EUCTR2020-001031-27-ES进行中（未招募）1 期
Treatment of non-severe confirmed cases of COVID-19 and chemoprophylaxis of their contacts as prevention strategy: a Cluster Randomized Clinical Trial (PEP CoV-2 Study) - Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention
FUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA0 个研究点目标入组 3,040 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
- 3,040
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
- •Inclusion Criteria for Index Cases:
- •1.Patients who meet the requirements of the New Coronavirus Infection Diagnosis (Acute respiratory infection symptoms or acute cough alone and positive PCR)
- •2.Aged =18 years male or female
- •3.In women of childbearing potential(1), negative pregnancy test and commitment to use contraceptive method(2) throughout the study.
- •4.Willing to take study medication
- •5.Willing to comply with all study procedures, including repeat nasal swab at day 3
- •6.Able to provide oral and written informed consent
- •2Contraceptive methods: male or female condom with or without spermicide, cap, diaphragm or sponge with or without spermicide, intrauterine device, bilateral tubal occlusion, vasectomized partner, sexual abstinence during the study.
- •Data currently available in population older than 65 years are limited, so caution will be taken before administering Rezolsta to patients of this age. This will be minimized as a thorough review of the clinical records including laboratory tests in advance.
- •Inclusion Criteria for contacts:
- •1.Patients who meet the definition of a contact according to the Catalan Public Health Department Guidelines
- •2.Aged =18 years male or female;
- •3.Willing to take study medication;
- •4.Willing to comply with all study procedures;
- •5.Able to provide oral, informed consent and/or assent.
- •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 2432
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 608
排除标准
- •Exclusion Criteria for Index Cases:
- •1.Serious condition meeting one of the following: (1) respiratory distress with respiratory rate >=30 breaths/min; (2) oxygen saturation<=93% on quiet status; (3) Arterial partial pressure of oxygen (PaO2)/oxygen concentration<=300mmHg;
- •2.Critically ill patients meeting one of the following: (1) Experience respiratory failure and need to receive mechanical ventilation; (2) Experience shock; (3) Complicated with other organs failure and need intensive care and therapy in ICU;
- •3.Participants under treatment with medications likely to interfere with experimental drugs Unable to take drugs by mouth;
- •4.With significantly abnormal liver function (Child Pugh C)
- •5.Need of dialysis treatment, or GFR=30 mL/min/1.73 m2;
- •6.Participants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit
- •7.Participants with severe neurological and mental illness;
- •8.Pregnant or lactating women;
- •9.Inability to consent and/or comply with study protocol;
- •10.Individuals with known hypersensitivity to the study drugs;
- •11.Persons already treated with any of the study drugs during the last 30 days.
- •12.Concomitant administration of enzyme inducers (such as carbamazepine) which could lead to ineffectiveness of darunavir; and those who receive CYP3A4 substrates (such as statins) because of the risk of increased toxicity.
- •13.HIV patients (because these are already on antiretroviral treatment)
- •14.Any contraindications as per the Data Sheet of Rezolsta or Hydroxychloroquine.
- •Exclusion Criteria for contacts:
- •1. Participants under treatment with medications likely to interfere with experimental drugs
- •2. Unable to take drugs by mouth;
- •3. With significantly abnormal liver function (Child Pugh C)
- •4. Need of dialysis treatment, or GFR=30 mL/min/1.73 m2;
- •5. Participants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit Participants with retinal disease, hearing loss;
- •6. Persons already treated with any of the study drugs during the last 30 days;
- •7. Pregnant or lactating women;
- •8. Any contraindications as per the Data Sheet of Hydroxychloroquine.
研究者
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