A Phase 3 Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Remdesivir (GS-5734â„¢) Treatment of COVID-19 in an Outpatient Setting
A Phase 3 Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Remdesivir (GS-5734â„¢) Treatment of COVID-19 in an Outpatient Setting
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.
Key Inclusion Criteria:
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:
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 Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sacramento, California 95823, United States
San Francisco, California 94080, United States
San Francisco, California 94115, United States
San Jose, California 95119, United States
Burr Ridge, Illinois 60527, United States
College Station, Texas 77845, United States