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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.
Hayward, Gail; Butler, Christopher C; Yu, Ly-Mee; Saville, Benjamin R; Berry, Nicholas; Dorward, Jienchi; Gbinigie, Oghenekome; van Hecke, Oliver; Ogburn, Emma; Swayze, Hannah; Bongard, Emily; Allen, Julie; Tonner, Sharon; Rutter, Heather; Tonkin-Crine, Sarah; Borek, Aleksandra; Judge, David; Grabey, Jenna; de Lusignan, Simon; Thomas, Nicholas P B; Evans, Philip H; Andersson, Monique I; Llewelyn, Martin; Patel, Mahendra; Hopkins, Susan; Hobbs, F D Richard.
  • Hayward G; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Butler CC; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK christopher.butler@phc.ox.ac.uk.
  • Yu LM; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Saville BR; Berry Consultants, Austin, Texas, USA.
  • Berry N; Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
  • Dorward J; Berry Consultants, Austin, Texas, USA.
  • Gbinigie O; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • van Hecke O; Centre for the Aids Programme of Research in South Africa, Durban, South Africa.
  • Ogburn E; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Swayze H; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Bongard E; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Allen J; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Tonner S; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Rutter H; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Tonkin-Crine S; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Borek A; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Judge D; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Grabey J; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • de Lusignan S; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Thomas NPB; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Evans PH; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Andersson MI; Department of Clinical and Experimental Medicine, University of Surrey, Guildford, UK.
  • Llewelyn M; Windrush Medical Practice, Witney, UK.
  • Patel M; Royal College of General Practitioners, London, UK.
  • Hopkins S; St Leonard's Research Practice, Exeter, UK.
  • Hobbs FDR; University of Exeter Medical School, Exeter, UK.
BMJ Open ; 11(6): e046799, 2021 06 18.
Article in English | MEDLINE | ID: covidwho-1276961
Semantic information from SemMedBD (by NLM)
1. COVID-19 PROCESS_OF Older people
Subject
COVID-19
Predicate
PROCESS_OF
Object
Older people
2. Intervention regimes TREATS Community
Subject
Intervention regimes
Predicate
TREATS
Object
Community
3. Intervention regimes TREATS Persons
Subject
Intervention regimes
Predicate
TREATS
Object
Persons
4. Therapeutic procedure TREATS COVID-19
Subject
Therapeutic procedure
Predicate
TREATS
Object
COVID-19
5. Hospital admission TREATS At higher risk
Subject
Hospital admission
Predicate
TREATS
Object
At higher risk
6. Intervention regimes TREATS COVID-19
Subject
Intervention regimes
Predicate
TREATS
Object
COVID-19
7. COVID-19 PROCESS_OF Community
Subject
COVID-19
Predicate
PROCESS_OF
Object
Community
8. Possible PROCESS_OF Community
Subject
Possible
Predicate
PROCESS_OF
Object
Community
9. COVID-19 PROCESS_OF Older people
Subject
COVID-19
Predicate
PROCESS_OF
Object
Older people
10. Intervention regimes TREATS Community
Subject
Intervention regimes
Predicate
TREATS
Object
Community
11. Intervention regimes TREATS Persons
Subject
Intervention regimes
Predicate
TREATS
Object
Persons
12. Therapeutic procedure TREATS COVID-19
Subject
Therapeutic procedure
Predicate
TREATS
Object
COVID-19
13. Hospital admission TREATS At higher risk
Subject
Hospital admission
Predicate
TREATS
Object
At higher risk
14. Intervention regimes TREATS COVID-19
Subject
Intervention regimes
Predicate
TREATS
Object
COVID-19
15. COVID-19 PROCESS_OF Community
Subject
COVID-19
Predicate
PROCESS_OF
Object
Community
16. Possible PROCESS_OF Community
Subject
Possible
Predicate
PROCESS_OF
Object
Community
ABSTRACT

INTRODUCTION:

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. 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.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Controlled clinical trial / Etiology study / Clinical Practice Guide / Observational study / Randomized controlled trials / Risk factors Topics: Long Covid Limits: Aged / Humans Language: English Journal: BMJ Open Year: 2021 Document Type: Article Affiliation country: Bmjopen-2020-046799

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Controlled clinical trial / Etiology study / Clinical Practice Guide / Observational study / Randomized controlled trials / Risk factors Topics: Long Covid Limits: Aged / Humans Language: English Journal: BMJ Open Year: 2021 Document Type: Article Affiliation country: Bmjopen-2020-046799