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, Inc.0 个研究点目标入组 1,113 人开始时间: 2020年3月10日最近更新: 2022年1月10日

试验速览

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•1) Willing and able to provide written informed consent (participants =
•18 years of age) or 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 IRB/IEC)
•3) SARS-CoV-2 infection confirmed by PCR = 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 as described in Protocol Appendix 3.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 100
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 500
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1000

•1) Participation in any other clinical trial of an experimental agent 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 {Cockcroft 1976} and Schwartz
•Formula for participants < 18 years of age
•6) Positive pregnancy test (Protocol Appendix 3)
•7) Breastfeeding woman
•8) Known hypersensitivity to the study drug, the metabolites, or formulation excipient

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