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
Year: 2023
Type: article
Study design: Study Protocol
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.
Source: BMJ Open
Authors: Oghenekome Gbinigie, Emma Ogburn, Julie Allen, Jienchi Dorward, Melissa Dobson, Tracie-Ann Madden, Ly-Mee Yu, David M Lowe, Najib Rahman, Stavros Petrou, Duncan Richards, Kerenza Hood, Mahendra Patel, Benjamin R Saville, Joe Marion, Jane Holmes, May Ee Png, Gail Hayward, Mark Lown, Victoria Harris, Bhautesh Jani, Nigel Hart, Saye Khoo, Heather Rutter, Jem Chalk, Joseph F Standing, Judith Breuer, Layla Lavallee, Elizabeth Hadley, Lucy Cureton, Magdalena Benysek, Monique I Andersson, Nick Francis, Nicholas P B Thomas, Philip Evans, Oliver van Hecke, Mona Koshkouei, Maria Coates, Sarah Barrett, Clare Bateman, Jennifer Davies, Ivy Raymundo-Wood, Andrew Ustianowski, Jonathan Nguyen-Van-Tam, Andrew Carson-Stevens, Richard Hobbs, Paul Little, Christopher C Butler
Institutions: University of Oxford, Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Cardiff University, University College London, NIHR Oxford Biomedical Research Centre, Berry Consultants, LLC (United States), Vanderbilt University Medical Center, University of Southampton, University of Glasgow, Queen's University Belfast, University of Liverpool, Great Ormond Street Hospital, Oxford University Hospitals NHS Trust, National Institute for Health and Care Research, Clinical Research Network Thames Valley and South Midlands, Royal College of General Practitioners, University of Exeter, North Manchester General Hospital, University of Nottingham
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,839
Funders: Wellcome Trust, Health and Care Research Wales, UK Research and Innovation, National Institute for Health Research Health Protection Research Unit, Cancer Research UK, National Institute for Health and Care Research, Public Health Agency, Medical Research Council, National Institute for Health and Care Research Applied Research Collaboration Oxford and Thames Valley
Awards: Point-of-care viral load testing to enhance primary care HIV services in South Africa, NIHR Development and Skills Enhancement Award, Platform Adaptive trial of NOvel antiviRals for eArly treatMent of COVID-19 In the Community (PANORAMIC), MICA: Pharmacokinetic/Pharmacodynamic (PKPD) Model Development to Inform SARS-CoV-2 Antiviral Development, G5365565055, Point-of-care viral load testing to enhance primary care HIV services in South Africa, G6196811712, NIHR Senior Investigator Award, Mathematical and Statistical Modelling to Optimise Paediatric Medicines Research, G8415457339, NIHR Senior Investigator Award, Improving the Diagnosis of Recurrent Urinary Tract Infection in Primary Care
OpenAlex ID: W4385622189