Trial Outcomes & Findings for Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment (NCT NCT04292730)

Last Updated: 2021-01-26

Results Overview

Clinical status was derived from death, hospital discharge, and ordinal scale as follows: score of "1" was used for all days on or after the date of death; score of "7" was used for all days on or after discharged alive date; last available assessment for missing value. 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 low flow supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus (COVID-19) related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol remdesivir administration; 7. Not hospitalized. The odds ratio represents the odds of improvement in the ordinal scale for a RDV group relative to the SOC group.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1113 participants

Primary outcome timeframe

Day 11

Results posted on

2021-01-26

Participant Flow

Participants were enrolled at study sites in the United States, Europe, and Asia. The first participant was screened on 15 March 2020. The last study visit occurred on 26 June 2020.

1138 participants were screened.

Participant milestones

Participant milestones
Measure	Part A: Remdesivir (RDV) for 5 Days Participants received continued standard of care (SOC) therapy together with intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.	Part A: Remdesivir for 10 Days Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.	Part A: SOC Therapy Participants received continued SOC therapy.	Part B: Extension Treatment, Remdesivir for 10 Days Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
Overall Study STARTED	199	197	200	517
Overall Study COMPLETED	179	176	178	437
Overall Study NOT COMPLETED	20	21	22	80

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Remdesivir (RDV) for 5 Days Participants received continued standard of care (SOC) therapy together with intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.	Part A: Remdesivir for 10 Days Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.	Part A: SOC Therapy Participants received continued SOC therapy.	Part B: Extension Treatment, Remdesivir for 10 Days Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
Overall Study Lost to Follow-up	8	12	12	48
Overall Study Death	2	2	4	12
Overall Study Withdrew Consent	2	2	5	6
Overall Study Non-Compliance with Study Drug	0	1	0	0
Overall Study Protocol Violation	0	0	1	0
Overall Study Randomized but not Treated	8	4	0	14

Baseline Characteristics

Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Remdesivir for 5 Days n=191 Participants Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.	Part A: Remdesivir for 10 Days n=193 Participants Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.	Part A: SOC Therapy n=200 Participants Participants received continued SOC therapy.	Part B: Extension Treatment, Remdesivir for 10 Days n=503 Participants Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.	Total n=1087 Participants Total of all reporting groups
Age, Customized Age, Categorical · < 65 Years	142 Participants n=5 Participants	141 Participants n=7 Participants	142 Participants n=5 Participants	351 Participants n=4 Participants	776 Participants n=21 Participants
Age, Customized Age, Categorical · >= 65 Years	49 Participants n=5 Participants	52 Participants n=7 Participants	58 Participants n=5 Participants	152 Participants n=4 Participants	311 Participants n=21 Participants
Sex: Female, Male Female	77 Participants n=5 Participants	75 Participants n=7 Participants	75 Participants n=5 Participants	221 Participants n=4 Participants	448 Participants n=21 Participants
Sex: Female, Male Male	114 Participants n=5 Participants	118 Participants n=7 Participants	125 Participants n=5 Participants	282 Participants n=4 Participants	639 Participants n=21 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants
Race/Ethnicity, Customized Race · Asian	34 Participants n=5 Participants	31 Participants n=7 Participants	37 Participants n=5 Participants	61 Participants n=4 Participants	163 Participants n=21 Participants
Race/Ethnicity, Customized Race · Black	35 Participants n=5 Participants	37 Participants n=7 Participants	27 Participants n=5 Participants	107 Participants n=4 Participants	206 Participants n=21 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Race · White	109 Participants n=5 Participants	107 Participants n=7 Participants	112 Participants n=5 Participants	260 Participants n=4 Participants	588 Participants n=21 Participants
Race/Ethnicity, Customized Race · Not Permitted	5 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	21 Participants n=4 Participants	38 Participants n=21 Participants
Race/Ethnicity, Customized Race · Other	5 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants	50 Participants n=4 Participants	82 Participants n=21 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	25 Participants n=5 Participants	42 Participants n=7 Participants	34 Participants n=5 Participants	156 Participants n=4 Participants	257 Participants n=21 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	162 Participants n=5 Participants	144 Participants n=7 Participants	152 Participants n=5 Participants	325 Participants n=4 Participants	783 Participants n=21 Participants
Race/Ethnicity, Customized Ethnicity · Not Permitted	4 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants	22 Participants n=4 Participants	46 Participants n=21 Participants
Race/Ethnicity, Customized Ethnicity · Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment United States	76 Participants n=5 Participants	99 Participants n=7 Participants	85 Participants n=5 Participants	318 Participants n=4 Participants	578 Participants n=21 Participants
Region of Enrollment Spain	37 Participants n=5 Participants	28 Participants n=7 Participants	31 Participants n=5 Participants	44 Participants n=4 Participants	140 Participants n=21 Participants
Region of Enrollment Italy	30 Participants n=5 Participants	23 Participants n=7 Participants	26 Participants n=5 Participants	54 Participants n=4 Participants	133 Participants n=21 Participants
Region of Enrollment United Kingdom	7 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants	27 Participants n=4 Participants	60 Participants n=21 Participants
Region of Enrollment South Korea	7 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants	16 Participants n=4 Participants	37 Participants n=21 Participants
Region of Enrollment Germany	8 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	13 Participants n=4 Participants	35 Participants n=21 Participants
Region of Enrollment Singapore	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants	14 Participants n=4 Participants	32 Participants n=21 Participants
Region of Enrollment Hong Kong	9 Participants n=5 Participants	11 Participants n=7 Participants	7 Participants n=5 Participants	1 Participants n=4 Participants	28 Participants n=21 Participants
Region of Enrollment Switzerland	4 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	18 Participants n=21 Participants
Region of Enrollment France	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants	8 Participants n=21 Participants
Region of Enrollment Taiwan	5 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Region of Enrollment Netherlands	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Region of Enrollment Japan	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants
Region of Enrollment Sweden	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 11

Population: Full Analysis Set (FAS) included all participants who were randomized into Part A of the study and received at least 1 dose of study treatment if randomized to 1 of the RDV treatment groups. Participants in the SOC arm who had protocol Day 1 visit were included in the FAS.

Outcome measures

Outcome measures
Measure	Part A: Remdesivir for 5 Days n=191 Participants Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.	Part A: Remdesivir for 10 Days n=193 Participants Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.	Part A: SOC Therapy n=200 Participants Participants received continued SOC therapy.
Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11 Score: 1	0.0 percentage of participants	1.0 percentage of participants	2.0 percentage of participants
Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11 Score: 4	3.7 percentage of participants	6.2 percentage of participants	5.5 percentage of participants
Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11 Score: 2	0.0 percentage of participants	0.5 percentage of participants	2.0 percentage of participants
Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11 Score: 7	70.2 percentage of participants	64.8 percentage of participants	60.0 percentage of participants
Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11 Score: 3	2.6 percentage of participants	0.0 percentage of participants	3.5 percentage of participants
Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11 Score: 5	19.9 percentage of participants	22.8 percentage of participants	23.0 percentage of participants
Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11 Score: 6	3.7 percentage of participants	4.7 percentage of participants	4.0 percentage of participants

SECONDARY outcome

Timeframe: First dose date up to last dose date (maximum: 10 days) plus 30 days

Population: Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group).

TEAEs were defined as the following: any AE with an onset date on or after the study treatment start date and no later than 30 days after permanent discontinuation of study treatment and/or any AE leading to premature discontinuation of study treatment. For participants randomized to the SOC group, all AEs reported on or after the protocol-specified Day 1 visit were considered as treatment emergent.

Outcome measures

Outcome measures
Measure	Part A: Remdesivir for 5 Days n=191 Participants Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.	Part A: Remdesivir for 10 Days n=193 Participants Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.	Part A: SOC Therapy n=200 Participants Participants received continued SOC therapy.
Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)	51.3 percentage of participants Interval 44.0 to 58.6	58.5 percentage of participants Interval 51.3 to 65.6	46.5 percentage of participants Interval 39.4 to 53.7

Adverse Events

Part A: Remdesivir for 5 Days

Serious events: 9 serious events

Other events: 41 other events

Deaths: 2 deaths

Part A: Remdesivir for 10 Days

Serious events: 10 serious events

Other events: 42 other events

Deaths: 3 deaths

Part A: SOC Therapy

Serious events: 18 serious events

Other events: 30 other events

Deaths: 4 deaths

Part B: Extension Treatment, Remdesivir for 10 Days

Serious events: 40 serious events

Other events: 113 other events

Deaths: 13 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Part A: Remdesivir for 5 Days n=191 participants at risk Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.	Part A: Remdesivir for 10 Days n=193 participants at risk Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.	Part A: SOC Therapy n=200 participants at risk Participants received continued SOC therapy.	Part B: Extension Treatment, Remdesivir for 10 Days n=503 participants at risk Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
Gastrointestinal disorders Constipation	4.2% 8/191 • First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days. Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.	2.6% 5/193 • First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days. Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.	4.5% 9/200 • First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days. Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.	5.2% 26/503 • First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days. Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	6.3% 12/191 • First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days. Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.	5.2% 10/193 • First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days. Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.	7.0% 14/200 • First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days. Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.	5.6% 28/503 • First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days. Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	9.9% 19/191 • First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days. Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.	9.3% 18/193 • First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days. Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.	3.0% 6/200 • First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days. Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.	8.2% 41/503 • First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days. Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	5.2% 10/191 • First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days. Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.	6.7% 13/193 • First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days. Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.	2.0% 4/200 • First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days. Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.	4.6% 23/503 • First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days. Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.
Nervous system disorders Headache	5.2% 10/191 • First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days. Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.	5.2% 10/193 • First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days. Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.	2.5% 5/200 • First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days. Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.	5.4% 27/503 • First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days. Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER