Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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 3
研究概览
简要总结
The study aims to evaluate the efficacy and safety of hydroxychloroquine 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 hydroxychloroquine 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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 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;
- •Participants aged over 18;
- •Written the informed consent.
排除标准
- •Hypersensitivity to chloroquine or hydroxychloroquine;
- •Women during pregnancy;
- •Severe heart, lung, kidney, brain, blood diseases or other important systemic diseases;
- •Participants with retinal disease, hearing loss;
- •Participants with severe neurological and mental illness;
- •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
Hydroxychloroquine and conventional treatments
After randomization, subjects take hydroxychloroquine 400mg per day for 5 days, also take conventional treatments.
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3
时间窗: 3 days after randomization
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5
时间窗: 5 days after randomization
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7
时间窗: 7 days after randomization
The mortality rate of subjects at weeks 2
时间窗: 14 days after randomization
次要结局
- 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