Participants n=5 Participants	52 Participants n=7 Participants	54 Participants n=5 Participants	63 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	227 Participants n=115 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	5 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	27 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants

PRIMARY outcome

Timeframe: Up to 29 days

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

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.

Outcome measures

Measure	Part 1: Molnupiravir 200 mg n=73 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time-to-sustained Recovery	9.0 days Interval 7.0 to 10.0	9.0 days Interval 8.0 to 10.0	9.0 days Interval 8.0 to 11.0	9.0 days Interval 8.0 to 11.0	—	—

PRIMARY outcome

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

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

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.

Outcome measures

Measure	Part 1: Molnupiravir 200 mg n=73 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Number of Participants With an Adverse Event (AE)	40 Participants	36 Participants	45 Participants	46 Participants	—	—

PRIMARY outcome

Timeframe: Up to 5 days

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

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.

Outcome measures

Measure	Part 1: Molnupiravir 200 mg n=73 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Number of Participants Who Discontinued Study Intervention Due to an AE	0 Participants	1 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to 29 days

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

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.

Outcome measures

Measure	Part 1: Molnupiravir 200 mg n=73 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Number of Participants With All-cause Mortality	4 Participants	5 Participants	4 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Day 3

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

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.

Outcome measures

Measure	Part 1: Molnupiravir 200 mg n=73 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 1	25 Participants	20 Participants	21 Participants	16 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 2	2 Participants	7 Participants	0 Participants	7 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 3	21 Participants	20 Participants	23 Participants	25 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 4	16 Participants	16 Participants	19 Participants	14 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 5	7 Participants	9 Participants	6 Participants	10 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 6	1 Participants	0 Participants	3 Participants	1 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 7	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 Missing	1 Participants	1 Participants	0 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: EOT (Day 5)

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

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.

Outcome measures

Measure	Part 1: Molnupiravir 200 mg n=73 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) 1	30 Participants	22 Participants	26 Participants	27 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) 2	6 Participants	5 Participants	4 Participants	4 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) 3	17 Participants	18 Participants	15 Participants	16 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) 4	10 Participants	14 Participants	14 Participants	14 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) 5	7 Participants	8 Participants	8 Participants	8 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) 6	1 Participants	1 Participants	3 Participants	1 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) 7	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) Missing	2 Participants	5 Participants	2 Participants	5 Participants	—	—

SECONDARY outcome

Timeframe: Day 10

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

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.

Outcome measures

Measure	Part 1: Molnupiravir 200 mg n=73 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 1	44 Participants	39 Participants	33 Participants	38 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 2	4 Participants	4 Participants	4 Participants	5 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 3	8 Participants	8 Participants	14 Participants	10 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 4	5 Participants	7 Participants	8 Participants	10 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 5	4 Participants	3 Participants	5 Participants	4 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 6	3 Participants	0 Participants	3 Participants	3 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 7	0 Participants	3 Participants	0 Participants	0 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 Missing	5 Participants	9 Participants	5 Participants	5 Participants	—	—

SECONDARY outcome

Timeframe: Day 15

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

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.

Outcome measures

Measure	Part 1: Molnupiravir 200 mg n=73 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 1	45 Participants	44 Participants	41 Participants	42 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 2	7 Participants	2 Participants	2 Participants	5 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 3	6 Participants	6 Participants	14 Participants	10 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 4	3 Participants	5 Participants	3 Participants	6 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 5	2 Participants	1 Participants	0 Participants	4 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 6	4 Participants	1 Participants	7 Participants	3 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 7	0 Participants	3 Participants	1 Participants	1 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 Missing	6 Participants	11 Participants	4 Participants	4 Participants	—	—

SECONDARY outcome

Timeframe: Day 29

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

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.

Outcome measures

Measure	Part 1: Molnupiravir 200 mg n=73 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 1	46 Participants	47 Participants	47 Participants	49 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 2	2 Participants	2 Participants	2 Participants	5 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 3	4 Participants	5 Participants	9 Participants	7 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 4	5 Participants	1 Participants	3 Participants	5 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 5	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 6	2 Participants	0 Participants	5 Participants	2 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 7	4 Participants	4 Participants	3 Participants	1 Participants	—	—
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 Missing	10 Participants	14 Participants	3 Participants	6 Participants	—	—

SECONDARY outcome

Timeframe: Day 3

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

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.

Outcome measures

Measure	Part 1: Molnupiravir 200 mg n=73 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 1	25 Participants	20 Participants	21 Participants	16 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 2	2 Participants	7 Participants	0 Participants	7 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 3	20 Participants	20 Participants	23 Participants	25 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 4	16 Participants	16 Participants	19 Participants	14 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 5	7 Participants	9 Participants	6 Participants	10 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 6	2 Participants	0 Participants	3 Participants	1 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 7	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 Missing	1 Participants	1 Participants	0 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: EOT (Day 5)

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

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.

Outcome measures

Measure	Part 1: Molnupiravir 200 mg n=73 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) 1	30 Participants	22 Participants	26 Participants	27 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) 2	6 Participants	5 Participants	4 Participants	4 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) 3	16 Participants	18 Participants	15 Participants	16 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) 4	10 Participants	14 Participants	14 Participants	14 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) 5	7 Participants	8 Participants	8 Participants	8 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) 6	2 Participants	1 Participants	3 Participants	1 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) 7	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) Missing	2 Participants	5 Participants	2 Participants	5 Participants	—	—

SECONDARY outcome

Timeframe: Day 10

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

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.

Outcome measures

Measure	Part 1: Molnupiravir 200 mg n=73 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 1	44 Participants	39 Participants	33 Participants	38 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 2	4 Participants	4 Participants	4 Participants	5 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 3	8 Participants	8 Participants	14 Participants	10 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 4	4 Participants	7 Participants	8 Participants	10 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 5	4 Participants	3 Participants	4 Participants	4 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 6	4 Participants	0 Participants	4 Participants	3 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 7	0 Participants	3 Participants	0 Participants	0 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 Missing	5 Participants	9 Participants	5 Participants	5 Participants	—	—

SECONDARY outcome

Timeframe: Day 15

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

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.

Outcome measures

Measure	Part 1: Molnupiravir 200 mg n=73 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 7	0 Participants	3 Participants	1 Participants	1 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 Missing	6 Participants	11 Participants	4 Participants	4 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 1	45 Participants	44 Participants	41 Participants	42 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 2	7 Participants	2 Participants	2 Participants	5 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 3	6 Participants	6 Participants	14 Participants	10 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 4	3 Participants	5 Participants	3 Participants	6 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 5	2 Participants	1 Participants	0 Participants	4 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 6	4 Participants	1 Participants	7 Participants	3 Participants	—	—

SECONDARY outcome

Timeframe: Day 29

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

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.

Outcome measures

Measure	Part 1: Molnupiravir 200 mg n=73 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 3	4 Participants	5 Participants	9 Participants	7 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 1	46 Participants	47 Participants	47 Participants	49 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 2	2 Participants	2 Participants	2 Participants	5 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 4	5 Participants	1 Participants	3 Participants	5 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 5	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 6	2 Participants	0 Participants	5 Participants	2 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 7	4 Participants	4 Participants	3 Participants	1 Participants	—	—
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 Missing	10 Participants	14 Participants	3 Participants	6 Participants	—	—

SECONDARY outcome

Timeframe: EOT (Day 5)

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

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.

Outcome measures

Measure	Part 1: Molnupiravir 200 mg n=73 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score Low	57 Participants	45 Participants	52 Participants	55 Participants	—	—
Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score Medium	8 Participants	8 Participants	9 Participants	11 Participants	—	—
Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score High	5 Participants	11 Participants	8 Participants	3 Participants	—	—
Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score Missing	3 Participants	9 Participants	3 Participants	6 Participants	—	—

SECONDARY outcome

Timeframe: Day 3

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

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.

Outcome measures

Measure	Part 1: Molnupiravir 200 mg n=73 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 0	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 1	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 2	1 Participants	1 Participants	0 Participants	2 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 3	1 Participants	0 Participants	0 Participants	1 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 4	27 Participants	27 Participants	21 Participants	24 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 5	36 Participants	36 Participants	42 Participants	37 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 6	7 Participants	9 Participants	6 Participants	10 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 7	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 8	0 Participants	0 Participants	2 Participants	0 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 9	1 Participants	0 Participants	1 Participants	1 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 10	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 Missing	0 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: EOT (Day 5)

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

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.

Outcome measures

Measure	Part 1: Molnupiravir 200 mg n=73 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) 0	2 Participants	0 Participants	1 Participants	0 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) 1	2 Participants	1 Participants	1 Participants	2 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) 2	3 Participants	5 Participants	0 Participants	9 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) 3	0 Participants	2 Participants	2 Participants	1 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) 4	29 Participants	20 Participants	27 Participants	25 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) 5	27 Participants	31 Participants	28 Participants	26 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) 6	7 Participants	8 Participants	8 Participants	8 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) 7	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) 8	1 Participants	1 Participants	1 Participants	0 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) 9	0 Participants	0 Participants	2 Participants	1 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) 10	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) Missing	2 Participants	5 Participants	2 Participants	3 Participants	—	—

SECONDARY outcome

Timeframe: Day 10

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

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.

Outcome measures

Measure	Part 1: Molnupiravir 200 mg n=73 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 0	3 Participants	4 Participants	2 Participants	3 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 1	10 Participants	7 Participants	7 Participants	7 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 2	26 Participants	19 Participants	22 Participants	21 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 3	3 Participants	4 Participants	7 Participants	8 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 4	8 Participants	16 Participants	7 Participants	13 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 5	11 Participants	9 Participants	14 Participants	11 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 6	4 Participants	2 Participants	5 Participants	3 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 7	0 Participants	0 Participants	1 Participants	0 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 8	2 Participants	0 Participants	0 Participants	3 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 9	1 Participants	0 Participants	2 Participants	0 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 10	0 Participants	3 Participants	0 Participants	0 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 Missing	5 Participants	9 Participants	5 Participants	6 Participants	—	—

SECONDARY outcome

Timeframe: Day 15

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

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.

Outcome measures

Measure	Part 1: Molnupiravir 200 mg n=73 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 0	10 Participants	8 Participants	10 Participants	8 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 1	12 Participants	12 Participants	9 Participants	11 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 2	25 Participants	25 Participants	27 Participants	27 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 3	7 Participants	5 Participants	4 Participants	8 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 4	4 Participants	3 Participants	3 Participants	5 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 5	4 Participants	4 Participants	7 Participants	4 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 6	2 Participants	0 Participants	0 Participants	3 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 7	0 Participants	0 Participants	2 Participants	1 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 8	3 Participants	0 Participants	1 Participants	0 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 9	0 Participants	1 Participants	4 Participants	2 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 10	0 Participants	3 Participants	1 Participants	1 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 Missing	6 Participants	12 Participants	4 Participants	5 Participants	—	—

SECONDARY outcome

Timeframe: Day 29

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

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.

Outcome measures

Measure	Part 1: Molnupiravir 200 mg n=73 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 0	25 Participants	17 Participants	29 Participants	22 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 1	4 Participants	13 Participants	7 Participants	9 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 2	24 Participants	21 Participants	17 Participants	24 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 3	3 Participants	2 Participants	7 Participants	7 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 4	0 Participants	2 Participants	0 Participants	0 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 5	1 Participants	0 Participants	0 Participants	4 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 6	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 7	0 Participants	0 Participants	2 Participants	0 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 8	2 Participants	0 Participants	2 Participants	2 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 9	0 Participants	0 Participants	1 Participants	0 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 10	4 Participants	4 Participants	3 Participants	1 Participants	—	—
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 Missing	10 Participants	14 Participants	4 Participants	6 Participants	—	—

Adverse Events

Part 1: Molnupiravir 200 mg

Serious events: 11 serious events

Other events: 11 other events

Deaths: 6 deaths

Part 1: Molnupiravir 400 mg

Serious events: 9 serious events

Other events: 11 other events

Deaths: 4 deaths

Part 1: Molnupiravir 800 mg

Serious events: 13 serious events

Other events: 7 other events

Deaths: 7 deaths

Part 1: Placebo

Serious events: 12 serious events

Other events: 13 other events

Deaths: 2 deaths

Part 2: Molnupiravir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2: Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part 1: Molnupiravir 200 mg n=73 participants at risk 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 participants at risk 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 participants at risk 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 participants at risk Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Blood and lymphatic system disorders Anaemia	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Cardiac disorders Cardiac arrest	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Cardiac disorders Supraventricular tachycardia	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.3% 1/75 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Gastrointestinal disorders Haemorrhoids	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
General disorders Physical deconditioning	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/72 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Hepatobiliary disorders Cholestasis	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/72 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Infections and infestations Bacteraemia	2.7% 2/73 • Number of events 2 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Infections and infestations COVID-19	9.6% 7/73 • Number of events 7 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	5.5% 4/73 • Number of events 4 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	6.9% 5/72 • Number of events 5 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	8.0% 6/75 • Number of events 6 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Infections and infestations COVID-19 pneumonia	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	4.2% 3/72 • Number of events 3 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	6.7% 5/75 • Number of events 5 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Infections and infestations Peritonitis bacterial	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Infections and infestations Pneumonia	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	2.8% 2/72 • Number of events 2 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Infections and infestations Pulmonary sepsis	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.3% 1/75 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Infections and infestations Septic shock	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/72 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Infections and infestations Urinary tract infection enterococcal	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/72 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Investigations Haemoglobin decreased	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Investigations Transaminases increased	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/72 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/72 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.3% 1/75 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Renal and urinary disorders Acute kidney injury	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/72 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Renal and urinary disorders Chronic kidney disease	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/72 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/72 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	4.1% 3/73 • Number of events 3 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	2.8% 2/72 • Number of events 2 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	2.7% 2/75 • Number of events 2 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.3% 1/75 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.1% 3/73 • Number of events 3 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	5.5% 4/73 • Number of events 4 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	4.2% 3/72 • Number of events 3 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	4.0% 3/75 • Number of events 3 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.3% 1/75 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Skin and subcutaneous tissue disorders Urticaria	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Vascular disorders Deep vein thrombosis	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/72 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Vascular disorders Hypotension	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Vascular disorders Shock	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Infections and infestations Pneumonia bacterial	1.4% 1/73 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/73 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	2.8% 2/72 • Number of events 2 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/75 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.

Other adverse events

Measure	Part 1: Molnupiravir 200 mg n=73 participants at risk 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 participants at risk 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=72 participants at risk 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=75 participants at risk Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Metabolism and nutrition disorders Hyperglycaemia	5.5% 4/73 • Number of events 4 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	6.8% 5/73 • Number of events 5 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	1.3% 1/75 • Number of events 1 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Gastrointestinal disorders Constipation	6.8% 5/73 • Number of events 5 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	2.7% 2/73 • Number of events 2 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	0.00% 0/72 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	6.7% 5/75 • Number of events 5 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Investigations Alanine aminotransferase increased	5.5% 4/73 • Number of events 4 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	6.8% 5/73 • Number of events 5 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	9.7% 7/72 • Number of events 7 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	10.7% 8/75 • Number of events 8 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
Investigations Aspartate aminotransferase increased	4.1% 3/73 • Number of events 3 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	6.8% 5/73 • Number of events 5 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	6.9% 5/72 • Number of events 6 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	4.0% 3/75 • Number of events 3 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.	— 0/0 • Up to 7 months All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme, LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
• Publication restrictions are in place

Restriction type: OTHER