Viruses (Feb 2023)

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)

  • Tommaso Manciulli,
  • Michele Spinicci,
  • Barbara Rossetti,
  • Roberta Maria Antonello,
  • Filippo Lagi,
  • Anna Barbiero,
  • Flavia Chechi,
  • Giuseppe Formica,
  • Emanuela Francalanci,
  • Mirco Alesi,
  • Samuele Gaggioli,
  • Giulia Modi,
  • Sara Modica,
  • Riccardo Paggi,
  • Cecilia Costa,
  • Alessandra Morea,
  • Lorenzo Paglicci,
  • Ilaria Rancan,
  • Francesco Amadori,
  • Agnese Tamborrino,
  • Marta Tilli,
  • Giulia Bandini,
  • Alberto Moggi Pignone,
  • Beatrice Valoriani,
  • Francesca Montagnani,
  • Mario Tumbarello,
  • Pierluigi Blanc,
  • Massimo Di Pietro,
  • Luisa Galli,
  • Donatella Aquilini,
  • Antonella Vincenti,
  • Spartaco Sani,
  • Cesira Nencioni,
  • Sauro Luchi,
  • Danilo Tacconi,
  • Lorenzo Zammarchi,
  • Alessandro Bartoloni

DOI
https://doi.org/10.3390/v15020438
Journal volume & issue
Vol. 15, no. 2
p. 438

Abstract

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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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