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/5/2020 |
Estimated Primary Completion Date: | April/8/2020 |
Estimated Study Completion Date: | June/29/2020 |
Study Type: | Interventional |
Allocation: | Randomized |
Primary Purpose: | Treatment |
Masking: | None (Open Label) |
Arm | Intervention/treatment |
---|---|
Experimental: Part A: Remdesivir (RDV), 5 Days (Not Mechanically Ventilated) Participants who are not mechanically ventilated 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 (Not Mechanically Ventilated) Participants who are not mechanically ventilated 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. | |
Experimental: Part B: Remdesivir, 5 or 10 Days (Extension) Part B (Extension) will enroll participants after enrollment to Part A is complete. Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10. | |
Experimental: Part B: Remdesivir 10 days (Mechanically Ventilated) Participants on mechanical ventilation will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10 |
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, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥18), or willing and able to provide assent (age ≥12 to <18, where locally and nationally approved) prior to performing study procedures - Aged ≥ 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 the relevant institutional review board (IRB) or independent ethics committee (IEC)) - Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization - Currently hospitalized - Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen at screening Key Exclusion Criteria: - Participation in any other clinical trial of an experimental treatment for COVID-19 - Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing - Evidence of multiorgan failure - Mechanically ventilated (including V-V ECMO) ≥ 5 days, or any duration of V-A ECMO. - 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. |