Early COVID-19 treatments can prevent progression to severe disease. However, real-life data are still limited, and studies are warranted to monitor the efficacy and tolerability of these drugs. We retrospectively enrolled outpatients receiving early treatment for COVID-19 in 11 infectious diseases units in the Tuscany region of Italy between 1 January and 31 March 2022, when Omicron sublineages BA.1 and BA.2 were circulating. Eligible COVID-19 patients were treated with sotrovimab (SOT), remdesivir (RMD), nirmatrelvir/ritonavir (NRM/r), or molnupiravir (MOL). We gathered demographic and clinical features, 28-day outcomes (hospitalization or death), and drugs tolerability. A total of 781 patients (median age 69.9, 66% boosted for SARS-CoV-2) met the inclusion criteria, of whom 314 were treated with SOT (40.2%), 205 with MOL (26.3%), 142 with RMD (18.2%), and 120 with NRM/r (15.4%). Overall, 28-day hospitalization and death occurred in 18/781 (2.3%) and 3/781 (0.3%), respectively. Multivariable Cox regression showed that patients receiving SOT had a reduced risk of meeting the composite outcome (28-day hospitalization and/or death) in comparison to the RMD cohort, while no significant differences were evidenced for the MOL and NRM/r groups in comparison to the RMD group. Other predictors of negative outcomes included cancer, chronic kidney disease, and a time between symptoms onset and treatment administration > 3 days. All treatments showed good safety and tolerability, with only eight patients (1%) whose treatment was interrupted due to intolerance. In the first Italian multicenter study presenting real-life data on COVID-19 early treatments, all regimens demonstrated good safety and efficacy. SOT showed a reduced risk of progression versus RMD. No significant differences of outcome were observed in preventing 28-day hospitalization and death among patients treated with RMD, MOL, and NRM/r.
Safety and Efficacy of Outpatient Treatments for COVID-19: Real-Life Data from a Regionwide Cohort of High-Risk Patients in Tuscany, Italy (the FEDERATE Cohort) / Manciulli, Tommaso; Spinicci, Michele; Rossetti, Barbara; Antonello, Roberta Maria; Lagi, Filippo; Barbiero, Anna; Chechi, Flavia; Formica, Giuseppe; Francalanci, Emanuela; Alesi, Mirco; Gaggioli, Samuele; Modi, Giulia; Modica, Sara; Paggi, Riccardo; Costa, Cecilia; Morea, Alessandra; Paglicci, Lorenzo; Rancan, Ilaria; Amadori, Francesco; Tamborrino, Agnese; Tilli, Marta; Bandini, Giulia; Pignone, Alberto Moggi; Valoriani, Beatrice; Montagnani, Francesca; Tumbarello, Mario; Blanc, Pierluigi; Di Pietro, Massimo; Galli, Luisa; Aquilini, Donatella; Vincenti, Antonella; Sani, Spartaco; Nencioni, Cesira; Luchi, Sauro; Tacconi, Danilo; Zammarchi, Lorenzo; Bartoloni, Alessandro. - In: VIRUSES. - ISSN 1999-4915. - ELETTRONICO. - 15:(2023), pp. 0-0. [10.3390/v15020438]
Safety and Efficacy of Outpatient Treatments for COVID-19: Real-Life Data from a Regionwide Cohort of High-Risk Patients in Tuscany, Italy (the FEDERATE Cohort)
Manciulli, Tommaso;Spinicci, Michele;Antonello, Roberta Maria;Lagi, Filippo;Barbiero, Anna;Chechi, Flavia;Formica, Giuseppe;Francalanci, Emanuela;Alesi, Mirco;Gaggioli, Samuele;Modi, Giulia;Modica, Sara;Paggi, Riccardo;Morea, Alessandra;Paglicci, Lorenzo;Rancan, Ilaria;Amadori, Francesco;Tilli, Marta;Bandini, Giulia;Pignone, Alberto Moggi;Valoriani, Beatrice;Tumbarello, Mario;Galli, Luisa;Aquilini, Donatella;Tacconi, Danilo;Zammarchi, Lorenzo;Bartoloni, Alessandro
2023
Abstract
Early COVID-19 treatments can prevent progression to severe disease. However, real-life data are still limited, and studies are warranted to monitor the efficacy and tolerability of these drugs. We retrospectively enrolled outpatients receiving early treatment for COVID-19 in 11 infectious diseases units in the Tuscany region of Italy between 1 January and 31 March 2022, when Omicron sublineages BA.1 and BA.2 were circulating. Eligible COVID-19 patients were treated with sotrovimab (SOT), remdesivir (RMD), nirmatrelvir/ritonavir (NRM/r), or molnupiravir (MOL). We gathered demographic and clinical features, 28-day outcomes (hospitalization or death), and drugs tolerability. A total of 781 patients (median age 69.9, 66% boosted for SARS-CoV-2) met the inclusion criteria, of whom 314 were treated with SOT (40.2%), 205 with MOL (26.3%), 142 with RMD (18.2%), and 120 with NRM/r (15.4%). Overall, 28-day hospitalization and death occurred in 18/781 (2.3%) and 3/781 (0.3%), respectively. Multivariable Cox regression showed that patients receiving SOT had a reduced risk of meeting the composite outcome (28-day hospitalization and/or death) in comparison to the RMD cohort, while no significant differences were evidenced for the MOL and NRM/r groups in comparison to the RMD group. Other predictors of negative outcomes included cancer, chronic kidney disease, and a time between symptoms onset and treatment administration > 3 days. All treatments showed good safety and tolerability, with only eight patients (1%) whose treatment was interrupted due to intolerance. In the first Italian multicenter study presenting real-life data on COVID-19 early treatments, all regimens demonstrated good safety and efficacy. SOT showed a reduced risk of progression versus RMD. No significant differences of outcome were observed in preventing 28-day hospitalization and death among patients treated with RMD, MOL, and NRM/r.
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