A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734*) in Participants with Severe COVID-19
- Conditions
- COVID-19Corona10047438
- Registration Number
- NL-OMON49233
- Lead Sponsor
- Gilead Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
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 * 4 days before randomization
4) Currently hospitalized
5) SpO2 > 94% on room air or requiring supplemental oxygen at screening
6) Radiographc 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 as
described in Protocol Appendix 3.
Subjects who meet any of the following exclusion criteria are not to be
enrolled in this study:
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 is prohibited < 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 >5xULN
6) Creatinine clearance < 50mL/min using the Cockroft-Gault formula for
participants * 18 years of age {Cockroft 1976} 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Clinical status assessed by a 7-point ordinal scale on Day 14</p><br>
- Secondary Outcome Measures
Name Time Method <p>The proportion of participants with treatment emergent adverse events.</p><br>