• Ilaria Mastrorosa, Alessandro Cozzi Lepri, BorgoCosmo DelCDInfectious Diseases Unit, Santa Maria Goretti Hospital, Sapienza University of Rome, Latina, Italy., Silvia Rosati, Martina Rueca, Loredana Sarmati, Claudio Mastroianni, Massimo Fantoni, Fabrizio Maggi, Emanuele Nicastri, Enrico Girardi, Miriam Lichtner, Andrea Antinori, Valentina Mazzotta, and Early Treatment for COVID‐19 Lazio Study Group.
• Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy.
• J. Intern. Med. 2024 Nov 13.

ObjectivesTo estimate the risk of COVID-19-related hospitalization and death (CovH/D), among high-risk individuals early treated for COVID-19 and to identify associated factors.Methods And ResultsA multicenter cohort of 12,475 high-risk outpatients (female 50.2%, median age 70 years [IQR 57-80], fully vaccinated 79.1%, immunocompromised 23.2%) treated with monoclonal antibodies or antivirals for mild-to-moderate COVID-19 (March 2021-May 2023) in the Lazio region, Italy. The unadjusted risk of CovH/D by Day 30 was 3.08% (95% CI 2.7%-3.4%). By means of logistic regression models, which included a specific set of potential confounders for each exposure of interest, we observed a higher risk for the elderly, unvaccinated and immunocompromised participants. Using the "Delta period" as a reference, a decreased risk was observed for Omicron waves.ConclusionsDespite the administration of COVID-19 early treatment and the decreasing risk of CovH/D across the calendar periods, the elderly, the unvaccinated and the immunocompromised people remain at high risk of clinical progression.© 2024 The Author(s). Journal of Internal Medicine published by John Wiley & Sons Ltd on behalf of Association for Publication of The Journal of Internal Medicine.

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