EUCTR2020-001536-98-ES进行中（未招募）1 期
Prophylaxis of COVID-19 infection with hydroxychloroquine in healthcarepersonnel with high risk of infection.
HOSPITAL UNIVERSITARI MÚTUA TERRASSA0 个研究点目标入组 300 人开始时间: 2020年4月20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
- 300
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
- •- Be over 18 years old and sign the informed consent.
- •-Not having previously presented or at the time of inclusion SARS-CoV-2
- •- In the case of fertile women, a written commitment to use a reliable
- •contraceptive method for the duration of the study and for 3 months
- •after the end of treatment.
- •- Sign the informed consent.
- •-Groups of patients:
- •1. Active treatment group (Group A): healthcare professionals with high
- •risk of exposure to patients with COVID-19 (ICU staff, emergency
- •departments, medical plants that have patients with COVID-19
- •hospitalized) who agree to take treatment with hydroxychloroquine. for
- •2. Control group 1 (Group C1): health professionals with high risk of
- •exposure to patients with COVID-19 (ICU staff, emergency departments,
- •medical plants that have patients with COVID-19 hospitalized) who do
- •not want to take treatment with hydroxychloroquine for one month.
- •3. Control group 2 (Group C2): health professionals with low risk of
- •exposure to patients with COVID.
- •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 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •- Pregnant or lactating women.
- •- Having previously had a positive PCR for SARS-CoV-2, presenting
- •positive serologies for SARS-CoV-2 or compatible clinic at the time of
- •- Long QT syndrome
- •- Diseases of the retina or cornea
- •- Glomerular filtration <30ml / min
- •- Severe liver dysfunction (Child Pugh 3)
- •- Hypersensitivity to study medication
- •- Greater drug interaction between your chronic medication and
- •hydroxychloroquine.
- •- Any other contraindication included in the technical sheet of the study
研究者
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