CT changes in a randomized trial comparing early therapies in an outpatient population at high risk of severe COVID19 disease
| Title: | CT changes in a randomized trial comparing early therapies in an outpatient population at high risk of severe COVID19 disease |
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| Authors: | Mastrorosa I.; Cozzi-Lepri A.; Matusali G.; Colavita F.; Lanini S.; Rueca M.; Oliva A.; Berno G.; Vergori A.; Rosati S.; Paulicelli J.; Girardi E.; Nicastri E.; Maggi F.; Antinori A.; Mazzotta V.; Vittozzi P.; Vita S.; Viale P.; Torti C.; Tavio M.; Specchiarello E.; Scorzolini L.; Saracino A.; Rizzardini G.; Puoti M.; Parrella R.; Mussini C.; Milozzi E.; Meschi S.; Mastroianni C. M.; Massari M.; Mariano A.; Loiacono L.; Lichtner M.; Libertone R.; Libanore M.; Iaria C.; Iacobello C.; Gruber C. E. M.; Grossi P.; Gori A.; Giombini E.; Giancola M. L.; Gentile I.; Gavaruzzi F.; Faraglia F.; Donno D. R.; Di Pietro M.; Di Perri G.; Di Bari S.; De Zottis F.; D'Abramo A.; Corpolongo A.; Cerva C.; Carletti F.; Cauda R.; Cattelan A. M.; Cascio A.; Caraffa E.; Bruno R.; Blanc P.; Biliotti E.; Bevilacqua N.; Andreoni M.; Al Moghazi S. |
| Contributors: | Mastrorosa, I.; Cozzi-Lepri, A.; Matusali, G.; Colavita, F.; Lanini, S.; Rueca, M.; Oliva, A.; Berno, G.; Vergori, A.; Rosati, S.; Paulicelli, J.; Girardi, E.; Nicastri, E.; Maggi, F.; Antinori, A.; Mazzotta, V.; Vittozzi, P.; Vita, S.; Viale, P.; Torti, C.; Tavio, M.; Specchiarello, E.; Scorzolini, L.; Saracino, A.; Rizzardini, G.; Puoti, M.; Parrella, R.; Mussini, C.; Milozzi, E.; Meschi, S.; Mastroianni, C. M.; Massari, M.; Mariano, A.; Loiacono, L.; Lichtner, M.; Libertone, R.; Libanore, M.; Iaria, C.; Iacobello, C.; Gruber, C. E. M.; Grossi, P.; Gori, A.; Giombini, E.; Giancola, M. L.; Gentile, I.; Gavaruzzi, F.; Faraglia, F.; Donno, D. R.; Di Pietro, M.; Di Perri, G.; Di Bari, S.; De Zottis, F.; D'Abramo, A.; Corpolongo, A.; Cerva, C.; Carletti, F.; Cauda, R.; Cattelan, A. M.; Cascio, A.; Caraffa, E.; Bruno, R.; Blanc, P.; Biliotti, E.; Bevilacqua, N.; Andreoni, M.; Al Moghazi, S. |
| Publisher Information: | NATURE PORTFOLIO; HEIDELBERGER PLATZ 3, BERLIN, 14197, GERMANY |
| Publication Year: | 2025 |
| Collection: | Sapienza Università di Roma: CINECA IRIS |
| Subject Terms: | Antibodies response; Antiviral agent; CT value; Inflammatory marker; Monoclonal antibodie; RCT; SARS coronavirus |
| Description: | 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. |
| Document Type: | article in journal/newspaper |
| Language: | English |
| Relation: | info:eu-repo/semantics/altIdentifier/pmid/40825809; info:eu-repo/semantics/altIdentifier/wos/WOS:001553528800045; volume:15; issue:1; journal:SCIENTIFIC REPORTS; https://hdl.handle.net/11573/1751686 |
| DOI: | 10.1038/s41598-025-15641-1 |
| Availability: | https://hdl.handle.net/11573/1751686; https://doi.org/10.1038/s41598-025-15641-1 |
| Accession Number: | edsbas.8AE24802 |
| Database: | BASE |