A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants with Severe COVID-19

Gilead Sciences, Inc.0 个研究点目标入组 6,000 人开始时间: 2020年3月20日最近更新: 2020年11月16日

适应症

试验速览

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•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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 250
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1500
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4250

•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 x upper limit of normal (ULN)
•6) 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
•7) Positive pregnancy test (Protocol; Appendix 3)
•8) Breastfeeding woman
•9) Known hypersensitivity to the study drug, the metabolites, or formulation excipient

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