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Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)
Recruiting
Trial ID: NCT04292899
Purpose
The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV)
regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.
Official Title
A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe COVID-19
Stanford Investigator(s)
Aruna Subramanian
Clinical Professor, Medicine - Infectious Diseases
Eligibility
Key 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 (age ≥ 18), or willing and able to provide assent (age ≥ 12 to < 18,
where locally and nationally approved) prior to performing study procedures
- Aged ≥ 18 years (at all sites), 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))
- Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by
polymerase chain reaction (PCR) test ≤ 4 days before randomization
- Currently hospitalized
- Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen
at screening
Key Exclusion Criteria:
- 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 is prohibited < 24 hours prior to study drug dosing
- Evidence of multiorgan failure
- Mechanically ventilated [including veno-venous (V-V) extracorporeal membrane
oxygenation (ECMO)] ≥ 5 days, or any duration of veno-arterial (V-A) ECMO.
- Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit
of normal (ULN)
- Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants ≥
18 years of age {Cockcroft 1976} and Schwartz Formula for participants < 18 years of
age
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention(s):
drug: Remdesivir
drug: Standard of Care
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305