Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting

Key Inclusion Criteria:

• 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 studyprocedures. Individuals age ≥ 18 years may be enrolled with the consent of a legalrepresentative where permitted according to local law and approved nationally and bythe 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 willingand 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 therelevant IRB or IEC with at least 1 pre-existing risk factor for progression tohospitalization (chronic lung disease, hypertension, cardiovascular orcerebrovascular disease, diabetes, obesity (body mass index ≥ 30),immunocompromised, chronic mild or moderate kidney disease, chronic liverdisease, current cancer, or sickle cell disease)
• Or aged ≥ 60 years
• Severe acute respiratory syndrome (SARS)-coronavirus (CoV)-2 infection confirmed bymolecular 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 torandomization
• Not currently requiring hospitalization (hospitalization defined as ≥ 24 hours ofacute care)

Key Exclusion Criteria:

• Participation in any other clinical trial of an experimental treatment and preventionfor COVID-19
• Prior hospitalization for COVID-19
• Treatment with other agents with actual or possible direct antiviral activity againstSARS-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.