the EARLY TREATMENT WITH BAMLANIVIMAB ALONE DOES NOT PREVENT COVID-19 HOSPITALIZATION AND ITS POST-ACUTE SEQUELAE. A REAL EXPERIENCE IN UMBRIA, ITALY.

Main Article Content

Elisabetta Schiaroli
Giuseppe Vittorio De Socio
Laura Martinelli Martinelli
lisa malincarne
Martina Savoia
Anna Laura Spinelli
Daniela Francisci

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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References

References
1. Bryan E Jones , Patricia L Brown-Augsburger , Kizzmekia S Corbett , Kathryn Westendorf , Julian Davies , Thomas P Cujec , Christopher M Wiethoff , Jamie L Blackbourne , Beverly A Heinz , Denisa Foster , Richard E Higgs , Deepa Balasubramaniam , Lingshu Wang , Yi Zhang , Eun Sung Yang , Roza Bidshahri , Lucas Kraft , Yuri Hwang , Stefanie Žentelis , Kevin R Jepson , Rodrigo Goya , Maia A Smith , David W Collins , Samuel J Hinshaw , Sean A Tycho , Davide Pellacani , Ping Xiang , Krithika Muthuraman , Solmaz Sobhanifar , Marissa H Piper , Franz J Triana , Jorg Hendle , Anna Pustilnik , Andrew C Adams , Shawn J Berens , Ralph S Baric , David R Martinez , Robert W Cross , Thomas W Geisbert , Viktoriya Borisevich , Olubukola Abiona , Hayley M Belli , Maren de Vries , Adil Mohamed , Meike Dittmann , Marie I Samanovic , Mark J Mulligan , Jory A Goldsmith , Ching-Lin Hsieh , Nicole V Johnson , Daniel Wrapp , Jason S McLellan , Bryan C Barnhart , Barney S Graham , John R Mascola , Carl L Hansen , Ester Falconer. The neutralizing antibody, LY-CoV555, protects against SARS-CoV-2 infection in nonhuman primates. Sci Transl Med. 2021 May 12;13(593):eabf1906. doi: 10.1126/scitranslmed.abf1906. Epub 2021 Apr 5.
2. Peter Chen , Ajay Nirula , Barry Heller , Robert L Gottlieb, Joseph Boscia , Jason Morris , Gregory Huhn , Jose Cardona , Bharat Mocherla , Valentina Stosor , Imad Shawa , Andrew C Adams , Jacob Van Naarden , Kenneth L Custer , Lei Shen , Michael Durante, Gerard Oakley, Andrew E Schade , Janelle Sabo , Dipak R Patel , Paul Klekotka , Daniel M Skovronsky , BLAZE-1 Investigators. SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19. N Engl J Med 2021 Jan 21; 384(3): 229-237.doi: 10.1056/NEJMoa2029849. Epub 2020 Oct 28.
3. Food and Drug Administration. Letter to Eli Lilly and Company. 10 Nov 2020. https://www.fda.gov/media/143602/download.
4. Food and Drug Administration.April 16, 2021 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-monoclonal-antibody-bamlanivimab.
5. Anthony Ramos-Yataco, Kelly Meza,Reyna Cecilia Farfán-García, Solange Ortega-Rojas, Isaac Salinas-Mamani, Ivonne Silva-Arrieta Ontaneda and Ricardo Correa . DKA in patients with pre-existing type 2 diabetes mellitus related to COVID-19: a case series Endocrinol Diabetes Metab Case Rep. 2021; 2021: 20-0148. Published online 2021 Mar 5. doi: 10.1530/EDM-20-0148.
6. Ahmet Burak Dirim, Erol Demir, Serap Yadigar, Nurana Garayeva, Ergun Parmaksiz, Seda Safak , Kubra Aydin Bahat , Ali Riza Ucar , Meric Oruc , Ozgur Akin Oto , Alpay Medetalibeyoglu , Seniha Basaran , Gunseli Orhun , Halil Yazici , Aydin Turkmen. COVID-19 in chronic kidney disease: a retrospective, propensity score-matched cohort study. Int Urol Nephrol. 2021 Feb 6;1-9. doi: 10.1007/s11255-021-02783-0. Online ahead of print.
7. Nalbandian A, Sehgal K, Gupta A, Madhavan MV, McGroder C, Stevens JS, Cook JR, Nordvig AS, Shalev D, Sehrawat TS, Ahluwalia N, Bikdeli B, Dietz D, Der-Nigoghossian C, Liyanage-Don N, Rosner GF, Bernstein EJ, Mohan S, Beckley AA, Seres DS, Choueiri TK, Uriel N, Ausiello JC, Accili D, Freedberg DE, Baldwin M, Schwartz A, Brodie D, Garcia CK, Elkind MSV, Connors JM, Bilezikian JP, Landry DW, Wan EY. Post-acute COVID-19 syndrome Nat Med. 2021 Apr;27(4):601-615. doi: 10.1038/s41591-021-01283-z. Epub 2021 Mar 22.PMID: 33753937.
8. Ministero della Salute , Circolare n. 6251 del 17 febbraio 2021 “Indagine rapida per la valutazione della prevalenza delle varianti VOC 202012/01 (ovvero lineage B.1.1.7-Regno Unito), P1 (ovvero Brasiliana), e 501.V2 (ovvero lineage B.1.351-Sud Africana) in Italia.”
9. Marek Widera, Alexander Wilhelm, Sebastian Hoehl, Christiane Pallas, Niko Kohmer, Timo Wolf, Holger F Rabenau, Victor Corman, Christian Drosten, Maria JGT Vehreschild, Udo Goetsch, Rene Gottschalk, Sandra Ciesek, Bamlanivimab does not neutralize two SARS-CoV-2 variants carrying E484K in vitro medRxiv preprint doi: https://doi.org/10.1101/2021.02.24.21252372

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