Status:
TERMINATED
Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting
Lead Sponsor:
Gilead Sciences
Conditions:
COVID-19
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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-h...
Eligibility Criteria
Inclusion
- Key
- Willing and able to provide written informed consent, (individuals ≥ 18 years of age) or assent (individuals ≥ 12 and \< 18 years of age) prior to performing study procedures. Individuals age ≥ 18 years may be enrolled with the consent of a legal representative where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC). For individuals ≥ 12 and \< 18 years of age, a parent or legal guardian must be willing and able to provide written informed consent prior to performing study procedures
- Either:
- Age ≥ 18 years (at all sites) or aged ≥ 12 and \< 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant IRB or IEC with at least 1 pre-existing risk factor for progression to hospitalization (chronic lung disease, hypertension, cardiovascular or cerebrovascular disease, diabetes, obesity (body mass index ≥ 30), immunocompromised, chronic mild or moderate kidney disease, chronic liver disease, current cancer, or sickle cell disease)
- Or aged ≥ 60 years
- Severe acute respiratory syndrome (SARS)-coronavirus (CoV)-2 infection confirmed by molecular diagnosis (nucleic acid (polymerase chain reaction (PCR) or antigen testing) ≤ 4 days prior to screening
- Presence of ≥ 1 symptom(s) consistent with COVID-19 for ≤ 7 days prior to randomization
- Not currently requiring hospitalization (hospitalization defined as ≥ 24 hours of acute care)
- Key
Exclusion
- Participation in any other clinical trial of an experimental treatment and prevention for COVID-19
- Prior hospitalization for COVID-19
- Treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 or administration of any SARS-CoV-2 (or COVID-19) vaccine
- Requiring oxygen supplementation
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
September 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2021
Estimated Enrollment :
584 Patients enrolled
Trial Details
Trial ID
NCT04501952
Start Date
September 18 2020
End Date
May 6 2021
Last Update
November 16 2021
Active Locations (104)
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1
Arizona Liver Health
Chandler, Arizona, United States, 85224
2
Arizona Clinical Trials
Tucson, Arizona, United States, 85712
3
St Joseph Hospital Eureka
Eureka, California, United States, 95501
4
St. Joseph Heritage Healthcare
Fullerton, California, United States, 92385