1 Unit of Infectious Diseases, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.
2 Internal Medicine of Città di Castello Hospital, USL Umbria 1, Italy.
3 Hospital Pharmacy of Foligno Hospital, USL Umbria 2, Italy.
4 Internal Medicine of Spoleto Hospital, USL Umbria 2, Italy.
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Background and Objective:
The use of monoclonal antibodies to the SARS-Cov-2 spike protein for
early treatment of COVID-19 disease is being evaluated, with only phase
2 studies available to date. The emergency authorization of
bamlanivimab monotherapy was obtained in November 2020 by the FDA and
in March 2021 by Italian agency AIFA. Its use was then revoked in April
2021 by both. This study reports the results of bamlanivimab
utilization in monotherapy in Umbria (Italian region) to verify
whether, in a population with multiple risk factors, comparable results
to the phase 2 BLAZE1 trial had been obtained.
Materials and Methods
|Table 1. AIFA criteria for patients eligible for monoclonal antibody therapy for COVD-19 included in the Ministerial Decree of 6 February 2021 (GU n.32 of 8-2-2021).|
|Table 2. Demographic, clinic and laboratory characteristics of total patients.
|Figure 1. Symptoms before and 30 days after Bamlanivimab treatment.