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A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants with Severe COVID-19 (GS-US-540-5773)

Study Type/Phase: Phase 3. Status: Not Recruiting. (with Severe COVID-19 )

Study Type/Phase: Phase 3
Status: Not Recruiting

The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called Remdesivir (RDV) for COVID-19. There are no approved medications to treat COVID-19, a disease caused by a virus called SARS-CoV-2 that was identified in late 2019. Some people who become sick with COVID-19 develop a very serious disease. Prior testing of RDV has shown antiviral activity against SARS-CoV-2, and has been shown to be safe and tolerable in humans who received this drug in prior studies. Participants with severe COVID-19 symptoms will receive RDV for either 5 days or 10 days while they are at the hospital.

Speak with your doctor to determine whether you meet the following criteria for participation in this study.

Inclusion Criteria Exclusion Criteria
  • Willing and able to provide written informed consent (≥ 18 years of age) or assent (≥ 12 and < 18 years of age) 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
  • At least 18 years of age, or ≥ 12 and < 18 years of age weighing at least 40 kg
  • SARS-CoV-2 infection confirmed by PCR test ≤4 days before randomization
  • Currently hospitalized
  • SpO2 ≤ 94% on room air or requiring supplemental oxygen
  • Radiographic evidence of pulmonary infiltrates
  • Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
  • 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
  • Evidence of multiorgan failure
  • Mechanically ventilated (including V-V ECMO) for 5 or more days or any duration of V-A ECMO
  • ALT or AST > 5 x ULN
  • Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants ≥ 18 years of age and Schwartz Formula for participants < 18 years of age
  • Positive pregnancy test
  • Breastfeeding woman
  • Known hypersensitivity to the study drug, the metabolites, or formulation excipient

Principal Investigator

Daniel Shin, MD

Sponsor

Gilead Sciences, Inc.

NCT Number

NCT04292899

Contact

Kara Turner, Clinical Research Coordinator
Taft Center for Clinical Research
650-962-4562
kara_turner@elcaminohealth.org

 

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

 

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