Last Verified: | June/30/2020 |
First Submitted: | March/23/2020 |
Estimated Enrollment Submitted: | March/23/2020 |
First Posted: | March/26/2020 |
Last Update Submitted: | July/20/2020 |
Last Update Posted: | July/22/2020 |
Ages Eligible for Study: | 12 Years to 12 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria: | 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 (participants ≥ 18 years of age), or willing and able to provide assent (participants ≥ 12 and < 18 years of age, where locally and nationally approved) 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. - Age ≥ 18 years 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)) - Hospitalized with confirmed SARS-CoV2 by polymerase chain reaction (PCR) or known contact of confirmed case with syndrome consistent with coronavirus disease (COVID-19) with PCR pending - Oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen at baseline - Alanine aminotransferase (ALT) < 5 x upper limit of normal (ULN) by local laboratory measure and/or ALT < 3 x ULN and bilirubin < 2 x ULN - Females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception - Lactating females must agree to discontinue nursing before the study drug is administered and while they are participating in the study Exclusion Criteria: - Evidence of multiorgan failure including but not limited to coagulopathy (significant thrombocytopenia), hepatic failure (elevated bilirubin) or renal failure (low urine output or estimated glomerular filtration rate (eGFR) < 30 mL/min), or significant cardiomyopathy (low cardiac output) - Use of more than 1 pressor for septic shock (note that use of 1 pressor at low/medium doses for inotropic support due to the use of sedation and paralytics while on the ventilator is allowed) - Renal failure (eGRF < 30 mL/min using the Cockcroft-Gault formula for participants ≥ 18 years of age and Schwartz Formula for participants < 18 years of age) or dialysis or continuous Veno-Venous Hemofiltration) - Eligible for enrollment in a randomized clinical trial studying remdesivir for treatment of SARS-CoV2 at the medical facility where the participant is admitted - Known hypersensitivity to the study drug, the metabolites, or formulation excipient - Requiring venous arterial (V-A) extracorporeal membrane oxygen (ECMO) (venous venous (V-V) ECMO is not an exclusion criteria) |