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Randomized controlled trial of molnupiravir SARS-CoV-2 viral and antibody response in at-risk adult outpatients.
Standing, Joseph F; Buggiotti, Laura; Guerra-Assuncao, Jose Afonso; Woodall, Maximillian; Ellis, Samuel; Agyeman, Akosua A; Miller, Charles; Okechukwu, Mercy; Kirkpatrick, Emily; Jacobs, Amy I; Williams, Charlotte A; Roy, Sunando; Martin-Bernal, Luz M; Williams, Rachel; Smith, Claire M; Sanderson, Theo; Ashford, Fiona B; Emmanuel, Beena; Afzal, Zaheer M; Shields, Adrian; Richter, Alex G; Dorward, Jienchi; Gbinigie, Oghenekome; Van Hecke, Oliver; Lown, Mark; Francis, Nick; Jani, Bhautesh; Richards, Duncan B; Rahman, Najib M; Yu, Ly-Mee; Thomas, Nicholas P B; Hart, Nigel D; Evans, Philip; Andersson, Monique; Hayward, Gail; Hood, Kerenza; Nguyen-Van-Tam, Jonathan S; Little, Paul; Hobbs, F D Richard; Khoo, Saye; Butler, Christopher; Lowe, David M; Breuer, Judith.
Afiliação
  • Standing JF; Infection, Immunity and Inflammation, Great Ormond Street Institute of Child Health, University College London, London, UK. j.standing@ucl.ac.uk.
  • Buggiotti L; Great Ormond Street Hospital for Children NHS Trust, London, UK. j.standing@ucl.ac.uk.
  • Guerra-Assuncao JA; Infection, Immunity and Inflammation, Great Ormond Street Institute of Child Health, University College London, London, UK.
  • Woodall M; Infection, Immunity and Inflammation, Great Ormond Street Institute of Child Health, University College London, London, UK.
  • Ellis S; Infection, Immunity and Inflammation, Great Ormond Street Institute of Child Health, University College London, London, UK.
  • Agyeman AA; Infection, Immunity and Inflammation, Great Ormond Street Institute of Child Health, University College London, London, UK.
  • Miller C; Infection, Immunity and Inflammation, Great Ormond Street Institute of Child Health, University College London, London, UK.
  • Okechukwu M; Great Ormond Street Hospital for Children NHS Trust, London, UK.
  • Kirkpatrick E; Infection, Immunity and Inflammation, Great Ormond Street Institute of Child Health, University College London, London, UK.
  • Jacobs AI; Infection, Immunity and Inflammation, Great Ormond Street Institute of Child Health, University College London, London, UK.
  • Williams CA; Infection, Immunity and Inflammation, Great Ormond Street Institute of Child Health, University College London, London, UK.
  • Roy S; Genetics and Genomic Medicine Department, Great Ormond Street Institute of Child Health, University College London, London, UK.
  • Martin-Bernal LM; Genetics and Genomic Medicine Department, Great Ormond Street Institute of Child Health, University College London, London, UK.
  • Williams R; Genetics and Genomic Medicine Department, Great Ormond Street Institute of Child Health, University College London, London, UK.
  • Smith CM; Genetics and Genomic Medicine Department, Great Ormond Street Institute of Child Health, University College London, London, UK.
  • Sanderson T; Infection, Immunity and Inflammation, Great Ormond Street Institute of Child Health, University College London, London, UK.
  • Ashford FB; Francis Crick Institute, London, UK.
  • Emmanuel B; Clinical Immunology Service, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.
  • Afzal ZM; Clinical Immunology Service, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.
  • Shields A; Clinical Immunology Service, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.
  • Richter AG; Clinical Immunology Service, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.
  • Dorward J; Clinical Immunology Service, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.
  • Gbinigie O; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Van Hecke O; Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa.
  • Lown M; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Francis N; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Jani B; Primary Care Research Centre, University of Southampton, Southampton, UK.
  • Richards DB; Primary Care Research Centre, University of Southampton, Southampton, UK.
  • Rahman NM; School of Health and Wellbeing, University of Glasgow, Glasgow, UK.
  • Yu LM; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
  • Thomas NPB; Respiratory Trials Unit and Oxford NIHR Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Hart ND; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Evans P; Windrush Medical Practice, Witney, UK.
  • Andersson M; School of Medicine, Dentistry and Biomedical Sciences. Queen's University Belfast, Belfast, UK.
  • Hayward G; APEx (Exeter Collaboration for Academic Primary Care), University of Exeter Medical School, Exeter, UK.
  • Hood K; National Institute of Health and Care Research, Clinical Research Network, University of Leeds, Leeds, UK.
  • Nguyen-Van-Tam JS; Radcliffe Department of Medicine, University of Oxford, Oxford, UK.
  • Little P; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Hobbs FDR; Centre for Trials Research, Cardiff University, Wales, UK.
  • Khoo S; Lifespan and Population Health, University of Nottingham School of Medicine, Nottingham, UK.
  • Butler C; Primary Care Research Centre, University of Southampton, Southampton, UK.
  • Lowe DM; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Breuer J; Department of Pharmacology, University of Liverpool and Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.
Nat Commun ; 15(1): 1652, 2024 Feb 23.
Article em En | MEDLINE | ID: mdl-38396069
ABSTRACT
Viral clearance, antibody response and the mutagenic effect of molnupiravir has not been elucidated in at-risk populations. Non-hospitalised participants within 5 days of SARS-CoV-2 symptoms randomised to receive molnupiravir (n = 253) or Usual Care (n = 324) were recruited to study viral and antibody dynamics and the effect of molnupiravir on viral whole genome sequence from 1437 viral genomes. Molnupiravir accelerates viral load decline, but virus is detectable by Day 5 in most cases. At Day 14 (9 days post-treatment), molnupiravir is associated with significantly higher viral persistence and significantly lower anti-SARS-CoV-2 spike antibody titres compared to Usual Care. Serial sequencing reveals increased mutagenesis with molnupiravir treatment. Persistence of detectable viral RNA at Day 14 in the molnupiravir group is associated with higher transition mutations following treatment cessation. Viral viability at Day 14 is similar in both groups with post-molnupiravir treated samples cultured up to 9 days post cessation of treatment. The current 5-day molnupiravir course is too short. Longer courses should be tested to reduce the risk of potentially transmissible molnupiravir-mutated variants being generated. Trial registration ISRCTN30448031.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Citidina / SARS-CoV-2 / COVID-19 / Hidroxilaminas Limite: Adult / Humans Idioma: En Ano de publicação: 2024 Tipo de documento: Article
Texto completo
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Citidina / SARS-CoV-2 / COVID-19 / Hidroxilaminas Limite: Adult / Humans Idioma: En Ano de publicação: 2024 Tipo de documento: Article