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

Gilead Sciences, K.K.1 个研究点目标入组 2,400 人开始时间: 待定最近更新: 2022年6月21日

试验速览

暂无简介。

•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
•Aged >= 18 years (at all sites), or aged >= 12 and < 18 years of age weighing >= 40kg (where permitted according to local law and approved nationally and by the relevant institutional review board(IRB) or independent ethics committee (IEC))
•SARS-CoV-2 infection confirmed by PCR test =< 4 days before randomization
•Currently hospitalized
•SpO2 =< 94% on room air or requiring supplemental oxygen at screening
•Radiographic evidence of pulmonary infiltrates

•Participation in any other clinical trial of an experimental treatment for COVID-19
•Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 < 24 hours prior to study drug dosing
•Evidence of multiorgan failure
•Mechanically ventilated(including V-V ECMO) >= 5 days,or any duration of V-A ECMO
•ALT or AST > 5 X ULN
•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

efficacy Clinical status assessed by a 7-point ordinal scale on Day 14

未报告次要终点

发起方

Loading locations...