for people ages 12-64 (full criteria)
at San Francisco, California and other locations
study started
completion around



The goal of this clinical study is to test if obeldesivir (formerly GS-5245) is safe and effective for the treatment of coronavirus disease 2019 (COVID-19) in participants who have a standard risk of developing severe illness. This study will also measure how much obeldesivir gets into the blood and how long it takes for the body to get rid of it.

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Nonhospitalized Participants


COVID-19, Obeldesivir


You can join if…

Open to people ages 12-64

  • Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed, ≤ 3 days before randomization, by polymerase chain reaction (PCR), rapid antigen test, or an approved alternative assay. Serologic tests will not be accepted.
  • Willing and able to complete the coronavirus disease 19 (COVID-19) symptom questionnaire prior to first dose and daily throughout the study period.
  • Initial onset of COVID-19 signs/symptoms ≤ 3 days before randomization with ≥ 2 of the following targeted symptoms, at moderate or higher severity, present at randomization.
    • Stuffy or runny nose.
    • Sore throat.
    • Shortness of breath (difficulty breathing).
    • Cough.
    • Low energy or tiredness.
    • Muscle or body aches.
    • Headache.
    • Chills or shivering.
    • Feeling hot or feverish.
  • Not currently hospitalized or requiring hospitalization.

You CAN'T join if...

  • Any risk factors for progression to severe disease.
  • Planning to receive a direct acting antiviral or monoclonal antibody against SARS-CoV-2 for the treatment of COVID-19.
  • Received any direct acting antiviral drug or monoclonal antibody against SARS-CoV-2 for the treatment of COVID-19 < 28 days or < 5 half-lives, whichever is longer, before randomization.
  • Received any convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2 prophylaxis at any time prior to study entry.
  • Received an COVID-19 vaccine (including booster dose) < 120 days before randomization.
  • Self-reported COVID-19 diagnosis < 120 days before randomization.
  • Anticipated need for hospitalization < 48 hours after randomization.
  • New oxygen requirement < 24 hours before randomization.
  • Known influenza, or any other suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study drug.
  • Known history of chronic liver disease, limited to cirrhosis, nonalcoholic steatohepatitis, alcoholic liver disease, and autoimmune hepatitis.
  • Undergoing dialysis, or known history of chronic kidney disease.
  • Persistent symptoms from previous COVID-19 illness that may interfere with the evaluation of response to the study drug.
  • Pregnant or breastfeeding.
  • Unwilling to use protocol-mandated contraception.
  • Any other factor, including inability to complete the patient-reported outcome (PRO) questionnaire for the primary endpoint, making the individual, in the opinion of the investigator, unsuitable to participate in the study.
  • Concurrent participation/enrollment in a separate therapeutic clinical study.

    Note: Other protocol defined Inclusion/Exclusion criteria may apply.


  • Zuckerberg San Francisco General Hospital
    San Francisco California 94110 United States
  • Franco Felizarta, MD
    Bakersfield California 93301 United States


in progress, not accepting new patients
Start Date
Completion Date
Gilead Sciences
Gilead Clinical Trials Website
Phase 3 COVID-19 Research Study
Study Type
About 2011 people participating
Last Updated