Status:
APPROVED_FOR_MARKETING
Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection (COVID-19)
Lead Sponsor:
Gilead Sciences
Conditions:
SARS-CoV2 Infection
Eligibility:
All Genders
12+ years
Brief Summary
The primary objective of this study is to provide expanded access of remdesivir (RDV) for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04323761
Last Update
November 13 2020
Active Locations (272)
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1
University of Alabama- Birmingham
Birmingham, Alabama, United States, 35294
2
Banner- University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
3
Community Regional Medical Centers (CRMC)
Fresno, California, United States, 93721
4
St. Jude Medical Center
Fullerton, California, United States, 92835