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

Study results available
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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

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04501952 on ClinicalTrials.gov