Platform Randomised trial of INterventions against COVID-19 In older peoPLE (PRINCIPLE): protocol for a randomised, controlled, open-label, adaptive platform, trial of community treatment of COVID-19 syndromic illness in people at higher risk.
Platform Randomised trial of INterventions against COVID-19 In older peoPLE (PRINCIPLE): protocol for a randomised, controlled, open-label, adaptive platform, trial of community treatment of COVID-19 syndromic illness in people at higher risk.
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DOI：
10.1136/bmjopen-2020-046799
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发表时间：
2021-06-18
期刊：
影响因子：
2.9
通讯作者：
Hobbs FDR
中科院分区：
文献类型：
--
作者：
Hayward G;Butler CC;Yu LM;Saville BR;Berry N;Dorward J;Gbinigie O;van Hecke O;Ogburn E;Swayze H;Bongard E;Allen J;Tonner S;Rutter H;Tonkin-Crine S;Borek A;Judge D;Grabey J;de Lusignan S;Thomas NPB;Evans PH;Andersson MI;Llewelyn M;Patel M;Hopkins S;Hobbs FDR
目前迫切需要找到针对COVID-19的治疗方法，减少病程较长和并发症风险较高的患者的病程和住院时间。老年人COVID-19干预措施平台随机试验是一项开放标签、多组、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。一项总协议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干预手段。前三种干预措施是羟氯喹、阿奇霉素和强力霉素。符合条件的参与者必须在过去14天内出现可能或确诊的COVID-19症状，并且(1)年龄在65岁及以上，或(2)年龄在50-64岁之间并伴有合并症。招募通过全科医生、卫生服务热线、COVID-19“热点中心”和直接通过试验网站进行。参与者被随机分配接受常规治疗或研究药物加常规治疗，通过每日在线症状日记收集随机化后28天的结果。如果在线日记未完成，研究小组将在第7、14和28天联系参与者和/或他们的研究伙伴。该试验有两个主要终点：首次自我报告感觉从可能的COVID-19中恢复的时间，以及可能的COVID-19感染住院或死亡的时间，均在随机分组后的28天内。预先指定的中期分析评估干预措施的有效性或无效性，并修改随机化概率，将更多的参与者分配到具有更好结果的干预措施中。伦理批准编号：20/SC/0158 South Central - Berkshire Research Ethics Committee；IRAS项目编号：281958；稿号：2020-001209-22。研究结果将提交给决策者和会议，并在同行评议的期刊上发表。ISRCTN86534580。
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.
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