the EARLY TREATMENT WITH BAMLANIVIMAB ALONE DOES NOT PREVENT COVID-19 HOSPITALIZATION AND ITS POST-ACUTE SEQUELAE. A REAL EXPERIENCE IN UMBRIA, ITALY.
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 Mar...
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| Format: | Article |
| Language: | English |
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PAGEPress Publications
2021-10-01
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| Series: | Mediterranean Journal of Hematology and Infectious Diseases |
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| Online Access: | http://mjhid.org/index.php/mjhid/article/view/4690 |
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| author | Elisabetta Schiaroli Giuseppe Vittorio De Socio Laura Martinelli Martinelli lisa malincarne Martina Savoia Anna Laura Spinelli Daniela Francisci |
| author_facet | Elisabetta Schiaroli Giuseppe Vittorio De Socio Laura Martinelli Martinelli lisa malincarne Martina Savoia Anna Laura Spinelli Daniela Francisci |
| author_sort | Elisabetta Schiaroli |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-5f449eb357844670a40bbb07fcd693a4 |
| institution | OA Journals |
| issn | 2035-3006 |
| language | English |
| publishDate | 2021-10-01 |
| publisher | PAGEPress Publications |
| record_format | Article |
| series | Mediterranean Journal of Hematology and Infectious Diseases |
| spelling | doaj-art-5f449eb357844670a40bbb07fcd693a42025-08-20T02:08:32ZengPAGEPress PublicationsMediterranean Journal of Hematology and Infectious Diseases2035-30062021-10-0113110.4084/MJHID.2021.061the EARLY TREATMENT WITH BAMLANIVIMAB ALONE DOES NOT PREVENT COVID-19 HOSPITALIZATION AND ITS POST-ACUTE SEQUELAE. A REAL EXPERIENCE IN UMBRIA, ITALY.Elisabetta Schiaroli0Giuseppe Vittorio De Socio1Laura Martinelli Martinelli2lisa malincarne3Martina Savoia4Anna Laura Spinelli5Daniela Francisci6Unit of Infectious Diseases, Department of Medicine, University of Perugia, Perugia, ItalyUnit of Infectious Diseases, Department of Medicine and Surgery, University of Perugia, Perugia, ItalyInternal Medicine of Città di Castello Hospital, USL Umbria1, ItalyUnit of Infectious Diseases, Department of Medicine and Surgery, University of Perugia, Perugia, ItalyHospital Pharmacy of Foligno Hospital, USL Umbria2, ItalyInternal Medicine of Spoleto Hospital, USL Umbria 2, ItalyUnit of Infectious Diseases, Department of Medicine and Surgery, University of Perugia, Perugia, ItalyBackground 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.http://mjhid.org/index.php/mjhid/article/view/4690BamlanivimabCOVID-19 hospitalizationreal experienceUmbria |
| spellingShingle | Elisabetta Schiaroli Giuseppe Vittorio De Socio Laura Martinelli Martinelli lisa malincarne Martina Savoia Anna Laura Spinelli Daniela Francisci the EARLY TREATMENT WITH BAMLANIVIMAB ALONE DOES NOT PREVENT COVID-19 HOSPITALIZATION AND ITS POST-ACUTE SEQUELAE. A REAL EXPERIENCE IN UMBRIA, ITALY. Mediterranean Journal of Hematology and Infectious Diseases Bamlanivimab COVID-19 hospitalization real experience Umbria |
| title | the EARLY TREATMENT WITH BAMLANIVIMAB ALONE DOES NOT PREVENT COVID-19 HOSPITALIZATION AND ITS POST-ACUTE SEQUELAE. A REAL EXPERIENCE IN UMBRIA, ITALY. |
| title_full | the EARLY TREATMENT WITH BAMLANIVIMAB ALONE DOES NOT PREVENT COVID-19 HOSPITALIZATION AND ITS POST-ACUTE SEQUELAE. A REAL EXPERIENCE IN UMBRIA, ITALY. |
| title_fullStr | the EARLY TREATMENT WITH BAMLANIVIMAB ALONE DOES NOT PREVENT COVID-19 HOSPITALIZATION AND ITS POST-ACUTE SEQUELAE. A REAL EXPERIENCE IN UMBRIA, ITALY. |
| title_full_unstemmed | the EARLY TREATMENT WITH BAMLANIVIMAB ALONE DOES NOT PREVENT COVID-19 HOSPITALIZATION AND ITS POST-ACUTE SEQUELAE. A REAL EXPERIENCE IN UMBRIA, ITALY. |
| title_short | the EARLY TREATMENT WITH BAMLANIVIMAB ALONE DOES NOT PREVENT COVID-19 HOSPITALIZATION AND ITS POST-ACUTE SEQUELAE. A REAL EXPERIENCE IN UMBRIA, ITALY. |
| title_sort | early treatment with bamlanivimab alone does not prevent covid 19 hospitalization and its post acute sequelae a real experience in umbria italy |
| topic | Bamlanivimab COVID-19 hospitalization real experience Umbria |
| url | http://mjhid.org/index.php/mjhid/article/view/4690 |
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