tetano
Editor, Senior Moderator
J Med Virol
. 2025 May;97(5):e70379.
doi: 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
Valentina Mazzotta[SUP] 1 [/SUP], Alessandro Cozzi Lepri[SUP] 2 [/SUP], Cosmo Del Borgo[SUP] 3 [/SUP], Simone Lanini[SUP] 4 [/SUP], Silvia Meschi[SUP] 5 [/SUP], Silvia Garattini[SUP] 3 [/SUP], Silvia Rosati[SUP] 1 [/SUP], Valentina Siciliano[SUP] 6 [/SUP], Alessandra Vergori[SUP] 1 7 [/SUP], Luigi Coppola[SUP] 8 [/SUP], Antonio Falletta[SUP] 9 [/SUP], Anna Carraro[SUP] 3 [/SUP], Giulia Gramigna[SUP] 5 [/SUP], Alessandra Oliva[SUP] 1 [/SUP], Elena Matteini[SUP] 6 [/SUP], Andrea Gasperin[SUP] 3 [/SUP], Giuseppina Giannico[SUP] 1 [/SUP], Ilaria Mastrorosa[SUP] 1 [/SUP], Giulia Matusali[SUP] 5 [/SUP], Alessandra D'Abramo[SUP] 1 [/SUP], Raffaella Marocco[SUP] 3 [/SUP], Eugenia Milozzi[SUP] 1 [/SUP], Carlotta Cerva[SUP] 1 [/SUP], Francesca Gavaruzzi[SUP] 1 [/SUP], Martina Rueca[SUP] 5 [/SUP], Claudia Cimaglia[SUP] 10 [/SUP], Pierluca Piselli[SUP] 10 [/SUP], Massimo Fantoni[SUP] 11 [/SUP], Enrico Girardi[SUP] 12 [/SUP], Loredana Sarmati[SUP] 8 [/SUP], Claudio M Mastroianni[SUP] 9 [/SUP], Massimo Andreoni[SUP] 8 [/SUP], Carlo Torti[SUP] 6 11 [/SUP], Emanuele Nicastri[SUP] 1 [/SUP], Fabrizio Maggi[SUP] 5 [/SUP], Miriam Lichtner[SUP] 3 [/SUP], Andrea Antinori[SUP] 1 [/SUP]; Early Treatment for COVID‐19 Lazio Study Group
Affiliations
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.
Keywords: SARS coronavirus; antiviral agents; epidemiology; virus classification.
. 2025 May;97(5):e70379.
doi: 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
Valentina Mazzotta[SUP] 1 [/SUP], Alessandro Cozzi Lepri[SUP] 2 [/SUP], Cosmo Del Borgo[SUP] 3 [/SUP], Simone Lanini[SUP] 4 [/SUP], Silvia Meschi[SUP] 5 [/SUP], Silvia Garattini[SUP] 3 [/SUP], Silvia Rosati[SUP] 1 [/SUP], Valentina Siciliano[SUP] 6 [/SUP], Alessandra Vergori[SUP] 1 7 [/SUP], Luigi Coppola[SUP] 8 [/SUP], Antonio Falletta[SUP] 9 [/SUP], Anna Carraro[SUP] 3 [/SUP], Giulia Gramigna[SUP] 5 [/SUP], Alessandra Oliva[SUP] 1 [/SUP], Elena Matteini[SUP] 6 [/SUP], Andrea Gasperin[SUP] 3 [/SUP], Giuseppina Giannico[SUP] 1 [/SUP], Ilaria Mastrorosa[SUP] 1 [/SUP], Giulia Matusali[SUP] 5 [/SUP], Alessandra D'Abramo[SUP] 1 [/SUP], Raffaella Marocco[SUP] 3 [/SUP], Eugenia Milozzi[SUP] 1 [/SUP], Carlotta Cerva[SUP] 1 [/SUP], Francesca Gavaruzzi[SUP] 1 [/SUP], Martina Rueca[SUP] 5 [/SUP], Claudia Cimaglia[SUP] 10 [/SUP], Pierluca Piselli[SUP] 10 [/SUP], Massimo Fantoni[SUP] 11 [/SUP], Enrico Girardi[SUP] 12 [/SUP], Loredana Sarmati[SUP] 8 [/SUP], Claudio M Mastroianni[SUP] 9 [/SUP], Massimo Andreoni[SUP] 8 [/SUP], Carlo Torti[SUP] 6 11 [/SUP], Emanuele Nicastri[SUP] 1 [/SUP], Fabrizio Maggi[SUP] 5 [/SUP], Miriam Lichtner[SUP] 3 [/SUP], Andrea Antinori[SUP] 1 [/SUP]; Early Treatment for COVID‐19 Lazio Study Group
Affiliations
- PMID: 40326978
- PMCID: PMC12054396
- DOI: 10.1002/jmv.70379
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.
Keywords: SARS coronavirus; antiviral agents; epidemiology; virus classification.