EUCTR2020-001565-37-ES进行中（未招募）1 期
PRE-EXPOSURE PROPHYLAXIS WITH HYDROXYCHLOROQUINE FOR HIGH-RISK HEALTHCARE WORKERS DURING THE COVID-19 PANDEMIC (PrEP_COVID): A UNICENTRIC, DOUBLE-BLINDED RANDOMIZED CONTROLLED TRIAL. - PrEP_COVID
ISGlobal0 个研究点目标入组 440 人开始时间: 2020年4月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 440
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age = 18 years
- •- Negative PCR and negative serology at day 0
- •- Healthcare worker at Hospital Clinic of Barcelona
- •- Female participants: negative for pregnancy test
- •- Willing to participate in the study
- •- Able to sign the informed consent form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 435
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- Age <18 years
- •- Pregnancy or breastfeeding
- •- Ongoing antiviral or antiretroviral treatment or HIV positive
- •- Ongoing anti inflammatory treatment (NSAID, corticosteroids)
- •- Ongoing 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 5 days a week in the Hospital Clinic of Barcelona.
- •- Any contraindication for hydroxychloroquine treatment (9):
- •o Hydroxychloroquine hypersensitivity or 4-aminoquinoline hypersensitivity
- •o Retinopathy, visual field or visual acuity disturbances
- •o QT prolongation, bradycardia (<50bpm), ventricular tachycardia, other arrhythmia, as determined on day 0 ECG or medical history
- •o Potassium < 3 mEq/L or AST or ALT > 5 upper normal limit, as determined on day 0 blood test
- •o Previous myocardial infarction
- •o Myasthenia gravis
- •o Psoriasis or porphyria
- •o Glomerular clearance < 10ml/min
- •o Previous history of severe hypoglycaemia
- •o Ongoing treatment with: antimalarials, antiarrhythmic, tricyclic antidepressants, natalizumab, quinolones, macrolides, agalsidase alfa and beta.
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