the EARLY TREATMENT WITH BAMLANIVIMAB ALONE DOES NOT PREVENT COVID-19 HOSPITALIZATION AND ITS POST-ACUTE SEQUELAE. A REAL EXPERIENCE IN UMBRIA, ITALY.
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Keywords
Bamlanivimab, COVID-19 hospitalization, real experience, Umbria
Abstract
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.
Emergency authorization of bamlanivimab monotherapy was get 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), in order to verify whether, in a population with multiple risk factors, comparable results to phase 2 BLAZE1 trial had been obtained.
Methods
Retrospective observational study, between March and April 2021, in patients treated with bamlanivimab was performed. Demographic and clinical characteristics before and after infusion were evaluated. Moreover, a telephone interview about 30 days after the infusion was carried out to evaluate the overall course.
Results
All patients had an early infection (mean 4±1.73 days), almost all by alpha variant (97%).
No adverse events to treatment were observed. Altogether within 30 days, the hospitalization rate was 20%, 15% for COVID-19 related pathologies , versus 4% at 11 days in BLAZE1 phase 2 study. Worsening of some symptoms observed at baseline such as asthenia (77 vs 51.3%), shortness of breath (38 vs 23%) was registered, as well as the onset of non-restorative sleep (41%).
Conclusions
The clinical outcome after bamlanivimab monotherapy was far below the expectation despite the patients had been infected by a theoretically sensitive viral variant.
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