Chemoprophylaxis With Hydroxychloroquine in Healthcare Personnel in Contact With COVID-19 Patients: A Randomized Controlled Trial (PHYDRA Trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 289
- 试验地点
- 1
- 主要终点
- Symptomatic COVID-19 infection rate
研究概览
简要总结
Triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients.
详细描述
Healthcare personnel infection with COVID-19 is a major setback in epidemiological emergencies. Hydroxychloroquine has proven to inhibit coronavirus in-vitro but no data to date has proven in-vivo effects. Nevertheless, hydroxychloroquine is a low cost, limited toxicity and broadly used agent. Since there is currently no treatment for COVID-19 exposure prophylaxis, the investigators will implement a triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) for 60 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization will happen after previous assignment of recruited individual to high-risk or low-risk exposure according to he or her activities. An independent member of the team will randomly assign treatment or placebo following a computer based program. Blinding will end in case elimination criteria are met.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years old upon study start
- •Healthcare personnel exposed to patients with COVID-19 respiratory disease: physicians, nurses, chemists, pharmacists, janitors, stretcher-bearer, administrative and respiratory therapists.
- •Signed consent for randomization to any study arm.
排除标准
- •Known hypersensitivity to hydroxychloroquine manifested as anaphylaxis
- •Current treatment to chloroquine or hydroxychloroquine
- •Women with last menstruation date farther than a month without negative pregnancy test.
- •Women with positive pregnancy test
- •Breastfeeding women
- •Chronic hepatic disease history (Child-Pugh B or C)
- •Chronic renal disease (GFR less or equal to 30)
研究组 & 干预措施
High-risk Treatment
Hydroxychloroquine 200mg per day for 60 days.
干预措施: Hydroxychloroquine (Drug)
High-risk Placebo
Placebo tablet per day for 60 days.
干预措施: Placebo oral tablet (Drug)
Low-risk Treatment
Hydroxychloroquine 200mg per day for 60 days
干预措施: Hydroxychloroquine (Drug)
Low-risk Placebo
Placebo tablet per day for 60 days.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Symptomatic COVID-19 infection rate
时间窗: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start
Symptomatic infection rate by COVID-19 defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive COVID-19 real-time polymerase chain reaction test.
次要结局
- Days of labor absenteeism(From date of randomization until study completion 60 days after treatment start)
- Rate of labor absenteeism(From date of randomization until study completion 60 days after treatment start)
- Rate of severe respiratory COVID-19 disease in healthcare personnel(From date of randomization until the appearance of symptoms or study completion 60 days after treatment start)
- Symptomatic non-COVID viral infection rate(From date of randomization until the appearance of symptoms or study completion 60 days after treatment start)