Efficacy of Hydroxychloroquine for Post-exposure Prophylaxis (PEP) to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Among Adults Exposed to Coronavirus Disease (COVID-19): a Blinded, Randomized Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 943
- 试验地点
- 8
- 主要终点
- The Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection
研究概览
简要总结
This is a clinical study for the prevention of SARS-CoV-2 infection in adults exposed to the virus. This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) who are close contacts of persons with laboratory confirmed SARS-CoV-2 or clinically suspected COVID-19. Eligible participants will be enrolled and randomized to receive the intervention or placebo at the level of the household (all eligible participants in one household will receive the same intervention).
详细描述
This is a randomized, multi-center, placebo-equivalent (ascorbic acid) controlled, blinded study of Hydroxychloroquine (HCQ) post-exposure prophylaxis (PEP) for the prevention of SARS-CoV-2 infection in adults exposed to the virus.The overarching goal of this study is to assess the effectiveness of HCQ PEP on the incidence of SARS-CoV-2 detection by polymerase chain reaction (PCR) to inform public health control strategies.This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) at baseline who are close contacts of persons with PCR-confirmed SARS-CoV-2 or clinically suspected COVID-19 and a pending SARS-CoV-2 PCR test. Eligible participants will be enrolled and randomized 1:1 to HCQ or ascorbic acid at the level of the household (all eligible participants in one household will receive the same intervention). Participants will be counseled about the preliminary in vitro data on HCQ activity against SARS CoV-2 and equipoise regarding efficacy in humans.The duration of study participation will be approximately 28 days.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women 18 to 80 years of age inclusive, at the time of signing the informed consent
- •Willing and able to provide informed consent
- •Had a close contact of a person (index) with known PCR-confirmed SARS-CoV-2 infection or who is currently being assessed for COVID-
- •Close contact defined as:
- •Household contact (i.e., residing with the index case in the 14 days prior to index diagnosis)
- •Medical staff, first responders, or other care persons who cared for the index case without personal protection (mask and gloves)
- •Less than 4 days since last exposure (close contact with a person with SARS-CoV-2 infection) to the index case
- •Body weight < 100 kg (self-reported)
- •Access to device and internet for Telehealth visits
排除标准
- •Known hypersensitivity to HCQ or other 4-aminoquinoline compounds
- •Currently hospitalized
- •Symptomatic with subjective fever, cough, or sore throat
- •Current medications exclude concomitant use of HCQ
- •Concomitant use of other anti-malarial treatment or chemoprophylaxis
- •History of retinopathy of any etiology
- •Psoriasis
- •Porphyria
- •Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes < 1500) or thrombocytopenia (< 100 K)
- •Concomitant use of digoxin, cyclosporin, cimetidine, or tamoxifen
- •Known liver disease
- •Known long QT syndrome
- •Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of the study drugs, or planned use during the study period
研究组 & 干预措施
Ascorbic Acid
Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days
干预措施: Ascorbic Acid (Drug)
Hydroxychloroquine
Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days
干预措施: Hydroxychloroquine Sulfate (Drug)
结局指标
主要结局
The Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection
时间窗: Day 28 after enrolment
Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit
Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection
时间窗: Day 1 through Day 14 after enrolment
Polymerase chain reaction (PCR) confirmed severe acute respiratory syndrome coronavirus 2 of the genus Betacoronavirus (SARS-CoV-2) infection from self-collected samples collected daily for 14 days
次要结局
- Number of Participants Who Had COVID-19 Disease(28 days from enrolment)
- Rate of Participant-reported Adverse Events(28 days from start of Hydroxychloroquine therapy)
研究者
Ruanne Barnabas
Associate Professor, School of Medicine: Global Health
University of Washington