NCT04252274Unknown3 期
Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7
研究概览
简要总结
The study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of COVID-19 pneumonia
详细描述
There is no vaccine or antiviral treatment for human coronavirus, so this study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of COVID-19 pneumonia.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participants were diagnosed as COVID-19 pneumonia, according to the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4 or update version) made by National Health Commission of the People's Republic of China.
- •Written the informed consent
排除标准
- •Hypersensitivity to darunavir, cobicistat, or any excipients
- •Patients with severe liver injury (Child-Pugh Class C)
- •Concomitant medications that are highly dependent on CYP3A clearance, and the elevated plasma concentrations are associated with serious or life-threatening events.
- •Subjects were considered to be unable to complete the study, or not suitable for the study by researchers
- •Exit criteria:
- •Subjects asked to withdraw the study
- •Subject will benefit if withdraw according to researchers' suggestions
研究组 & 干预措施
Darunavir, Cobicistat and conventional treatments
Experimental
After randomization, subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments.
干预措施: Darunavir and Cobicistat (Drug)
结局指标
主要结局
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7
时间窗: 7 days after randomization
次要结局
- The mortality rate of subjects at weeks 2(14 days after randomization)
- The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3(3 days after randomization)
- The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5(5 days after randomization)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(14 days after randomization)
- The critical illness rate of subjects at weeks 2(14 days after randomization)
研究者
Hongzhou Lu
professor
Shanghai Public Health Clinical Center
研究点 (1)
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