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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2022
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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. |
format | Online Article Text |
id | pubmed-9353117 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
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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