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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
journal contribution
posted on 2023-06-10, 00:56 authored by Gail Hayward, Christopher C Butler, Ly-Mee Yu, Benjamin R Saville, Nicholas Berry, Jienchi Dorward, Oghenekome Gbinigie, Oliver Van Hecke, Emma Ogburn, Hannah Swayze, Emily Bongard, Julie Allen, Sharon Tonner, Heather Rutter, Martin LlewelynMartin Llewelyn, othersIntroduction: 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. Methods and analysis: 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.
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Publication status
- Published
File Version
- Published version
Journal
BMJ OpenISSN
2044-6055Publisher
BMJ Publishing GroupExternal DOI
Issue
6Volume
11Page range
1-9Article number
a046799Event location
EnglandDepartment affiliated with
- Global Health and Infection Publications
Full text available
- Yes
Peer reviewed?
- Yes
Legacy Posted Date
2021-09-10First Open Access (FOA) Date
2021-09-10First Compliant Deposit (FCD) Date
2021-09-10Usage metrics
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