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
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| ClinicalTrials.gov Identifier: NCT04292730 |
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Recruitment Status :
Completed
First Posted : March 3, 2020
Results First Posted : January 26, 2021
Last Update Posted : January 26, 2021
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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| Study Type | Interventional |
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| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
COVID-19 |
| Interventions |
Drug: Remdesivir Drug: Standard of Care |
| Enrollment | 1113 |
Participant Flow
| Recruitment Details | 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. |
| Pre-assignment Details | 1138 participants were screened. |
| Arm/Group Title | Part A: Remdesivir (RDV) for 5 Days | Part A: Remdesivir for 10 Days | Part A: SOC Therapy | Part B: Extension Treatment, Remdesivir for 10 Days |
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 Arm/Group Description |
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. | Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10. | Participants received continued SOC therapy. | Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10. |
| Period Title: Overall Study | ||||
| Started | 199 | 197 | 200 | 517 |
| Completed | 179 | 176 | 178 | 437 |
| Not Completed | 20 | 21 | 22 | 80 |
| Reason Not Completed | ||||
| Lost to Follow-up | 8 | 12 | 12 | 48 |
| Death | 2 | 2 | 4 | 12 |
| Withdrew Consent | 2 | 2 | 5 | 6 |
| Non-Compliance with Study Drug | 0 | 1 | 0 | 0 |
| Protocol Violation | 0 | 0 | 1 | 0 |
| Randomized but not Treated | 8 | 4 | 0 | 14 |
Baseline Characteristics
| Arm/Group Title | Part A: Remdesivir for 5 Days | Part A: Remdesivir for 10 Days | Part A: SOC Therapy | Part B: Extension Treatment, Remdesivir for 10 Days | Total | |
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Arm/Group Description |
Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5. | Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10. | Participants received continued SOC therapy. | 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 of all reporting groups | |
| Overall Number of Baseline Participants | 191 | 193 | 200 | 503 | 1087 | |
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Baseline Analysis Population Description |
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.
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Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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| Age, Categorical | Number Analyzed | 191 participants | 193 participants | 200 participants | 503 participants | 1087 participants |
| < 65 Years | 142 | 141 | 142 | 351 | 776 | |
| >= 65 Years | 49 | 52 | 58 | 152 | 311 | |
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 191 participants | 193 participants | 200 participants | 503 participants | 1087 participants | |
| Female | 77 | 75 | 75 | 221 | 448 | |
| Male | 114 | 118 | 125 | 282 | 639 | |
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Race/Ethnicity, Customized
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Race | Number Analyzed | 191 participants | 193 participants | 200 participants | 503 participants | 1087 participants |
| American Indian or Alaska Native | 2 | 0 | 1 | 3 | 6 | |
| Asian | 34 | 31 | 37 | 61 | 163 | |
| Black | 35 | 37 | 27 | 107 | 206 | |
| Native Hawaiian or Pacific Islander | 1 | 1 | 1 | 1 | 4 | |
| White | 109 | 107 | 112 | 260 | 588 | |
| Not Permitted | 5 | 5 | 7 | 21 | 38 | |
| Other | 5 | 12 | 15 | 50 | 82 | |
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[1]
Measure Description: Not Permitted means local regulators did not allow collection of race information.
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Race/Ethnicity, Customized
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Ethnicity | Number Analyzed | 191 participants | 193 participants | 200 participants | 503 participants | 1087 participants |
| Hispanic or Latino | 25 | 42 | 34 | 156 | 257 | |
| Not Hispanic or Latino | 162 | 144 | 152 | 325 | 783 | |
| Not Permitted | 4 | 7 | 13 | 22 | 46 | |
| Missing | 0 | 0 | 1 | 0 | 1 | |
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[1]
Measure Description: Not Permitted means local regulators did not allow collection of ethnicity information.
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 191 participants | 193 participants | 200 participants | 503 participants | 1087 participants |
| United States | 76 | 99 | 85 | 318 | 578 | |
| Spain | 37 | 28 | 31 | 44 | 140 | |
| Italy | 30 | 23 | 26 | 54 | 133 | |
| United Kingdom | 7 | 9 | 17 | 27 | 60 | |
| South Korea | 7 | 4 | 10 | 16 | 37 | |
| Germany | 8 | 6 | 8 | 13 | 35 | |
| Singapore | 3 | 6 | 9 | 14 | 32 | |
| Hong Kong | 9 | 11 | 7 | 1 | 28 | |
| Switzerland | 4 | 5 | 6 | 3 | 18 | |
| France | 2 | 1 | 0 | 5 | 8 | |
| Taiwan | 5 | 1 | 0 | 0 | 6 | |
| Netherlands | 3 | 0 | 1 | 1 | 5 | |
| Japan | 0 | 0 | 0 | 4 | 4 | |
| Sweden | 0 | 0 | 0 | 3 | 3 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
| Name/Title: | Gilead Clinical Study Information Center |
| Organization: | Gilead Sciences |
| Phone: | 1-833-445-3230 (GILEAD-0) |
| EMail: | GileadClinicalTrials@gilead.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT04292730 |
| Other Study ID Numbers: |
GS-US-540-5774 2020-000842-32 ( EudraCT Number ) ISRCTN85762140 ( Other Identifier: ISRCTN ) |
| First Submitted: | February 28, 2020 |
| First Posted: | March 3, 2020 |
| Results First Submitted: | December 15, 2020 |
| Results First Posted: | January 26, 2021 |
| Last Update Posted: | January 26, 2021 |