BMJ Open (Aug 2023)
Platform adaptive trial of novel antivirals for early treatment of COVID-19 In the community (PANORAMIC): protocol for a randomised, controlled, open-label, adaptive platform trial of community novel antiviral treatment of COVID-19 in people at increased risk of more severe disease
- Najib Rahman,
- Andrew Carson-Stevens,
- Stavros Petrou,
- Judith Breuer,
- Paul Little,
- Melissa Dobson,
- Kerenza Hood,
- Jienchi Dorward,
- May Ee Png,
- Richard Hobbs,
- Gail Hayward,
- Mark Lown,
- Nigel Hart,
- Ly-Mee Yu,
- Nick Francis,
- Philip Evans,
- Oliver van Hecke,
- Julie Allen,
- Joseph F Standing,
- Emma Ogburn,
- Jennifer Davies,
- Christopher C Butler,
- Saye Khoo,
- Andrew Ustianowski,
- Victoria Harris,
- Bhautesh Jani,
- Jane Holmes,
- Heather Rutter,
- Oghenekome Gbinigie,
- Lucy Cureton,
- Sarah Barrett,
- Benjamin R Saville,
- Nicholas P B Thomas,
- Monique I Andersson,
- Mahendra Patel,
- Jonathan Nguyen-Van-Tam,
- Duncan Richards,
- Layla Lavallee,
- David M Lowe,
- Tracie-Ann Madden,
- Joe Marion,
- Jem Chalk,
- Elizabeth Hadley,
- Magdalena Benysek,
- Mona Koshkouei,
- Maria Coates,
- Clare Bateman,
- Ivy Raymundo-Wood
Affiliations
- Najib Rahman
- Oxford Respiratory Trials Unit, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
- Andrew Carson-Stevens
- Division of Population Medicine, Cardiff University, Cardiff, UK
- Stavros Petrou
- Nuffield Department of Primary Care Health Sciences, Oxford, UK
- Judith Breuer
- Institute of Child Health, University College London, London, UK
- Paul Little
- Primary Care Research Centre, Primary Care Population Sciences and Medical Education Unit, Faculty of Medicine, University of Southampton, Southampton, UK
- Melissa Dobson
- Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK
- Kerenza Hood
- Centre for Trials Research, Cardiff University, Cardiff, UK
- Jienchi Dorward
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- May Ee Png
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- Richard Hobbs
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- Gail Hayward
- 1 NIHR Community Healthcare MedTech and IVD Co-operative, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK
- Mark Lown
- Primary Care Population Sciences and Medical Education, University of Southampton School, Southampton, UK
- Nigel Hart
- School of Medicine, Dentistry and Biomedical Sciences - Centre for Public Health, Queen`s University Belfast, Belfast, UK
- Ly-Mee Yu
- Department of Primary Care Health Sciences, University of Oxford Nuffield, Oxford, UK
- Nick Francis
- Primary Care Research Centre, Faculty of Medicine, School of Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK
- Philip Evans
- consultant and associate professor
- Oliver van Hecke
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- Julie Allen
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- Joseph F Standing
- 7 Great Ormond Street Institute of Child Health, University College London, London, UK
- Emma Ogburn
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- Jennifer Davies
- consultant obstetrician and gynaecologist
- Christopher C Butler
- 4 Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- Saye Khoo
- Department of Pharmacology, University of Liverpool, Liverpool, UK
- Andrew Ustianowski
- clinical lead for the COVID Vaccine Research Programme
- Victoria Harris
- Foundation for Innovative New Diagnostics, Geneva, Switzerland
- Bhautesh Jani
- General Practice and Primary Care, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
- Jane Holmes
- Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
- Heather Rutter
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- Oghenekome Gbinigie
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- Lucy Cureton
- NDORMS, University of Oxford, Oxford, UK
- Sarah Barrett
- 2Umbrella Health, Birmingham, UK
- Benjamin R Saville
- Berry Consultants, Austin, Texas, USA
- Nicholas P B Thomas
- Windrush Medical Practice, Witney, UK
- Monique I Andersson
- Department of Microbiology, Oxford University Hospitals NHS Foundation Trust, Oxford, Oxfordshire, UK
- Mahendra Patel
- School of Pharmacy and Medical Sciences (Faculty of Life Sciences), University of Bradford, Bradford, UK
- Jonathan Nguyen-Van-Tam
- Population and Lifespan Health, University of Nottingham, Nottingham, UK
- Duncan Richards
- Oxford Clinical Trials Research Unit, Botnar Research Centre, University of Oxford, Oxford, UK
- Layla Lavallee
- research midwife
- David M Lowe
- Institute for Immunity and Transplantation, Divison of Infection and Immunity, University College London, London, UK
- Tracie-Ann Madden
- Centre for Trials Research, Cardiff University, Cardiff, UK
- Joe Marion
- Berry Consultants, Austin, Texas, USA
- Jem Chalk
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- Elizabeth Hadley
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- Magdalena Benysek
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- Mona Koshkouei
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- Maria Coates
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- Clare Bateman
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- Ivy Raymundo-Wood
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- DOI
- https://doi.org/10.1136/bmjopen-2022-069176
- Journal volume & issue
-
Vol. 13,
no. 8
Abstract
Introduction There is an urgent need to determine the safety, effectiveness and cost-effectiveness of novel antiviral treatments for COVID-19 in vaccinated patients in the community at increased risk of morbidity and mortality from COVID-19.Methods and analysis PANORAMIC is a UK-wide, open-label, prospective, adaptive, multiarm platform, randomised clinical trial that evaluates antiviral treatments for COVID-19 in the community. A master protocol governs the addition of new antiviral treatments as they become available, and the introduction and cessation of existing interventions via interim analyses. The first two interventions to be evaluated are molnupiravir (Lagevrio) and nirmatrelvir/ritonavir (Paxlovid). Eligibility criteria: community-dwelling within 5 days of onset of symptomatic COVID-19 (confirmed by PCR or lateral flow test), and either (1) aged 50 years and over, or (2) aged 18–49 years with qualifying comorbidities. Registration occurs via the trial website and by telephone. Recruitment occurs remotely through the central trial team, or in person through clinical sites. Participants are randomised to receive either usual care or a trial drug plus usual care. Outcomes are collected via a participant-completed daily electronic symptom diary for 28 days post randomisation. Participants and/or their Trial Partner are contacted by the research team after days 7, 14 and 28 if the diary is not completed, or if the participant is unable to access the diary. The primary efficacy endpoint is all-cause, non-elective hospitalisation and/or death within 28 days of randomisation. Multiple prespecified interim analyses allow interventions to be stopped for futility or superiority based on prespecified decision criteria. A prospective economic evaluation is embedded within the trial.Ethics and dissemination Ethical approval granted by South Central–Berkshire REC number: 21/SC/0393; IRAS project ID: 1004274. Results will be presented to policymakers and at conferences, and published in peer-reviewed journals.Trial registration number ISRCTN30448031; EudraCT number: 2021-005748-31.
