RBD-specific polyclonal F(ab´)2 fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, ad...

Autores: Lopardo, Gustavo; Belloso, Waldo H.; Nannini, Esteban; Colonna, Mariana; Sanguineti, Santiago; Zylberman, Vanesa; Muñoz, Luciana; Dobarro, Martín; Lebersztein, Gabriel; Farina, Javier; Vidiella, Gabriela; Bertetti, Anselmo; Crudo, Favio; Alzogaray, Maria Fernanda; Barcelona, Laura; Teijeiro, Ricardo; Lambert, Sandra; Scublinsky, Darío; Iacono, Marisa; Stanek, Vanina; Solari, Rubén; Cruz, Pablo; Casas, Marcelo Martín; Abusamra, Lorena; Luciardi, Héctor Lucas; Cremona, Alberto; Caruso, Diego; de Miguel, Bernardo; Perez Lloret, Santiago; Millán, Susana; Kilstein, Yael; Pereiro, Ana; Sued, Omar; Cahn, Pedro; Spatz, Linus; Goldbaum, Fernando Alberto
Año de publicación: 2021
Idioma: inglés
Tipo de recurso: artículo
Estado: versión publicada
Descripción: Background: passive immunotherapy is a therapeutic alternative for patients with COVID-19. Equine polyclonal antibodies (EpAbs) could represent a source of scalable neutralizing antibodies against SARS-CoV-2. Methods: we conducted a double-blind, randomized, placebo-controlled trial to assess efficacy and safety of EpAbs (INM005) in hospitalized adult patients with moderate and severe COVID-19 pneumonia in 19 hospitals of Argentina. Primary endpoint was improvement in at least two categories in WHO ordinal clinical scale at day 28 or hospital discharge (ClinicalTrials.gov number NCT04494984). Findings: between August 1st and October 26th, 2020, a total of 245 patients were enrolled. Enrolled patients were assigned to receive two blinded doses of INM005 (n = 118) or placebo (n = 123). Median age was 54 years old, 65 1% were male and 61% had moderate disease at baseline. Median time from symptoms onset to study treatment was 6 days (interquartile range 5 to 8). No statistically significant difference was noted between study groups on primary endpoint (risk difference [95% IC]: 5 28% [-3 95; 14 50]; p = 0 15). Rate of improvement in at least two categories was statistically significantly higher for INM005 at days 14 and 21 of follow-up. Time to improvement in two ordinal categories or hospital discharge was 14 2 (§ 0 7) days in the INM005 group and 16 3 (§ 0 7) days in the placebo group, hazard ratio 1 31 (95% CI 1 0 to 1 74). Subgroup analyses showed a beneficial effect of INM005 over severe patients and in those with negative baseline antibodies. Overall mortality was 6 9% the INM005 group and 11 4% in the placebo group (risk difference [95% IC]: 0 57 [0 24 to 1 37]). Adverse events of special interest were mild or moderate; no anaphylaxis was reported. Interpretation: Albeit not having reached the primary endpoint, we found clinical improvement of hospitalized patients with SARS-CoV-2 pneumonia, particularly those with severe disease.
Fil: Lopardo, Gustavo. Municipalidad de Vicente Lopez (buenos Aires). Hospital Municipal Doctor Bernardo Houssay.; Argentina
Fil: Belloso, Waldo H.. Hospital Italiano; Argentina
Fil: Nannini, Esteban. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Colonna, Mariana. Inmunova; Argentina
Fil: Sanguineti, Santiago. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Inmunova; Argentina
Fil: Zylberman, Vanesa. Inmunova; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Muñoz, Luciana. Inmunova; Argentina
Fil: Dobarro, Martín. Sanatorio Sagrado Corazón; Argentina
Fil: Lebersztein, Gabriel. Sanatorio Sagrado Corazón; Argentina
Fil: Farina, Javier. Gobierno de la Provincia de Buenos Aires. Hospital de Alta Complejidad Cuenca Alta Doctor Nestor Carlos Kirchner.; Argentina
Fil: Vidiella, Gabriela. Sanatorio Agote. Dr. Luis Agote; Argentina
Fil: Bertetti, Anselmo. Sanatorio Guemes Sociedad Anonima.; Argentina
Fil: Crudo, Favio. Universidad Nacional de San Antonio de Areco; Argentina
Fil: Alzogaray, Maria Fernanda. Instituto Medico Platense.; Argentina
Fil: Barcelona, Laura. Municipalidad de Vicente Lopez (buenos Aires). Hospital Municipal Doctor Bernardo Houssay.; Argentina
Fil: Teijeiro, Ricardo. Gobierno de la Ciudad Autónoma de Buenos Aires. Hospital General de Agudos Doctor Ignacio Pirovano; Argentina
Fil: Lambert, Sandra. Provincia de Buenos Aires. Ministerio de Salud. Hospital Alta Complejidad en Red El Cruce Dr. Néstor Carlos Kirchner Samic; Argentina
Fil: Scublinsky, Darío. Clinica Zabala.; Argentina
Fil: Iacono, Marisa. Provincia del Neuquen. Hospital Provincial Neuquen "dr. E. Castro Rendon"; Argentina
Fil: Stanek, Vanina. Hospital Italiano; Argentina
Fil: Solari, Rubén. Gobierno de la Ciudad de Buenos Aires. Hospital de Infecciosas "Dr. Francisco Javier Muñiz"; Argentina
Fil: Cruz, Pablo. No especifíca;
Fil: Casas, Marcelo Martín. Clinica Adventista Belgrano; Argentina
Fil: Abusamra, Lorena. Hospital Municipal Dr. Diego Thompson; Argentina
Fil: Luciardi, Héctor Lucas. Provincia de Tucuman. Ministerio de Salud. Sistema Provincial de Salud. Hosp. Centro de Salud "zenon Santillan"; Argentina
Fil: Cremona, Alberto. Hospital Italiano de La Plata; Argentina
Fil: Caruso, Diego. Hospital Español; Argentina
Fil: de Miguel, Bernardo. No especifíca;
Fil: Perez Lloret, Santiago. Pontificia Universidad Católica Argentina "Santa María de los Buenos Aires"; Argentina. Universidad Abierta Interamericana. Secretaría de Investigación. Centro de Altos Estudios En Ciencias Humanas y de la Salud - Sede Buenos Aires; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Millán, Susana. No especifíca;
Fil: Kilstein, Yael. No especifíca;
Fil: Pereiro, Ana. Fundación Mundo Sano; Argentina
Fil: Sued, Omar. Fundación Huésped; Argentina
Fil: Cahn, Pedro. Fundación Huésped; Argentina
Fil: Spatz, Linus. Inmunova; Argentina
Fil: Goldbaum, Fernando Alberto. Inmunova; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Instituto de Investigaciones Bioquímicas de Buenos Aires. Fundación Instituto Leloir. Instituto de Investigaciones Bioquímicas de Buenos Aires; Argentina. Universidad Nacional de San Martin. Centro de Rediseño E Ingenieria de Proteinas.; Argentina
Materia: PASSIVE IMMUNOTHERAPY
COVID-19
EQUINE POLYCLONAL ANTIBODIES
CLINICAL TRIAL
Nivel de accesibilidad: acceso abierto
Condiciones de uso: https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
Institución: Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador: oai:ri.conicet.gov.ar:11336/139002

Acceder

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oai_identifier_str	oai:ri.conicet.gov.ar:11336/139002
network_acronym_str	CONICETDig
repository_id_str	3498
network_name_str	CONICET Digital (CONICET)
spelling	RBD-specific polyclonal F(ab´)2 fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, adaptive phase 2/3 clinical trialLopardo, GustavoBelloso, Waldo H.Nannini, EstebanColonna, MarianaSanguineti, SantiagoZylberman, VanesaMuñoz, LucianaDobarro, MartínLebersztein, GabrielFarina, JavierVidiella, GabrielaBertetti, AnselmoCrudo, FavioAlzogaray, Maria FernandaBarcelona, LauraTeijeiro, RicardoLambert, SandraScublinsky, DaríoIacono, MarisaStanek, VaninaSolari, RubénCruz, PabloCasas, Marcelo MartínAbusamra, LorenaLuciardi, Héctor LucasCremona, AlbertoCaruso, Diegode Miguel, BernardoPerez Lloret, SantiagoMillán, SusanaKilstein, YaelPereiro, AnaSued, OmarCahn, PedroSpatz, LinusGoldbaum, Fernando AlbertoPASSIVE IMMUNOTHERAPYCOVID-19EQUINE POLYCLONAL ANTIBODIESCLINICAL TRIALhttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Background: passive immunotherapy is a therapeutic alternative for patients with COVID-19. Equine polyclonal antibodies (EpAbs) could represent a source of scalable neutralizing antibodies against SARS-CoV-2. Methods: we conducted a double-blind, randomized, placebo-controlled trial to assess efficacy and safety of EpAbs (INM005) in hospitalized adult patients with moderate and severe COVID-19 pneumonia in 19 hospitals of Argentina. Primary endpoint was improvement in at least two categories in WHO ordinal clinical scale at day 28 or hospital discharge (ClinicalTrials.gov number NCT04494984). Findings: between August 1st and October 26th, 2020, a total of 245 patients were enrolled. Enrolled patients were assigned to receive two blinded doses of INM005 (n = 118) or placebo (n = 123). Median age was 54 years old, 65 1% were male and 61% had moderate disease at baseline. Median time from symptoms onset to study treatment was 6 days (interquartile range 5 to 8). No statistically significant difference was noted between study groups on primary endpoint (risk difference [95% IC]: 5 28% [-3 95; 14 50]; p = 0 15). Rate of improvement in at least two categories was statistically significantly higher for INM005 at days 14 and 21 of follow-up. Time to improvement in two ordinal categories or hospital discharge was 14 2 (§ 0 7) days in the INM005 group and 16 3 (§ 0 7) days in the placebo group, hazard ratio 1 31 (95% CI 1 0 to 1 74). Subgroup analyses showed a beneficial effect of INM005 over severe patients and in those with negative baseline antibodies. Overall mortality was 6 9% the INM005 group and 11 4% in the placebo group (risk difference [95% IC]: 0 57 [0 24 to 1 37]). Adverse events of special interest were mild or moderate; no anaphylaxis was reported. Interpretation: Albeit not having reached the primary endpoint, we found clinical improvement of hospitalized patients with SARS-CoV-2 pneumonia, particularly those with severe disease.Fil: Lopardo, Gustavo. Municipalidad de Vicente Lopez (buenos Aires). Hospital Municipal Doctor Bernardo Houssay.; ArgentinaFil: Belloso, Waldo H.. Hospital Italiano; ArgentinaFil: Nannini, Esteban. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Colonna, Mariana. Inmunova; ArgentinaFil: Sanguineti, Santiago. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Inmunova; ArgentinaFil: Zylberman, Vanesa. Inmunova; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Muñoz, Luciana. Inmunova; ArgentinaFil: Dobarro, Martín. Sanatorio Sagrado Corazón; ArgentinaFil: Lebersztein, Gabriel. Sanatorio Sagrado Corazón; ArgentinaFil: Farina, Javier. Gobierno de la Provincia de Buenos Aires. Hospital de Alta Complejidad Cuenca Alta Doctor Nestor Carlos Kirchner.; ArgentinaFil: Vidiella, Gabriela. Sanatorio Agote. Dr. Luis Agote; ArgentinaFil: Bertetti, Anselmo. Sanatorio Guemes Sociedad Anonima.; ArgentinaFil: Crudo, Favio. Universidad Nacional de San Antonio de Areco; ArgentinaFil: Alzogaray, Maria Fernanda. Instituto Medico Platense.; ArgentinaFil: Barcelona, Laura. Municipalidad de Vicente Lopez (buenos Aires). Hospital Municipal Doctor Bernardo Houssay.; ArgentinaFil: Teijeiro, Ricardo. Gobierno de la Ciudad Autónoma de Buenos Aires. Hospital General de Agudos Doctor Ignacio Pirovano; ArgentinaFil: Lambert, Sandra. Provincia de Buenos Aires. Ministerio de Salud. Hospital Alta Complejidad en Red El Cruce Dr. Néstor Carlos Kirchner Samic; ArgentinaFil: Scublinsky, Darío. Clinica Zabala.; ArgentinaFil: Iacono, Marisa. Provincia del Neuquen. Hospital Provincial Neuquen "dr. E. Castro Rendon"; ArgentinaFil: Stanek, Vanina. Hospital Italiano; ArgentinaFil: Solari, Rubén. Gobierno de la Ciudad de Buenos Aires. Hospital de Infecciosas "Dr. Francisco Javier Muñiz"; ArgentinaFil: Cruz, Pablo. No especifíca;Fil: Casas, Marcelo Martín. Clinica Adventista Belgrano; ArgentinaFil: Abusamra, Lorena. Hospital Municipal Dr. Diego Thompson; ArgentinaFil: Luciardi, Héctor Lucas. Provincia de Tucuman. Ministerio de Salud. Sistema Provincial de Salud. Hosp. Centro de Salud "zenon Santillan"; ArgentinaFil: Cremona, Alberto. Hospital Italiano de La Plata; ArgentinaFil: Caruso, Diego. Hospital Español; ArgentinaFil: de Miguel, Bernardo. No especifíca;Fil: Perez Lloret, Santiago. Pontificia Universidad Católica Argentina "Santa María de los Buenos Aires"; Argentina. Universidad Abierta Interamericana. Secretaría de Investigación. Centro de Altos Estudios En Ciencias Humanas y de la Salud - Sede Buenos Aires; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Millán, Susana. No especifíca;Fil: Kilstein, Yael. No especifíca;Fil: Pereiro, Ana. Fundación Mundo Sano; ArgentinaFil: Sued, Omar. Fundación Huésped; ArgentinaFil: Cahn, Pedro. Fundación Huésped; ArgentinaFil: Spatz, Linus. Inmunova; ArgentinaFil: Goldbaum, Fernando Alberto. Inmunova; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Instituto de Investigaciones Bioquímicas de Buenos Aires. Fundación Instituto Leloir. Instituto de Investigaciones Bioquímicas de Buenos Aires; Argentina. Universidad Nacional de San Martin. Centro de Rediseño E Ingenieria de Proteinas.; ArgentinaLancet Publishing Group2021-04info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/139002Lopardo, Gustavo; Belloso, Waldo H.; Nannini, Esteban; Colonna, Mariana; Sanguineti, Santiago; et al.; RBD-specific polyclonal F(ab´)2 fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, adaptive phase 2/3 clinical trial; Lancet Publishing Group; EClinicalMedicine; 34; 4-2021; 1-112589-5370CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://linkinghub.elsevier.com/retrieve/pii/S2589537021001231info:eu-repo/semantics/altIdentifier/doi/10.1016/j.eclinm.2021.100843info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T10:46:50Zoai:ri.conicet.gov.ar:11336/139002instacron: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 10:46:50.327CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv	RBD-specific polyclonal F(ab´)2 fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, adaptive phase 2/3 clinical trial
title	RBD-specific polyclonal F(ab´)2 fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, adaptive phase 2/3 clinical trial
spellingShingle	RBD-specific polyclonal F(ab´)2 fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, adaptive phase 2/3 clinical trial Lopardo, Gustavo PASSIVE IMMUNOTHERAPY COVID-19 EQUINE POLYCLONAL ANTIBODIES CLINICAL TRIAL
title_short	RBD-specific polyclonal F(ab´)2 fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, adaptive phase 2/3 clinical trial
title_full	RBD-specific polyclonal F(ab´)2 fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, adaptive phase 2/3 clinical trial
title_fullStr	RBD-specific polyclonal F(ab´)2 fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, adaptive phase 2/3 clinical trial
title_full_unstemmed	RBD-specific polyclonal F(ab´)2 fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, adaptive phase 2/3 clinical trial
title_sort	RBD-specific polyclonal F(ab´)2 fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, adaptive phase 2/3 clinical trial
dc.creator.none.fl_str_mv	Lopardo, Gustavo Belloso, Waldo H. Nannini, Esteban Colonna, Mariana Sanguineti, Santiago Zylberman, Vanesa Muñoz, Luciana Dobarro, Martín Lebersztein, Gabriel Farina, Javier Vidiella, Gabriela Bertetti, Anselmo Crudo, Favio Alzogaray, Maria Fernanda Barcelona, Laura Teijeiro, Ricardo Lambert, Sandra Scublinsky, Darío Iacono, Marisa Stanek, Vanina Solari, Rubén Cruz, Pablo Casas, Marcelo Martín Abusamra, Lorena Luciardi, Héctor Lucas Cremona, Alberto Caruso, Diego de Miguel, Bernardo Perez Lloret, Santiago Millán, Susana Kilstein, Yael Pereiro, Ana Sued, Omar Cahn, Pedro Spatz, Linus Goldbaum, Fernando Alberto
author	Lopardo, Gustavo
author_facet	Lopardo, Gustavo Belloso, Waldo H. Nannini, Esteban Colonna, Mariana Sanguineti, Santiago Zylberman, Vanesa Muñoz, Luciana Dobarro, Martín Lebersztein, Gabriel Farina, Javier Vidiella, Gabriela Bertetti, Anselmo Crudo, Favio Alzogaray, Maria Fernanda Barcelona, Laura Teijeiro, Ricardo Lambert, Sandra Scublinsky, Darío Iacono, Marisa Stanek, Vanina Solari, Rubén Cruz, Pablo Casas, Marcelo Martín Abusamra, Lorena Luciardi, Héctor Lucas Cremona, Alberto Caruso, Diego de Miguel, Bernardo Perez Lloret, Santiago Millán, Susana Kilstein, Yael Pereiro, Ana Sued, Omar Cahn, Pedro Spatz, Linus Goldbaum, Fernando Alberto
author_role	author
author2	Belloso, Waldo H. Nannini, Esteban Colonna, Mariana Sanguineti, Santiago Zylberman, Vanesa Muñoz, Luciana Dobarro, Martín Lebersztein, Gabriel Farina, Javier Vidiella, Gabriela Bertetti, Anselmo Crudo, Favio Alzogaray, Maria Fernanda Barcelona, Laura Teijeiro, Ricardo Lambert, Sandra Scublinsky, Darío Iacono, Marisa Stanek, Vanina Solari, Rubén Cruz, Pablo Casas, Marcelo Martín Abusamra, Lorena Luciardi, Héctor Lucas Cremona, Alberto Caruso, Diego de Miguel, Bernardo Perez Lloret, Santiago Millán, Susana Kilstein, Yael Pereiro, Ana Sued, Omar Cahn, Pedro Spatz, Linus Goldbaum, Fernando Alberto
author2_role	author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author
dc.subject.none.fl_str_mv	PASSIVE IMMUNOTHERAPY COVID-19 EQUINE POLYCLONAL ANTIBODIES CLINICAL TRIAL
topic	PASSIVE IMMUNOTHERAPY COVID-19 EQUINE POLYCLONAL ANTIBODIES CLINICAL TRIAL
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: passive immunotherapy is a therapeutic alternative for patients with COVID-19. Equine polyclonal antibodies (EpAbs) could represent a source of scalable neutralizing antibodies against SARS-CoV-2. Methods: we conducted a double-blind, randomized, placebo-controlled trial to assess efficacy and safety of EpAbs (INM005) in hospitalized adult patients with moderate and severe COVID-19 pneumonia in 19 hospitals of Argentina. Primary endpoint was improvement in at least two categories in WHO ordinal clinical scale at day 28 or hospital discharge (ClinicalTrials.gov number NCT04494984). Findings: between August 1st and October 26th, 2020, a total of 245 patients were enrolled. Enrolled patients were assigned to receive two blinded doses of INM005 (n = 118) or placebo (n = 123). Median age was 54 years old, 65 1% were male and 61% had moderate disease at baseline. Median time from symptoms onset to study treatment was 6 days (interquartile range 5 to 8). No statistically significant difference was noted between study groups on primary endpoint (risk difference [95% IC]: 5 28% [-3 95; 14 50]; p = 0 15). Rate of improvement in at least two categories was statistically significantly higher for INM005 at days 14 and 21 of follow-up. Time to improvement in two ordinal categories or hospital discharge was 14 2 (§ 0 7) days in the INM005 group and 16 3 (§ 0 7) days in the placebo group, hazard ratio 1 31 (95% CI 1 0 to 1 74). Subgroup analyses showed a beneficial effect of INM005 over severe patients and in those with negative baseline antibodies. Overall mortality was 6 9% the INM005 group and 11 4% in the placebo group (risk difference [95% IC]: 0 57 [0 24 to 1 37]). Adverse events of special interest were mild or moderate; no anaphylaxis was reported. Interpretation: Albeit not having reached the primary endpoint, we found clinical improvement of hospitalized patients with SARS-CoV-2 pneumonia, particularly those with severe disease. Fil: Lopardo, Gustavo. Municipalidad de Vicente Lopez (buenos Aires). Hospital Municipal Doctor Bernardo Houssay.; Argentina Fil: Belloso, Waldo H.. Hospital Italiano; Argentina Fil: Nannini, Esteban. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina Fil: Colonna, Mariana. Inmunova; Argentina Fil: Sanguineti, Santiago. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Inmunova; Argentina Fil: Zylberman, Vanesa. Inmunova; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina Fil: Muñoz, Luciana. Inmunova; Argentina Fil: Dobarro, Martín. Sanatorio Sagrado Corazón; Argentina Fil: Lebersztein, Gabriel. Sanatorio Sagrado Corazón; Argentina Fil: Farina, Javier. Gobierno de la Provincia de Buenos Aires. Hospital de Alta Complejidad Cuenca Alta Doctor Nestor Carlos Kirchner.; Argentina Fil: Vidiella, Gabriela. Sanatorio Agote. Dr. Luis Agote; Argentina Fil: Bertetti, Anselmo. Sanatorio Guemes Sociedad Anonima.; Argentina Fil: Crudo, Favio. Universidad Nacional de San Antonio de Areco; Argentina Fil: Alzogaray, Maria Fernanda. Instituto Medico Platense.; Argentina Fil: Barcelona, Laura. Municipalidad de Vicente Lopez (buenos Aires). Hospital Municipal Doctor Bernardo Houssay.; Argentina Fil: Teijeiro, Ricardo. Gobierno de la Ciudad Autónoma de Buenos Aires. Hospital General de Agudos Doctor Ignacio Pirovano; Argentina Fil: Lambert, Sandra. Provincia de Buenos Aires. Ministerio de Salud. Hospital Alta Complejidad en Red El Cruce Dr. Néstor Carlos Kirchner Samic; Argentina Fil: Scublinsky, Darío. Clinica Zabala.; Argentina Fil: Iacono, Marisa. Provincia del Neuquen. Hospital Provincial Neuquen "dr. E. Castro Rendon"; Argentina Fil: Stanek, Vanina. Hospital Italiano; Argentina Fil: Solari, Rubén. Gobierno de la Ciudad de Buenos Aires. Hospital de Infecciosas "Dr. Francisco Javier Muñiz"; Argentina Fil: Cruz, Pablo. No especifíca; Fil: Casas, Marcelo Martín. Clinica Adventista Belgrano; Argentina Fil: Abusamra, Lorena. Hospital Municipal Dr. Diego Thompson; Argentina Fil: Luciardi, Héctor Lucas. Provincia de Tucuman. Ministerio de Salud. Sistema Provincial de Salud. Hosp. Centro de Salud "zenon Santillan"; Argentina Fil: Cremona, Alberto. Hospital Italiano de La Plata; Argentina Fil: Caruso, Diego. Hospital Español; Argentina Fil: de Miguel, Bernardo. No especifíca; Fil: Perez Lloret, Santiago. Pontificia Universidad Católica Argentina "Santa María de los Buenos Aires"; Argentina. Universidad Abierta Interamericana. Secretaría de Investigación. Centro de Altos Estudios En Ciencias Humanas y de la Salud - Sede Buenos Aires; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina Fil: Millán, Susana. No especifíca; Fil: Kilstein, Yael. No especifíca; Fil: Pereiro, Ana. Fundación Mundo Sano; Argentina Fil: Sued, Omar. Fundación Huésped; Argentina Fil: Cahn, Pedro. Fundación Huésped; Argentina Fil: Spatz, Linus. Inmunova; Argentina Fil: Goldbaum, Fernando Alberto. Inmunova; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Instituto de Investigaciones Bioquímicas de Buenos Aires. Fundación Instituto Leloir. Instituto de Investigaciones Bioquímicas de Buenos Aires; Argentina. Universidad Nacional de San Martin. Centro de Rediseño E Ingenieria de Proteinas.; Argentina
description	Background: passive immunotherapy is a therapeutic alternative for patients with COVID-19. Equine polyclonal antibodies (EpAbs) could represent a source of scalable neutralizing antibodies against SARS-CoV-2. Methods: we conducted a double-blind, randomized, placebo-controlled trial to assess efficacy and safety of EpAbs (INM005) in hospitalized adult patients with moderate and severe COVID-19 pneumonia in 19 hospitals of Argentina. Primary endpoint was improvement in at least two categories in WHO ordinal clinical scale at day 28 or hospital discharge (ClinicalTrials.gov number NCT04494984). Findings: between August 1st and October 26th, 2020, a total of 245 patients were enrolled. Enrolled patients were assigned to receive two blinded doses of INM005 (n = 118) or placebo (n = 123). Median age was 54 years old, 65 1% were male and 61% had moderate disease at baseline. Median time from symptoms onset to study treatment was 6 days (interquartile range 5 to 8). No statistically significant difference was noted between study groups on primary endpoint (risk difference [95% IC]: 5 28% [-3 95; 14 50]; p = 0 15). Rate of improvement in at least two categories was statistically significantly higher for INM005 at days 14 and 21 of follow-up. Time to improvement in two ordinal categories or hospital discharge was 14 2 (§ 0 7) days in the INM005 group and 16 3 (§ 0 7) days in the placebo group, hazard ratio 1 31 (95% CI 1 0 to 1 74). Subgroup analyses showed a beneficial effect of INM005 over severe patients and in those with negative baseline antibodies. Overall mortality was 6 9% the INM005 group and 11 4% in the placebo group (risk difference [95% IC]: 0 57 [0 24 to 1 37]). Adverse events of special interest were mild or moderate; no anaphylaxis was reported. Interpretation: Albeit not having reached the primary endpoint, we found clinical improvement of hospitalized patients with SARS-CoV-2 pneumonia, particularly those with severe disease.
publishDate	2021
dc.date.none.fl_str_mv	2021-04
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/11336/139002 Lopardo, Gustavo; Belloso, Waldo H.; Nannini, Esteban; Colonna, Mariana; Sanguineti, Santiago; et al.; RBD-specific polyclonal F(ab´)2 fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, adaptive phase 2/3 clinical trial; Lancet Publishing Group; EClinicalMedicine; 34; 4-2021; 1-11 2589-5370 CONICET Digital CONICET
url	http://hdl.handle.net/11336/139002
identifier_str_mv	Lopardo, Gustavo; Belloso, Waldo H.; Nannini, Esteban; Colonna, Mariana; Sanguineti, Santiago; et al.; RBD-specific polyclonal F(ab´)2 fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, adaptive phase 2/3 clinical trial; Lancet Publishing Group; EClinicalMedicine; 34; 4-2021; 1-11 2589-5370 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://linkinghub.elsevier.com/retrieve/pii/S2589537021001231 info:eu-repo/semantics/altIdentifier/doi/10.1016/j.eclinm.2021.100843
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dc.publisher.none.fl_str_mv	Lancet Publishing Group
publisher.none.fl_str_mv	Lancet Publishing Group
dc.source.none.fl_str_mv	reponame:CONICET Digital (CONICET) instname:Consejo Nacional de Investigaciones Científicas y Técnicas
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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
_version_	1844614510643511296
score	13.070432

RBD-specific polyclonal F(ab´)2 fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, ad...

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