| Last Verified: | June/30/2020 |
| First Submitted: | February/27/2020 |
| Estimated Enrollment Submitted: | February/27/2020 |
| First Posted: | March/2/2020 |
| Last Update Submitted: | July/22/2020 |
| Last Update Posted: | July/26/2020 |
| Actual Study Start Date: | March/14/2020 |
| Estimated Primary Completion Date: | April/28/2020 |
| Estimated Study Completion Date: | June/25/2020 |
| Study Type: | Interventional |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
| Masking: | None (Open Label) |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Part A: Remdesivir (RDV), 5 Days Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, and 5. | |
| Experimental: Part A: Remdesivir, 10 Days Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10. | |
| Active Comparator: Part A: Continued SOC Therapy Participants will receive continued standard of care therapy. | |
| Experimental: Part B: Extension Treatment, Remdesivir 5 or 10 days Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10. |
| Ages Eligible for Study: | 12 Years to 12 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Criteria: | Key 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. |