Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection (COVID-19)

APPROVED_FOR_MARKETING

Conditions studied: SARS-CoV2 Infection

In brief

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.

Key facts

Study ID

NCT04323761

Run by

Gilead Sciences

Last updated by the study team

2020-11-13

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Banner- University Medical Center Phoenix — Phoenix, Arizona, United States
• Community Regional Medical Centers (CRMC) — Fresno, California, United States
• St. Jude Medical Center — Fullerton, California, United States
• Scripps Memorial Hospital La Jolla — La Jolla, California, United States
• Long Beach Memorial Medical Center — Long Beach, California, United States
• Huntington Hospital — Pasadena, California, United States
• Scripps Mercy Hospital — San Diego, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University of California, Medical Center (Parnassus Campus) — San Francisco, California, United States
• Regional Medical Center — San Jose, California, United States
• San Mateo Medical Center — San Mateo, California, United States
• Santa Rosa Memorial Hospital — Santa Rosa, California, United States
• Los Robles Regional Medical Center — Thousand Oaks, California, United States
• PIH Health Whittier Hospital — Whittier, California, United States
• The Medical Center Of Aurora — Aurora, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Greenwich Hospital — Greenwich, Connecticut, United States
• Middlesex Health — Middletown, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• The Stamford Health Medical Group- Pulmonary Associates — Stamford, Connecticut, United States
• George Washington University Hospital — Washington D.C., District of Columbia, United States
• Aventura Hospital and Medical Center — Aventura, Florida, United States
• Lawnwood Regional Medical Center — Ft. Pierce, Florida, United States
• University of Alabama- Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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