Trial Outcomes & Findings for Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19) (NCT NCT04292899)

Last Updated: 2020-12-31

Results Overview

Clinical status was derived from death, hospital discharge, and the 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 assessment carried forward for any missing values.The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or 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 (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 the Remdesivir for 10 days group vs the Remdesivir for 5 days group.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

4891 participants

Primary outcome timeframe

Day 14

Results posted on

2020-12-31

Participant Flow

Participants were enrolled at study sites in the United States, Europe, and Asia. The first participant was screened on 06 March 2020. The last study visit occurred on 30 June 2020.

4958 participants were screened. 4891 participants were enrolled. 4 participants in Part A and 49 participants in Part B did not receive treatment and are not included in the analyses.

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 B: Remdesivir for 10 Days (Mechanically Ventilated Group) Participants on mechanical ventilation received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.	Part B: Remdesivir for 10 Days (Extension Group) Participants who were not mechanically ventilated 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	200	197	844	3597
Overall Study COMPLETED	168	164	621	2952
Overall Study NOT COMPLETED	32	33	223	645

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 B: Remdesivir for 10 Days (Mechanically Ventilated Group) Participants on mechanical ventilation received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.	Part B: Remdesivir for 10 Days (Extension Group) Participants who were not mechanically ventilated 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 Death	21	28	188	371
Overall Study Lost to Follow-up	8	4	22	235
Overall Study Withdrew consent	1	0	11	32
Overall Study Adverse Event	2	1	2	2
Overall Study Investigator's Discretion	0	0	0	3
Overall Study Non-compliance With Study Drug	0	0	0	1
Overall Study Protocol Violation	0	0	0	1

Baseline Characteristics

Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Remdesivir (RDV) for 5 Days n=200 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=197 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 B: Remdesivir for 10 Days (Mechanically Ventilated Group) n=844 Participants Participants on mechanical ventilation received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.	Part B: Remdesivir for 10 Days (Extension Group) n=3597 Participants Participants who were not mechanically ventilated 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=4838 Participants Total of all reporting groups
Age, Customized Age Categories · < 65	116 Participants n=5 Participants	113 Participants n=7 Participants	581 Participants n=5 Participants	2399 Participants n=4 Participants	3209 Participants n=21 Participants
Age, Customized Age Categories · ≥ 65	84 Participants n=5 Participants	84 Participants n=7 Participants	263 Participants n=5 Participants	1198 Participants n=4 Participants	1629 Participants n=21 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	64 Participants n=7 Participants	312 Participants n=5 Participants	1351 Participants n=4 Participants	1807 Participants n=21 Participants
Sex: Female, Male Male	120 Participants n=5 Participants	133 Participants n=7 Participants	532 Participants n=5 Participants	2246 Participants n=4 Participants	3031 Participants n=21 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	40 Participants n=4 Participants	47 Participants n=21 Participants
Race/Ethnicity, Customized Race · Asian	20 Participants n=5 Participants	25 Participants n=7 Participants	88 Participants n=5 Participants	313 Participants n=4 Participants	446 Participants n=21 Participants
Race/Ethnicity, Customized Race · Black	21 Participants n=5 Participants	23 Participants n=7 Participants	149 Participants n=5 Participants	611 Participants n=4 Participants	804 Participants n=21 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	11 Participants n=5 Participants	29 Participants n=4 Participants	41 Participants n=21 Participants
Race/Ethnicity, Customized Race · White	142 Participants n=5 Participants	134 Participants n=7 Participants	376 Participants n=5 Participants	1915 Participants n=4 Participants	2567 Participants n=21 Participants
Race/Ethnicity, Customized Race · Not Permitted	0 Participants n=5 Participants	5 Participants n=7 Participants	56 Participants n=5 Participants	179 Participants n=4 Participants	240 Participants n=21 Participants
Race/Ethnicity, Customized Race · Other	14 Participants n=5 Participants	10 Participants n=7 Participants	159 Participants n=5 Participants	510 Participants n=4 Participants	693 Participants n=21 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	47 Participants n=5 Participants	38 Participants n=7 Participants	328 Participants n=5 Participants	1341 Participants n=4 Participants	1754 Participants n=21 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	152 Participants n=5 Participants	150 Participants n=7 Participants	478 Participants n=5 Participants	2123 Participants n=4 Participants	2903 Participants n=21 Participants
Race/Ethnicity, Customized Ethnicity · Not Permitted	1 Participants n=5 Participants	9 Participants n=7 Participants	37 Participants n=5 Participants	129 Participants n=4 Participants	176 Participants n=21 Participants
Race/Ethnicity, Customized Ethnicity · Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants
Region of Enrollment United States	118 Participants n=5 Participants	111 Participants n=7 Participants	722 Participants n=5 Participants	2927 Participants n=4 Participants	3878 Participants n=21 Participants
Region of Enrollment Spain	31 Participants n=5 Participants	30 Participants n=7 Participants	27 Participants n=5 Participants	134 Participants n=4 Participants	222 Participants n=21 Participants
Region of Enrollment Italy	39 Participants n=5 Participants	38 Participants n=7 Participants	16 Participants n=5 Participants	108 Participants n=4 Participants	201 Participants n=21 Participants
Region of Enrollment United Kingdom	0 Participants n=5 Participants	0 Participants n=7 Participants	33 Participants n=5 Participants	144 Participants n=4 Participants	177 Participants n=21 Participants
Region of Enrollment Sweden	0 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	83 Participants n=4 Participants	88 Participants n=21 Participants
Region of Enrollment Singapore	1 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	44 Participants n=4 Participants	60 Participants n=21 Participants
Region of Enrollment Switzerland	0 Participants n=5 Participants	0 Participants n=7 Participants	13 Participants n=5 Participants	44 Participants n=4 Participants	57 Participants n=21 Participants
Region of Enrollment Netherlands	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	45 Participants n=4 Participants	47 Participants n=21 Participants
Region of Enrollment Germany	3 Participants n=5 Participants	1 Participants n=7 Participants	12 Participants n=5 Participants	27 Participants n=4 Participants	43 Participants n=21 Participants
Region of Enrollment France	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	25 Participants n=4 Participants	27 Participants n=21 Participants
Region of Enrollment South Korea	6 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants	22 Participants n=21 Participants
Region of Enrollment Hong Kong	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Region of Enrollment Japan	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants
Region of Enrollment Taiwan	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants
Clinical Status (7-point ordinal scale) Score: 1	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Clinical Status (7-point ordinal scale) Score: 2	4 Participants n=5 Participants	9 Participants n=7 Participants	844 Participants n=5 Participants	0 Participants n=4 Participants	857 Participants n=21 Participants
Clinical Status (7-point ordinal scale) Score: 3	49 Participants n=5 Participants	59 Participants n=7 Participants	0 Participants n=5 Participants	1069 Participants n=4 Participants	1177 Participants n=21 Participants
Clinical Status (7-point ordinal scale) Score: 4	113 Participants n=5 Participants	108 Participants n=7 Participants	0 Participants n=5 Participants	2214 Participants n=4 Participants	2435 Participants n=21 Participants
Clinical Status (7-point ordinal scale) Score: 5	34 Participants n=5 Participants	21 Participants n=7 Participants	0 Participants n=5 Participants	314 Participants n=4 Participants	369 Participants n=21 Participants
Clinical Status (7-point ordinal scale) Score: 6	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Clinical Status (7-point ordinal scale) Score: 7	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 14

Population: Full Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment.

Outcome measures

Outcome measures
Measure	Part A: Remdesivir (RDV) for 5 Days n=200 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=197 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: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 Score: 1	8.0 percentage of participants	10.7 percentage of participants
Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 Score: 2	8.5 percentage of participants	16.8 percentage of participants
Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 Score: 3	4.0 percentage of participants	5.1 percentage of participants
Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 Score: 4	9.5 percentage of participants	7.6 percentage of participants
Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 Score: 5	6.0 percentage of participants	6.1 percentage of participants
Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 Score: 6	4.0 percentage of participants	1.5 percentage of participants
Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 Score: 7	60.0 percentage of participants	52.3 percentage of participants

SECONDARY outcome

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

Population: Part A: Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study drug

Treatment-emergent Adverse Events (TEAE) were defined as AEs with onset dates on or after the study treatment start date and no later than 30 days after the permanent discontinuation of the study treatment and/or the AEs that led to premature discontinuation of study treatment.

Outcome measures

Outcome measures
Measure	Part A: Remdesivir (RDV) for 5 Days n=200 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=197 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: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)	71.5 percentage of participants Interval 64.7 to 77.6	75.1 percentage of participants Interval 68.5 to 81.0

Adverse Events

Part A: Remdesivir (RDV) for 5 Days

Serious events: 43 serious events

Other events: 79 other events

Deaths: 25 deaths

Part A: Remdesivir for 10 Days

Serious events: 68 serious events

Other events: 92 other events

Deaths: 28 deaths

Part B: Remdesivir for 10 Days (Mechanically Ventilated Group)

Serious events: 362 serious events

Other events: 508 other events

Deaths: 213 deaths

Part B: Remdesivir for 10 Days (Extension Group)

Serious events: 851 serious events

Other events: 1258 other events

Deaths: 422 deaths

Serious adverse events

Other adverse events

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