Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Trial (HERO-HCQ Trial), United States, 2020-2021

Severe acute respiratory syndrome coronavirus 2 associated disease (COVID-19) is caused by a novel betacoronavirus, SARS-CoV-2, that was first isolated in January 2020 and has since caused a global pandemic unseen in decades in cases and mortality. At the time of initial protocol submission in April 2020, human vaccine clinical trials had just begun and experts predicted that a vaccine would not be available until April 2021 at the earliest. Therefore, new measures remained needed to prevent the spread of disease. In vitro studies suggested a potential moderate antiviral effect of hydroxychloroquine (HCQ).
This study aimed to evaluate the efficacy of HCQ to prevent COVID-19 clinical infection and to prevent viral shedding of SARS-CoV-2 among healthcare workers (HCWs), as well as to evaluate the safety and tolerability of HCQ. Participants prescreened through the Healthcare Exposure Response and Outcomes (HERO) Registry across 34 U.S. clinical centers were randomly assigned to take a placebo (n=676) or HCQ (n=683) for 30 days, with in-person clinic visits at baseline and 30 days, and an end-of-study virtual visit at 60 days. This collection contains analysis (DS1 through DS6) and tabulation (DS7 through DS44) data and accompanying documentation.

严重急性呼吸综合征冠状病毒2型相关疾病（COVID-19）由新型β冠状病毒SARS-CoV-2引起，该病毒于2020年1月首次分离，自此引发了数十年来在感染病例与死亡规模上均前所未有的全球大流行。2020年4月研究方案首次提交之际，人类疫苗临床试验刚刚启动，专家预测疫苗最早仅能在2021年4月获批投入使用。因此，仍需探索新的疾病传播防控策略。体外研究显示，羟氯喹（hydroxychloroquine, HCQ）具备潜在的中等强度抗病毒活性。本研究旨在评估羟氯喹对医护人员（healthcare workers, HCWs）感染COVID-19的临床预防效果，以及阻断SARS-CoV-2病毒排毒的作用，同时评价羟氯喹的安全性与耐受性。本研究的受试者通过美国34家临床中心的医护暴露反应与结局（Healthcare Exposure Response and Outcomes, HERO）登记系统完成预筛选，随后被随机分配至安慰剂组（n=676）与羟氯喹组（n=683），干预周期为30天；受试者需在基线及第30天前往门诊接受线下访视，并于第60天完成研究结束后的线上随访。本数据集包含分析类数据（DS1至DS6）、制表类数据（DS7至DS44）及配套文档资料。