Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment
Study Phase: Phase 3
Recruitment Status: Recruiting
Start Date: March 15, 2020
End Date: May 01, 2020
Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
1-833-445-3230 (GILEAD-0)
Inclusion Criteria:
- Willing and able to provide written informed consent prior to performing study procedures (participants ≥ 18 years of age) or assent (participants ≥ 12 and < 18 years of age) prior to performing study procedures. For participants ≥ 12 and < 18 years of age, a parent or legal guardian willing and able to provide written informed consent prior to performing study procedures
- Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization
- Currently hospitalized and requiring medical care for COVID-19
- Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening
- Radiographic evidence of pulmonary infiltrates Key
Exclusion Criteria:
- Participation in any other clinical trial of an experimental treatment for COVID-19
- Concurrent treatment or planned concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2
- Requiring mechanical ventilation at screening
- Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
- Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants ≥ 18 years of age {Cockcroft 1976} and Schwartz Formula for participants < 18 years of age Note: Other protocol defined Inclusion/Exclusion criteria may apply.