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Nimotuzumab Increases the Recovery Rate of Severe and Critical COVID-19 Patients: Evaluation in the Real-World Scenario

EGFR signaling is an important regulator of SARS-CoV induced lung damage, inflammation and fibrosis. Nimotuzumab is a humanized anti-EGFR antibody registered for several cancer indications. An expanded access study was conducted to evaluate the safety and recovery rate of severe and critical patient...

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Autores principales: Diaz, Henrry, Jiménez, Jorge, Hernández, Aray, Valdés, Leivis, Martínez, Ariadna, Porto, Leonor, Hernández, Raity, Travieso, Nadina, Jova, Julio Héctor, Medel, Loipa, Troche, Mayelin, Gorte, Annia, Batista, Delmis, Valls, Ana Rosa, Cabrera, Leticia, Domeq, Milagros, Pérez, Leslie, Lorenzo-Luaces, Patricia, Sánchez, Lizet, Saavedra, Danay, Ramos, Mayra, Crombet, Tania
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9353117/
https://www.ncbi.nlm.nih.gov/pubmed/35937253
http://dx.doi.org/10.3389/fpubh.2022.948520
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author Diaz, Henrry
Jiménez, Jorge
Hernández, Aray
Valdés, Leivis
Martínez, Ariadna
Porto, Leonor
Hernández, Raity
Travieso, Nadina
Jova, Julio Héctor
Medel, Loipa
Troche, Mayelin
Gorte, Annia
Batista, Delmis
Valls, Ana Rosa
Cabrera, Leticia
Domeq, Milagros
Pérez, Leslie
Lorenzo-Luaces, Patricia
Sánchez, Lizet
Saavedra, Danay
Ramos, Mayra
Crombet, Tania
author_facet Diaz, Henrry
Jiménez, Jorge
Hernández, Aray
Valdés, Leivis
Martínez, Ariadna
Porto, Leonor
Hernández, Raity
Travieso, Nadina
Jova, Julio Héctor
Medel, Loipa
Troche, Mayelin
Gorte, Annia
Batista, Delmis
Valls, Ana Rosa
Cabrera, Leticia
Domeq, Milagros
Pérez, Leslie
Lorenzo-Luaces, Patricia
Sánchez, Lizet
Saavedra, Danay
Ramos, Mayra
Crombet, Tania
author_sort Diaz, Henrry
collection PubMed
description EGFR signaling is an important regulator of SARS-CoV induced lung damage, inflammation and fibrosis. Nimotuzumab is a humanized anti-EGFR antibody registered for several cancer indications. An expanded access study was conducted to evaluate the safety and recovery rate of severe and critical patients with confirmed SARS-CoV-2 infection, treated with nimotuzumab in combination with the standard of care in the real-world scenario. The antibody was administered as an intravenous infusions every 72 h, up to 5 doses. In order to assess the impact of nimotuzumab, the recovery rate was compared with a paired retrospective cohort. Control patients received standard treatment according the national protocol but not nimotuzumab. Overall, 1,151 severe or critical patients received nimotuzumab in 21 hospitals of Cuba. Median age was 65 and 773 patients had at least one comorbidity. Nimotuzumab was very well-tolerated and mild or moderate adverse events were detected in 19 patients. 1,009 controls matching with the nimotuzumab patients, were selected using a “propensity score” method. The 14-day recovery rate of the nimotuzumab cohort was 72 vs. 42% in the control group. Controls had a higher mortality risk (RR 2.08, 95% CI: 1.79, 2.38) than the nimotuzumab treated patients. The attributable fraction was 0.52 (95% CI: 0.44%; 0.58), and indicates the proportion of deaths that were prevented with nimotuzumab. Our preliminary results suggest that nimotuzumab is a safe antibody that can reduce the mortality of severe and critical COVID-19 patients.
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spelling pubmed-93531172022-08-06 Nimotuzumab Increases the Recovery Rate of Severe and Critical COVID-19 Patients: Evaluation in the Real-World Scenario Diaz, Henrry Jiménez, Jorge Hernández, Aray Valdés, Leivis Martínez, Ariadna Porto, Leonor Hernández, Raity Travieso, Nadina Jova, Julio Héctor Medel, Loipa Troche, Mayelin Gorte, Annia Batista, Delmis Valls, Ana Rosa Cabrera, Leticia Domeq, Milagros Pérez, Leslie Lorenzo-Luaces, Patricia Sánchez, Lizet Saavedra, Danay Ramos, Mayra Crombet, Tania Front Public Health Public Health EGFR signaling is an important regulator of SARS-CoV induced lung damage, inflammation and fibrosis. Nimotuzumab is a humanized anti-EGFR antibody registered for several cancer indications. An expanded access study was conducted to evaluate the safety and recovery rate of severe and critical patients with confirmed SARS-CoV-2 infection, treated with nimotuzumab in combination with the standard of care in the real-world scenario. The antibody was administered as an intravenous infusions every 72 h, up to 5 doses. In order to assess the impact of nimotuzumab, the recovery rate was compared with a paired retrospective cohort. Control patients received standard treatment according the national protocol but not nimotuzumab. Overall, 1,151 severe or critical patients received nimotuzumab in 21 hospitals of Cuba. Median age was 65 and 773 patients had at least one comorbidity. Nimotuzumab was very well-tolerated and mild or moderate adverse events were detected in 19 patients. 1,009 controls matching with the nimotuzumab patients, were selected using a “propensity score” method. The 14-day recovery rate of the nimotuzumab cohort was 72 vs. 42% in the control group. Controls had a higher mortality risk (RR 2.08, 95% CI: 1.79, 2.38) than the nimotuzumab treated patients. The attributable fraction was 0.52 (95% CI: 0.44%; 0.58), and indicates the proportion of deaths that were prevented with nimotuzumab. Our preliminary results suggest that nimotuzumab is a safe antibody that can reduce the mortality of severe and critical COVID-19 patients. Frontiers Media S.A. 2022-07-22 /pmc/articles/PMC9353117/ /pubmed/35937253 http://dx.doi.org/10.3389/fpubh.2022.948520 Text en Copyright © 2022 Diaz, Jiménez, Hernández, Valdés, Martínez, Porto, Hernández, Travieso, Jova, Medel, Troche, Gorte, Batista, Valls, Cabrera, Domeq, Pérez, Lorenzo-Luaces, Sánchez, Saavedra, Ramos and Crombet. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Public Health
Diaz, Henrry
Jiménez, Jorge
Hernández, Aray
Valdés, Leivis
Martínez, Ariadna
Porto, Leonor
Hernández, Raity
Travieso, Nadina
Jova, Julio Héctor
Medel, Loipa
Troche, Mayelin
Gorte, Annia
Batista, Delmis
Valls, Ana Rosa
Cabrera, Leticia
Domeq, Milagros
Pérez, Leslie
Lorenzo-Luaces, Patricia
Sánchez, Lizet
Saavedra, Danay
Ramos, Mayra
Crombet, Tania
Nimotuzumab Increases the Recovery Rate of Severe and Critical COVID-19 Patients: Evaluation in the Real-World Scenario
title Nimotuzumab Increases the Recovery Rate of Severe and Critical COVID-19 Patients: Evaluation in the Real-World Scenario
title_full Nimotuzumab Increases the Recovery Rate of Severe and Critical COVID-19 Patients: Evaluation in the Real-World Scenario
title_fullStr Nimotuzumab Increases the Recovery Rate of Severe and Critical COVID-19 Patients: Evaluation in the Real-World Scenario
title_full_unstemmed Nimotuzumab Increases the Recovery Rate of Severe and Critical COVID-19 Patients: Evaluation in the Real-World Scenario
title_short Nimotuzumab Increases the Recovery Rate of Severe and Critical COVID-19 Patients: Evaluation in the Real-World Scenario
title_sort nimotuzumab increases the recovery rate of severe and critical covid-19 patients: evaluation in the real-world scenario
topic Public Health
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9353117/
https://www.ncbi.nlm.nih.gov/pubmed/35937253
http://dx.doi.org/10.3389/fpubh.2022.948520
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