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
| العنوان: | 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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| المؤلفون: | Oliver van Hecke, Mahendra G Patel, Aleksandra J Borek, Gail Hayward, Jenna Grabey, Philip Evans, Benjamin R. Saville, Christopher C Butler, David Judge, Martin J. Llewelyn, Hannah Swayze, Simon de Lusignan, Sarah Tonkin-Crine, Monique Andersson, Ly-Mee Yu, Susan Hopkins, Nicholas P B Thomas, Jienchi Dorward, Emma Ogburn, Oghenekome Gbinigie, Julie Allen, Nicholas Berry, Emily Bongard, FD Richard Hobbs, Sharon Tonner, Heather Rutter |
| المصدر: | BMJ Open, Vol 11, Iss 6 (2021) BMJ Open |
| بيانات النشر: | BMJ Publishing Group, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | medicine.medical_specialty, media_common.quotation_subject, Psychological intervention, 030204 cardiovascular system & hematology, infectious diseases, 03 medical and health sciences, primary care, 0302 clinical medicine, Interim, Intervention (counseling), medicine, Humans, 030212 general & internal medicine, Prospective Studies, Prospective cohort study, media_common, Aged, Randomized Controlled Trials as Topic, Protocol (science), Research ethics, clinical trials, business.industry, SARS-CoV-2, COVID-19, General Medicine, Clinical trial, Treatment Outcome, Feeling, Physical therapy, Medicine, business, General practice / Family practice, Hydroxychloroquine |
| الوصف: | IntroductionThere 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.Methods and analysisThe 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.Ethics and disseminationEthical 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.Trial registration numberISRCTN86534580. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 2044-6055 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4daec3b8003426a19cb57ee7187e6baf https://bmjopen.bmj.com/content/11/6/e046799.full |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....4daec3b8003426a19cb57ee7187e6baf |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 20446055 |
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