Preliminary Evidence of Good Safety Profile and Outcomes of Early Treatment With Tixagevimab/Cilgavimab Compared to Previously Employed Monoclonal Antibodies for COVID-19 in Immunocompromised Patients
et al., MDPI AG, doi:10.20944/preprints202301.0359.v1 (Preprint)
, Preliminary Evidence of Good Safety Profile and Outcomes of Early Treatment With Tixagevimab/Cilgavimab.., MDPI AG, doi:10.20944/preprints202301.0359.v1 (Preprint)
Retrospective immunocompromised patients, showing no significant difference between tixagevimab/cilgavimab and other mAbs.Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2.75.2, BA.4.6, and BQ.1.1 [Planas].
This study is excluded in the after exclusion results of meta
analysis:
study compares against another treatment showing significant efficacy.
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risk of death, 368.4% higher, RR 4.68, p = 0.32, treatment 1 of 19 (5.3%), control 1 of 89 (1.1%), day 14.
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risk of hospitalization, 33.1% lower, RR 0.67, p = 1.00, treatment 1 of 19 (5.3%), control 7 of 89 (7.9%), NNT 38, day 14.
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risk of no viral clearance, 23.7% higher, RR 1.24, p = 0.30, treatment 14 of 19 (73.7%), control 53 of 89 (59.6%), day 14.
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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Lombardi et al., 19 Jan 2023, retrospective, Italy, preprint, 21 authors, study period 28 August, 2022 - 15 October, 2022, this trial compares with another treatment - results may be better when compared to placebo.
Contact:
andrea.lombardi@unimi.it.
Abstract: Preprints (www.preprints.org) | NOT PEER-REVIEWED | Posted: 19 January 2023
doi:10.20944/preprints202301.0359.v1
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Preliminary evidence of good safety profile and outcomes of early treatment with
tixagevimab/cilgavimab compared to previously employed monoclonal antibodies for COVID19 in immunocompromised patients
Andrea Lombardi1,2,3*, Giulia Viero1*, Simone Villa2, Simona Biscarini1, Emanuele Palomba1, Cecilia
Azzarà1, Nathalie Iannotti1, Bianca Mariani1, Camilla Genovese1, Mara Tomasello1, Anna Tonizzo1,
Marco Fava1, Antonia Grazia Valzano4, Letizia Corinna Morlacchi5, Francesca Donato6, Giuseppe
Castellano7, Ramona Cassin8, Maria Carrabba9, Antonio Muscatello1, Andrea Gori1,2,3, Alessandra
Bandera1,2,3
1. Infectious Diseases Unit, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan,
Italy
2. Centre for Multidisciplinary Research in Health Science (MACH), University of Milano, 20122
Milano, Italy
3. Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy
4. Clinical Laboratory, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
5. Respiratory Unit and Cystic Fibrosis Adult Center, Foundation IRCCS Ca' Granda Ospedale
Maggiore Policlinico, Milan, Italy
6. A.M. & A. Migliavacca Center for Liver Disease, Division of Gastroenterology and Hepatology,
Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
7. Department of Nephrology, Dialysis, and Renal Transplantation, Foundation IRCCS Ca’ Granda
Ospedale Maggiore Policlinico, Milan, Italy
8. Hematology Unit, Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy
9. Department of Internal Medicine, Adult Primary Immunodeficiencies Centre, Foundation IRCCS
Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy
*
Shared first authorship
Corresponding
author:
Andrea
Lombardi,
MD.
Department
of
Pathophysiology
and
Transplantation, University of Milan, via Francesco Sforza 35, Milan, Italy. 0039-0255034767
andrea.lombardi@unimi.it
1
© 2023 by the author(s). Distributed under a Creative Commons CC BY license.
Preprints (www.preprints.org) | NOT PEER-REVIEWED | Posted: 19 January 2023
doi:10.20944/preprints202301.0359.v1
Abstract electronic word count: 242
Main text electronic word count: 1,207
References: 11
Figures and tables: 3
Keywords: monoclonal antibodies; tixagevimab/cilgavimab; immunocompromised
2
Preprints (www.preprints.org) | NOT PEER-REVIEWED | Posted: 19 January 2023
doi:10.20944/preprints202301.0359.v1
Abstract
Objectives Monoclonal antibodies (mAbs) have proven to be a valuable tool against COVID-19,
mostly among subjects with risk factors for progression to severe illness. Tixagevimab/cilgavimab
(TIX/CIL), a combination of two Fc-modified human monoclonal antibodies, has been recently
approved to be employed as early treatment.
Methods Two groups of immunocompromised patients exposed to different early treatments (i.e.,
TIX/CIL vs. other mAbs [casirivimab/imdevimab, bamlanivimab/etesevimab, sotrovimab]) were
compared in terms of clinical outcomes (hospitalization and mortality within 14 days..
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