NCT04371523撤回3 期
Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers (PROVIDE): A Parallel Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Positive for SARS-CoV-2
研究概览
简要总结
The objectives of PROVIDE are to:
- Determine if prophylactic once weekly hydroxychloroquine reduces the incidence of conversion from SARS-2-CoVnasopharyngeal swab negative to positive
- To determine if weekly prophylactic hydroxychloroquine reduced the severity of COVID-19 symptoms
- To determine the safety of taking weekly prophylactic hydroxychloroquine
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
Neither the participant, nor the investigators, study coordinators, adjudicator, and data analysts will know if the subject is receiving the hydroxychloroquine or placebo.
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 of age or older to participate.
- •Healthcare workers with primary practice in intensive care unit, general internal medicine,
- •COVID-19 testing centres, emergency rooms, and nursing homes.
- •COVID_19 symptom free at the time of randomization and have a negative diagnostic swab.
排除标准
- •Known COVID-19 positivity defined as: a laboratory confirmed case as defined by the local public health institutes
- •Suspected COVID-19 positivity defined as possessing symptoms consistent with COVID-19 infections such as: headache, fever, nausea, vomiting, diarrhea, dyspnea, dry cough
- •Healthcare workers with pre-existing retinopathy or serious visual problems
- •Healthcare workers with known malignancies receiving active chemotherapy or immune modifying medications
- •Healthcare workers with known autoimmune disorders
- •Healthcare workers with known QT prolongation
- •History of ventricular arrhythmias
- •Participants at risk of malignant arrythmias ○ At risk defined as: A sudden loss of consciousness with injury; anyone in their immediate family, under the age of 45year, with sudden cardiac death; anyone family history of long QT syndrome
- •Known sensitivity/allergy to hydroxychloroquine
- •Healthcare workers that are currently pregnant
- •Healthcare workers that are already taking chloroquine or hydroxychloroquine
- •Healthcare workers on colchicine or any other anti-viral medication
- •Healthcare workers taking a medication that may interact with hydroxychloroquine (see table below
- •Inability to take oral medications
- •Inability to provide written consent
- •Known G6PD deficiency
研究组 & 干预措施
Intervention - Hydroxychloroquine
Experimental
干预措施: Apo-Hydroxychloroquine (Drug)
Control
Placebo Comparator
干预措施: Matched Placebo (Drug)
结局指标
主要结局
Positive for SARS-CoV-2
时间窗: 8 weeks
The number of HCW that tested positive for SARS-CoV-2
次要结局
- Mortality(from randomization to 60 days)
- Incidence of adverse events(from randomization to 60 days)
- Intensive care unit admissions(at any time after first dose to hospital discharge, truncated at 60 days)
- Hospital admissions(at any time after first dose to hospital discharge, truncated at 60 days)
- Intubation and mechanical ventilation(at any time after first dose, truncated at 60 days)
- ICU length of stay(from randomization to hospital discharge, truncated at 60 days)
- Hospital length of stay(from randomization to hospital discharge, truncated at 60 days)
研究者
Waleed Al-Hazzani
Intensivist
St. Joseph's Healthcare Hamilton
研究点 (1)
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