Randomized controlled trial of molnupiravir SARS-CoV-2 viral and antibody response in at-risk adult outpatients

Joseph F. Standing (), Laura Buggiotti, Jose Afonso Guerra-Assuncao, Maximillian Woodall, Samuel Ellis, Akosua A. Agyeman, Charles Miller, Mercy Okechukwu, Emily Kirkpatrick, Amy I. Jacobs, Charlotte A. Williams, Sunando Roy, Luz M. Martin-Bernal, Rachel Williams, Claire M. Smith, Theo Sanderson, Fiona B. Ashford, Beena Emmanuel, Zaheer M. Afzal, Adrian Shields, Alex G. Richter, Jienchi Dorward, Oghenekome Gbinigie, Oliver Hecke, Mark Lown, Nick Francis, Bhautesh Jani, Duncan B. Richards, Najib M. Rahman, Ly-Mee Yu, Nicholas P. B. Thomas, Nigel D. Hart, Philip Evans, Monique Andersson, Gail Hayward, Kerenza Hood, Jonathan S. Nguyen- Van-Tam, Paul Little, F. D. Richard Hobbs, Saye Khoo, Christopher Butler, David M. Lowe and Judith Breuer
Additional contact information
Joseph F. Standing: University College London
Laura Buggiotti: University College London
Jose Afonso Guerra-Assuncao: University College London
Maximillian Woodall: University College London
Samuel Ellis: University College London
Akosua A. Agyeman: University College London
Charles Miller: Great Ormond Street Hospital for Children NHS Trust
Mercy Okechukwu: University College London
Emily Kirkpatrick: University College London
Amy I. Jacobs: University College London
Charlotte A. Williams: University College London
Sunando Roy: University College London
Luz M. Martin-Bernal: University College London
Rachel Williams: University College London
Claire M. Smith: University College London
Theo Sanderson: Francis Crick Institute
Fiona B. Ashford: University of Birmingham
Beena Emmanuel: University of Birmingham
Zaheer M. Afzal: University of Birmingham
Adrian Shields: University of Birmingham
Alex G. Richter: University of Birmingham
Jienchi Dorward: University of Oxford
Oghenekome Gbinigie: University of Oxford
Oliver Hecke: University of Oxford
Mark Lown: University of Southampton
Nick Francis: University of Southampton
Bhautesh Jani: University of Glasgow
Duncan B. Richards: University of Oxford
Najib M. Rahman: University of Oxford
Ly-Mee Yu: University of Oxford
Nicholas P. B. Thomas: Windrush Medical Practice
Nigel D. Hart: Dentistry and Biomedical Sciences. Queen’s University Belfast
Philip Evans: University of Exeter Medical School
Monique Andersson: Radcliffe Department of Medicine, University of Oxford
Gail Hayward: University of Oxford
Kerenza Hood: Centre for Trials Research
Jonathan S. Nguyen- Van-Tam: University of Nottingham School of Medicine
Paul Little: University of Southampton
F. D. Richard Hobbs: University of Oxford
Saye Khoo: University of Liverpool and Liverpool University Hospitals NHS Foundation Trust
Christopher Butler: University of Oxford
David M. Lowe: Royal Free London NHS Foundation Trust
Judith Breuer: University College London

Nature Communications, 2024, vol. 15, issue 1, 1-14

Abstract: 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

Date: 2024
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DOI: 10.1038/s41467-024-45641-0

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