Gbinigie, O. et al. (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. BMJ Open, 13(8), e069176. (doi: 10.1136/bmjopen-2022-069176) (PMID:37550022) (PMCID:PMC10407406)
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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.
| Item Type: | Articles |
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| Additional Information: | This work is supported by the UKRI/NIHR, Grant number NIHR135366. Virology team members are partly supported by an MRC COVID modelling grant, Grant number MR/W015560/1. JD is funded by the Wellcome Trust PhD Programme for Primary Care Clinicians (216421/Z/19/Z). |
| Status: | Published |
| Refereed: | Yes |
| Glasgow Author(s) Enlighten ID: | Jani, Dr Bhautesh |
| Authors: | Gbinigie, O., Ogburn, E., Allen, J., Dorward, J., Dobson, M., Madden, T.-A., Yu, L.-M., Lowe, D. M., Rahman, N., Petrou, S., Richards, D., Hood, K., Patel, M., Saville, B. R., Marion, J., Holmes, J., Png, M. E., Hayward, G., Lown, M., Harris, V., Jani, B., Hart, N., Khoo, S., Rutter, H., Chalk, J., Standing, J. F., Breuer, J., Lavallee, L., Hadley, E., Cureton, L., Benysek, M., Andersson, M. I., Francis, N., Thomas, N. P. B., Evans, P., van Hecke, O., Koshkouei, M., Coates, M., Barrett, S., Bateman, C., Davies, J., Raymundo-Wood, I., Ustianowski, A., Nguyen-Van-Tam, J., Carson-Stevens, A., Hobbs, R., Little, P., and Butler, C. C. |
| College/School: | College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > General Practice and Primary Care |
| Journal Name: | BMJ Open |
| Publisher: | BMJ Publishing Group |
| ISSN: | 2044-6055 |
| ISSN (Online): | 2044-6055 |
| Copyright Holders: | Copyright © Author(s) (or their employer(s)) 2023 |
| First Published: | First published in BMJ Open 13(8):e069176 |
| Publisher Policy: | Reproduced under a Creative Commons licence |
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