Protecting Health Care Workers From COVID-19 With Hydroxychloroquine Pre-exposure Prophylaxis: A Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 374
- 试验地点
- 1
- 主要终点
- Cumulative Incidence of COVID-19 Infection
研究概览
简要总结
This is a double-blinded, randomized placebo-controlled trial to determine if pre-exposure prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily, for health care workers in the hospital reduces symptomatic and asymptomatic COVID-19 disease during the pandemic. 374 health care workers will be randomized at a 1:1 allocation between the intervention and placebo arms and followed for 90 days. The cumulative incidence of COVID-19 infection in the intervention group will be compared to the cumulative incidence of COVID-19 in the placebo group with relative (risk ratio and 95% CI) and absolute measures (risk difference and 95% CI).
详细描述
This is a double-blinded, randomized placebo-controlled trial to determine if pre-exposure prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily, for health care workers in the hospital reduces symptomatic and asymptomatic COVID-19 disease during the pandemic.
Secondary outcomes include 1) Adverse events; 2) Duration of symptomatic COVID-19 disease; 3) Days hospitalized attributed to COVID-19; 4) Respiratory failure attributable to COVID-19 disease requiring i) non-invasive ventilation or ii) intubation/mechanical ventilation; 5) Mortality attributed to COVID-19 disease, and; 6) Number of days unable to work attributed to COVID-19. Laboratory markers within participants with confirmed COVID-19 will also be explored.
A total of 374 HCW will be randomized using a fixed 1:1 allocation ratio with randomization in permuted block of varying sizes from four to eight will be used to ensure equal allocation to each group. The study population will be health care workers at the New York Presbyterian Hospital - Cornell Campus and they will participate in the study for 90 days.
To determine if the intervention has been successful, the cumulative incidence of COVID-19 infection in the intervention group will be compared to the cumulative incidence of COVID-19 in the placebo group with relative (risk ratio and 95% CI) and absolute measures (risk difference and 95% CI). Investigators will also calculate adjusted risk ratios and risk differences including job class as a covariate and any other baseline clinical and demographic characteristics that are not balanced between the treatment and placebo arms using a log-binomial regression model.
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 in the study will be randomized to either the investigational drug (HCQ) or placebo. The investigational drug and placebo will have identical appearance and be taken at the same frequency and dosage. The administration of the drug and assessment will be blinded. Study arms will be unmasked at the end of the study for the final analysis.
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
- •Health care worker (HCW) at the hospital who work on a "full time" basis during the study period. For the purposes of the study, "health care workers" are physicians, nurses, nurse practitioners, physician assistants, respiratory therapists, X-ray technicians, social workers and support staff (including but not limited to house-keeping, and porters).
- •Age ≥18 years.
- •Ability to communicate with study staff in English
排除标准
- •Known hypersensitivity/allergy to hydroxychloroquine or to 4-aminoquinoline compounds.
- •Current use of hydroxychloroquine for the treatment of a medical condition.
- •Known prolonged QT syndrome, or concomitant medications which simultaneously may prolong the QTC that cannot be temporarily suspended/replaced. These are including but not limited to Class IA, IC and III antiarrhythmics; certain antidepressants, antipsychotics, and anti-infectives; domperidone; 5-hydroxytryptamine (5-HT)3 receptor antagonists; kinase inhibitors; histone deacetylase inhibitors beta-2 adrenoceptor agonists.
- •Known pre-existing retinopathy of the eye.
- •Disclosure of self-administered use of hydroxychloroquine or chloroquine currently under investigation <4 weeks prior to study. This window is intended to account for the drug half-life of HCQ (21 days).
- •Baseline symptom of COVID-19 disease at enrollment and baseline viral detection specimen positive for SARS-COV-
- •All participants with COVID-19 symptoms at enrollment will be directed to have confirmatory testing (within the department or occupational health as per the site guidelines). Participants who are negative for SARS-COV-2 will be redirected to enrollment procedures, those testing positive will be excluded.
研究组 & 干预措施
Hydrocholoroquine Pre-exposure prophylaxis
HCQ will be administered as 400mg orally once for 60 days.
干预措施: Hydroxychloroquine Pre-Exposure Prophylaxis (Drug)
Placebo
Placebo will be administered as 400mg orally once for 60 days.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Cumulative Incidence of COVID-19 Infection
时间窗: 90 days
Incidence of symptomatic and asymptomatic COVID-19 infection in health care workers
次要结局
- Adverse events incidence(90 days)
- Duration of symptomatic COVID-19 disease(90 days)
- Days hospitalized attributed to COVID-19(90 days)
- Number or respiratory failure attributable to COVID-19 disease(90 days)
- Mortality Incidence(90 days)
- Days of work lost(90 days)
研究者
Bradley A. Connor, M.D.
Clinical Professor of Medicine, Weill Cornell Medicine
GeoSentinel Foundation