Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started

Description

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.

Official Title

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

Keywords

SARS-CoV2 Infection Infection Communicable Diseases Remdesivir

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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
  • Requiring invasive mechanical ventilation (e.g., via endotracheal intubation or tracheostomy)
  • Alanine aminotransferase (ALT) ≤ 5 x upper limit of normal (ULN) by local laboratory measure

You CAN'T join 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

Locations

  • University of California, Medical Center (Parnassus Campus) not accepting new patients
    San Francisco California 94143 United States
  • Community Regional Medical Centers (CRMC) not accepting new patients
    Fresno California 93721 United States
  • California Pacific Medical Center not accepting new patients
    San Francisco California 94115 United States

Details

Status
not accepting new patients
Start Date
Sponsor
Gilead Sciences
ID
NCT04323761
Study Type
Expanded Access
Last Updated