Hydroxychloroquine Treatment for Severe COVID-19 Respiratory Disease: Randomised Clinical Trial (HYDRA Trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- All-cause hospital mortality
研究概览
简要总结
Double blinded randomized clinical trial designed to evaluate the security and efficacy of hydroxychloroquine as treatment for COVID-19 severe respiratory disease. The investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory COVID-19 disease.
详细描述
Since hydroxychloroquine is a low cost and safe anti-malaria drug that has proven effects against COVID-19 in vitro. The investigators aim to study the security and efficacy of this drug in trough a double blinded randomized clinical trial. Recruited patients with severe respiratory disease from COVID-19 will be randomized to an intervention group (400mg per day dose of hydroxychloroquine) and placebo. The investigators' main outcome will be all cause hospital mortality. The investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory COVID-19 disease. Results will be compared in an intention to treat analysis. All clinical, analysis and data team members will be blinded to treatment assignment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Clinical practitioners and data analysts will remain blinded all through the study. Blinding will end in case the attending physician considers the patient should abandon the study or some of the exclusion/elimination criteria apply.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •negative pregnancy test in women
- •COVID-19 confirmed by rtPCR in any respiratory sample.
- •Severe COVID-19 disease defined as any from the following:
- •Pulse oximetry less than 91% or a 3% drop from base pulse oximetry or need to increase supplementary oxygen in chronic hypoxia
- •Need for mechanical ventilation (invasive or non invasive )
- •Sepsis/septic shock.
排除标准
- •history of anaphylactic shock to hydroxychloroquine.
- •History of previous administration of chloroquine or hydroxychloroquine (within 1 month)
- •decision of attending physician by any reason.
- •History of chronic hepatic disease (Child-Pugh B or C)
- •History of Chronic renal disease (GFR less than 30)
研究组 & 干预措施
placebo
identical placebo, one tablet every 12 hours for 10 days
干预措施: Placebo oral tablet (Drug)
treatment
Hydroxychloroquine tablet 200mg every 12 hours for 10 days.
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
All-cause hospital mortality
时间窗: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days
incidence of all-cause mortality
次要结局
- Length of hospital stay(From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days)
- Need of mechanical ventilation(From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days)
- Ventilator free days(From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days)
- Grade 3-4 adverse reaction(From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days)