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

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences

Criteria

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.