EUCTR2020-000841-15-DE进行中（未招募）1 期
A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants with Severe COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 6,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
排除标准
- •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 > 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
研究者
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