Study Evaluating GS-5245 in Nonhospitalized Participants With COVID-19

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

Key Inclusion Criteria: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 alternative validated assay.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.Key Exclusion Criteria: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) < 4 months before randomization.Self-reported COVID-19 diagnosis < 4 months before randomization.Anticipated need for hospitalization < 48 hours after randomization.New oxygen requirement < 24 hours before randomization.Suspected or confirmed concurrent active systemic infection (including influenza) 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 fatty liver disease, alcoholic liver disease, and autoimmune hepatitis.Undergoing dialysis, or known history of chronic kidney disease.Prior diagnosis of post-acute sequelae of COVID-19 (PASC) or long COVID.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.