A Trial of Favipiravir Therapy in Adults With Mild Coronavirus Disease COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 231
- 试验地点
- 7
- 主要终点
- PCR negative
研究概览
简要总结
Favipiravir is a selective and potent inhibitor of influenza viral RNA polymerase. It acts as a purine analogue, which selectively inhibits viral RNA-dependent RNA polymerase (RdRps). It has the characteristic of acting on RNA viruses including Ebola and Coronaviruses especially novel coronavirus (2019-nCoV). The purpose of this study is to evaluate the clinical efficacy and safety of Favipiravir in comparison to placebo in the treatment of mild COVID-19 cases. It is a Multicenter, randomized double-blinded, parallel-group trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Favipiravir
Favipiravir: 1800 mg (9 tablets) by mouth twice daily for one day, followed by 800mg (4 tablets) twice daily (Maximum days of therapy is 7 days)
干预措施: Favipiravir (Drug)
Placebo
9 tablets by mouth twice daily for one day, followed by 4 tablets twice daily (Maximum days of therapy is 7 days).
干预措施: Placebo (Drug)
结局指标
主要结局
PCR negative
时间窗: 15 days
Time from randomization to negativity in RT-PCR nucleic acid test for COVID-19 within 15 days of randomization
次要结局
- Evaluate Faviparivirs effect(15 days)
- Evaluate the safety of Favipiravir(28 days)
- Evaluate Favipiravir's effect(28 days)
- Time from randomization to clinical recovery(15 days)
- Evaluate symptoms progression(28 days)