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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.
Gbinigie, Oghenekome; Ogburn, Emma; Allen, Julie; Dorward, Jienchi; Dobson, Melissa; Madden, Tracie-Ann; Yu, Ly-Mee; Lowe, David M; Rahman, Najib; Petrou, Stavros; Richards, Duncan; Hood, Kerenza; Patel, Mahendra; Saville, Benjamin R; Marion, Joe; Holmes, Jane; Png, May Ee; Hayward, Gail; Lown, Mark; Harris, Victoria; Jani, Bhautesh; Hart, Nigel; Khoo, Saye; Rutter, Heather; Chalk, Jem; Standing, Joseph F; Breuer, Judith; Lavallee, Layla; Hadley, Elizabeth; Cureton, Lucy; Benysek, Magdalena; Andersson, Monique I; Francis, Nick; Thomas, Nicholas P B; Evans, Philip; van Hecke, Oliver; Koshkouei, Mona; Coates, Maria; Barrett, Sarah; Bateman, Clare; Davies, Jennifer; Raymundo-Wood, Ivy; Ustianowski, Andrew; Nguyen-Van-Tam, Jonathan; Carson-Stevens, Andrew; Hobbs, Richard; Little, Paul; Butler, Christopher C.
Affiliation
  • Gbinigie O; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Ogburn 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.
  • Dorward J; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Dobson M; Centre for the Aids Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa.
  • Madden TA; Nuffield Department of Medicine, Oxford Respiratory Trials Unit, Oxford, UK.
  • Yu LM; Centre for Trials Research, Cardiff University, Cardiff, UK.
  • Lowe DM; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Rahman N; University College London, Institute of Immunity and Transplantation, London, UK.
  • Petrou S; Nuffield Department of Medicine, Oxford Respiratory Trials Unit, Oxford, UK.
  • Richards D; NIHR Oxford Biomedical Research Centre, Oxford, UK.
  • Hood K; Chinese Academy of Medicine Oxford Institute, University of Oxford, Oxford, UK.
  • Patel M; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Saville BR; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.
  • Marion J; Centre for Trials Research, Cardiff University, Cardiff, UK.
  • Holmes J; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Png ME; Berry Consultants, Austin, Texas, USA.
  • Hayward G; Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
  • Lown M; Berry Consultants, Austin, Texas, USA.
  • Harris V; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Jani B; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Hart N; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Khoo S; Primary Care Research Centre, University of Southampton, Southampton, UK.
  • Rutter H; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Chalk J; General Practice and Primary Care, School of Health and Wellbeing, MVLS, University of Glasgow, Glasgow, UK.
  • Standing JF; School of Medicine, Dentistry and Biomedical Sciences - Centre for Public Health, Queen's University Belfast, Belfast, UK.
  • Breuer J; Department of Pharmacology, University of Liverpool, Liverpool, UK.
  • Lavallee L; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Hadley E; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Cureton L; Infection Inflammation and Immunology, UCL Great Ormond Street Institute of Child Health Population Policy and Practice, London, UK.
  • Benysek M; Department of Pharmacy, Great Ormond Street Hospital for Children, London, UK.
  • Andersson MI; Infection Inflammation and Immunology, UCL Great Ormond Street Institute of Child Health Population Policy and Practice, London, UK.
  • Francis N; 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 P; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • van Hecke O; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Koshkouei M; Department of Microbiology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
  • Coates M; Primary Care Research Centre, University of Southampton, Southampton, UK.
  • Barrett S; Windrush Medical Practice, Witney, UK.
  • Bateman C; Thames Valley and South Midlands Clinical Research Network, National Institute for Health and Care Research, Oxford, UK.
  • Davies J; Royal College of General Practitioners, London, UK.
  • Raymundo-Wood I; Faculty of Health and Life Sciences, University of Exeter, Exeter, UK.
  • Ustianowski A; National Institute for Health Research Clinical Research Network, London, UK.
  • Nguyen-Van-Tam J; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Carson-Stevens A; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Hobbs R; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Little P; 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.
BMJ Open ; 13(8): e069176, 2023 08 07.
Article in En | MEDLINE | ID: mdl-37550022
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.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: COVID-19 Type of study: Clinical_trials / Etiology_studies / Guideline / Observational_studies / Prognostic_studies / Risk_factors_studies Aspects: Ethics Limits: Aged / Humans / Middle aged Language: En Journal: BMJ Open Year: 2023 Document type: Article Affiliation country: Reino Unido
Fulltext
Add to My VHL
Print
XML
PubMed Links
Search on Google

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: COVID-19 Type of study: Clinical_trials / Etiology_studies / Guideline / Observational_studies / Prognostic_studies / Risk_factors_studies Aspects: Ethics Limits: Aged / Humans / Middle aged Language: En Journal: BMJ Open Year: 2023 Document type: Article Affiliation country: Reino Unido