Comparative Analysis of Early COVID‐19 Treatment Efficacy in a Multicentric Regional Cohort in Italy: Emulation of a Series of Target Trials

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.

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Journal
Journal of Medical Virology
Published
2025-05-01
DOI
https://doi.org/10.1002/jmv.70379
Citations
1
Primary Topic
SARS-CoV-2 and COVID-19 Research
Type
article
Field-Weighted Citation Impact
1.40

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article

Comparative Analysis of Early COVID‐19 Treatment Efficacy in a Multicentric Regional Cohort in Italy: Emulation of a Series of Target Trials

Giuseppina Giannico, Miriam Lichtner, Antonio Falletta, Ilaria Mastrorosa et al.
1 citations
Journal of Medical Virology
SARS-CoV-2 and COVID-19 Research
1.40
article

Comparative Analysis of Early COVID‐19 Treatment Efficacy in a Multicentric Regional Cohort in Italy: Emulation of a Series of Target Trials

Giuseppina Giannico, Miriam Lichtner, Antonio Falletta, Ilaria Mastrorosa, Valentina Siciliano, Carlotta Cerva, Loredana Sarmati, Martina Rueca, Claudio Maria Mastroianni, Andrea Antinori, Alessandra Oliva, Claudia Cimaglia, Francesca Gavaruzzi, Anna Carraro, Elena Matteini, Silvia Meschi, Alessandro Cozzi‐Lepri, Emanuele Nicastri, Alessandra D’Abramo, Alessandra Vergori, Pierluca Piselli, Massimo Andreoni, Valentina Mazzotta, Andrea Gasperin, Silvio Garattini, Carlo Torti, Giulia Matusali, Giulia Gramigna, Enrico Girardi, Eugenia Milozzi, Fabrizio Maggi, Luigi Coppola, Cosmo Del Borgo, Simone Lanini, Massimo Fantoni, Raffaella Marocco, Silvia Rosati
article en
1 citations

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.

Journal of Medical VirologyVol. 97(5)
Università Cattolica del Sacro Cuore (IT), University of Rome Tor Vergata (IT), University of Udine (IT), Agostino Gemelli University Polyclinic (IT), National Institute for Health and Care Research (GB), Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani (IT), Ospedale Santa Maria Goretti (IT), Istituti di Ricovero e Cura a Carattere Scientifico (IT), University College London (GB), Sapienza University of Rome (IT)
Ministero della Salute, HORIZON EUROPE Framework Programme
Good health and well-being
Openalex Percentile: Top 21%
SARS-CoV-2 and COVID-19 Research
1.40
DOIOpen Access PDFOpenAlex
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