NCT04331834已完成3 期
Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic: A Multicentre, Double-Blinded Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Confirmed cases of a COVID-19
研究概览
简要总结
The investigators aim to evaluate the efficacy of pre-exposure prophylaxis with hydroxychloroquine in healthcare workers with high-risk of SARS-CoV-2 infection.
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)
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
- •Negative PCR and negative serology on day 0
- •Healthcare worker at any of the trial sites
- •Female participants: negative for pregnancy test
- •Willing to participate in the study
- •Able to sign the informed consent form
排除标准
- •Age <18 years
- •Pregnancy or breastfeeding
- •Ongoing antiviral or antiretroviral treatment or HIV positive
- •Ongoing anti-inflammatory treatment (corticosteroids)
- •Ongoing or previous (1 month) chloroquine or hydroxychloroquine treatment
- •Confirmed case of SARS-CoV-2 infection (positive PCR) at day 0
- •Positive serology for SARS-CoV-1 infection at day 0
- •Impossibility of signing the informed consent form
- •Rejection of participation
- •Working less than 3 days a week in the Hospital Clinic of Barcelona.
- •Any contraindication for hydroxychloroquine treatment:
- •Hydroxychloroquine hypersensitivity or 4-aminoquinoline hypersensitivity
- •Retinopathy, visual field or visual acuity disturbances
- •QT prolongation, bradycardia (<50bpm), ventricular tachycardia, other arrhythmias, as determined on day 0 ECG or medical history
- •Potassium < 3 mEq/L or AST or ALT > 5 upper normal limit, as determined on day 0 blood test
- •Previous myocardial infarction
- •Myasthenia gravis
- •Porphyria
- •Glomerular clearance < 10ml/min
- •Previous history of severe hypoglycaemia
- •Ongoing treatment with antimalarials, antiarrhythmic, tricyclic antidepressants, selective serotonin reuptake inhibitors, natalizumab, quinolones, macrolides, agalsidase alfa and beta.
研究组 & 干预措施
Pre-exposure prophylaxis of SARS-CoV-2
Experimental
Participants will receive hydroxychloroquine 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months
干预措施: Hydroxychloroquine (Drug)
Control group with placebo
Placebo Comparator
Participants will receive placebo 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months
干预措施: Placebos (Drug)
结局指标
主要结局
Confirmed cases of a COVID-19
时间窗: Up to 6 months after start of treatment
Confirmed cases of a COVID-19 (defined by a positive PCR for SARS-CoV-2 or symptoms compatible with COVID-19 with seroconversion) in the PrEP group compared to the placebo group at any time during the 6 months of the follow-up in healthcare workers with negative PCR for SARS-CoV-2 on day 0 and negative serology for SARS-CoV-2 on day 0.
次要结局
- Occurrence of any adverse event related with hydroxychloroquine treatment(Up to 6 months after start of treatment)
- Risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19(Up to 6 months after start of treatment)
- Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers(Up to 6 months after start of treatment)
- SARS-CoV-2 seroconversion(Up to 6 months after start of treatment)
- COVID-19 Biobank(Up to 6 months after start of treatment)
研究者
研究点 (1)
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