JPRN-jRCT2080225160已完成3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 596
研究概览
简要总结
Remdesivir administered for 5 days to participants with moderate COVID-19 resulted in significantly better odds of improvement in clinical status at Day 11, as assessed by a 7-point ordinal scale compared with those who received only standard of care treatment. - Remdesivir administered for 5 days or 10 days was generally safe and well tolerated with a similar safety profile as standard of care in participants with moderate COVID-19.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Willing and able to provide written informed consent (participants >= 18 years of age) or assent (participants >= 12 and < 18 years of age) 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 >= 40 kg (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 =< 4 days before randomization
- •-Currently hospitalized and requiring medical care for COVID-19
- •-SpO2 > 94% on room air at screening
- •-Radiographic evidence of pulmonary infiltrates
排除标准
- •-Participation in any other clinical trial of an experimental agent 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
- •-Requiring mechanical ventilation at screening
- •-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
研究者
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