Trial Outcomes & Findings for Adaptive COVID-19 Treatment Trial 3 (ACTT-3) (NCT NCT04492475)

Last Updated: 2022-03-14

Results Overview

Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

969 participants

Primary outcome timeframe

Day 1 through Day 29

Results posted on

2022-03-14

Participant Flow

Participants were recruited at the participating sites from those admitted with symptoms of COVID-19 confirmed by PCR. Enrollment occurred between 05AUG2020 and 11NOV2020.

Participant milestones

Participant milestones
Measure	Remdesivir Plus Interferon Beta-1a 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses. Interferon beta-1a: Rebif (R) is a purified 166 amino acid human interferon beta glycoprotein with an amino acid sequence identical to natural fibroblast derived human interferon beta. Each 0.5 mL prefilled syringe contains 44 mcg of interferon beta-1a, 4 mg human albumin, USP; 27.3 mg mannitol, USP; 0.4 mg sodium acetate; and water for injection, USP. Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.	Remdesivir Plus Placebo 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses. Placebo: The interferon beta-1a placebo contains either 0.5 mL 0.9% normal saline or 0.5 mL sterile water for injection. Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
Overall Study STARTED	487	482
Overall Study ITT and Modified ITT Population	487	482
Overall Study As Treated Population	477	468
Overall Study COMPLETED	473	474
Overall Study NOT COMPLETED	14	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Remdesivir Plus Interferon Beta-1a 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses. Interferon beta-1a: Rebif (R) is a purified 166 amino acid human interferon beta glycoprotein with an amino acid sequence identical to natural fibroblast derived human interferon beta. Each 0.5 mL prefilled syringe contains 44 mcg of interferon beta-1a, 4 mg human albumin, USP; 27.3 mg mannitol, USP; 0.4 mg sodium acetate; and water for injection, USP. Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.	Remdesivir Plus Placebo 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses. Placebo: The interferon beta-1a placebo contains either 0.5 mL 0.9% normal saline or 0.5 mL sterile water for injection. Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
Overall Study Enrolled but not treated	8	8
Overall Study Withdrawal by Subject	4	0
Overall Study Became ineligible after enrollment	2	0

Baseline Characteristics

Adaptive COVID-19 Treatment Trial 3 (ACTT-3)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Remdesivir Plus Interferon Beta-1a n=487 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses.	Remdesivir Plus Placebo n=482 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses.	Total n=969 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	301 Participants n=5 Participants	304 Participants n=7 Participants	605 Participants n=5 Participants
Age, Categorical >=65 years	186 Participants n=5 Participants	178 Participants n=7 Participants	364 Participants n=5 Participants
Age, Continuous	58.3 years STANDARD_DEVIATION 15.8 • n=5 Participants	59.1 years STANDARD_DEVIATION 16.1 • n=7 Participants	58.7 years STANDARD_DEVIATION 15.9 • n=5 Participants
Sex: Female, Male Female	190 Participants n=5 Participants	216 Participants n=7 Participants	406 Participants n=5 Participants
Sex: Female, Male Male	297 Participants n=5 Participants	266 Participants n=7 Participants	563 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	154 Participants n=5 Participants	157 Participants n=7 Participants	311 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	323 Participants n=5 Participants	317 Participants n=7 Participants	640 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Asian	44 Participants n=5 Participants	39 Participants n=7 Participants	83 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Black or African American	76 Participants n=5 Participants	84 Participants n=7 Participants	160 Participants n=5 Participants
Race (NIH/OMB) White	299 Participants n=5 Participants	285 Participants n=7 Participants	584 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	54 Participants n=5 Participants	63 Participants n=7 Participants	117 Participants n=5 Participants
Region of Enrollment South Korea	16 participants n=5 Participants	14 participants n=7 Participants	30 participants n=5 Participants
Region of Enrollment Singapore	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment United States	432 participants n=5 Participants	428 participants n=7 Participants	860 participants n=5 Participants
Region of Enrollment Japan	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants
Region of Enrollment Mexico	28 participants n=5 Participants	29 participants n=7 Participants	57 participants n=5 Participants
Baseline Ordinal Score Ordinal Score 4	84 Participants n=5 Participants	68 Participants n=7 Participants	152 Participants n=5 Participants
Baseline Ordinal Score Ordinal Score 5	368 Participants n=5 Participants	380 Participants n=7 Participants	748 Participants n=5 Participants
Baseline Ordinal Score Ordinal Score 6	35 Participants n=5 Participants	34 Participants n=7 Participants	69 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 29

Population: The modified intention-to-treat (mITT) population includes all participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=487 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=482 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6	5.0 Days A large number of participants at the median estimate means there is little variability at the 50th percentile and the methodology described by Klein and Moeschberger (1997) is unable to compute a confidence interval. Also, if less than 50% of participants recover then the median time can not be estimated.	5.0 Days A large number of participants at the median estimate means there is little variability at the 50th percentile and the methodology described by Klein and Moeschberger (1997) is unable to compute a confidence interval. Also, if less than 50% of participants recover then the median time can not be estimated.	—	—

PRIMARY outcome

Timeframe: Day 1 through Day 29

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=487 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=482 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Race Asian	8.0 Days Interval 6.0 to 9.0	8.0 Days Interval 6.0 to 12.0	—	—
Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Race Black or African American	4.0 Days Interval 4.0 to 5.0	4.0 Days Interval 4.0 to 5.0	—	—
Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Race White	4.0 Days Interval 4.0 to 5.0	5.0 Days Interval 4.0 to 5.0	—	—
Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Race Other	6.0 Days Interval 5.0 to 7.0	5.0 Days Interval 4.0 to 6.0	—	—

PRIMARY outcome

Timeframe: Day 1 through Day 29

Population: The modified intention-to-treat (mITT) population includes all participants who were randomized and for whom Ethnicity was reported. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=477 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=474 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Ethnicity Not Hispanic or Latino	5.0 Days Interval 4.0 to 5.0	5.0 Days Interval 4.0 to 5.0	—	—
Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Ethnicity Hispanic or Latino	6.0 Days Interval 5.0 to 7.0	5.0 Days A large number of participants at the median estimate means there is little variability at the 50th percentile and the methodology described by Klein and Moeschberger (1997) is unable to compute a confidence interval. Also, if less than 50% of participants recover then the median time can not be estimated.	—	—

PRIMARY outcome

Timeframe: Day 1 through Day 29

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=487 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=482 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Sex Male	5.0 Days Interval 5.0 to 6.0	5.0 Days Interval 5.0 to 6.0	—	—
Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Sex Female	4.5 Days Interval 4.0 to 5.0	5.0 Days Interval 4.0 to 5.0	—	—

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15 and 29

Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The measure was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=432 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=418 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=31 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Change From Baseline in Alanine Aminotransferase (ALT) Day 11	9.9 Units/Liter (U/L) Interval -0.6 to 20.4	-15.1 Units/Liter (U/L) Interval -27.4 to -2.9	9.0 Units/Liter (U/L) Interval 1.1 to 16.8	-11.1 Units/Liter (U/L) Interval -28.1 to 5.8
Change From Baseline in Alanine Aminotransferase (ALT) Day 15	3.5 Units/Liter (U/L) Interval -2.0 to 9.0	-4.9 Units/Liter (U/L) Interval -19.5 to 9.7	2.6 Units/Liter (U/L) Interval -2.1 to 7.4	-17.6 Units/Liter (U/L) Interval -43.7 to 8.4
Change From Baseline in Alanine Aminotransferase (ALT) Day 3	17.6 Units/Liter (U/L) Interval 13.7 to 21.5	2.6 Units/Liter (U/L) Interval -4.6 to 9.8	5.0 Units/Liter (U/L) Interval 2.1 to 7.9	10.9 Units/Liter (U/L) Interval -11.9 to 33.6
Change From Baseline in Alanine Aminotransferase (ALT) Day 5	41.4 Units/Liter (U/L) Interval 32.7 to 50.0	1.5 Units/Liter (U/L) Interval -8.5 to 11.5	13.5 Units/Liter (U/L) Interval 9.0 to 18.0	3.8 Units/Liter (U/L) Interval -9.9 to 17.4
Change From Baseline in Alanine Aminotransferase (ALT) Day 8	18.8 Units/Liter (U/L) Interval 10.4 to 27.3	4.0 Units/Liter (U/L) Interval -8.6 to 16.6	5.3 Units/Liter (U/L) Interval 0.0 to 10.6	-8.7 Units/Liter (U/L) Interval -23.4 to 6.0
Change From Baseline in Alanine Aminotransferase (ALT) Day 29	-3.2 Units/Liter (U/L) Interval -13.9 to 7.5	-9.3 Units/Liter (U/L) Interval -54.1 to 35.5	-6.4 Units/Liter (U/L) Interval -13.3 to 0.6	-13.8 Units/Liter (U/L) Interval -51.5 to 23.8

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15 and 29

Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The measure was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=429 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=416 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=31 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Change From Baseline in Aspartate Aminotransferase (AST) Day 15	-10.9 U/L Interval -14.9 to -6.9	-19.0 U/L Interval -32.0 to -6.0	-13.9 U/L Interval -18.2 to -9.6	-30.8 U/L Interval -60.8 to -0.7
Change From Baseline in Aspartate Aminotransferase (AST) Day 29	-10.8 U/L Interval -16.3 to -5.3	-26.3 U/L Interval -58.0 to 5.4	-15.8 U/L Interval -23.3 to -8.2	-22.2 U/L Interval -50.7 to 6.4
Change From Baseline in Aspartate Aminotransferase (AST) Day 11	-12.6 U/L Interval -22.3 to -2.9	-27.2 U/L Interval -39.3 to -15.1	-13.5 U/L Interval -22.9 to -4.0	-26.3 U/L Interval -47.7 to -4.9
Change From Baseline in Aspartate Aminotransferase (AST) Day 3	8.0 U/L Interval 4.7 to 11.4	-5.1 U/L Interval -15.8 to 5.5	-4.6 U/L Interval -8.3 to 0.8	-10.0 U/L Interval -23.4 to 3.3
Change From Baseline in Aspartate Aminotransferase (AST) Day 5	13.2 U/L Interval 7.7 to 18.6	-11.3 U/L Interval -20.0 to -2.6	-5.2 U/L Interval -8.6 to 1.7	-19.8 U/L Interval -32.2 to -7.3
Change From Baseline in Aspartate Aminotransferase (AST) Day 8	-6.2 U/L Interval -15.0 to 2.6	-10.8 U/L Interval -20.5 to -1.1	-16.5 U/L Interval -21.5 to -11.5	-20.6 U/L Interval -39.2 to -1.9

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15 and 29

Population: The mITT population includes all participants by their randomized treatment assignment and baseline ordinal score. For any missing data, if results were available for visits before or after that visit, the average of the two nearest visits was imputed for all missing visits between them. If a subject died or was lost to follow-up, their last available observation was carried forward. If baseline was missing, another pre-treatment dose was used, or the earliest post-treatment dose was used. .

Blood to evaluate CRP was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The measure was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=432 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=429 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=31 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Change From Baseline in C-reactive Protein (CRP) Day 3	-44.3 mg/L Interval -52.4 to -36.2	-46.6 mg/L Interval -73.0 to -20.3	-40.0 mg/L Interval -45.9 to -34.0	-37.6 mg/L Interval -68.8 to -6.3
Change From Baseline in C-reactive Protein (CRP) Day 5	-59.0 mg/L Interval -69.2 to -48.7	-55.6 mg/L Interval -87.0 to -24.1	-58.2 mg/L Interval -67.0 to -49.4	-40.5 mg/L Interval -76.7 to -4.3
Change From Baseline in C-reactive Protein (CRP) Day 8	-63.8 mg/L Interval -72.6 to -55.0	-57.4 mg/L Interval -96.3 to -18.6	-63.3 mg/L Interval -72.7 to -53.9	-69.3 mg/L Interval -104.8 to -33.9
Change From Baseline in C-reactive Protein (CRP) Day 11	-65.6 mg/L Interval -75.3 to -56.0	-36.0 mg/L Interval -69.6 to -2.5	-66.6 mg/L Interval -76.3 to -56.9	-75.6 mg/L Interval -107.0 to -44.2
Change From Baseline in C-reactive Protein (CRP) Day 15	-66.6 mg/L Interval -76.4 to -56.8	-27.8 mg/L Interval -71.6 to 16.0	-65.6 mg/L Interval -75.4 to -55.7	-72.1 mg/L Interval -106.0 to -38.1
Change From Baseline in C-reactive Protein (CRP) Day 29	-69.2 mg/L Interval -79.6 to -58.8	-46.5 mg/L Interval -91.8 to -1.2	-70.2 mg/L Interval -81.3 to -59.2	-76.8 mg/L Interval -110.0 to -43.6

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15 and 29

Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The measure was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=431 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=420 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=31 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Change From Baseline in Creatinine Day 3	-0.076 mg/dL Interval -0.098 to -0.054	0.054 mg/dL Interval -0.242 to 0.349	-0.069 mg/dL Interval -0.102 to -0.036	-0.074 mg/dL Interval -0.169 to 0.021
Change From Baseline in Creatinine Day 5	-0.122 mg/dL Interval -0.16 to -0.084	0.121 mg/dL Interval -0.219 to 0.461	-0.077 mg/dL Interval -0.109 to -0.046	-0.050 mg/dL Interval -0.174 to 0.074
Change From Baseline in Creatinine Day 8	-0.144 mg/dL Interval -0.209 to -0.078	0.415 mg/dL Interval -0.261 to 1.091	-0.109 mg/dL Interval -0.195 to -0.023	0.005 mg/dL Interval -0.141 to 0.151
Change From Baseline in Creatinine Day 11	-0.205 mg/dL Interval -0.315 to -0.095	0.361 mg/dL Interval -0.359 to 1.081	-0.103 mg/dL Interval -0.168 to -0.038	-0.004 mg/dL Interval -0.17 to 0.162
Change From Baseline in Creatinine Day 15	-0.049 mg/dL Interval -0.101 to -0.003	0.099 mg/dL Interval -0.229 to 0.427	-0.057 mg/dL Interval -0.095 to -0.02	0.178 mg/dL Interval -0.278 to 0.633
Change From Baseline in Creatinine Day 29	-0.075 mg/dL Interval -0.161 to 0.011	-0.182 mg/dL Interval -0.307 to -0.057	-0.029 mg/dL Interval -0.07 to -0.012	0.140 mg/dL Interval -0.683 to 0.963

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15, and 29

Blood to evaluate d-dimer concentration was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=421 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=35 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=422 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=30 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Change From Baseline in D-dimer Concentration Day 8	-0.2 mg/L fibrinogen-equivalent units (FEU) Interval -0.5 to 0.1	-9.9 mg/L fibrinogen-equivalent units (FEU) Interval -23.4 to 3.7	0.2 mg/L fibrinogen-equivalent units (FEU) Interval -0.2 to 0.6	0.0 mg/L fibrinogen-equivalent units (FEU) Interval -1.0 to 0.9
Change From Baseline in D-dimer Concentration Day 11	-0.2 mg/L fibrinogen-equivalent units (FEU) Interval -0.5 to 0.1	-10.9 mg/L fibrinogen-equivalent units (FEU) Interval -24.5 to 2.8	0.1 mg/L fibrinogen-equivalent units (FEU) Interval -0.3 to 0.4	-0.3 mg/L fibrinogen-equivalent units (FEU) Interval -1.2 to 0.7
Change From Baseline in D-dimer Concentration Day 29	-0.1 mg/L fibrinogen-equivalent units (FEU) Interval -0.5 to 0.2	-8.9 mg/L fibrinogen-equivalent units (FEU) Interval -23.2 to 5.4	0.1 mg/L fibrinogen-equivalent units (FEU) Interval -0.4 to 0.6	-0.4 mg/L fibrinogen-equivalent units (FEU) Interval -1.3 to 0.4
Change From Baseline in D-dimer Concentration Day 3	-0.2 mg/L fibrinogen-equivalent units (FEU) Interval -0.4 to 0.1	2.2 mg/L fibrinogen-equivalent units (FEU) Interval -10.4 to 14.9	0.1 mg/L fibrinogen-equivalent units (FEU) Interval -0.3 to 0.4	0.5 mg/L fibrinogen-equivalent units (FEU) Interval -0.5 to 1.4
Change From Baseline in D-dimer Concentration Day 5	-0.2 mg/L fibrinogen-equivalent units (FEU) Interval -0.5 to 0.1	-4.0 mg/L fibrinogen-equivalent units (FEU) Interval -19.6 to 11.7	0.2 mg/L fibrinogen-equivalent units (FEU) Interval -0.2 to 0.7	0.8 mg/L fibrinogen-equivalent units (FEU) Interval -0.8 to 2.5
Change From Baseline in D-dimer Concentration Day 15	-0.2 mg/L fibrinogen-equivalent units (FEU) Interval -0.5 to 0.2	-9.1 mg/L fibrinogen-equivalent units (FEU) Interval -23.1 to 4.8	-0.1 mg/L fibrinogen-equivalent units (FEU) Interval -0.4 to 0.3	-0.3 mg/L fibrinogen-equivalent units (FEU) Interval -1.2 to 0.5

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15 and 29

Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=430 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=418 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=31 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Change From Baseline in Hemoglobin Day 15	-0.58 grams/deciliter (g/dL) Interval -0.81 to -0.36	-3.18 grams/deciliter (g/dL) Interval -4.22 to -2.13	-0.43 grams/deciliter (g/dL) Interval -0.68 to -0.18	-2.65 grams/deciliter (g/dL) Interval -3.87 to -1.44
Change From Baseline in Hemoglobin Day 3	-0.19 grams/deciliter (g/dL) Interval -0.28 to -0.1	-0.14 grams/deciliter (g/dL) Interval -0.49 to 0.22	-0.20 grams/deciliter (g/dL) Interval -0.29 to -0.1	-0.10 grams/deciliter (g/dL) Interval -1.1 to 0.9
Change From Baseline in Hemoglobin Day 11	-0.71 grams/deciliter (g/dL) Interval -1.08 to -0.33	-1.98 grams/deciliter (g/dL) Interval -2.87 to -1.09	-0.47 grams/deciliter (g/dL) Interval -0.79 to -0.15	-1.32 grams/deciliter (g/dL) Interval -2.27 to -0.37
Change From Baseline in Hemoglobin Day 5	-0.04 grams/deciliter (g/dL) Interval -0.17 to 0.09	-0.47 grams/deciliter (g/dL) Interval -0.9 to -0.04	-0.13 grams/deciliter (g/dL) Interval -0.27 to 0.0	-0.81 grams/deciliter (g/dL) Interval -1.19 to -0.44
Change From Baseline in Hemoglobin Day 8	-0.34 grams/deciliter (g/dL) Interval -0.57 to -0.11	-1.13 grams/deciliter (g/dL) Interval -1.7 to -0.57	-0.29 grams/deciliter (g/dL) Interval -0.5 to -0.08	-1.01 grams/deciliter (g/dL) Interval -1.49 to -0.53
Change From Baseline in Hemoglobin Day 29	-0.39 grams/deciliter (g/dL) Interval -0.6 to -0.17	-3.89 grams/deciliter (g/dL) Interval -5.55 to -2.23	-0.13 grams/deciliter (g/dL) Interval -0.37 to 0.11	-1.15 grams/deciliter (g/dL) Interval -5.12 to 2.82

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15 and 29

Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Blood to evaluate INR was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=386 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=30 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=376 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=28 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Change From Baseline in Prothrombin International Normalized Ratio (INR) Day 3	-0.03 ratio Interval -0.09 to 0.03	0.05 ratio Interval 0.01 to 0.09	0.07 ratio Interval 0.01 to 0.14	-0.08 ratio Interval -0.31 to 0.16
Change From Baseline in Prothrombin International Normalized Ratio (INR) Day 5	-0.03 ratio Interval -0.11 to 0.04	0.02 ratio Interval -0.03 to 0.07	0.09 ratio Interval 0.04 to 0.15	-0.08 ratio Interval -0.32 to 0.16
Change From Baseline in Prothrombin International Normalized Ratio (INR) Day 8	-0.07 ratio Interval -0.19 to 0.05	0.01 ratio Interval -0.06 to 0.09	0.04 ratio Interval -0.09 to 0.17	0.02 ratio Interval -0.06 to 0.09
Change From Baseline in Prothrombin International Normalized Ratio (INR) Day 11	0.05 ratio Interval -0.14 to 0.24	0.02 ratio Interval -0.07 to 0.12	0.06 ratio Interval -0.01 to 0.13	0.05 ratio Interval -0.07 to 0.16
Change From Baseline in Prothrombin International Normalized Ratio (INR) Day 15	-0.09 ratio Interval -0.17 to -0.01	0.02 ratio Interval -0.07 to 0.12	-0.09 ratio Interval -0.18 to 0.0	0.01 ratio Interval -0.16 to 0.18
Change From Baseline in Prothrombin International Normalized Ratio (INR) Day 29	-0.07 ratio Interval -0.13 to 0.0	0.00 ratio Interval -0.22 to 0.22	-0.10 ratio Interval -0.2 to 0.0	-0.11 ratio Interval -0.31 to 0.09

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15 and 29

Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=430 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=417 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=31 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Change From Baseline in Platelets Day 5	82.1 10^9 cells/liter Interval 73.7 to 90.5	63.9 10^9 cells/liter Interval 29.7 to 98.1	97.8 10^9 cells/liter Interval 89.6 to 106.0	82.2 10^9 cells/liter Interval 52.6 to 111.7
Change From Baseline in Platelets Day 15	29.4 10^9 cells/liter Interval 11.6 to 47.2	-40.0 10^9 cells/liter Interval -103.0 to 23.0	33.3 10^9 cells/liter Interval 18.3 to 48.2	-14.5 10^9 cells/liter Interval -66.3 to 37.4
Change From Baseline in Platelets Day 3	46.5 10^9 cells/liter Interval 41.7 to 51.2	38.4 10^9 cells/liter Interval 12.7 to 64.2	57.6 10^9 cells/liter Interval 52.7 to 62.4	58.8 10^9 cells/liter Interval 40.2 to 77.5
Change From Baseline in Platelets Day 8	96.8 10^9 cells/liter Interval 77.6 to 116.0	45.2 10^9 cells/liter Interval 2.2 to 88.3	126.8 10^9 cells/liter Interval 110.4 to 143.2	92.0 10^9 cells/liter Interval 44.1 to 140.0
Change From Baseline in Platelets Day 11	70.9 10^9 cells/liter Interval 48.2 to 93.6	20.0 10^9 cells/liter Interval -37.4 to 77.5	98.9 10^9 cells/liter Interval 78.9 to 118.8	61.2 10^9 cells/liter Interval 16.3 to 106.1
Change From Baseline in Platelets Day 29	56.7 10^9 cells/liter Interval 43.0 to 70.4	52.4 10^9 cells/liter Interval -72.0 to 176.8	52.3 10^9 cells/liter Interval 38.5 to 66.1	4.5 10^9 cells/liter Interval -95.6 to 104.6

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15 and 29

Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=429 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=418 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=31 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Change From Baseline in Total Bilirubin Day 5	-0.07 mg/dL Interval -0.1 to -0.03	0.03 mg/dL Interval -0.05 to 0.11	0.00 mg/dL Interval -0.04 to 0.03	0.02 mg/dL Interval -0.07 to 0.11
Change From Baseline in Total Bilirubin Day 11	0.00 mg/dL Interval -0.08 to 0.09	0.16 mg/dL Interval -0.01 to 0.34	0.09 mg/dL Interval 0.01 to 0.17	-0.01 mg/dL Interval -0.14 to 0.11
Change From Baseline in Total Bilirubin Day 3	-0.08 mg/dL Interval -0.1 to -0.06	0.07 mg/dL Interval -0.02 to 0.17	-0.07 mg/dL Interval -0.09 to -0.05	0.03 mg/dL Interval -0.05 to 0.11
Change From Baseline in Total Bilirubin Day 8	-0.03 mg/dL Interval -0.09 to 0.02	0.10 mg/dL Interval 0.02 to 0.19	0.04 mg/dL Interval -0.01 to 0.09	0.04 mg/dL Interval -0.03 to 0.12
Change From Baseline in Total Bilirubin Day 15	0.09 mg/dL Interval 0.02 to 0.15	0.34 mg/dL Interval 0.03 to 0.65	0.03 mg/dL Interval -0.01 to 0.08	0.13 mg/dL Interval -0.22 to 0.47
Change From Baseline in Total Bilirubin Day 29	-0.01 mg/dL Interval -0.05 to 0.03	0.01 mg/dL Interval -0.3 to 0.32	-0.06 mg/dL Interval -0.11 to -0.01	0.03 mg/dL Interval -0.21 to 0.28

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15 and 29

Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=430 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=418 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=31 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Change From Baseline in White Blood Cell Count (WBC) Day 3	-0.166 10^9 cells/liter Interval -0.437 to 0.106	0.255 10^9 cells/liter Interval -0.823 to 1.333	0.720 10^9 cells/liter Interval 0.446 to 0.994	0.856 10^9 cells/liter Interval -0.8 to 2.512
Change From Baseline in White Blood Cell Count (WBC) Day 5	0.486 10^9 cells/liter Interval 0.109 to 0.863	0.434 10^9 cells/liter Interval -0.97 to 1.839	1.894 10^9 cells/liter Interval 1.496 to 2.293	0.908 10^9 cells/liter Interval -1.047 to 2.864
Change From Baseline in White Blood Cell Count (WBC) Day 8	1.037 10^9 cells/liter Interval 0.449 to 1.626	3.062 10^9 cells/liter Interval 1.01 to 5.115	3.529 10^9 cells/liter Interval 2.834 to 4.224	3.261 10^9 cells/liter Interval 0.89 to 5.632
Change From Baseline in White Blood Cell Count (WBC) Day 11	3.145 10^9 cells/liter Interval 1.878 to 4.411	4.420 10^9 cells/liter Interval 1.436 to 7.404	3.646 10^9 cells/liter Interval 2.659 to 4.632	3.153 10^9 cells/liter Interval 0.065 to 6.24
Change From Baseline in White Blood Cell Count (WBC) Day 15	0.649 10^9 cells/liter Interval -0.015 to 1.314	3.030 10^9 cells/liter Interval -0.186 to 6.246	1.211 10^9 cells/liter Interval 0.592 to 1.83	1.562 10^9 cells/liter Interval -1.396 to 4.519
Change From Baseline in White Blood Cell Count (WBC) Day 29	-0.470 10^9 cells/liter Interval -1.157 to 0.217	-0.472 10^9 cells/liter Interval -4.07 to 3.126	-0.294 10^9 cells/liter Interval -0.89 to 0.302	-2.123 10^9 cells/liter Interval -7.21 to 2.963

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15 and 29

Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=421 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=33 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=408 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=31 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Change From Baseline in Neutrophils Day 3	-0.622 10^9 cells/liter Interval -0.88 to -0.365	-0.324 10^9 cells/liter Interval -1.346 to 0.698	0.329 10^9 cells/liter Interval 0.062 to 0.596	0.479 10^9 cells/liter Interval -1.022 to 1.981
Change From Baseline in Neutrophils Day 8	0.187 10^9 cells/liter Interval -0.401 to 0.776	1.712 10^9 cells/liter Interval 0.108 to 3.316	2.583 10^9 cells/liter Interval 1.913 to 3.252	2.312 10^9 cells/liter Interval 0.09 to 4.534
Change From Baseline in Neutrophils Day 11	2.069 10^9 cells/liter Interval 0.77 to 3.368	3.419 10^9 cells/liter Interval 0.837 to 6.002	2.612 10^9 cells/liter Interval 1.634 to 3.59	1.146 10^9 cells/liter Interval -1.269 to 3.561
Change From Baseline in Neutrophils Day 5	-0.307 10^9 cells/liter Interval -0.678 to 0.064	-0.123 10^9 cells/liter Interval -1.439 to 1.192	1.096 10^9 cells/liter Interval 0.702 to 1.489	0.323 10^9 cells/liter Interval -1.437 to 2.083
Change From Baseline in Neutrophils Day 15	-0.383 10^9 cells/liter Interval -1.018 to 0.251	1.311 10^9 cells/liter Interval -1.617 to 4.238	0.165 10^9 cells/liter Interval -0.429 to 0.758	-0.004 10^9 cells/liter Interval -2.582 to 2.574
Change From Baseline in Neutrophils Day 29	-1.779 10^9 cells/liter Interval -2.387 to -1.171	-1.867 10^9 cells/liter Interval -5.061 to 1.327	-1.492 10^9 cells/liter Interval -2.053 to -0.93	-3.317 10^9 cells/liter Interval -7.447 to 0.814

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15 and 29

Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=421 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=33 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=408 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=31 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Change From Baseline in Lymphoctyes Day 3	0.301 10^9 cells/liter Interval 0.25 to 0.352	0.237 10^9 cells/liter Interval 0.058 to 0.416	0.227 10^9 cells/liter Interval 0.128 to 0.326	0.137 10^9 cells/liter Interval -0.004 to 0.277
Change From Baseline in Lymphoctyes Day 5	0.492 10^9 cells/liter Interval 0.417 to 0.568	0.289 10^9 cells/liter Interval 0.093 to 0.484	0.470 10^9 cells/liter Interval 0.392 to 0.548	0.242 10^9 cells/liter Interval 0.009 to 0.475
Change From Baseline in Lymphoctyes Day 8	0.390 10^9 cells/liter Interval 0.297 to 0.484	0.281 10^9 cells/liter Interval 0.104 to 0.458	0.404 10^9 cells/liter Interval 0.263 to 0.544	0.377 10^9 cells/liter Interval 0.101 to 0.653
Change From Baseline in Lymphoctyes Day 11	0.536 10^9 cells/liter Interval 0.352 to 0.719	0.347 10^9 cells/liter Interval 0.146 to 0.548	0.486 10^9 cells/liter Interval 0.356 to 0.617	0.867 10^9 cells/liter Interval 0.186 to 1.547
Change From Baseline in Lymphoctyes Day 15	0.655 10^9 cells/liter Interval 0.558 to 0.753	0.384 10^9 cells/liter Interval 0.131 to 0.637	0.679 10^9 cells/liter Interval 0.557 to 0.801	0.642 10^9 cells/liter Interval 0.223 to 1.061
Change From Baseline in Lymphoctyes Day 29	0.863 10^9 cells/liter Interval 0.773 to 0.953	0.575 10^9 cells/liter Interval 0.264 to 0.885	0.909 10^9 cells/liter Interval 0.823 to 0.994	0.873 10^9 cells/liter Interval 0.535 to 1.211

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15 and 29

Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=420 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=33 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=407 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=31 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Change From Baseline in Monocytes Day 3	0.157 10^9 cells/liter Interval 0.131 to 0.184	0.112 10^9 cells/liter Interval 0.01 to 0.215	0.127 10^9 cells/liter Interval 0.099 to 0.155	0.179 10^9 cells/liter Interval 0.04 to 0.318
Change From Baseline in Monocytes Day 5	0.229 10^9 cells/liter Interval 0.193 to 0.266	0.136 10^9 cells/liter Interval -0.006 to 0.277	0.212 10^9 cells/liter Interval 0.173 to 0.252	0.172 10^9 cells/liter Interval -0.019 to 0.362
Change From Baseline in Monocytes Day 8	0.301 10^9 cells/liter Interval 0.244 to 0.359	0.147 10^9 cells/liter Interval 0.021 to 0.273	0.311 10^9 cells/liter Interval 0.229 to 0.392	0.348 10^9 cells/liter Interval 0.155 to 0.541
Change From Baseline in Monocytes Day 11	0.381 10^9 cells/liter Interval 0.262 to 0.5	0.365 10^9 cells/liter Interval 0.144 to 0.585	0.403 10^9 cells/liter Interval 0.303 to 0.503	0.333 10^9 cells/liter Interval -0.022 to 0.689
Change From Baseline in Monocytes Day 15	0.207 10^9 cells/liter Interval 0.152 to 0.262	0.107 10^9 cells/liter Interval -0.047 to 0.26	0.212 10^9 cells/liter Interval 0.143 to 0.28	0.262 10^9 cells/liter Interval 0.077 to 0.447
Change From Baseline in Monocytes Day 29	0.131 10^9 cells/liter Interval 0.085 to 0.176	0.310 10^9 cells/liter Interval 0.057 to 0.563	0.114 10^9 cells/liter Interval 0.069 to 0.16	0.015 10^9 cells/liter Interval -0.807 to 0.838

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15 and 29

Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=417 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=33 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=405 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=30 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Change From Baseline in Basophils Day 3	0.000 10^9 cells/liter Interval -0.004 to 0.003	0.003 10^9 cells/liter Interval -0.003 to 0.008	0.001 10^9 cells/liter Interval -0.002 to 0.005	0.002 10^9 cells/liter Interval -0.014 to 0.018
Change From Baseline in Basophils Day 5	0.002 10^9 cells/liter Interval -0.002 to 0.006	0.011 10^9 cells/liter Interval 0.001 to 0.021	0.009 10^9 cells/liter Interval 0.001 to 0.018	0.003 10^9 cells/liter Interval -0.008 to 0.015
Change From Baseline in Basophils Day 8	0.015 10^9 cells/liter Interval 0.0 to 0.03	0.004 10^9 cells/liter Interval -0.004 to 0.012	0.010 10^9 cells/liter Interval 0.001 to 0.018	0.007 10^9 cells/liter Interval -0.001 to 0.014
Change From Baseline in Basophils Day 11	0.009 10^9 cells/liter Interval 0.0 to 0.019	0.022 10^9 cells/liter Interval 0.0 to 0.044	0.016 10^9 cells/liter Interval 0.009 to 0.023	0.015 10^9 cells/liter Interval 0.006 to 0.024
Change From Baseline in Basophils Day 15	0.021 10^9 cells/liter Interval 0.014 to 0.028	0.007 10^9 cells/liter Interval -0.004 to 0.018	0.027 10^9 cells/liter Interval 0.021 to 0.034	0.022 10^9 cells/liter Interval 0.004 to 0.039
Change From Baseline in Basophils Day 29	0.027 10^9 cells/liter Interval 0.019 to 0.035	0.049 10^9 cells/liter Interval 0.013 to 0.085	0.031 10^9 cells/liter Interval 0.024 to 0.039	0.028 10^9 cells/liter Interval -0.017 to 0.074

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15 and 29

Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=417 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=33 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=405 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=30 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Change From Baseline in Eosinophils Day 3	0.011 10^9 cells/liter Interval 0.002 to 0.019	0.014 10^9 cells/liter Interval -0.001 to 0.029	0.013 10^9 cells/liter Interval 0.007 to 0.019	0.006 10^9 cells/liter Interval -0.009 to 0.02
Change From Baseline in Eosinophils Day 5	0.016 10^9 cells/liter Interval 0.009 to 0.024	0.037 10^9 cells/liter Interval 0.009 to 0.066	0.032 10^9 cells/liter Interval 0.021 to 0.043	0.019 10^9 cells/liter Interval 0.0 to 0.038
Change From Baseline in Eosinophils Day 8	0.043 10^9 cells/liter Interval 0.031 to 0.054	0.028 10^9 cells/liter Interval 0.003 to 0.053	0.041 10^9 cells/liter Interval 0.025 to 0.057	0.038 10^9 cells/liter Interval 0.001 to 0.074
Change From Baseline in Eosinophils Day 11	0.044 10^9 cells/liter Interval 0.03 to 0.058	0.117 10^9 cells/liter Interval -0.021 to 0.254	0.063 10^9 cells/liter Interval 0.044 to 0.082	0.105 10^9 cells/liter Interval 0.058 to 0.151
Change From Baseline in Eosinophils Day 15	0.116 10^9 cells/liter Interval 0.101 to 0.132	0.135 10^9 cells/liter Interval 0.076 to 0.194	0.130 10^9 cells/liter Interval 0.112 to 0.147	0.166 10^9 cells/liter Interval 0.096 to 0.235
Change From Baseline in Eosinophils Day 29	0.189 10^9 cells/liter Interval 0.135 to 0.243	0.291 10^9 cells/liter Interval 0.06 to 0.521	0.172 10^9 cells/liter Interval 0.152 to 0.192	0.199 10^9 cells/liter Interval 0.025 to 0.374

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15, 22, and 29

Population: The intent-to-treat (ITT) population includes all participants who were randomized with data at baseline and at each timepoint. Missing values were imputed using Last Observation Carried Forward.

The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=452 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=35 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=448 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Change in National Early Warning Score (NEWS) From Baseline Day 3	-0.7 units on a scale Interval -0.9 to -0.5	1.0 units on a scale Interval 0.0 to 2.0	-0.6 units on a scale Interval -0.8 to -0.4	-0.7 units on a scale Interval -1.7 to 0.3
Change in National Early Warning Score (NEWS) From Baseline Day 5	-1.1 units on a scale Interval -1.3 to -0.8	1.6 units on a scale Interval 0.4 to 2.8	-1.0 units on a scale Interval -1.2 to -0.7	-1.3 units on a scale Interval -2.3 to -0.3
Change in National Early Warning Score (NEWS) From Baseline Day 8	-1.4 units on a scale Interval -1.6 to -1.1	1.7 units on a scale Interval 0.3 to 3.2	-1.3 units on a scale Interval -1.5 to -1.0	-0.6 units on a scale Interval -2.2 to 0.9
Change in National Early Warning Score (NEWS) From Baseline Day 11	-1.6 units on a scale Interval -1.8 to -1.3	1.4 units on a scale Interval -0.2 to 3.0	-1.4 units on a scale Interval -1.7 to -1.2	-1.0 units on a scale Interval -2.7 to 0.7
Change in National Early Warning Score (NEWS) From Baseline Day 15	-1.6 units on a scale Interval -1.9 to -1.4	1.9 units on a scale Interval 0.0 to 3.7	-1.6 units on a scale Interval -1.9 to -1.2	-1.5 units on a scale Interval -3.2 to 0.2
Change in National Early Warning Score (NEWS) From Baseline Day 22	-1.5 units on a scale Interval -1.8 to -1.2	1.6 units on a scale Interval -0.5 to 3.8	-1.6 units on a scale Interval -2.0 to -1.3	-1.7 units on a scale Interval -3.8 to 0.4
Change in National Early Warning Score (NEWS) From Baseline Day 29	-1.7 units on a scale Interval -2.1 to -1.4	1.9 units on a scale Interval -0.4 to 4.3	-1.9 units on a scale Interval -2.2 to -1.5	-1.8 units on a scale Interval -3.9 to 0.3

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The safety population includes all participants with available data post baseline, analyzed as treated.

Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=442 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=35 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=435 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=33 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)	38.9 percentage of participants	60.0 percentage of participants	31.7 percentage of participants	36.4 percentage of participants

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The safety population includes all participants with available data post baseline, analyzed as treated.

An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=442 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=35 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=435 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=33 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Percentage of Participants Reporting Serious Adverse Events (SAEs)	14.7 percentage of participants	60.0 percentage of participants	13.3 percentage of participants	24.2 percentage of participants

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The intent-to-treat (ITT) population includes all participants who were randomized.

Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=452 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=35 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=448 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Duration of Hospitalization Including imputations for participants who died	6 Days Interval 4.0 to 9.0	28 Days Interval 9.0 to 28.0	6 Days Interval 4.0 to 10.0	10 Days Interval 7.0 to 17.0
Duration of Hospitalization Among participants who did not die	6 Days Interval 4.0 to 9.0	16.5 Days Interval 8.5 to 28.0	6 Days Interval 4.0 to 9.0	10 Days Interval 7.0 to 14.0

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The analysis population is restricted to randomized participants who were on invasive ventilation.

Duration of invasive ventilation was measured in days among participants who required invasive ventilation, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=20 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=19 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=21 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=5 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Duration of Invasive Mechanical Ventilation Including imputations for participants who died	28 Days Interval 15.0 to 28.0	23 Days Interval 14.0 to 28.0	26.5 Days Interval 12.0 to 28.0	28 Days Interval 20.0 to 28.0
Duration of Invasive Mechanical Ventilation Among participants who did not die	14 Days Interval 6.0 to 16.0	19 Days Interval 9.0 to 23.0	14 Days Interval 7.0 to 20.0	13.5 Days Interval 7.0 to 20.0

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The analysis population is restricted to randomized participants who were not on noninvasive ventilation or high-flow oxygen at baseline but who subsequently required non-invasive or high-flow oxygen.

Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=67 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=67 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Duration of New Non-invasive Ventilation or High Flow Oxygen Use Including imputations for participants who died	5 Days Interval 2.0 to 12.0	6 Days Interval 3.0 to 14.0	—	—
Duration of New Non-invasive Ventilation or High Flow Oxygen Use Among participants who did not die	4 Days Interval 2.0 to 7.0	5 Days Interval 3.0 to 7.0	—	—

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The analysis population is restricted to randomized participants who were not on oxygen at baseline but who subsequently required oxygen.

Duration of new oxygen use was measured in days among participants who were not on oxygen at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=43 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=39 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Duration of New Oxygen Use Including imputations for participants who died	3 Days Interval 1.0 to 10.0	3 Days Interval 1.0 to 8.0	—	—
Duration of New Oxygen Use Among participants who did not die	3 Days Interval 1.0 to 7.0	3 Days Interval 1.0 to 8.0	—	—

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The analysis population is restricted to randomized participants not on a ventilator or ECMO at baseline but who subsequently required a ventilator or ECMO.

Duration of new ventilator or ECMO use was measured in days among participants who were not on a ventilator or ECMO at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=20 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=19 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=21 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=5 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use Including imputations for participants who died	28 Days Interval 15.0 to 28.0	23 Days Interval 14.0 to 28.0	26.5 Days Interval 12.0 to 28.0	28 Days Interval 20.0 to 28.0
Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use Among participants who did not die	14 Days Interval 6.0 to 16.0	19 Days Interval 9.0 to 23.0	14 Days Interval 7.0 to 20.0	13.5 Days Interval 7.0 to 20.0

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The analysis population is restricted to participants who required non invasive ventilation or high flow oxygen use.

Duration of non invasive ventilation or high flow oxygen use was measured in days, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=67 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=35 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=67 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Duration of Non Invasive Ventilation or High Flow Oxygen Use Including imputations for participants who died	5 Days Interval 2.0 to 12.0	6 Days Interval 3.0 to 28.0	6 Days Interval 3.0 to 14.0	5.5 Days Interval 3.0 to 10.0
Duration of Non Invasive Ventilation or High Flow Oxygen Use Among participants who did not die	4 Days Interval 2.0 to 7.0	4 Days Interval 3.0 to 7.0	5 Days Interval 3.0 to 7.0	4 Days Interval 2.0 to 7.0

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The analysis population is restricted to randomized participants who were on oxygen at baseline.

Duration of oxygen use was measured in days among participants who were on oxygen in based, calculated in two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=368 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=35 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=380 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Duration of Oxygen Use Including imputations for participants who died	6 Days Interval 3.0 to 22.5	28 Days Interval 15.0 to 28.0	7.5 Days Interval 3.0 to 24.0	21.5 Days Interval 9.0 to 28.0
Duration of Oxygen Use Among participants who did not die	6 Days Interval 3.0 to 20.5	27.5 Days Interval 14.5 to 28.0	7 Days Interval 3.0 to 23.0	20.5 Days Interval 9.0 to 28.0

SECONDARY outcome

Timeframe: Day 1 through Day 10

Population: The ITT population incudes all participants who were randomized

Discontinuation or temporary suspension of study product administration, including participants who died or were discharged, was evaluated by baseline ordinal scale category (categories 4 and 5 versus category 6).

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=443 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=35 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=441 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration Interferon Beta-1a/Placebo	337 Participants	13 Participants	341 Participants	19 Participants
Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration Remdesivir	400 Participants	25 Participants	382 Participants	22 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The modified intention-to-treat (mITT) population includes all Ordinal Score 4 and 5 participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment.

Proportion of participants with new non-invasive ventilation or high flow oxygen use was assessed as for participants in Ordinal Score 4 and 5.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=452 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=448 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Proportion of Participants With New Non-invasive Ventilation or High Flow Oxygen Use	0.15 Proportion of participants Interval 0.12 to 0.18	0.15 Proportion of participants Interval 0.12 to 0.19	—	—

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The modified intention-to-treat (mITT) population includes all participants in Ordinal Score 4 and 5 who were randomized and not on oxygen at baseline. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment.

Incidence of new oxygen use was assessed as for participants in Ordinal Score 4 and 5 who were not on oxygen at baseline.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=84 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=68 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Proportion of Participants With New Oxygen Use	0.51 Proportion of participants Interval 0.41 to 0.62	0.57 Proportion of participants Interval 0.46 to 0.68	—	—

SECONDARY outcome

Timeframe: Day 1 through Day 29

Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use was assessed among participants not on ventilator or extracorporeal membrane oxygenation (ECMO) use at baseline.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=452 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=35 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=448 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Proportion of Participants With New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use	0.04 Proportion of participants Interval 0.03 to 0.07	0.54 Proportion of participants Interval 0.38 to 0.7	0.05 Proportion of participants Interval 0.03 to 0.07	0.15 Proportion of participants Interval 0.06 to 0.3

SECONDARY outcome

Timeframe: Day 1, 3, 5, 8, 11, 15, 22, and 29

Population: The intent-to-treat (ITT) population includes all participants who were randomized reporting a clinical score. Missing values were imputed using Last Observation Carried Forward.

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. A positive change indicates a worsening and a negative change is an improvement.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=452 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=35 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=448 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Mean Change From Baseline in the Ordinal Scale Day 8	-0.2 units on a scale Interval -0.3 to -0.1	0.3 units on a scale Interval -0.1 to 0.6	-0.1 units on a scale Interval -0.2 to 0.0	-0.4 units on a scale Interval -0.8 to 0.0
Mean Change From Baseline in the Ordinal Scale Day 3	0.1 units on a scale Interval 0.0 to 0.1	0.1 units on a scale Interval 0.0 to 0.3	0.1 units on a scale Interval 0.0 to 0.1	0.0 units on a scale Interval -0.2 to 0.1
Mean Change From Baseline in the Ordinal Scale Day 5	-0.1 units on a scale Interval -0.1 to 0.0	0.3 units on a scale Interval 0.1 to 0.6	0.0 units on a scale Interval -0.1 to 0.0	-0.1 units on a scale Interval -0.3 to 0.1
Mean Change From Baseline in the Ordinal Scale Day 11	-0.4 units on a scale Interval -0.5 to -0.3	0.1 units on a scale Interval -0.4 to 0.5	-0.4 units on a scale Interval -0.5 to -0.3	-0.6 units on a scale Interval -1.0 to -0.2
Mean Change From Baseline in the Ordinal Scale Day 15	-2.5 units on a scale Interval -2.7 to -2.4	-0.8 units on a scale Interval -1.7 to 0.0	-2.5 units on a scale Interval -2.7 to -2.3	-2.3 units on a scale Interval -3.0 to -1.5
Mean Change From Baseline in the Ordinal Scale Day 22	-2.8 units on a scale Interval -2.9 to -2.6	-1.3 units on a scale Interval -2.3 to -0.4	-2.8 units on a scale Interval -2.9 to -2.7	-2.9 units on a scale Interval -3.7 to -2.1
Mean Change From Baseline in the Ordinal Scale Day 29	-2.9 units on a scale Interval -3.0 to -2.7	-1.5 units on a scale Interval -2.5 to -0.5	-3.0 units on a scale Interval -3.1 to -2.8	-3.2 units on a scale Interval -4.0 to -2.4

SECONDARY outcome

Timeframe: Day 15

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Data was imputed using last observation carried forward or worst possible score based on hospitalization status (2 if not hospitalized, 7 if hospitalized) when there was a change in hospitalization status since last score. Deaths were imputed as an 8.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=452 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=448 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 Not hospitalized, limit on activities/req home O2	53.1 percentage of participants Interval 48.5 to 57.7	52.5 percentage of participants Interval 47.8 to 57.0	—	—
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 Death at or before study visit	1.3 percentage of participants Interval 0.6 to 2.9	2.0 percentage of participants Interval 1.1 to 3.8	—	—
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 Hospitalized, on invasive mech. vent. or ECMO	2.2 percentage of participants Interval 1.2 to 4.0	3.1 percentage of participants Interval 1.9 to 5.2	—	—
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 Hospitalized, on noninvasive vent./high flow O2	1.1 percentage of participants Interval 0.5 to 2.6	1.8 percentage of participants Interval 0.9 to 3.5	—	—
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 Hospitalized, requiring supplemental oxygen	6.0 percentage of participants Interval 4.1 to 8.6	6.0 percentage of participants Interval 4.2 to 8.6	—	—
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 Hospitalized, not on O2, requiring ongoing care	3.1 percentage of participants Interval 1.9 to 5.1	2.5 percentage of participants Interval 1.4 to 4.3	—	—
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 Hospitalized, not requiring O2, no longer req care	0.4 percentage of participants Interval 0.1 to 1.6	0.9 percentage of participants Interval 0.3 to 2.3	—	—
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 Not hospitalized, no limitations on activities	32.7 percentage of participants Interval 28.6 to 37.2	31.3 percentage of participants Interval 27.1 to 35.7	—	—

SECONDARY outcome

Timeframe: Day 1

Population: The intent-to-treat (ITT) population includes all participants who were randomized.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=452 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=35 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=448 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 Death at or before study visit	0.0 percentage of participants Interval 0.0 to 0.8	0.0 percentage of participants Interval 0.0 to 9.9	0.0 percentage of participants Interval 0.0 to 0.9	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 Hospitalized, on invasive mech. vent. or ECMO	0.0 percentage of participants Interval 0.0 to 0.8	0.0 percentage of participants Interval 0.0 to 9.9	0.0 percentage of participants Interval 0.0 to 0.9	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 Hospitalized, on non-invasive vent./high flow O2	81.4 percentage of participants Interval 77.6 to 84.7	100 percentage of participants Interval 90.1 to 100.0	84.8 percentage of participants Interval 81.2 to 87.8	100 percentage of participants Interval 89.8 to 100.0
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 Hospitalized, requiring supplemental oxygen	18.6 percentage of participants Interval 15.3 to 22.4	0.0 percentage of participants Interval 0.0 to 9.9	15.2 percentage of participants Interval 12.2 to 18.8	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 Hospitalized, not on O2, requiring ongoing care	0.0 percentage of participants Interval 0.0 to 0.8	0.0 percentage of participants Interval 0.0 to 9.9	0.0 percentage of participants Interval 0.0 to 0.9	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 Hospitalized, not requiring O2, no longer req care	0.0 percentage of participants Interval 0.0 to 0.8	0.0 percentage of participants Interval 0.0 to 9.9	0.0 percentage of participants Interval 0.0 to 0.9	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 Not hospitalized, limit on activities/req home O2	0.0 percentage of participants Interval 0.0 to 0.8	0.0 percentage of participants Interval 0.0 to 9.9	0.0 percentage of participants Interval 0.0 to 0.9	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 Not hospitalized, no limitations on activities	0.0 percentage of participants Interval 0.0 to 0.8	0.0 percentage of participants Interval 0.0 to 9.9	0.0 percentage of participants Interval 0.0 to 0.9	0.0 percentage of participants Interval 0.0 to 10.2

SECONDARY outcome

Timeframe: Day 3

Population: The intent-to-treat (ITT) population includes all participants who were randomized. Missing values were imputed using Last Observation Carried Forward.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=452 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=35 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=448 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 Hospitalized, not requiring O2, no longer req care	0.2 percentage of participants Interval 0.0 to 1.2	0.0 percentage of participants Interval 0.0 to 9.9	0.0 percentage of participants Interval 0.0 to 0.9	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 Not hospitalized, limit on activities/req home O2	0.0 percentage of participants Interval 0.0 to 0.8	0.0 percentage of participants Interval 0.0 to 9.9	0.2 percentage of participants Interval 0.0 to 1.3	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 Not hospitalized, no limitations on activities	0.0 percentage of participants Interval 0.0 to 0.8	0.0 percentage of participants Interval 0.0 to 9.9	0.0 percentage of participants Interval 0.0 to 0.9	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 Death at or before study visit	0.0 percentage of participants Interval 0.0 to 0.8	0.0 percentage of participants Interval 0.0 to 9.9	0.2 percentage of participants Interval 0.0 to 1.3	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 Hospitalized, on invasive mech. vent. or ECMO	0.9 percentage of participants Interval 0.3 to 2.3	17.1 percentage of participants Interval 8.1 to 32.7	1.6 percentage of participants Interval 0.8 to 3.2	5.9 percentage of participants Interval 1.6 to 19.1
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 Hospitalized, on non-invasive vent./high flow O2	6.0 percentage of participants Interval 4.1 to 8.6	80.0 percentage of participants Interval 64.1 to 90.0	6.3 percentage of participants Interval 4.4 to 8.9	85.3 percentage of participants Interval 69.9 to 93.6
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 Hospitalized, requiring supplemental oxygen	74.1 percentage of participants Interval 69.9 to 77.9	2.9 percentage of participants Interval 0.5 to 14.5	73.7 percentage of participants Interval 69.4 to 77.5	8.8 percentage of participants Interval 3.0 to 23.0
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 Hospitalized, not on O2, requiring ongoing care	18.8 percentage of participants Interval 15.5 to 22.7	0.0 percentage of participants Interval 0.0 to 9.9	18.1 percentage of participants Interval 14.8 to 21.9	0.0 percentage of participants Interval 0.0 to 10.2

SECONDARY outcome

Timeframe: Day 5

Population: The intent-to-treat (ITT) population includes all participants who were randomized. Missing values were imputed using Last Observation Carried Forward.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=452 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=35 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=448 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 Death at or before study visit	0.2 percentage of participants Interval 0.0 to 1.2	2.9 percentage of participants Interval 0.5 to 14.5	0.7 percentage of participants Interval 0.2 to 2.0	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 Hospitalized, on invasive mech. vent. or ECMO	1.8 percentage of participants Interval 0.9 to 3.5	37.1 percentage of participants Interval 23.2 to 53.7	2.7 percentage of participants Interval 1.5 to 4.6	14.7 percentage of participants Interval 6.4 to 30.1
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 Hospitalized, on non-invasive vent./high flow O2	8.4 percentage of participants Interval 6.2 to 11.3	48.6 percentage of participants Interval 33.0 to 64.4	8.7 percentage of participants Interval 6.4 to 11.7	58.8 percentage of participants Interval 42.2 to 73.6
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 Hospitalized, requiring supplemental oxygen	49.1 percentage of participants Interval 44.5 to 53.7	11.4 percentage of participants Interval 4.5 to 26.0	46.2 percentage of participants Interval 41.6 to 50.8	20.6 percentage of participants Interval 10.3 to 36.8
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 Hospitalized, not on O2, requiring ongoing care	26.5 percentage of participants Interval 22.7 to 30.8	0.0 percentage of participants Interval 0.0 to 9.9	26.3 percentage of participants Interval 22.5 to 30.6	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 Hospitalized, not requiring O2, no longer req care	0.7 percentage of participants Interval 0.2 to 1.9	0.0 percentage of participants Interval 0.0 to 9.9	0.0 percentage of participants Interval 0.0 to 0.9	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 Not hospitalized, limit on activities/req home O2	13.3 percentage of participants Interval 10.5 to 16.7	0.0 percentage of participants Interval 0.0 to 9.9	15.2 percentage of participants Interval 12.2 to 18.8	5.9 percentage of participants Interval 1.6 to 19.1
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 Not hospitalized, no limitations on activities	0.0 percentage of participants Interval 0.0 to 0.8	0.0 percentage of participants Interval 0.0 to 9.9	0.2 percentage of participants Interval 0.0 to 1.3	0.0 percentage of participants Interval 0.0 to 10.2

SECONDARY outcome

Timeframe: Day 8

Population: The intent-to-treat (ITT) population includes all participants who were randomized. Missing values were imputed using Last Observation Carried Forward.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=452 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=35 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=448 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 Not hospitalized, no limitations on activities	0.0 percentage of participants Interval 0.0 to 0.8	0.0 percentage of participants Interval 0.0 to 9.9	0.0 percentage of participants Interval 0.0 to 0.9	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 Death at or before study visit	0.2 percentage of participants Interval 0.0 to 1.2	5.7 percentage of participants Interval 1.6 to 18.6	0.9 percentage of participants Interval 0.3 to 2.3	5.9 percentage of participants Interval 1.6 to 19.1
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 Hospitalized, on invasive mech. vent. or ECMO	2.7 percentage of participants Interval 1.5 to 4.6	45.7 percentage of participants Interval 30.5 to 61.8	2.9 percentage of participants Interval 1.7 to 4.9	11.8 percentage of participants Interval 4.7 to 26.6
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 Hospitalized, on non-invasive vent./high flow O2	4.4 percentage of participants Interval 2.9 to 6.7	22.9 percentage of participants Interval 12.1 to 39.0	7.4 percentage of participants Interval 5.3 to 10.2	29.4 percentage of participants Interval 16.8 to 46.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 Hospitalized, requiring supplemental oxygen	24.1 percentage of participants Interval 20.4 to 28.3	14.3 percentage of participants Interval 6.3 to 29.4	21.0 percentage of participants Interval 17.5 to 25.0	26.5 percentage of participants Interval 14.6 to 43.1
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 Hospitalized, not on O2, requiring ongoing care	11.9 percentage of participants Interval 9.3 to 15.3	2.9 percentage of participants Interval 0.5 to 14.5	9.8 percentage of participants Interval 7.4 to 12.9	8.8 percentage of participants Interval 3.0 to 23.0
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 Hospitalized, not requiring O2, no longer req care	0.7 percentage of participants Interval 0.2 to 1.9	0.0 percentage of participants Interval 0.0 to 9.9	0.2 percentage of participants Interval 0.0 to 1.3	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 Not hospitalized, limit on activities/req home O2	56.0 percentage of participants Interval 51.4 to 60.5	8.6 percentage of participants Interval 3.0 to 22.4	57.8 percentage of participants Interval 53.2 to 62.3	17.6 percentage of participants Interval 8.3 to 33.5

SECONDARY outcome

Timeframe: Day 11

Population: The intent-to-treat (ITT) population includes all participants who were randomized. Missing values were imputed using Last Observation Carried Forward.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=452 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=35 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=448 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 Hospitalized, on invasive mech. vent. or ECMO	3.1 percentage of participants Interval 1.9 to 5.1	42.9 percentage of participants Interval 28.0 to 59.1	2.7 percentage of participants Interval 1.5 to 4.6	11.8 percentage of participants Interval 4.7 to 26.6
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 Death at or before study visit	0.9 percentage of participants Interval 0.3 to 2.3	8.6 percentage of participants Interval 3.0 to 22.4	1.6 percentage of participants Interval 0.8 to 3.2	5.9 percentage of participants Interval 1.6 to 19.1
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 Hospitalized, on non-invasive vent./high flow O2	2.9 percentage of participants Interval 1.7 to 4.9	14.3 percentage of participants Interval 6.3 to 29.4	2.9 percentage of participants Interval 1.7 to 4.9	14.7 percentage of participants Interval 6.4 to 30.1
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 Hospitalized, requiring supplemental oxygen	10.0 percentage of participants Interval 7.5 to 13.1	5.7 percentage of participants Interval 1.6 to 18.6	12.7 percentage of participants Interval 10.0 to 16.1	26.5 percentage of participants Interval 14.6 to 43.1
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 Hospitalized, not on O2, requiring ongoing care	5.8 percentage of participants Interval 4.0 to 8.3	2.9 percentage of participants Interval 0.5 to 14.5	5.8 percentage of participants Interval 4.0 to 8.4	2.9 percentage of participants Interval 0.5 to 14.9
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 Hospitalized, not requiring O2, no longer req care	0.9 percentage of participants Interval 0.3 to 2.3	2.9 percentage of participants Interval 0.5 to 14.5	0.4 percentage of participants Interval 0.1 to 1.6	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 Not hospitalized, limit on activities/req home O2	73.9 percentage of participants Interval 69.7 to 77.7	22.9 percentage of participants Interval 12.1 to 39.0	70.5 percentage of participants Interval 66.2 to 74.6	38.2 percentage of participants Interval 23.9 to 55.0
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 Not hospitalized, no limitations on activities	2.7 percentage of participants Interval 1.5 to 4.6	0.0 percentage of participants Interval 0.0 to 9.9	3.3 percentage of participants Interval 2.0 to 5.5	0.0 percentage of participants Interval 0.0 to 10.2

SECONDARY outcome

Timeframe: Day 15

Population: The intent-to-treat (ITT) population includes all participants who were randomized. Missing values were imputed using Last Observation Carried Forward.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=452 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=35 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=448 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 Hospitalized, not requiring O2, no longer req care	0.4 percentage of participants Interval 0.1 to 1.6	0.0 percentage of participants Interval 0.0 to 9.9	0.9 percentage of participants Interval 0.3 to 2.3	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 Death at or before study visit	1.3 percentage of participants Interval 0.6 to 2.9	14.3 percentage of participants Interval 6.3 to 29.4	2.0 percentage of participants Interval 1.1 to 3.8	8.8 percentage of participants Interval 3.0 to 23.0
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 Hospitalized, on invasive mech. vent. or ECMO	2.2 percentage of participants Interval 1.2 to 4.0	31.4 percentage of participants Interval 18.6 to 48.0	3.1 percentage of participants Interval 1.9 to 5.2	5.9 percentage of participants Interval 1.6 to 19.1
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 Hospitalized, on non-invasive vent./high flow O2	1.1 percentage of participants Interval 0.5 to 2.6	8.6 percentage of participants Interval 3.0 to 22.4	1.8 percentage of participants Interval 0.9 to 3.5	5.9 percentage of participants Interval 1.6 to 19.1
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 Hospitalized, requiring supplemental oxygen	6.0 percentage of participants Interval 4.1 to 8.6	11.4 percentage of participants Interval 4.5 to 26.0	6.0 percentage of participants Interval 4.2 to 8.6	23.5 percentage of participants Interval 12.4 to 40.0
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 Hospitalized, not on O2, requiring ongoing care	3.1 percentage of participants Interval 1.9 to 5.1	2.9 percentage of participants Interval 0.5 to 14.5	2.5 percentage of participants Interval 1.4 to 4.3	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 Not hospitalized, limit on activities/req home O2	53.1 percentage of participants Interval 48.5 to 57.7	22.9 percentage of participants Interval 12.1 to 39.0	52.5 percentage of participants Interval 47.8 to 57.0	47.1 percentage of participants Interval 31.5 to 63.3
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 Not hospitalized, no limitations on activities	32.7 percentage of participants Interval 28.6 to 37.2	8.6 percentage of participants Interval 3.0 to 22.4	31.3 percentage of participants Interval 27.1 to 35.7	8.8 percentage of participants Interval 3.0 to 23.0

SECONDARY outcome

Timeframe: Day 22

Population: The intent-to-treat (ITT) population includes all participants who were randomized. Missing values were imputed using Last Observation Carried Forward.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=452 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=35 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=448 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 Death at or before study visit	2.2 percentage of participants Interval 1.2 to 4.0	17.1 percentage of participants Interval 8.1 to 32.7	2.5 percentage of participants Interval 1.4 to 4.3	11.8 percentage of participants Interval 4.7 to 26.6
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 Hospitalized, on non-invasive vent./high flow O2	0.7 percentage of participants Interval 0.2 to 1.9	8.6 percentage of participants Interval 3.0 to 22.4	0.2 percentage of participants Interval 0.0 to 1.3	2.9 percentage of participants Interval 0.5 to 14.9
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 Hospitalized, requiring supplemental oxygen	4.0 percentage of participants Interval 2.5 to 6.2	8.6 percentage of participants Interval 3.0 to 22.4	4.2 percentage of participants Interval 2.7 to 6.5	8.8 percentage of participants Interval 3.0 to 23.0
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 Hospitalized, not requiring O2, no longer req care	0.0 percentage of participants Interval 0.0 to 0.8	0.0 percentage of participants Interval 0.0 to 9.9	0.2 percentage of participants Interval 0.0 to 1.3	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 Not hospitalized, no limitations on activities	41.6 percentage of participants Interval 37.1 to 46.2	20.0 percentage of participants Interval 10.0 to 35.9	40.2 percentage of participants Interval 35.7 to 44.8	17.6 percentage of participants Interval 8.3 to 33.5
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 Hospitalized, on invasive mech. vent. or ECMO	1.8 percentage of participants Interval 0.9 to 3.5	22.9 percentage of participants Interval 12.1 to 39.0	1.6 percentage of participants Interval 0.8 to 3.2	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 Hospitalized, not on O2, requiring ongoing care	1.8 percentage of participants Interval 0.9 to 3.5	0.0 percentage of participants Interval 0.0 to 9.9	1.6 percentage of participants Interval 0.8 to 3.2	2.9 percentage of participants Interval 0.5 to 14.9
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 Not hospitalized, limit on activities/req home O2	48.0 percentage of participants Interval 43.4 to 52.6	22.9 percentage of participants Interval 12.1 to 39.0	49.6 percentage of participants Interval 44.9 to 54.2	55.9 percentage of participants Interval 39.5 to 71.1

SECONDARY outcome

Timeframe: Day 29

Population: The intent-to-treat (ITT) population includes all participants who were randomized. Missing values were imputed using Last Observation Carried Forward.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=452 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=35 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=448 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 Death at or before study visit	3.1 percentage of participants Interval 1.9 to 5.1	20.0 percentage of participants Interval 10.0 to 35.9	2.9 percentage of participants Interval 1.7 to 4.9	11.8 percentage of participants Interval 4.7 to 26.6
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 Hospitalized, on invasive mech. vent. or ECMO	1.8 percentage of participants Interval 0.9 to 3.5	17.1 percentage of participants Interval 8.1 to 32.7	1.6 percentage of participants Interval 0.8 to 3.2	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 Hospitalized, on non-invasive vent./high flow O2	0.7 percentage of participants Interval 0.2 to 1.9	5.7 percentage of participants Interval 1.6 to 18.6	0.0 percentage of participants Interval 0.0 to 0.9	2.9 percentage of participants Interval 0.5 to 14.9
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 Hospitalized, requiring supplemental oxygen	2.7 percentage of participants Interval 1.5 to 4.6	8.6 percentage of participants Interval 3.0 to 22.4	2.0 percentage of participants Interval 1.1 to 3.8	2.9 percentage of participants Interval 0.5 to 14.9
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 Hospitalized, not on O2, requiring ongoing care	1.3 percentage of participants Interval 0.6 to 2.9	2.9 percentage of participants Interval 0.5 to 14.5	0.7 percentage of participants Interval 0.2 to 2.0	2.9 percentage of participants Interval 0.5 to 14.9
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 Hospitalized, not requiring O2, no longer req care	0.0 percentage of participants Interval 0.0 to 0.8	0.0 percentage of participants Interval 0.0 to 9.9	0.0 percentage of participants Interval 0.0 to 0.9	0.0 percentage of participants Interval 0.0 to 10.2
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 Not hospitalized, no limitations on activities	24.6 percentage of participants Interval 20.8 to 28.7	14.3 percentage of participants Interval 6.3 to 29.4	25.7 percentage of participants Interval 21.8 to 29.9	8.8 percentage of participants Interval 3.0 to 23.0
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 Not hospitalized, limit on activities/req home O2	65.9 percentage of participants Interval 61.4 to 70.1	31.4 percentage of participants Interval 18.6 to 48.0	67.2 percentage of participants Interval 62.7 to 71.4	70.6 percentage of participants Interval 53.8 to 83.2

SECONDARY outcome

Timeframe: Day 1 through Day 15

Population: The ITT population consists of all participants as randomized.

The mortality rate was determined as the proportion of participants who died by study Day 15. The proportions reported are Kaplan-Meier estimates

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=487 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=482 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
14-day Participant Mortality	0.02 Proportion of participants Interval 0.01 to 0.03	0.02 Proportion of participants Interval 0.01 to 0.04	—	—

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The ITT population consists of all participants as randomized

The mortality rate was determined as the proportion of participants who died by study Day 29. The proportions reported are Kaplan-Meier estimates.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=487 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=482 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
28-day Participant Mortality	0.05 Proportion of participants Interval 0.03 to 0.07	0.03 Proportion of participants Interval 0.02 to 0.06	—	—

SECONDARY outcome

Timeframe: Day 1 through Day 29

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Time to improvement by at least one category was determined for each participant.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=452 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=35 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=448 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Time to an Improvement of One Category Using an Ordinal Scale	12.0 Days Interval 11.0 to 12.0	15.0 Days Interval 7.0 to If no participants reach the upper limit of 95% CI of the KM estimator at the median then the upper limit of the median time to improvement of one category can not be estimated using the methodology described by Klein and Moeschberger (1997).	12.0 Days Interval 11.0 to 13.0	5.0 Days Interval 4.0 to 7.0

SECONDARY outcome

Timeframe: Day 1 through Day 29

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Time to improvement by at least two categories was determined for each participant.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=452 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=35 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=448 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Time to an Improvement of Two Categories Using an Ordinal Scale	13.0 Days A large number of participants at the median estimate means there is little variability at the 50th percentile and the methodology described by Klein and Moeschberger (1997) is unable to compute a confidence interval. If no participants reach the upper limit of 95% CI of the KM estimator at 50%, the upper limit of the median time can not be estimated.	NA Days Interval 14.0 to A large number of participants at the median estimate means there is little variability at the 50th percentile and the methodology described by Klein and Moeschberger (1997) is unable to compute a confidence interval. If no participants reach the upper limit of 95% CI of the KM estimator at 50%, the upper limit of the median time can not be estimated. Finally, if less than 50% of subjects improve by at least two categories then the median time cannot be estimated.	13.0 Days A large number of participants at the median estimate means there is little variability at the 50th percentile and the methodology described by Klein and Moeschberger (1997) is unable to compute a confidence interval. If no participants reach the upper limit of 95% CI of the KM estimator at 50%, the upper limit of the median time can not be estimated.	14.0 Days Interval 13.0 to 19.0

SECONDARY outcome

Timeframe: Day 1 through Day 29

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=356 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=33 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=354 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=34 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Time to Discharge or to a National Early Warning Score (NEWS) of </= 2 and Maintained for 24 Hours, Whichever Occurs First	4.0 Days Interval 4.0 to 5.0	NA Days Interval 10.0 to If no participants reach the upper limit of 95% CI of the KM estimator at the median then the upper limit of the median time can not be estimated using the methodology described by Klein and Moeschberger (1997). Also, if less than 50% of participants discharge or reach a NEWS of \</= 2 and maintain it for 24 Hours then the median time can not be estimated	4.0 Days Interval 4.0 to 5.0	9.0 Days Interval 6.0 to 11.0

SECONDARY outcome

Timeframe: Day 1 through Day 29

Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.

Outcome measures

Outcome measures
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=452 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=448 Participants 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Time to Recovery for Patients With a Baseline Ordinal Score of 4 and 5	5.0 Days Interval 4.0 to 5.0	5.0 Days Interval 4.0 to 5.0	—	—

Adverse Events

Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5

Serious events: 65 serious events

Other events: 49 other events

Deaths: 14 deaths

Remdesivir Plus Interferon Beta-1a in Ordinal Score 6

Serious events: 21 serious events

Other events: 12 other events

Deaths: 7 deaths

Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5

Serious events: 58 serious events

Other events: 45 other events

Deaths: 13 deaths

Remdesivir Plus Placebo in Baseline Ordinal Score 6

Serious events: 8 serious events

Other events: 7 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5 n=442 participants at risk 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Interferon Beta-1a in Ordinal Score 6 n=32 participants at risk 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6	Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 n=435 participants at risk 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.	Remdesivir Plus Placebo in Baseline Ordinal Score 6 n=31 participants at risk 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
Investigations Blood albumin decreased	0.00% 0/442 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	6.2% 2/32 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.00% 0/435 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.00% 0/31 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Investigations Glomerular filtration rate decreased	3.2% 14/442 • Number of events 16 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	12.5% 4/32 • Number of events 4 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	3.9% 17/435 • Number of events 18 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	3.2% 1/31 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Investigations Haemoglobin decreased	1.1% 5/442 • Number of events 5 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	12.5% 4/32 • Number of events 6 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	1.6% 7/435 • Number of events 7 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	6.5% 2/31 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Investigations Lymphocyte count decreased	6.8% 30/442 • Number of events 33 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	9.4% 3/32 • Number of events 4 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	6.2% 27/435 • Number of events 30 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	19.4% 6/31 • Number of events 6 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Renal and urinary disorders Acute kidney injury	0.90% 4/442 • Number of events 4 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	3.1% 1/32 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.46% 2/435 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	12.9% 4/31 • Number of events 4 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Vascular disorders Deep vein thrombosis	0.23% 1/442 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	9.4% 3/32 • Number of events 3 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.46% 2/435 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.00% 0/31 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported. Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.

Additional Information

John Beigel, MD

NIAID

Phone: 3014519881

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60