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)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,300
- 试验地点
- 1
- 主要终点
- Study 1- Clinical and virological outcome in exposed contacts
研究概览
简要总结
This study is a research project to evaluate the efficacy of hydroxychloroquine for post-exposure prophylaxis and early treatment of Covid-19. The intervention entails administering prophylactic hydroxychloroquine to all contacts (Study 1) and treating non severe confirmed cases with hydroxychloroquine (Study 2).
详细描述
Hydroxychloroquine (HCQ) is a drug that has been extensively used for the prevention of malaria. HCQ showed excellent in vitro results and strong antiviral effects on SARS-CoV-2 infection of primate cells at low concentration. Empirical data for the efficacy of HCQ in hospitalized Covid-19 patients became available after the start of this study; HCQ administration did not result in a significantly higher PCR negative conversion in a RCT including 150 patients and there was no reduction in the risk of death/intubation in two large observational studies.
Study 1 -We investigated the efficacy and safety of HCQ to prevent secondary SARS-CoV-2 infection and Covid-19 disease in contacts exposed to a PCR-positive Covid-19 case during.
Study 2- We also conducted a study to test the hypothesis that HCQ treatment would be more efficacious than no-treatment for patients with mild Covid-19.
Initially, the protocol included the use of combined treatment with a HIV protease inhibidor (cobicistat-boosted darunavir) for cases (study 2), but it was adapted to HCQ alone after the recommendation of the pharmaceutical company not to use DRVc for the treatment of Covid-19 due to lack of activity in-vitro.
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
- None
盲法说明
Open label
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
No Intervention- SARS-CoV-2 surveillance
Study 1- Contacts will complete a survey collecting demographic, epidemiological and clinical data and provides a swab for RT-PCR testing at baseline and day 14.
Study 2- Index case completes a survey collecting demographic, epidemiological and clinical data and provides a swab for RT-PCR testing at baseline and on days 3 and 7.
Isolation of patient and contact tracing as per national guidelines.
干预措施: Standard Public Health measures (Other)
Testing, treatment and prophylaxis of SARS-CoV-2
Study 1- Contacts receive Hydroxychloroquine prophylaxis. Contacts will complete a survey collecting demographic, epidemiological and clinical and provides a swab for RT-PCR testing at baseline and day 14.
Study 2- Index case receives Hydroxychloroquine. Index case completes a survey collecting demographic, epidemiological and clinical data and provides a swab for RT-PCR testing at baseline and on days 3, and 7.
Isolation of patient and contact tracing as per national guidelines.
干预措施: Treatment and prophylaxis (Drug)
Testing, treatment and prophylaxis of SARS-CoV-2
Study 1- Contacts receive Hydroxychloroquine prophylaxis. Contacts will complete a survey collecting demographic, epidemiological and clinical and provides a swab for RT-PCR testing at baseline and day 14.
Study 2- Index case receives Hydroxychloroquine. Index case completes a survey collecting demographic, epidemiological and clinical data and provides a swab for RT-PCR testing at baseline and on days 3, and 7.
Isolation of patient and contact tracing as per national guidelines.
干预措施: Standard Public Health measures (Other)
结局指标
主要结局
Study 1- Clinical and virological outcome in exposed contacts
时间窗: Up to 14 days after start of treatment
Incidence of secondary PCR confirmed symptomatic Covid-19 episodes among contacts after high risk PCR+ exposure
Study 2- Virological outcome in index cases
时间窗: Up to 7 days after start of treatment
Reduction of viral RNA load in nasopharyngeal swabs at days 3, and 7 after treatment start.
Study 1- Transmission of SARS-CoV-2 in exposed contacts
时间窗: Up to 14 days after start of treatment
Incidence of symptomatically compatible or a PCR-positive result regardless of symptoms
Study 2- Clinical outcome in index cases
时间窗: Up to 28 days after start of treatment
Time from randomization to complete resolution of symptoms at an extended 28-days follow-
次要结局
未报告次要终点
研究者
Oriol Mitja
Prof (Ass) Infectious Disease and Global Health
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia