Study of Obeldesivir in Nonhospitalized Participants With COVID-19

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.

• 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.