ISRCTN85762140
Completed
Phase 3
A phase 3 randomized study to evaluate the safety and antiviral activity of remdesivir (GS-5734™) in participants with moderate COVID-19 compared to standard of care treatment
Gilead Sciences (United States)0 sites1,113 target enrollmentNovember 3, 2020
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- COVID-19 (SARS-CoV-2 infection)
- Sponsor
- Gilead Sciences (United States)
- Enrollment
- 1113
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32821939/ (added 25/03/2021)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under 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
- •2\. 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])
- •3\. SARS\-CoV\-2 infection confirmed by PCR test \=4 days before randomization
- •4\. Currently hospitalized and requiring medical care for COVID\-19
- •5\. SpO2 \>94% on room air at screening
- •6\. Radiographic evidence of pulmonary infiltrates
- •7\. Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Exclusion Criteria
- •1\. Participation in any other clinical trial of an experimental treatment for COVID\-19
- •2\. Concurrent treatment or planned concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS\-CoV\-2
- •3\. Requiring mechanical ventilation at screening
- •4\. ALT or AST \>5 x ULN
- •Note: if per local practice only ALT is routinely measured, exclusion criteria will be evaluated on ALT alone
- •5\. 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
- •6\. Positive pregnancy test
- •7\. Breastfeeding woman
- •8\. Known hypersensitivity to the study drug, the metabolites, or formulation excipient
Outcomes
Primary Outcomes
Not specified
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