Studies comparing all available strategies for the early treatment of mild-to-moderate COVID-19 during the Omicron era are lacking. We included people with mild-to-moderate COVID-19 and at high risk of progressing to severe disease attending five outpatient clinics in Italy over 2022–2023. The primary outcome was the proportion of participants who experienced Day-30 hospitalization due to COVID-19 or death. Participants received either nirmatrelvir/ritonavir (NMV/r), molnupiravir (MLP), remdesivir (RDV), sotrovimab (SOT), or tixagevimab/cilgavimab (TIX/CIL). We included 10 038 individuals: females 5052 (50%), median age 71 years (IQR 59–81). In total, 1919 (19%) received SOT, 3732 (37.2%) MLP, 1444 (14%) RDV, 2510 (25%) NMV/r, and 433 (4%) TIX/CIL. Only 1689 (17%) had incomplete vaccination, and 2435 (24.3%) were not immunocompetent. The rate of hospitalization/death was 2.40% (95% CI 2.10–2.71). Unadjusted rates were 0.88% (95% CI 0.55–1.32) for NMV/r, 1.69% (95% CI 1.30–2.15) for MLP, 3.0% (95% CI 1.61–5.08) for TIX/CIL, 3.54% (95% CI 2.76–4.47) for SOT and 5.12% (95% CI 4.05–6.39) for RDV. Weighted analysis showed that NMV/r and MLP were superior to all other interventions. In our population of individuals at high risk of progression to severe disease, there was clinical benefit in using NMV/r or MLP instead of mAbs-based therapies or RDV.
Comparative Analysis of Early COVID‐19 Treatment Efficacy in a Multicentric Regional Cohort in Italy: Emulation of a Series of Target Trials / Mazzotta, Valentina; Lepri, Alessandro Cozzi; Del Borgo, Cosmo; Lanini, Simone; Meschi, Silvia; Garattini, Silvia; Rosati, Silvia; Siciliano, Valentina; Vergori, Alessandra; Coppola, Luigi; Falletta, Antonio; Carraro, Anna; Gramigna, Giulia; Oliva, Alessandra; Matteini, Elena; Gasperin, Andrea; Giannico, Giuseppina; Mastrorosa, Ilaria; Matusali, Giulia; D'Abramo, Alessandra; Marocco, Raffaella; Milozzi, Eugenia; Cerva, Carlotta; Gavaruzzi, Francesca; Rueca, Martina; Cimaglia, Claudia; Piselli, Pierluca; Fantoni, Massimo; Girardi, Enrico; Sarmati, Loredana; Mastroianni, Claudio M.; Andreoni, Massimo; Torti, Carlo; Nicastri, Emanuele; Maggi, Fabrizio; Lichtner, Miriam; Antinori, Andrea; Null, Null. - In: JOURNAL OF MEDICAL VIROLOGY. - ISSN 0146-6615. - 97:5(2025). [10.1002/jmv.70379]
Comparative Analysis of Early COVID‐19 Treatment Efficacy in a Multicentric Regional Cohort in Italy: Emulation of a Series of Target Trials
Lanini, Simone;Carraro, Anna;Matusali, Giulia;Marocco, Raffaella;Cerva, Carlotta;Gavaruzzi, Francesca;Mastroianni, Claudio M.;Andreoni, Massimo;Lichtner, Miriam;
2025
Abstract
Studies comparing all available strategies for the early treatment of mild-to-moderate COVID-19 during the Omicron era are lacking. We included people with mild-to-moderate COVID-19 and at high risk of progressing to severe disease attending five outpatient clinics in Italy over 2022–2023. The primary outcome was the proportion of participants who experienced Day-30 hospitalization due to COVID-19 or death. Participants received either nirmatrelvir/ritonavir (NMV/r), molnupiravir (MLP), remdesivir (RDV), sotrovimab (SOT), or tixagevimab/cilgavimab (TIX/CIL). We included 10 038 individuals: females 5052 (50%), median age 71 years (IQR 59–81). In total, 1919 (19%) received SOT, 3732 (37.2%) MLP, 1444 (14%) RDV, 2510 (25%) NMV/r, and 433 (4%) TIX/CIL. Only 1689 (17%) had incomplete vaccination, and 2435 (24.3%) were not immunocompetent. The rate of hospitalization/death was 2.40% (95% CI 2.10–2.71). Unadjusted rates were 0.88% (95% CI 0.55–1.32) for NMV/r, 1.69% (95% CI 1.30–2.15) for MLP, 3.0% (95% CI 1.61–5.08) for TIX/CIL, 3.54% (95% CI 2.76–4.47) for SOT and 5.12% (95% CI 4.05–6.39) for RDV. Weighted analysis showed that NMV/r and MLP were superior to all other interventions. In our population of individuals at high risk of progression to severe disease, there was clinical benefit in using NMV/r or MLP instead of mAbs-based therapies or RDV.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
