Trial · NCT04292899
Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)
NCT04292899, Phase 3, Completed, Gilead Sciences; results first posted 2020-12-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19). Trials, record NCT04292899. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04292899
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)
- NCT number
- NCT04292899
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,891 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- COVID-19
- Interventions
- Remdesivir, Standard of Care
- First posted
- 2020-03-03
- Last updated
- 2020-12-31
- Other registries' IDs
- eudract:2020-000841-15, isrctn:ISRCTN15874265
- Results first posted
- 2020-12-31
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 | Day 14 | 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. |
| Secondary | Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) | First dose date up to last dose date (maximum: 10 days) plus 30 days | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 | Day 14 | Full Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment. | percentage of participants | NUMBER |
| SECONDARY | Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) | First dose date up to last dose date (maximum: 10 days) 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 drug | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 | Part A: Remdesivir (RDV) for 5 Days | Score: 1 | 8.0 | percentage of participants | |
| Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 | Part A: Remdesivir for 10 Days | Score: 1 | 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 | Part A: Remdesivir (RDV) for 5 Days | Score: 2 | 8.5 | percentage of participants | |
| Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 | Part A: Remdesivir for 10 Days | Score: 2 | 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 | Part A: Remdesivir (RDV) for 5 Days | Score: 3 | 4.0 | percentage of participants | |
| Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 | Part A: Remdesivir for 10 Days | Score: 3 | 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 | Part A: Remdesivir (RDV) for 5 Days | Score: 4 | 9.5 | percentage of participants | |
| Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 | Part A: Remdesivir for 10 Days | Score: 4 | 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 | Part A: Remdesivir (RDV) for 5 Days | Score: 5 | 6.0 | percentage of participants | |
| Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 | Part A: Remdesivir for 10 Days | Score: 5 | 6.1 | percentage of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: Remdesivir (RDV) for 5 Days | 200 | |
| Overall Study | STARTED | Part A: Remdesivir for 10 Days | 197 | |
| Overall Study | STARTED | Part B: Remdesivir for 10 Days (Mechanically Ventilated Group) | 844 | |
| Overall Study | STARTED | Part B: Remdesivir for 10 Days (Extension Group) | 3,597 | |
| Overall Study | COMPLETED | Part A: Remdesivir (RDV) for 5 Days | 168 | |
| Overall Study | COMPLETED | Part A: Remdesivir for 10 Days | 164 | |
| Overall Study | COMPLETED | Part B: Remdesivir for 10 Days (Mechanically Ventilated Group) | 621 | |
| Overall Study | COMPLETED | Part B: Remdesivir for 10 Days (Extension Group) | 2,952 | |
| Overall Study | NOT COMPLETED | Part A: Remdesivir (RDV) for 5 Days | 32 | |
| Overall Study | NOT COMPLETED | Part A: Remdesivir for 10 Days | 33 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,180
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Part A: Remdesivir (RDV) for 5 Days | 7 | 200 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: Remdesivir for 10 Days | 7 | 197 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: Remdesivir for 10 Days (Mechanically Ventilated Group) | 88 | 844 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: Remdesivir for 10 Days (Extension Group) | 104 | 3,597 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Part A: Remdesivir (RDV) for 5 Days | 1 | 200 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Part A: Remdesivir for 10 Days | 1 | 197 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Part B: Remdesivir for 10 Days (Mechanically Ventilated Group) | 47 | 844 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Part B: Remdesivir for 10 Days (Extension Group) | 42 | 3,597 | |
| other | Constipation | Gastrointestinal disorders | Part A: Remdesivir (RDV) for 5 Days | 13 | 200 | |
| other | Constipation | Gastrointestinal disorders | Part A: Remdesivir for 10 Days | 13 | 197 |
1 to 10 of 1,180Source ClinicalTrials.gov
See all 1,180 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Remdesivir (RDV) for 5 Days | 25 | 200 |
| Total, all-cause mortality | Part A: Remdesivir for 10 Days | 28 | 197 |
| Total, all-cause mortality | Part B: Remdesivir for 10 Days (Mechanically Ventilated Group) | 213 | 844 |
| Total, all-cause mortality | Part B: Remdesivir for 10 Days (Extension Group) | 422 | 3,597 |
| Total, other adverse events | Part A: Remdesivir (RDV) for 5 Days | 79 | 200 |
| Total, other adverse events | Part A: Remdesivir for 10 Days | 92 | 197 |
| Total, other adverse events | Part B: Remdesivir for 10 Days (Mechanically Ventilated Group) | 508 | 844 |
| Total, other adverse events | Part B: Remdesivir for 10 Days (Extension Group) | 1,258 | 3,597 |
| Total, serious adverse events | Part A: Remdesivir (RDV) for 5 Days | 43 | 200 |
| Total, serious adverse events | Part A: Remdesivir for 10 Days | 68 | 197 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04292899
GET https://conductscience.org/api/trials/v1/NCT04292899/events?page=2