Favipiravir for COVID-19 in adults in the community in PRINCIPLE, an open-label, randomised, controlled, adaptive platform trial of short- and longer-term outcomes
Fd Richard Hobbs, Oghenekome A Gbinigie, Milensu Shanyinde, Ly-Mee Yu, Victoria Harris, Jienchi Dorward, Gail Hayward, Benjamin R Saville, Nicholas S Berry, Philip H Evans, Nicholas Pb Thomas, Mahendra G Patel, Duncan Richards, Oliver Van Hecke, Michelle A Detry, Christina T Saunders, Mark Fitzgerald, Jared Robinson, Charlotte Latimer-Bell, Julie Allen, Emma Ogburn, Jenna Grabey, Simon De Lusignan, Monique Andersson, Paul Little, Christopher C Butler
Journal of Infection, doi:10.1016/j.jinf.2024.106248
Background Evidence for the effect of favipiravir treatment of acute COVID-19 on recovery, hospital admissions and longer-term outcomes in community settings is limited.
Methods In this multicentre. open-label, multi-arm, adaptive platform randomised controlled trial participants aged ≥18 years in the community with a positive test for SARS-CoV-2 and symptoms lasting ≤14 days were randomised to: usual care; usual care plus favipiravir tablets (loading dose of 3600 mg in divided doses on day one, then 800 mg twice a day for four days); or, usual care plus other interventions. Co-primary endpoints were time to first selfreported recovery and hospitalisation/death related to COVID-19, within 28 days, analysed using Bayesian models. Recovery at six months was the primary longer-term outcome. Trial registration: ISRCTN86534580.
writing group critically revised the manuscript. The members of the PRINCIPLE Collaborative Group and their roles in the conduct of the trial are listed in the appendix.
Conflict of Interest statement Drs. Saville, Berry, Detry, Fitzgerald and Saunders report grants from The University of Oxford, for the Sponsor's grant from the UK NIHR, for statistical design and analyses for the
J o u r n a l P r e -p r o o f
Declaration of interests The authors declare the following financial interests/personal relationships which may be considered
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