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Multicenter Study
. 2023 Feb 5;15(2):438.
doi: 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)

Tommaso Manciulli  1 , Michele Spinicci  1   2 , Barbara Rossetti  3 , Roberta Maria Antonello  1 , Filippo Lagi  1   2 , Anna Barbiero  1 , Flavia Chechi  1   4 , Giuseppe Formica  1 , Emanuela Francalanci  1   5 , Mirco Alesi  1   5 , Samuele Gaggioli  1 , Giulia Modi  1   6 , Sara Modica  7 , Riccardo Paggi  1   4 , Cecilia Costa  6 , Alessandra Morea  8 , Lorenzo Paglicci  9 , Ilaria Rancan  1   10 , Francesco Amadori  11 , Agnese Tamborrino  12 , Marta Tilli  1   6 , Giulia Bandini  1 , Alberto Moggi Pignone  1 , Beatrice Valoriani  9 , Francesca Montagnani  10   13 , Mario Tumbarello  10   13 , Pierluigi Blanc  4 , Massimo Di Pietro  6 , Luisa Galli  12   14 , Donatella Aquilini  5 , Antonella Vincenti  11 , Spartaco Sani  8 , Cesira Nencioni  3 , Sauro Luchi  7 , Danilo Tacconi  9 , Lorenzo Zammarchi  1   2 , Alessandro Bartoloni  1   2
Affiliations
Multicenter Study

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 et al. Viruses. .

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.

Keywords: COVID-19; SARS-CoV-2; molnupiravir; nirmatrelvir/ritonavir; remdesivir; sotrovimab.

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Conflict of interest statement

The authors declare no conflict of interest for this work. Outside of this research work, Prof. Alessandro Bartoloni reports institutional grants from MSD and ViiV and personal honoraria from GSK and Gilead.

Figures

Figure 1
Figure 1
Kaplan–Meier survival curves of patients assigned to the four treatment groups (SOT n = 314; MOL n = 205; RMD n = 142; NRM/r n = 120). The failure event is a composite outcome of 28-day hospitalization and/or death related to COVD-19.
Figure 2
Figure 2
Multivariable Cox regression analysis. Predictors of composite outcome (28-day hospitalization and/or death related to COVD-19).
See this image and copyright information in PMC

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