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<p>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 &lt; 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 anti-Spike mAbs against Omicron sub lineages, confirming previous in vitro data.</p>

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CT changes in a randomized trial comparing early therapies in an outpatient population at high risk of severe COVID19 disease

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年8月18日

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  • Ilaria Mastrorosa,
  • Alessandro 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,
  • Samir Al Moghazi,
  • Massimo Andreoni,
  • Nazario Bevilacqua,
  • Elisa Biliotti,
  • Pierluigi Blanc,
  • Raffaele Bruno,
  • Emanuela Caraffa,
  • Antonio Cascio,
  • Anna Maria Cattelan,
  • Roberto Cauda,
  • Fabrizio Carletti,
  • Carlotta Cerva,
  • Angela Corpolongo,
  • Alessandra D’Abramo,
  • Federico De Zottis,
  • Silvia Di Bari,
  • Giovanni Di Perri,
  • Massimo Di Pietro,
  • Davide Roberto Donno,
  • Francesca Faraglia,
  • Francesca Gavaruzzi,
  • Ivan Gentile,
  • Maria Letizia Giancola,
  • Emanuela Giombini,
  • Andrea Gori,
  • Paolo Grossi,
  • Cesare Ernesto Maria Gruber,
  • Carmelo Iacobello,
  • Chiara Iaria,
  • Marco Libanore,
  • Raffaella Libertone,
  • Miriam Lichtner,
  • Laura Loiacono,
  • Andrea Mariano,
  • Marco Massari,
  • Claudio Maria Mastroianni,
  • Silvia Meschi,
  • Eugenia Milozzi,
  • Cristina Mussini,
  • Roberto Parrella,
  • Massimo Puoti,
  • Giuliano Rizzardini,
  • Annalisa Saracino,
  • Laura Scorzolini,
  • Eliana Specchiarello,
  • Marcello Tavio,
  • Carlo Torti,
  • Pierluigi Viale,
  • Serena Vita,
  • Pietro Vittozzi

摘要

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 anti-Spike mAbs against Omicron sub lineages, confirming previous in vitro data.