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SARS-COV-2 nasopharyngeal viral load change in a multicenter randomized clinical trial comparing early therapies for COVID-19 in non-hospitalized adults with high risk of severe COVID-19 (the MONET TRIAL)
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  • Ilaria Mastrorosa,
  • A. Cozzi-Lepri,
  • Giulia Matusali,
  • Francesca Colavita,
  • Simone Lanini,
  • Martina Rueca,
  • Alessandra Oliva,
  • Giulia Berno,
  • Alessandra Vergori,
  • Silvia Rosati,
  • Jessica Paulicelli,
  • Enrico Girardi,
  • Emanuele Nicastri,
  • Fabrizio Maggi,
  • Andrea Antinori,
  • Valentina Mazzotta
Ilaria Mastrorosa
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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A. Cozzi-Lepri
University College London Institute for Global Health

Corresponding Author:a.cozzi-lepri@ucl.ac.uk

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Giulia Matusali
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Francesca Colavita
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Simone Lanini
Universita degli Studi di Udine Dipartimento di Medicina
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Martina Rueca
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Alessandra Oliva
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Giulia Berno
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Alessandra Vergori
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Silvia Rosati
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Jessica Paulicelli
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Enrico Girardi
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Emanuele Nicastri
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Fabrizio Maggi
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Andrea Antinori
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Valentina Mazzotta
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Abstract

Although in vitro studies suggest that neutralization by monoclonal antibodies (mAbs) against SARS CoV2 Omicron sub lineages is reduced, in vivo virological response data are lacking. MONET (EudraCT: 2021-004188-28) was multi-centric phase 4 open-label parallel randomized clinical trial, conducted in Italy over 2022-2023, to assess the efficacy of sotrovimab (SOT), tixagevimab/cilgavimab (TIX/CIL) and Nirmatrelvir/ritonavir (NMV/r), in outpatients at high risk for severe COVID-19. The outcome (secondary in the trial protocol) was SARS-CoV-2 variation in cycle threshold (CT) values over the first 7 days (D1-D7) of the trial. CT variation was compared by trial arms using unadjusted linear regression and after controlling for age. We included 346 individuals: 116 (34%) received SOT, 113 (33%) TIX/CIL, 117 (34%) NMV/r. Main characteristics were balanced across arms. Most of the participants were infected with BA.2 (52%) or BA.4/5 (35.5%). The data carried strong evidence that the mean CT change over D1-D7 was larger in subjects receiving NMV/r vs. the other arms (p<0.001). We found no evidence that viral variant was an effect measure modifier for the contrasts of interest (p=0.14). Our analysis provides strong evidence that NMV/r exerts a greater in vivo antiviral effect than mAbs against Omicron sublineages, confirming previous in vitro data.