for people ages 12 years and up (full criteria)
at Sacramento, California and other locations
study started



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.

Official Title

A Phase 3 Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of COVID-19 in an Outpatient Setting


COVID-19, Remdesivir, RDV, Remdesivir (RDV)


You can join if…

Open to people ages 12 years and up

  • 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)

You CAN'T join if...

  • 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.


  • UC Davis Health
    Sacramento California 95817 United States
  • Kaiser Permanente Northern California, 6600 Bruceville Road
    Sacramento California 95823 United States
  • Kaiser Permanente Northern California, 2025 Morse Ave
    Sacramento California 95825 United States


accepting new patients
Start Date
Completion Date
Gilead Sciences
Sign up for this study
Phase 3 COVID-19 Research Study
Study Type
About 584 people participating
Last Updated