Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting
NCT04501952 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 584
Last updated 2021-11-16
Summary
The primary objectives of this study are to evaluate the efficacy of remdesivir (RDV) in reducing the rate of of coronavirus disease 2019 (COVID-19) related hospitalization or all-cause death in non-hospitalized participants with early stage COVID-19 and to evaluate the safety of RDV administered in an outpatient setting.
Conditions
Interventions
- DRUG
-
RDV
Administered as an intravenous infusion
- DRUG
-
Placebo to Match RDV
Administered as an intravenous infusion
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Gilead Study Director · Gilead Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-18
- Primary Completion
- 2021-05-06
- Completion
- 2021-05-06
- FDA Drug
- Yes
Countries
- United States
- Denmark
- Spain
- United Kingdom
Study Locations
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