Abstract: Real-life comparison of mortality in non-hospitalised patients with SARS- iew ed CoV-2 infection at risk for clinical progression treated with molnupiravir or nirmatrevir plus ritonavir during the Omicron era in Italy: a nationwide, observational study pe er re v Carlo Torti1₸, Pier Paolo Olimpieri2,3, Paolo Bonfanti4, Carlo Tascini5, Simone Celant2, Danilo Tacconi6, Emanuele Nicastri7, Evelina Tacconelli8, Bruno Cacopardo9, Alessandro Perrella10, Giovanni Battista Buccoliero11, Giustino Parruti12, Matteo Bassetti13,14, Carlo Biagetti15, Andrea Giacometti16, Elke Maria Erne17, Maria Frontuto18, Massimiliano Lanzafame19, Summa Valentina2, Alessandra Spagnoli3, Annarita Vestri3, Giovanni Di Perri20, Pierluigi Russo2† and Giorgio Palù2† ₸ Corresponding author † These authors contributed equally to this work 1Department of Medical and Surgical Sciences, “Magna Graecia” University, Catanzaro, Pr ep rin tn ot Italy. 2Italian Medicines Agency, Via del Tritone 181, 00187 Rome, Italy. 3Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy. 4Fondazione IRCCS San Gerardo dei Tintori – University of Milano-Bicocca, Monza, Italy. 5Department of medicine (DAME), Infectious Diseases Clinic, Udine University Hospital, Udine, Italy. 6 Department of Specialised and Internal Medicine, Infectious Diseases Unit, San Donato Hospital, Arezzo, Italy. 7 National Institute for Infectious Disease Lazzaron Spallanzani, IRCCS Via portuense 292 00149 Rome, Italy. 8 Infectious Diseases, Department of Diagnostic and Public Health, University of Verona, 37129 Verona, Italy. 9 Department of Internal and Experimental Medicine, University of Catania School of Medicine, Catania, Italy. 10 Division Emerging Infectious Disease and High Contagiousness, D. Cotugno Hospital, 80131 Naples, Italy. 11 Infectious Diseases Unit, San Giuseppe Moscati Hospital, Azienda Sanitaria Locale Taranto, 74121 Taranto, Italy. 12 Department of Medicine, Infectious Disease Unit, Pescara General Hospital, Pescara, Italy. 13 Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy. 14 Infectious Diseases Unit, Policlinico San Martino Hospital—IRCCS, Genoa, Italy. 15 Unit of Infectious disease Infermi Hospital, AUSL Romagna, Rimini, Italy. 16 Azienda Ospedaliera Universitaria, Ospedali Riuniti di Ancona, Ancona, Italy. 17 Azienda sanitaria dell’Alto Adige, Central Hospital of Bolzano, Department of Infectious Disease, Italy. 18 Infectious Diseases Unit – A.O.R. San Carlo - Potenza, Italy. 19 Department of Medical, Infectious Diseases Unit, Santa Chiara Hospital, Trento, Italy. 20 University of Torino, Department of Medical Sciences at the Unit of Infectious Diseases, Amedeo di Savoia Hospital, Torino, Italy. This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4444431 iew ed Background Comparative data on mortality in COVID-19 patients treated with molnupiravir or with nirmatrelvir plus ritonavir are scarce and inconclusive. In particular, no adequately powered studies have demonstrated statistically significant differences in mortality between the two oral antivirals. We therefore aimed to provide a comparison of all-cause mortality in community-dwelling COVID-19 patients treated during the Omicron era. pe er re v Methods In this observational study we used data collected in the nationwide, population-based, cohort of patients registered in the database of the..