EUCTR2020-001385-11-ES进行中（未招募）1 期
Prevention of SARS-CoV-2 (COVID-19) through Pre-Exposure Prophylaxis with Tenofovir disoproxil/Emtricitabine and Hydroxychloroquine in Healthcare Personnel: Randomized Clinical Trial controlled with placebo - EPICOS
Plan Nacional Sobre SIDA0 个研究点目标入组 4,000 人开始时间: 2020年4月3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
- 4,000
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
- •Participants that after receiving appropriate information on the study design, objectives, possible risks and acknowledging that they have the right to withdraw from the study consent at any time sing the informed consent for participation in the study.
- •Male or female aged 18-65 years.
- •Health care workers in public or private hospitals in Spain in an areas of risk of SARS-CoV-2 transmission.
- •Not previous diagnosis of SARS-CoV-2 (COVID-19) infection plus no symptoms of SARS-CoV-2 (COVID-19) since 1st of March 2020 until the date of enrolment in the study.
- •Understand the aim of the study and have not been on any previous active pre exposure prophylaxis treatment against SARS-CoV-2 (COVID-19) since 1st of March 2020 until the date of enrolment in the study. This include PrEP for HIV.
- •Negative PCR rapid test for SARS-CoV-2 (COVID-19) at enrolment.
- •Participant willing and able to give informed consent for participation in the study
- •Negative pregnancy test during the previous 7 days to start treatments or more than 2 years after menopause.
- •Women of reproductive age and their partners should commit to use and highly effective contraceptive method (such sterilisation, double barrier, hormonal contraception), during the study period and until 6 months after the last dose of treatment.
- •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 4000
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •HIV infection
- •Active hepatitis B infection. Infección activa por virus de la hepatitis B
- •Renal failure with estimated glomerular filtration rate (GFR) < 60 ml/min) and patients on Hemodialysis.
- •Osteoporosis
- •Myasthenia gravis
- •Pre-existent maculopathy.
- •Retinitis pigmentosa
- •Bradycardia < 50bpm
- •Weight < 40kg
- •Participant with any immunosuppressive condition or haematological disease
- •Treatment with drugs that may prolong QT in the last month before randomization for more than 7 days including: azithromycin, chlorpromazine, cisapride, clarithromycin, domperidone, droperidol, erythromycin, halofantrine, haloperidol, lumefantrine, mefloquine, methadone, pentamidine, procainamide, quinidine, quinine, sotalol, sparfloxacin, thioridazine, amiodarone.
- •Pregnancy or fertility desire during the estudy periodo r the following 6 months.
- •Breastfeeding
- •Known allergy to any of the medication used in this trial
- •Self-medication practice to prevent SARS-2-CoV infection
研究者
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