Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04501952 |
Recruitment Status :
Terminated
(The study was terminated due to study enrollment feasibility and changing needs of non-hospitalized participants. This decision is not based on efficacy or safety concerns.)
First Posted : August 6, 2020
Results First Posted : November 16, 2021
Last Update Posted : November 16, 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: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
COVID-19 |
Interventions |
Drug: RDV Drug: Placebo to Match RDV |
Enrollment | 584 |
Participant Flow
Recruitment Details | Participants were enrolled at study sites in Europe and the United States. The first participant was screened on 18 September 2020. The last study visit occurred on 06 May 2021. |
Pre-assignment Details | 630 participants were screened. |
Arm/Group Title | Remdesivir (RDV) | Placebo |
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Participants received a single dose of intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3. | Participants received IV placebo to match (PTM) RDV on Days 1 to 3. |
Period Title: Overall Study | ||
Started | 292 | 292 |
Completed | 266 | 272 |
Not Completed | 26 | 20 |
Reason Not Completed | ||
Adverse Event | 0 | 3 |
Investigator's Discretion | 0 | 1 |
Protocol Violation | 1 | 1 |
Withdrew Consent | 5 | 4 |
Lost to Follow-up | 7 | 2 |
Randomized and Never Treated | 13 | 9 |
Baseline Characteristics
Arm/Group Title | Remdesivir | Placebo | Total | |
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Participants received a single dose of IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3. | Participants received IV PTM RDV on Days 1 to 3. | Total of all reporting groups | |
Overall Number of Baseline Participants | 279 | 283 | 562 | |
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Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 279 participants | 283 participants | 562 participants | |
50 (15.3) | 51 (14.8) | 50 (15.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 279 participants | 283 participants | 562 participants | |
Female |
131 47.0%
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138 48.8%
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269 47.9%
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Male |
148 53.0%
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145 51.2%
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293 52.1%
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Race/Ethnicity, Customized
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Race | Number Analyzed | 279 participants | 283 participants | 562 participants |
American Indian or Alaska Native |
15 5.4%
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21 7.4%
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36 6.4%
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Asian |
6 2.2%
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7 2.5%
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13 2.3%
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Black |
20 7.2%
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22 7.8%
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42 7.5%
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Native Hawaiian or Pacific Islander |
1 0.4%
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0 0.0%
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1 0.2%
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White |
228 81.7%
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224 79.2%
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452 80.4%
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Other |
3 1.1%
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2 0.7%
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5 0.9%
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Not Permitted |
6 2.2%
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7 2.5%
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13 2.3%
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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 | 279 participants | 283 participants | 562 participants |
Hispanic or Latino |
123 44.1%
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112 39.6%
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235 41.8%
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Not Hispanic or Latino |
146 52.3%
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158 55.8%
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304 54.1%
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Not Permitted |
10 3.6%
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13 4.6%
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23 4.1%
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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 | 279 participants | 283 participants | 562 participants |
United States |
264 94.6%
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267 94.3%
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531 94.5%
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Denmark |
5 1.8%
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5 1.8%
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10 1.8%
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United Kingdom |
3 1.1%
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1 0.4%
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4 0.7%
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Spain |
7 2.5%
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10 3.5%
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17 3.0%
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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: | NCT04501952 |
Other Study ID Numbers: |
GS-US-540-9012 2020-003510-12 ( EudraCT Number ) |
First Submitted: | August 5, 2020 |
First Posted: | August 6, 2020 |
Results First Submitted: | November 4, 2021 |
Results First Posted: | November 16, 2021 |
Last Update Posted: | November 16, 2021 |