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Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform-adaptive randomised controlled trial.
Butler, Christopher C; Hobbs, F D Richard; Gbinigie, Oghenekome A; Rahman, Najib M; Hayward, Gail; Richards, Duncan B; Dorward, Jienchi; Lowe, David M; Standing, Joseph F; Breuer, Judith; Khoo, Saye; Petrou, Stavros; Hood, Kerenza; Nguyen-Van-Tam, Jonathan S; Patel, Mahendra G; Saville, Benjamin R; Marion, Joe; Ogburn, Emma; Allen, Julie; Rutter, Heather; Francis, Nick; Thomas, Nicholas P B; Evans, Philip; Dobson, Melissa; Madden, Tracie-Ann; Holmes, Jane; Harris, Victoria; Png, May Ee; Lown, Mark; van Hecke, Oliver; Detry, Michelle A; Saunders, Christina T; Fitzgerald, Mark; Berry, Nicholas S; Mwandigha, Lazaro; Galal, Ushma; Mort, Sam; Jani, Bhautesh D; Hart, Nigel D; Ahmed, Haroon; Butler, Daniel; McKenna, Micheal; Chalk, Jem; Lavallee, Layla; Hadley, Elizabeth; Cureton, Lucy; Benysek, Magdalena; Andersson, Monique; Coates, Maria; Barrett, Sarah.
Afiliação
  • Butler CC; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK. Electronic address: christopher.butler@phc.ox.ac.uk.
  • Hobbs FDR; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Gbinigie OA; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Rahman NM; Oxford Respiratory Trials Unit, Nuffield Department of Medicine, University of Oxford, Oxford, UK; Chinese Academy of Medical Sciences Oxford Institute, University of Oxford, Oxford, UK; Oxford National Institute for Health and Care Research Biomedical Research Centre, Oxford, UK.
  • Hayward G; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Richards DB; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
  • Dorward J; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa.
  • Lowe DM; Institute of Immunity and Transplantation, University College London, London, UK.
  • Standing JF; Infection, Inflammation and Immunology, UCL Great Ormond Street Institute of Child Health, London, UK; Department of Pharmacy, Great Ormond Street Hospital for Children, London, UK.
  • Breuer J; Infection, Inflammation and Immunology, UCL Great Ormond Street Institute of Child Health, London, UK.
  • Khoo S; Department of Pharmacology, University of Liverpool, Liverpool, UK.
  • Petrou S; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Hood K; Centre for Trials Research, Cardiff University, Cardiff, UK.
  • Nguyen-Van-Tam JS; Lifespan and Population Health Unit, University of Nottingham School of Medicine, Nottingham, UK.
  • Patel MG; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Saville BR; Berry Consultants, Austin, TX, USA; Department of Biostatistics, Vanderbilt School of Medicine, Nashville, TN, USA.
  • Marion J; Berry Consultants, Austin, TX, USA.
  • 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.
  • Rutter H; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Francis N; Primary Care Research Centre, University of Southampton, Southampton, UK.
  • Thomas NPB; Windrush Medical Practice, Witney, UK; National Institute for Health and Care Research Clinical Research Network: Thames Valley and South Midlands, Oxford, UK; Royal College of General Practitioners, London, UK.
  • Evans P; Faculty of Health and Life Sciences, University of Exeter, Exeter, UK; National Institute for Health and Care Research Clinical Research Network, Leeds, UK.
  • Dobson M; Oxford Respiratory Trials Unit, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Madden TA; Centre for Trials Research, Cardiff University, Cardiff, UK.
  • Holmes J; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Harris V; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Png ME; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Lown M; Primary Care Research Centre, University of Southampton, Southampton, UK.
  • van Hecke O; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Detry MA; Berry Consultants, Austin, TX, USA.
  • Saunders CT; Berry Consultants, Austin, TX, USA.
  • Fitzgerald M; Berry Consultants, Austin, TX, USA.
  • Berry NS; Berry Consultants, Austin, TX, USA.
  • Mwandigha L; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Galal U; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Mort S; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Jani BD; General Practice and Primary Care, School of Health and Wellbeing, College of Medical, Veterinary & Life Sciences, University of Glasgow, Glasgow, UK.
  • Hart ND; School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.
  • Ahmed H; Division of Population Medicine, Cardiff University, Cardiff, UK.
  • Butler D; School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.
  • McKenna M; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Chalk J; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, 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; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Benysek M; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Andersson M; Department of Microbiology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
  • Coates M; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Barrett S; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Lancet ; 401(10373): 281-293, 2023 01 28.
Article em En | MEDLINE | ID: mdl-36566761
BACKGROUND: The safety, effectiveness, and cost-effectiveness of molnupiravir, an oral antiviral medication for SARS-CoV-2, has not been established in vaccinated patients in the community at increased risk of morbidity and mortality from COVID-19. We aimed to establish whether the addition of molnupiravir to usual care reduced hospital admissions and deaths associated with COVID-19 in this population. METHODS: PANORAMIC was a UK-based, national, multicentre, open-label, multigroup, prospective, platform adaptive randomised controlled trial. Eligible participants were aged 50 years or older-or aged 18 years or older with relevant comorbidities-and had been unwell with confirmed COVID-19 for 5 days or fewer in the community. Participants were randomly assigned (1:1) to receive 800 mg molnupiravir twice daily for 5 days plus usual care or usual care only. A secure, web-based system (Spinnaker) was used for randomisation, which was stratified by age (<50 years vs ≥50 years) and vaccination status (yes vs no). COVID-19 outcomes were tracked via a self-completed online daily diary for 28 days after randomisation. The primary outcome was all-cause hospitalisation or death within 28 days of randomisation, which was analysed using Bayesian models in all eligible participants who were randomly assigned. This trial is registered with ISRCTN, number 30448031. FINDINGS: Between Dec 8, 2021, and April 27, 2022, 26 411 participants were randomly assigned, 12 821 to molnupiravir plus usual care, 12 962 to usual care alone, and 628 to other treatment groups (which will be reported separately). 12 529 participants from the molnupiravir plus usual care group, and 12 525 from the usual care group were included in the primary analysis population. The mean age of the population was 56·6 years (SD 12·6), and 24 290 (94%) of 25 708 participants had had at least three doses of a SARS-CoV-2 vaccine. Hospitalisations or deaths were recorded in 105 (1%) of 12 529 participants in the molnupiravir plus usual care group versus 98 (1%) of 12 525 in the usual care group (adjusted odds ratio 1·06 [95% Bayesian credible interval 0·81-1·41]; probability of superiority 0·33). There was no evidence of treatment interaction between subgroups. Serious adverse events were recorded for 50 (0·4%) of 12 774 participants in the molnupiravir plus usual care group and for 45 (0·3%) of 12 934 in the usual care group. None of these events were judged to be related to molnupiravir. INTERPRETATION: Molnupiravir did not reduce the frequency of COVID-19-associated hospitalisations or death among high-risk vaccinated adults in the community. FUNDING: UK National Institute for Health and Care Research.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: COVID-19 Tipo de estudo: Clinical_trials / Etiology_studies / Prognostic_studies / Risk_factors_studies Limite: Adult / Humans / Middle aged Idioma: En Revista: Lancet Ano de publicação: 2023 Tipo de documento: Article País de publicação: Reino Unido
Texto completo
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: COVID-19 Tipo de estudo: Clinical_trials / Etiology_studies / Prognostic_studies / Risk_factors_studies Limite: Adult / Humans / Middle aged Idioma: En Revista: Lancet Ano de publicação: 2023 Tipo de documento: Article País de publicação: Reino Unido