EUCTR2020-000842-32-IT
Active, not recruiting
Phase 1
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 - .
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Coronavirus disease 2019 (COVID-19)
- Sponsor
- Gilead Sciences, Inc.
- Enrollment
- 600
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Willing and able to provide written informed consent prior to performing study procedures
- •2\) Aged \= 18 years
- •3\) SARS\-CoV\-2 infection confirmed by PCR \= 4 days before randomization
- •4\) Currently hospitalized with fever defined as temperature \= 36\.6 °C armpit, \= 37\.2 °C oral, \= 37\.8 °C rectal
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •1\) Participation in any other clinical trial of an experimental agent 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\) Requiring mechanical ventilation at screening
- •4\) ALT or AST \> 5 x ULN
- •5\) Creatinine clearance \< 50 mL/min
- •6\) Positive pregnancy test (Appendix 3\)
- •7\) Breastfeeding woman
- •8\) Known hypersensitivity to the study drug, the metabolites, or formulation excipient
Outcomes
Primary Outcomes
Not specified
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