The World Health Organization declared the outbreak of SARS-CoV-2 a pandemic on February 11, 2020. This organism causes COVID-19 disease and the rapid rise in cases and geographic spread strained healthcare systems. Clinical research trials were hindered by infection control measures discouraging physical contact and diversion of resources to meet emergent requirements. The need for effective treatment and prevention of COVID-19 prompted an untested investigational response. Trial groups adapted approaches using remote enrolment and consenting, newly developed diagnostic tests, delivery of study medications and devices to participants’ homes, and remote monitoring to ensure investigator/enrollee safety while preserving ethical integrity, confidentiality, and data accuracy. Clinical researchers at our community health system in the USA undertook an outpatient randomized open-label study of hydroxychloroquine (HCQ) prophylaxis versus observation of SARS-CoV-2 infection in household COVID-19 contacts. Designed in March 2020, challenges included COVID-19 infection in the research group, HCQ shortage, and lack of well-established home SARS-CoV-2 tests and remote ECG monitoring protocols in populations naive to these procedures. The study was written, funded, and received ethical committee approval in 4 months and was completed by September 2020 during a period of fluctuating infection rates and conflicting political opinions on HCQ use; results have been published. Singular methodology included the use of a new RNA PCR saliva SARS-CoV-2 home diagnostic test and a remote smartphone-based 6-lead ECG recording system. Of 483 households contacted regarding trial participation, 209 (43.3%) did not respond to telephone calls/e-mails and 90 (18.6%) declined; others were not eligible by inclusion or exclusion criteria. Ultimately, 54 individuals were enrolled and 42 completed the study. Numbers were too small to determine the efficacy of HCQ prophylaxis. No serious treatment-related adverse events were encountered. Flexibility in design, a multidisciplinary research team, prompt cooperation among research, funding, ethics review groups, and finding innovative study approaches enabled this work. Concerns were balancing study recruitment against unduly influencing individuals anxious for protection from the pandemic and exclusion of groups based on lack of Internet access and technology. An issue to address going forward is establishing research cooperation across community health systems before emergencies develop. ClinicalTrials.gov NCT04652648 . Registered on December 3, 2020.

中文翻译：

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未来就是现在：我们在 COVID-19 大流行初期开始远程临床试验的经验

世界卫生组织于 2020 年 2 月 11 日宣布 SARS-CoV-2 的爆发为大流行病。这种生物导致 COVID-19 疾病以及病例和地理传播的迅速增加，使医疗保健系统紧张。临床研究试验受到感染控制措施的阻碍，这些措施不鼓励身体接触和转移资源以满足紧急需求。有效治疗和预防 COVID-19 的需要促使了未经检验的研究反应。试验组采用远程注册和同意、新开发的诊断测试、将研究药物和设备运送到参与者家中以及远程监控来调整方法，以确保研究人员/参与者的安全，同时保持道德完整性、保密性和数据准确性。我们美国社区卫生系统的临床研究人员进行了一项关于羟氯喹 (HCQ) 预防与观察家庭 COVID-19 接触者中 SARS-CoV-2 感染的门诊随机开放标签研究。设计于 2020 年 3 月，挑战包括研究小组中的 COVID-19 感染、HCQ 短缺以及缺乏完善的家用 SARS-CoV-2 测试和远程心电图监测协议，这些程序对这些程序不了解。该研究在 4 个月内编写、资助并获得伦理委员会批准，并于 2020 年 9 月在感染率波动和对 HCQ 使用的政治观点相互冲突期间完成；结果已经公布。单一方法包括使用新的 RNA PCR 唾液 SARS-CoV-2 家庭诊断测试和基于远程智能手机的 6 导联心电图记录系统。在就试验参与问题联系的 483 户家庭中，209 户（43.3%）没有回复电话/电子邮件，90 户（18.6%）拒绝回复；其他人不符合纳入或排除标准。最终，有 54 人被招募，42 人完成了研究。数量太少，无法确定 HCQ 预防的功效。没有遇到严重的治疗相关不良事件。设计的灵活性、多学科研究团队、研究、资助、伦理审查小组之间的迅速合作以及寻找创新的研究方法使这项工作成为可能。令人担忧的是，在研究招募与过度影响个人之间取得平衡，这些个人急于保护自己免受大流行的影响，以及因缺乏互联网访问和技术而被排除在外。未来需要解决的一个问题是在突发事件发生之前建立跨社区卫生系统的研究合作。ClinicalTrials.gov NCT04652648。2020 年 12 月 3 日注册。