Safety and efficacy of a MEURI Program for the use of high dose Ivermectin in COVID-19 patients

Autores
Mayer, Marcos Alejandro; Krolewiecki, Alejandro Javier; Ferrero, Alejandro Javier; Bocchio, Marcelo; Barbero, Juan Carlos; Marcos, Miguel; Paladini, Ariel; Delgado, Carlos; Ojeda, Juan Ramón; Elorza, Claudia; Bertone, Ana; Fleitas, Pedro Emanuel; Vera, Gustavo Daniel; Kohan, Mario Rubén
Año de publicación
2022
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Background: In the absence of antiviral alternatives, interventions under research for COVID-19 might be offered following guidelines from WHO for monitored emergency use of unregistered and experimental interventions (MEURI). Ivermectin is among several drugs explored for its role against SARS-CoV-2, with a well-known safety profile but conflicting data regarding clinical utility for COVID-19. The aim of this report is to inform on the results of a MEURI Program of high-dose ivermectin in COVID-19 carried out by the Ministry of Health of the Province of La Pampa, Argentina.Methods: COVID-19 subjects, within 5 days of symptoms onset were invited to participate in the program, which consisted in the administration of ivermectin 0.6 mg/kg/day for 5 days plus standard of care. Active pharmacosurveillance was performed for 21 days, and hepatic laboratory assessments were performed in a subset of patients. Frequency of Intensive Care Unit (ICU) admission and COVID-19-related mortality of subjects in the ivermectin intention to treat group were compared with that observed in inhabitants of the same province during the same period not participating in the program.Results: From 21,232 subjects with COVID-19, 3,266 were offered and agreed to participate in the ivermectin program and 17,966 did not and were considered as controls. A total of 567 participants reported 819 adverse events (AEs); 3.13% discontinued ivermectin due to adverse events. ICU admission was significantly lower in the ivermectin group compared to controls among participants ≥40 year-old (1.2 vs. 2.0%, odds ratio 0.608; p = 0.024). Similarly, mortality was lower in the ivermectin group in the full group analysis (1.5 vs. 2.1%, odds ratio 0.720; p = 0.029), as well as in subjects ≥ 40 year- old (2.7 vs. 4.1%, odds ratio 0.655; p = 0.005).Conclusions: This report highlights the safety and possible efficacy of high dose ivermectin as a potentially useful intervention deserving public health-based consideration for COVID-19 patients.
Fil: Mayer, Marcos Alejandro. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Patagonia Confluencia. Instituto de Ciencias de la Tierra y Ambientales de La Pampa. Grupo Vinculado Fundación Centro de Salud e Investigaciones Medicas | Universidad Nacional de la Pampa. Facultad de Ciencias Exactas y Naturales. Instituto de Ciencias de la Tierra y Ambientales de La Pampa. Grupo Vinculado Fundación Centro de Salud e Investigaciones Medicas; Argentina. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Krolewiecki, Alejandro Javier. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Salta; Argentina. Universidad Nacional de Salta. Sede Regional Orán. Instituto de Investigación de Enfermedades Tropicales; Argentina
Fil: Ferrero, Alejandro Javier. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Bocchio, Marcelo. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Barbero, Juan Carlos. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Marcos, Miguel. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Paladini, Ariel. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Delgado, Carlos. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Ojeda, Juan Ramón. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Elorza, Claudia. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Bertone, Ana. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Fleitas, Pedro Emanuel. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Salta. Sede Regional Orán. Instituto de Investigación de Enfermedades Tropicales; Argentina
Fil: Vera, Gustavo Daniel. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Kohan, Mario Rubén. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Materia
COVID-19
SARS-CoV-2
IVERMECTIN
MEURI
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/160712
Acceder
id CONICETDig_5c94a194ef0d18df27dbb72b79178ad4
oai_identifier_str oai:ri.conicet.gov.ar:11336/160712
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Safety and efficacy of a MEURI Program for the use of high dose Ivermectin in COVID-19 patientsMayer, Marcos AlejandroKrolewiecki, Alejandro JavierFerrero, Alejandro JavierBocchio, MarceloBarbero, Juan CarlosMarcos, MiguelPaladini, ArielDelgado, CarlosOjeda, Juan RamónElorza, ClaudiaBertone, AnaFleitas, Pedro EmanuelVera, Gustavo DanielKohan, Mario RubénCOVID-19SARS-CoV-2IVERMECTINMEURIhttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Background: In the absence of antiviral alternatives, interventions under research for COVID-19 might be offered following guidelines from WHO for monitored emergency use of unregistered and experimental interventions (MEURI). Ivermectin is among several drugs explored for its role against SARS-CoV-2, with a well-known safety profile but conflicting data regarding clinical utility for COVID-19. The aim of this report is to inform on the results of a MEURI Program of high-dose ivermectin in COVID-19 carried out by the Ministry of Health of the Province of La Pampa, Argentina.Methods: COVID-19 subjects, within 5 days of symptoms onset were invited to participate in the program, which consisted in the administration of ivermectin 0.6 mg/kg/day for 5 days plus standard of care. Active pharmacosurveillance was performed for 21 days, and hepatic laboratory assessments were performed in a subset of patients. Frequency of Intensive Care Unit (ICU) admission and COVID-19-related mortality of subjects in the ivermectin intention to treat group were compared with that observed in inhabitants of the same province during the same period not participating in the program.Results: From 21,232 subjects with COVID-19, 3,266 were offered and agreed to participate in the ivermectin program and 17,966 did not and were considered as controls. A total of 567 participants reported 819 adverse events (AEs); 3.13% discontinued ivermectin due to adverse events. ICU admission was significantly lower in the ivermectin group compared to controls among participants ≥40 year-old (1.2 vs. 2.0%, odds ratio 0.608; p = 0.024). Similarly, mortality was lower in the ivermectin group in the full group analysis (1.5 vs. 2.1%, odds ratio 0.720; p = 0.029), as well as in subjects ≥ 40 year- old (2.7 vs. 4.1%, odds ratio 0.655; p = 0.005).Conclusions: This report highlights the safety and possible efficacy of high dose ivermectin as a potentially useful intervention deserving public health-based consideration for COVID-19 patients.Fil: Mayer, Marcos Alejandro. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Patagonia Confluencia. Instituto de Ciencias de la Tierra y Ambientales de La Pampa. Grupo Vinculado Fundación Centro de Salud e Investigaciones Medicas | Universidad Nacional de la Pampa. Facultad de Ciencias Exactas y Naturales. Instituto de Ciencias de la Tierra y Ambientales de La Pampa. Grupo Vinculado Fundación Centro de Salud e Investigaciones Medicas; Argentina. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;Fil: Krolewiecki, Alejandro Javier. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Salta; Argentina. Universidad Nacional de Salta. Sede Regional Orán. Instituto de Investigación de Enfermedades Tropicales; ArgentinaFil: Ferrero, Alejandro Javier. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;Fil: Bocchio, Marcelo. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;Fil: Barbero, Juan Carlos. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;Fil: Marcos, Miguel. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;Fil: Paladini, Ariel. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;Fil: Delgado, Carlos. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;Fil: Ojeda, Juan Ramón. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;Fil: Elorza, Claudia. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;Fil: Bertone, Ana. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;Fil: Fleitas, Pedro Emanuel. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Salta. Sede Regional Orán. Instituto de Investigación de Enfermedades Tropicales; ArgentinaFil: Vera, Gustavo Daniel. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;Fil: Kohan, Mario Rubén. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;Frontiers Media2022-02info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/160712Mayer, Marcos Alejandro; Krolewiecki, Alejandro Javier; Ferrero, Alejandro Javier; Bocchio, Marcelo; Barbero, Juan Carlos; et al.; Safety and efficacy of a MEURI Program for the use of high dose Ivermectin in COVID-19 patients; Frontiers Media; Frontiers in Public Health; 10; 813378; 2-2022; 1-122296-2565CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://www.frontiersin.org/articles/10.3389/fpubh.2022.813378/fullinfo:eu-repo/semantics/altIdentifier/doi/10.3389/fpubh.2022.813378info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T10:36:49Zoai:ri.conicet.gov.ar:11336/160712instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-29 10:36:49.628CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Safety and efficacy of a MEURI Program for the use of high dose Ivermectin in COVID-19 patients
title Safety and efficacy of a MEURI Program for the use of high dose Ivermectin in COVID-19 patients
spellingShingle Safety and efficacy of a MEURI Program for the use of high dose Ivermectin in COVID-19 patients
Mayer, Marcos Alejandro
COVID-19
SARS-CoV-2
IVERMECTIN
MEURI
title_short Safety and efficacy of a MEURI Program for the use of high dose Ivermectin in COVID-19 patients
title_full Safety and efficacy of a MEURI Program for the use of high dose Ivermectin in COVID-19 patients
title_fullStr Safety and efficacy of a MEURI Program for the use of high dose Ivermectin in COVID-19 patients
title_full_unstemmed Safety and efficacy of a MEURI Program for the use of high dose Ivermectin in COVID-19 patients
title_sort Safety and efficacy of a MEURI Program for the use of high dose Ivermectin in COVID-19 patients
dc.creator.none.fl_str_mv Mayer, Marcos Alejandro
Krolewiecki, Alejandro Javier
Ferrero, Alejandro Javier
Bocchio, Marcelo
Barbero, Juan Carlos
Marcos, Miguel
Paladini, Ariel
Delgado, Carlos
Ojeda, Juan Ramón
Elorza, Claudia
Bertone, Ana
Fleitas, Pedro Emanuel
Vera, Gustavo Daniel
Kohan, Mario Rubén
author Mayer, Marcos Alejandro
author_facet Mayer, Marcos Alejandro
Krolewiecki, Alejandro Javier
Ferrero, Alejandro Javier
Bocchio, Marcelo
Barbero, Juan Carlos
Marcos, Miguel
Paladini, Ariel
Delgado, Carlos
Ojeda, Juan Ramón
Elorza, Claudia
Bertone, Ana
Fleitas, Pedro Emanuel
Vera, Gustavo Daniel
Kohan, Mario Rubén
author_role author
author2 Krolewiecki, Alejandro Javier
Ferrero, Alejandro Javier
Bocchio, Marcelo
Barbero, Juan Carlos
Marcos, Miguel
Paladini, Ariel
Delgado, Carlos
Ojeda, Juan Ramón
Elorza, Claudia
Bertone, Ana
Fleitas, Pedro Emanuel
Vera, Gustavo Daniel
Kohan, Mario Rubén
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv COVID-19
SARS-CoV-2
IVERMECTIN
MEURI
topic COVID-19
SARS-CoV-2
IVERMECTIN
MEURI
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Background: In the absence of antiviral alternatives, interventions under research for COVID-19 might be offered following guidelines from WHO for monitored emergency use of unregistered and experimental interventions (MEURI). Ivermectin is among several drugs explored for its role against SARS-CoV-2, with a well-known safety profile but conflicting data regarding clinical utility for COVID-19. The aim of this report is to inform on the results of a MEURI Program of high-dose ivermectin in COVID-19 carried out by the Ministry of Health of the Province of La Pampa, Argentina.Methods: COVID-19 subjects, within 5 days of symptoms onset were invited to participate in the program, which consisted in the administration of ivermectin 0.6 mg/kg/day for 5 days plus standard of care. Active pharmacosurveillance was performed for 21 days, and hepatic laboratory assessments were performed in a subset of patients. Frequency of Intensive Care Unit (ICU) admission and COVID-19-related mortality of subjects in the ivermectin intention to treat group were compared with that observed in inhabitants of the same province during the same period not participating in the program.Results: From 21,232 subjects with COVID-19, 3,266 were offered and agreed to participate in the ivermectin program and 17,966 did not and were considered as controls. A total of 567 participants reported 819 adverse events (AEs); 3.13% discontinued ivermectin due to adverse events. ICU admission was significantly lower in the ivermectin group compared to controls among participants ≥40 year-old (1.2 vs. 2.0%, odds ratio 0.608; p = 0.024). Similarly, mortality was lower in the ivermectin group in the full group analysis (1.5 vs. 2.1%, odds ratio 0.720; p = 0.029), as well as in subjects ≥ 40 year- old (2.7 vs. 4.1%, odds ratio 0.655; p = 0.005).Conclusions: This report highlights the safety and possible efficacy of high dose ivermectin as a potentially useful intervention deserving public health-based consideration for COVID-19 patients.
Fil: Mayer, Marcos Alejandro. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Patagonia Confluencia. Instituto de Ciencias de la Tierra y Ambientales de La Pampa. Grupo Vinculado Fundación Centro de Salud e Investigaciones Medicas | Universidad Nacional de la Pampa. Facultad de Ciencias Exactas y Naturales. Instituto de Ciencias de la Tierra y Ambientales de La Pampa. Grupo Vinculado Fundación Centro de Salud e Investigaciones Medicas; Argentina. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Krolewiecki, Alejandro Javier. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Salta; Argentina. Universidad Nacional de Salta. Sede Regional Orán. Instituto de Investigación de Enfermedades Tropicales; Argentina
Fil: Ferrero, Alejandro Javier. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Bocchio, Marcelo. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Barbero, Juan Carlos. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Marcos, Miguel. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Paladini, Ariel. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Delgado, Carlos. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Ojeda, Juan Ramón. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Elorza, Claudia. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Bertone, Ana. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Fleitas, Pedro Emanuel. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Salta. Sede Regional Orán. Instituto de Investigación de Enfermedades Tropicales; Argentina
Fil: Vera, Gustavo Daniel. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
Fil: Kohan, Mario Rubén. Ministerio de Salud ; Gobierno de la Provincia de la Pampa;
description Background: In the absence of antiviral alternatives, interventions under research for COVID-19 might be offered following guidelines from WHO for monitored emergency use of unregistered and experimental interventions (MEURI). Ivermectin is among several drugs explored for its role against SARS-CoV-2, with a well-known safety profile but conflicting data regarding clinical utility for COVID-19. The aim of this report is to inform on the results of a MEURI Program of high-dose ivermectin in COVID-19 carried out by the Ministry of Health of the Province of La Pampa, Argentina.Methods: COVID-19 subjects, within 5 days of symptoms onset were invited to participate in the program, which consisted in the administration of ivermectin 0.6 mg/kg/day for 5 days plus standard of care. Active pharmacosurveillance was performed for 21 days, and hepatic laboratory assessments were performed in a subset of patients. Frequency of Intensive Care Unit (ICU) admission and COVID-19-related mortality of subjects in the ivermectin intention to treat group were compared with that observed in inhabitants of the same province during the same period not participating in the program.Results: From 21,232 subjects with COVID-19, 3,266 were offered and agreed to participate in the ivermectin program and 17,966 did not and were considered as controls. A total of 567 participants reported 819 adverse events (AEs); 3.13% discontinued ivermectin due to adverse events. ICU admission was significantly lower in the ivermectin group compared to controls among participants ≥40 year-old (1.2 vs. 2.0%, odds ratio 0.608; p = 0.024). Similarly, mortality was lower in the ivermectin group in the full group analysis (1.5 vs. 2.1%, odds ratio 0.720; p = 0.029), as well as in subjects ≥ 40 year- old (2.7 vs. 4.1%, odds ratio 0.655; p = 0.005).Conclusions: This report highlights the safety and possible efficacy of high dose ivermectin as a potentially useful intervention deserving public health-based consideration for COVID-19 patients.
publishDate 2022
dc.date.none.fl_str_mv 2022-02
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/160712
Mayer, Marcos Alejandro; Krolewiecki, Alejandro Javier; Ferrero, Alejandro Javier; Bocchio, Marcelo; Barbero, Juan Carlos; et al.; Safety and efficacy of a MEURI Program for the use of high dose Ivermectin in COVID-19 patients; Frontiers Media; Frontiers in Public Health; 10; 813378; 2-2022; 1-12
2296-2565
CONICET Digital
CONICET
url http://hdl.handle.net/11336/160712
identifier_str_mv Mayer, Marcos Alejandro; Krolewiecki, Alejandro Javier; Ferrero, Alejandro Javier; Bocchio, Marcelo; Barbero, Juan Carlos; et al.; Safety and efficacy of a MEURI Program for the use of high dose Ivermectin in COVID-19 patients; Frontiers Media; Frontiers in Public Health; 10; 813378; 2-2022; 1-12
2296-2565
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/https://www.frontiersin.org/articles/10.3389/fpubh.2022.813378/full
info:eu-repo/semantics/altIdentifier/doi/10.3389/fpubh.2022.813378
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Frontiers Media
publisher.none.fl_str_mv Frontiers Media
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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score 13.070432

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