Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
BMJ Open. 2021 Jun 18;11(6):e046799. doi: 10.1136/bmjopen-2020-046799.
There is an urgent need to idenfy treatments for COVID-19 that reduce illness duration and hospital admission in those at higher risk of a longer illness course and complications.
The Platform Randomised trial of INterventions against COVID-19 In older peoPLE trial is an open-label, multiarm, prospective, adaptive platform, randomised clinical trial to evaluate potential treatments for COVID-19 in the community. A master protocol governs the addition of new interventions as they become available, as well as the inclusion and cessation of existing intervention arms via frequent interim analyses. The first three interventions are hydroxychloroquine, azithromycin and doxycycline. Eligible participants must be symptomatic in the community with possible or confirmed COVID-19 that started in the preceding 14 days and either (1) aged 65 years and over or (2) aged 50-64 years with comorbidities. Recruitment is through general practice, health service helplines, COVID-19 'hot hubs' and directly through the trial website. Participants are randomised to receive either usual care or a study drug plus usual care, and outcomes are collected via daily online symptom diary for 28 days from randomisation. The research team contacts participants and/or their study partner following days 7, 14 and 28 if the online diary is not completed. The trial has two coprimary endpoints: time to first self-report of feeling recovered from possible COVID-19 and hospital admission or death from possible COVID-19 infection, both within 28 days from randomisation. Prespecified interim analyses assess efficacy or futility of interventions and to modify randomisation probabilities that allocate more participants to interventions with better outcomes.
Ethical approval Ref: 20/SC/0158 South Central - Berkshire Research Ethics Committee; IRAS Project ID: 281958; EudraCT Number: 2020-001209-22. Results will be presented to policymakers and at conferences and published in peer-reviewed journals.
ISRCTN86534580.
迫切需要找到能够缩短病程和减少高危人群住院风险的 COVID-19 治疗方法。
Platform Randomised trial of INterventions against COVID-19 In older peoPLE 试验是一项开放标签、多臂、前瞻性、适应性平台、随机临床试验，旨在评估社区中 COVID-19 的潜在治疗方法。主方案规定了新干预措施的加入，以及通过频繁的中期分析纳入和停止现有的干预措施。前三种干预措施是羟氯喹、阿奇霉素和多西环素。符合条件的参与者必须在社区中有症状，且可能或确诊 COVID-19 发病时间在 14 天内，且（1）年龄在 65 岁及以上，或（2）年龄在 50-64 岁且有合并症。通过全科医生、卫生服务热线、COVID-19“热点中心”和直接通过试验网站招募参与者。参与者随机分配接受常规护理或研究药物加常规护理，从随机分组之日起 28 天内通过每日在线症状日记收集结果。如果在线日记未完成，研究团队将在第 7、14 和 28 天联系参与者及其研究伙伴。试验有两个主要终点：首次自我报告感觉从可能的 COVID-19 中康复的时间和随机分组后 28 天内因可能的 COVID-19 感染而住院或死亡的时间。预设的中期分析评估干预措施的疗效或无效性，并修改随机分配概率，将更多的参与者分配到疗效更好的干预措施中。
伦理批准参考号：20/SC/0158 南中英格兰-伯克郡研究伦理委员会；IRAS 项目 ID：281958；EudraCT 编号：2020-001209-22。结果将提交给决策者，并在会议上和发表在同行评议的期刊上。
ISRCTN86534580。
