Hydroxychloroquine as Primary Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)
试验速览
- 阶段
- 3 期
- 入组人数
- 1,700
- 试验地点
- 2
- 主要终点
- Incidence of symptomatic COVID-19 infection in healthcare workers
研究概览
简要总结
This a double-blind, randomized, placebo-controlled clinical trial to determine if primary prophylaxis with hydroxychloroquine in healthcare workers reduces symptomatic COVID-19 infection. Healthcare workers will be randomized at a 1:1 allocation between intervention and placebo arms and followed for 12 weeks. This study will enroll up to 1,700 participates in Lafayette, Louisiana. The primary outcome will number of symptomatic COVID-19 infections. Secondary endpoints included number of days healthcare workers are absent from work and rate of severe infection.
详细描述
The study is a double blind placebo controlled at two hospitals in Lafayette, Louisiana aiming to enroll 1700 participants with a 1:1 randomization. The HCQ dose in 400mg twice on day 1, then 200mg twice weekly. The primary outcome variable is development of symptomatic COVID-19 infection. The secondary objectives are number of days absent from work due to symptomatic COVID-19 infection and rate of severe disease due to COVID-19 (hypoxia in setting of >50% lung involvement on chest imaging, respiratory failure, shock or end-organ damage). The study will enroll participants for four weeks with and plan to treat with hydroxychloroquine versus placebo for a total of 12 weeks.
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
Participants will be randomized to the investigational drug (hydroxychloroquine) or placebo. Both will have identical appearance and will be taken at the same dosing interval. The administration of the drug and assessment will be blinded. After final analysis, study arms will be unmasked.
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
- •Age ≥ 18 years
- •Healthcare or Hospital Worker who has direct patient contact
- •Willing to participate in the research.
- •Able to understand and sign the informed consent form
排除标准
- •Age < 18 years
- •History of ventricular arrhythmia or use of Class IA, IC and III anti-arrhythmics
- •Known prolonged QTc interval
- •History of retinal disease
- •Kidney failure with GFR <10%
- •Chronic hepatic disease w/ Child-Pugh class B or C
- •Hypersensitivity to chloroquine or hydroxychloroquine
- •Currently taking chloroquine or hydroxychloroquine
- •Unwilling to participate
- •Unable to understand and/or sign the informed consent form.
研究组 & 干预措施
Hydroxychloroquine
Hydroxychloroquine loading dose will be given as 400mg for two doses 12 hours apart. This will then be followed by maintenance dosing of 200mg twice weekly for the remainder of the trial.
干预措施: Hydroxychloroquine (Drug)
Placebo
An identical placebo will be administered on an identical dosing interval and frequency.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of symptomatic COVID-19 infection in healthcare workers
时间窗: 12 weeks
Number of participants who develop symptoms of COVID-19 in the setting of a positive COVID-19 assay
次要结局
- Absenteeism from work due to COVID-19(12 weeks)
- Severity of COVID-19 infection(12 weeks)
研究者
Ann Chauffe
DO, MPH
Louisiana State University Health Sciences Center in New Orleans