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Clinical Trials/ISRCTN15874265
ISRCTN15874265
Completed
Phase 3

A phase 3 randomized study to evaluate the safety and antiviral activity of Remdesivir (GS-5734™) in participants with severe COVID-19

Gilead Sciences (United States)0 sites4,891 target enrollmentNovember 3, 2020
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ConditionsCOVID-19 (SARS-CoV-2 infection)Infections and Infestations

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
COVID-19 (SARS-CoV-2 infection)
Sponsor
Gilead Sciences (United States)
Enrollment
4891
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2020 results in https:doi.org/10.1056/NEJMoa2015301 (added 29/10/2020)

Registry
who.int
Start Date
November 3, 2020
End Date
June 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Gilead Sciences (United States)

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
  • •5\. SpO2 \=94% on room air or requiring supplemental oxygen 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 with other agents with actual or possible direct\-acting antiviral activity against SARS\-CoV\-2 \<24 hours prior to study drug dosing
  • •3\. Evidence of multiorgan failure
  • •4\. Mechanically ventilated (including V\-V ECMO) \=5 days, or any duration of V\-A ECMO
  • •5\. ALT or AST \>5 ULN
  • •6\. 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
  • •7\. Positive pregnancy test
  • •8\. Breastfeeding woman
  • •9\. Known hypersensitivity to the study drug, the metabolites, or formulation excipient

Outcomes

Primary Outcomes

Not specified

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