Evidence map›Paper›PMID 34145016›Full record

ArticleBMJ open2021

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.

Gail Hayward, Christopher C Butler, Ly-Mee Yu, Benjamin R Saville, Nicholas Berry, Jienchi Dorward, Oghenekome Gbinigie, Oliver van Hecke, Emma Ogburn, Hannah Swayze and 16 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
5.9field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. Pooled it
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  7. Precision Prevention Studies: A Targeted Approach to Cancer Prevention.Cancer prevention research (Philadelphia, Pa.) · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors at 9 institutions in 3 countries.

Gail HaywardNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.ORCID 0000-0003-0852-627X
Christopher C ButlerNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK christopher.butler@phc.ox.ac.uk.ORCID 0000-0002-0102-3453
Ly-Mee YuNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Benjamin R SavilleBerry Consultants, Austin, Texas, USA.
Nicholas BerryBerry Consultants, Austin, Texas, USA.
Jienchi DorwardNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.ORCID 0000-0001-6072-1430
Oghenekome GbinigieNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.ORCID 0000-0002-2963-4491
Oliver van HeckeNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Emma OgburnNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Hannah SwayzeNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Emily BongardNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.ORCID 0000-0001-5957-6280
Julie AllenNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Sharon TonnerNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Heather RutterNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Sarah Tonkin-CrineNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Aleksandra BorekNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.ORCID 0000-0001-6029-5291
David JudgeNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Jenna GrabeyNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Simon de LusignanNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.ORCID 0000-0001-5613-6810
Nicholas P B ThomasWindrush Medical Practice, Witney, UK.
Philip H EvansSt Leonard's Research Practice, Exeter, UK.
Monique I AnderssonNuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.
Martin LlewelynDepartment of Microbiology and Infection, University Hospitals Sussex NHS Foundation Trust, Brighton, UK.
Mahendra PatelNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Susan HopkinsPublic Health England, London, UK.ORCID 0000-0001-5179-5702
F D Richard HobbsNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
University of Oxford · GBBerry & Associates (United States) · USBrighton and Sussex Medical School · GBCentre for the AIDS Programme of Research in South Africa · ZAPublic Health England · GBRoyal College of General Practitioners · GBUniversity of Exeter · GBUniversity of Surrey · GBVanderbilt University · US

Funding

Medical Research Council MC_PC_19079Wellcome Trust
6 · The paper itself

Abstract

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 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: ISRCTN86534580.

Indexed as

COVID-19Adaptive Clinical Trials as TopicAgedHumansHydroxychloroquineProspective StudiesRandomized Controlled Trials as TopicSARS-CoV-2Treatment OutcomeHydroxychloroquineclinical trialsCOVID-19infectious diseasesprimary care

Identifiers

PMID34145016
PMCPMC8214989
OpenAlexW3170964438

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.