ISRCTN15874265已完成3 期
A phase 3 randomized study to evaluate the safety and antiviral activity of Remdesivir (GS-5734™) in participants with severe COVID-19
Gilead Sciences (United States)0 个研究点目标入组 4,891 人开始时间: 2020年11月3日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,891
研究概览
简要总结
2020 results in https:doi.org/10.1056/NEJMoa2015301 (added 29/10/2020)
研究设计
- 研究类型
- Interventional
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 test =4 days before randomization
- •4. Currently hospitalized
- •5. SpO2 =94% on room air or requiring supplemental oxygen 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
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 <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 ULN
- •6. Creatinine clearance <50 mL/min using the Cockcroft-Gault formula for participants =18 years of age and Schwartz Formula for participants <18 years of age
- •7. Positive pregnancy test
- •8. Breastfeeding woman
- •9. Known hypersensitivity to the study drug, the metabolites, or formulation excipient
研究者
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