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; Munoz, 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, Ruben; Cruz, Pablo; Casas, Marcelo Martín; Abusamra, Lorena; Luciardi, Hector Lucas; Cremona, Alberto; Caruso, Diego; Miguel, Bernardo de; Millan, Susana; Kilstein, Yael; Pereiro, Ana; Sued, Omar; Cahn, Pedro; Spatz, Linus; Goldbaum, Fernando; Pérez Lloret, Santiago
- Año de publicación
- 2021
- Idioma
- inglés
- Tipo de recurso
- artículo
- Estado
- versión publicada
- Descripción
- Fil: Lopardo, Gustavo. Hospital Municipal Dr. Bernardo Houssay; Argentina
Fil: Lopardo, Gustavo. Fundación del Centro de Estudios Infectológicos; Argentina
Fil: Belloso, Waldo H. Hospital Italiano de Buenos Aires. Department of Research; Argentina
Fil: Nannini, Esteban. Sanatorio Británico. Departamento de Enfermedades Infecciosas; Argentina
Fil: Nannini, Esteban. Consejo Nacional de Investigaciones Científicas y Tecnicas; Argentina
Fil: Colonna, Mariana. Inmunova S.A; Argentina
Fil: Sanguineti, Santiago. Inmunova S.A; Argentina
Fil: Zylberman, Vanesa. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Zylberman, Vanesa. Inmunova S.A; Argentina
Fil: Munoz, Luciana. Inmunova S.A; Argentina
Fil: Dobarro, Martín. Sanatorio Sagrado Corazón; Argentina
Fil: Lebersztein, Gabriel. Sanatorio Sagrado Corazón; Argentina
Fil: Farina, Javier. Hospital de Alta Complejidad Cuenca Alta Néstor Kirchner; Argentina
Fil: Vidiella, Gabriela. Sanatorio Agote; Argentina
Fil: Bertetti, Anselmo. Sanatorio Güemes; Argentina
Fil: Crudo, Favio. Hospital Municipal Emilio Zerboni; Argentina
Fil: Crudo, Favio. Universidad Nacional de San Antonio de Areco; Argentina
Fil: Alzogaray, María Fernanda. Instituto Medico Platense; Argentina
Fil: Barcelona, Laura. Hospital Municipal Dr. Bernardo Houssay; Argentina
Fil: Teijeiro, Ricardo. Hospital General de Agudos Dr. Ignacio Pirovano; Argentina
Fil: Lambert, Sandra. Hospital de Alta Complejidad El Cruce Néstor Kirchner; Argentina
Fil: Scublinsky, Darío. Clínica Zabala; Argentina
Fil: Iacono, Marisa. Hospital Provincial Neuquén Dr. Castro Rendón; Argentina
Fil: Stanek, Vanina. Hospital Italiano de Buenos Aires. Servicio de Medicina Interna. Sección de Infectología; Argentina
Fil: Solari, Ruben. Hospital de Infecciosas Francisco Javier Muñiz; Argentina
Fil: Cruz, Pablo. Centro Gallego de Buenos Aires; Argentina
Fil: Casas, Marcelo Martín. Clínica Adventista Belgrano; Argentina
Fil: Abusamra, Lorena. Hospital Municipal Dr. Diego Thompson; Argentina
Fil: Luciardi, Hector Lucas. Hospital Centro de Salud Zenón J. Santillán; Argentina
Fil: Cremona, Alberto. Hospital Italiano La Plata; Argentina
Fil: Caruso, Diego. Hospital Español; Argentina
Fil: Miguel, Bernardo de. mAbxience; España
Fil: Millan, Susana. mAbxience; España
Fil: Kilstein, Yael. Hospital Municipal Dr. Bernardo Houssay; Argentina
Fil: Kilstein, Yael. Hospital Italiano de Buenos Aires. Department of Research; Argentina
Fil: Pereiro, Ana. Hospital Municipal Dr. Bernardo Houssay; Argentina
Fil: Pereiro, Ana. Sanatorio Británico. Departamento de Enfermedades Infecciosas; Argentina
Fil: Sued, Omar. Hospital Municipal Dr. Bernardo Houssay; Argentina
Fil: Sued, Omar. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Cahn, Pedro. Hospital Municipal Dr. Bernardo Houssay; Argentina
Fil: Cahn, Pedro. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Spatz, Linus. Inmunova S.A.; Argentina
Fil: Goldbaum, Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones Bioquímicas de Buenos Aires; Argentina
Fil: Goldbaum, Fernando. Inmunova S.A.; Argentina
Fil: Goldbaum, Fernando. Fundación Instituto Leloir; Argentina
Fil: Goldbaum, Fernando. Universidad Nacional de San Martín Campus Miguelete. Centro de Rediseño e Ingeniería en Proteínas; Argentina
Fil: Pérez Lloret, Santiago. Consejo Nacional de Investigaciones Científicas y Tecnicas; Argentina
Fil: Pérez Lloret, Santiago. Pontificia Universidad Católica Argentina. Facultad de Ciencias Médicas. Departamento de Docencia e Investigación; Argentina
Fil: Pérez Lloret, Santiago. Universidad Abierta Interamericana. Centro de Altos Estudios en Ciencias Humanas y de la Salud; Argentina
Abstract: 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. - Fuente
- EClinicalMedicine Vol.34, 100843, 2021
- Materia
-
COVID-19
INMUNIZACION PASIVA
ANTICUERPOS NEUTRALIZANTES
NEUMONIA
TRATAMIENTO MEDICO - Nivel de accesibilidad
- acceso abierto
- Condiciones de uso
- https://creativecommons.org/licenses/by-nc-sa/4.0/
- Repositorio
.jpg)
- Institución
- Pontificia Universidad Católica Argentina
- OAI Identificador
- oai:ucacris:123456789/11639
Ver los metadatos del registro completo
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| network_acronym_str |
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| repository_id_str |
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| network_name_str |
Repositorio Institucional (UCA) |
| 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, VanesaMunoz, LucianaDobarro, MartínLebersztein, GabrielFarina, JavierVidiella, GabrielaBertetti, AnselmoCrudo, FavioAlzogaray, Maria FernandaBarcelona, LauraTeijeiro, RicardoLambert, SandraScublinsky, DaríoIacono, MarisaStanek, VaninaSolari, RubenCruz, PabloCasas, Marcelo MartínAbusamra, LorenaLuciardi, Hector LucasCremona, AlbertoCaruso, DiegoMiguel, Bernardo deMillan, SusanaKilstein, YaelPereiro, AnaSued, OmarCahn, PedroSpatz, LinusGoldbaum, FernandoPérez Lloret, SantiagoCOVID-19INMUNIZACION PASIVAANTICUERPOS NEUTRALIZANTESNEUMONIATRATAMIENTO MEDICOFil: Lopardo, Gustavo. Hospital Municipal Dr. Bernardo Houssay; ArgentinaFil: Lopardo, Gustavo. Fundación del Centro de Estudios Infectológicos; ArgentinaFil: Belloso, Waldo H. Hospital Italiano de Buenos Aires. Department of Research; ArgentinaFil: Nannini, Esteban. Sanatorio Británico. Departamento de Enfermedades Infecciosas; ArgentinaFil: Nannini, Esteban. Consejo Nacional de Investigaciones Científicas y Tecnicas; ArgentinaFil: Colonna, Mariana. Inmunova S.A; ArgentinaFil: Sanguineti, Santiago. Inmunova S.A; ArgentinaFil: Zylberman, Vanesa. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Zylberman, Vanesa. Inmunova S.A; ArgentinaFil: Munoz, Luciana. Inmunova S.A; ArgentinaFil: Dobarro, Martín. Sanatorio Sagrado Corazón; ArgentinaFil: Lebersztein, Gabriel. Sanatorio Sagrado Corazón; ArgentinaFil: Farina, Javier. Hospital de Alta Complejidad Cuenca Alta Néstor Kirchner; ArgentinaFil: Vidiella, Gabriela. Sanatorio Agote; ArgentinaFil: Bertetti, Anselmo. Sanatorio Güemes; ArgentinaFil: Crudo, Favio. Hospital Municipal Emilio Zerboni; ArgentinaFil: Crudo, Favio. Universidad Nacional de San Antonio de Areco; ArgentinaFil: Alzogaray, María Fernanda. Instituto Medico Platense; ArgentinaFil: Barcelona, Laura. Hospital Municipal Dr. Bernardo Houssay; ArgentinaFil: Teijeiro, Ricardo. Hospital General de Agudos Dr. Ignacio Pirovano; ArgentinaFil: Lambert, Sandra. Hospital de Alta Complejidad El Cruce Néstor Kirchner; ArgentinaFil: Scublinsky, Darío. Clínica Zabala; ArgentinaFil: Iacono, Marisa. Hospital Provincial Neuquén Dr. Castro Rendón; ArgentinaFil: Stanek, Vanina. Hospital Italiano de Buenos Aires. Servicio de Medicina Interna. Sección de Infectología; ArgentinaFil: Solari, Ruben. Hospital de Infecciosas Francisco Javier Muñiz; ArgentinaFil: Cruz, Pablo. Centro Gallego de Buenos Aires; ArgentinaFil: Casas, Marcelo Martín. Clínica Adventista Belgrano; ArgentinaFil: Abusamra, Lorena. Hospital Municipal Dr. Diego Thompson; ArgentinaFil: Luciardi, Hector Lucas. Hospital Centro de Salud Zenón J. Santillán; ArgentinaFil: Cremona, Alberto. Hospital Italiano La Plata; ArgentinaFil: Caruso, Diego. Hospital Español; ArgentinaFil: Miguel, Bernardo de. mAbxience; EspañaFil: Millan, Susana. mAbxience; EspañaFil: Kilstein, Yael. Hospital Municipal Dr. Bernardo Houssay; ArgentinaFil: Kilstein, Yael. Hospital Italiano de Buenos Aires. Department of Research; ArgentinaFil: Pereiro, Ana. Hospital Municipal Dr. Bernardo Houssay; ArgentinaFil: Pereiro, Ana. Sanatorio Británico. Departamento de Enfermedades Infecciosas; ArgentinaFil: Sued, Omar. Hospital Municipal Dr. Bernardo Houssay; ArgentinaFil: Sued, Omar. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Cahn, Pedro. Hospital Municipal Dr. Bernardo Houssay; ArgentinaFil: Cahn, Pedro. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Spatz, Linus. Inmunova S.A.; ArgentinaFil: Goldbaum, Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones Bioquímicas de Buenos Aires; ArgentinaFil: Goldbaum, Fernando. Inmunova S.A.; ArgentinaFil: Goldbaum, Fernando. Fundación Instituto Leloir; ArgentinaFil: Goldbaum, Fernando. Universidad Nacional de San Martín Campus Miguelete. Centro de Rediseño e Ingeniería en Proteínas; ArgentinaFil: Pérez Lloret, Santiago. Consejo Nacional de Investigaciones Científicas y Tecnicas; ArgentinaFil: Pérez Lloret, Santiago. Pontificia Universidad Católica Argentina. Facultad de Ciencias Médicas. Departamento de Docencia e Investigación; ArgentinaFil: Pérez Lloret, Santiago. Universidad Abierta Interamericana. Centro de Altos Estudios en Ciencias Humanas y de la Salud; ArgentinaAbstract: 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.ElsevierINM005 Study Group2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfhttps://repositorio.uca.edu.ar/handle/123456789/116392589-5370https://doi.org/10.1016/j.eclinm.2021.10084333870149Lopardo, G., 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 [en línea]. Postprint del artículo publicado en: EClinicalMedicine. 2021, 34 (100843). doi:10.1016/j.eclinm.2021.100843. Disponible en: https://repositorio.uca.edu.ar/handle/123456789/11639EClinicalMedicine Vol.34, 100843, 2021reponame:Repositorio Institucional (UCA)instname:Pontificia Universidad Católica Argentinaenginfo:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/4.0/2025-07-03T10:57:51Zoai:ucacris:123456789/11639instacron:UCAInstitucionalhttps://repositorio.uca.edu.ar/Universidad privadaNo correspondehttps://repositorio.uca.edu.ar/oaiclaudia_fernandez@uca.edu.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:25852025-07-03 10:57:51.714Repositorio Institucional (UCA) - Pontificia Universidad Católica Argentinafalse |
| 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 COVID-19 INMUNIZACION PASIVA ANTICUERPOS NEUTRALIZANTES NEUMONIA TRATAMIENTO MEDICO |
| 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 Munoz, 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, Ruben Cruz, Pablo Casas, Marcelo Martín Abusamra, Lorena Luciardi, Hector Lucas Cremona, Alberto Caruso, Diego Miguel, Bernardo de Millan, Susana Kilstein, Yael Pereiro, Ana Sued, Omar Cahn, Pedro Spatz, Linus Goldbaum, Fernando Pérez Lloret, Santiago |
| author |
Lopardo, Gustavo |
| author_facet |
Lopardo, Gustavo Belloso, Waldo H. Nannini, Esteban Colonna, Mariana Sanguineti, Santiago Zylberman, Vanesa Munoz, 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, Ruben Cruz, Pablo Casas, Marcelo Martín Abusamra, Lorena Luciardi, Hector Lucas Cremona, Alberto Caruso, Diego Miguel, Bernardo de Millan, Susana Kilstein, Yael Pereiro, Ana Sued, Omar Cahn, Pedro Spatz, Linus Goldbaum, Fernando Pérez Lloret, Santiago |
| author_role |
author |
| author2 |
Belloso, Waldo H. Nannini, Esteban Colonna, Mariana Sanguineti, Santiago Zylberman, Vanesa Munoz, 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, Ruben Cruz, Pablo Casas, Marcelo Martín Abusamra, Lorena Luciardi, Hector Lucas Cremona, Alberto Caruso, Diego Miguel, Bernardo de Millan, Susana Kilstein, Yael Pereiro, Ana Sued, Omar Cahn, Pedro Spatz, Linus Goldbaum, Fernando Pérez Lloret, Santiago |
| 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.contributor.none.fl_str_mv |
INM005 Study Group |
| dc.subject.none.fl_str_mv |
COVID-19 INMUNIZACION PASIVA ANTICUERPOS NEUTRALIZANTES NEUMONIA TRATAMIENTO MEDICO |
| topic |
COVID-19 INMUNIZACION PASIVA ANTICUERPOS NEUTRALIZANTES NEUMONIA TRATAMIENTO MEDICO |
| dc.description.none.fl_txt_mv |
Fil: Lopardo, Gustavo. Hospital Municipal Dr. Bernardo Houssay; Argentina Fil: Lopardo, Gustavo. Fundación del Centro de Estudios Infectológicos; Argentina Fil: Belloso, Waldo H. Hospital Italiano de Buenos Aires. Department of Research; Argentina Fil: Nannini, Esteban. Sanatorio Británico. Departamento de Enfermedades Infecciosas; Argentina Fil: Nannini, Esteban. Consejo Nacional de Investigaciones Científicas y Tecnicas; Argentina Fil: Colonna, Mariana. Inmunova S.A; Argentina Fil: Sanguineti, Santiago. Inmunova S.A; Argentina Fil: Zylberman, Vanesa. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina Fil: Zylberman, Vanesa. Inmunova S.A; Argentina Fil: Munoz, Luciana. Inmunova S.A; Argentina Fil: Dobarro, Martín. Sanatorio Sagrado Corazón; Argentina Fil: Lebersztein, Gabriel. Sanatorio Sagrado Corazón; Argentina Fil: Farina, Javier. Hospital de Alta Complejidad Cuenca Alta Néstor Kirchner; Argentina Fil: Vidiella, Gabriela. Sanatorio Agote; Argentina Fil: Bertetti, Anselmo. Sanatorio Güemes; Argentina Fil: Crudo, Favio. Hospital Municipal Emilio Zerboni; Argentina Fil: Crudo, Favio. Universidad Nacional de San Antonio de Areco; Argentina Fil: Alzogaray, María Fernanda. Instituto Medico Platense; Argentina Fil: Barcelona, Laura. Hospital Municipal Dr. Bernardo Houssay; Argentina Fil: Teijeiro, Ricardo. Hospital General de Agudos Dr. Ignacio Pirovano; Argentina Fil: Lambert, Sandra. Hospital de Alta Complejidad El Cruce Néstor Kirchner; Argentina Fil: Scublinsky, Darío. Clínica Zabala; Argentina Fil: Iacono, Marisa. Hospital Provincial Neuquén Dr. Castro Rendón; Argentina Fil: Stanek, Vanina. Hospital Italiano de Buenos Aires. Servicio de Medicina Interna. Sección de Infectología; Argentina Fil: Solari, Ruben. Hospital de Infecciosas Francisco Javier Muñiz; Argentina Fil: Cruz, Pablo. Centro Gallego de Buenos Aires; Argentina Fil: Casas, Marcelo Martín. Clínica Adventista Belgrano; Argentina Fil: Abusamra, Lorena. Hospital Municipal Dr. Diego Thompson; Argentina Fil: Luciardi, Hector Lucas. Hospital Centro de Salud Zenón J. Santillán; Argentina Fil: Cremona, Alberto. Hospital Italiano La Plata; Argentina Fil: Caruso, Diego. Hospital Español; Argentina Fil: Miguel, Bernardo de. mAbxience; España Fil: Millan, Susana. mAbxience; España Fil: Kilstein, Yael. Hospital Municipal Dr. Bernardo Houssay; Argentina Fil: Kilstein, Yael. Hospital Italiano de Buenos Aires. Department of Research; Argentina Fil: Pereiro, Ana. Hospital Municipal Dr. Bernardo Houssay; Argentina Fil: Pereiro, Ana. Sanatorio Británico. Departamento de Enfermedades Infecciosas; Argentina Fil: Sued, Omar. Hospital Municipal Dr. Bernardo Houssay; Argentina Fil: Sued, Omar. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina Fil: Cahn, Pedro. Hospital Municipal Dr. Bernardo Houssay; Argentina Fil: Cahn, Pedro. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina Fil: Spatz, Linus. Inmunova S.A.; Argentina Fil: Goldbaum, Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones Bioquímicas de Buenos Aires; Argentina Fil: Goldbaum, Fernando. Inmunova S.A.; Argentina Fil: Goldbaum, Fernando. Fundación Instituto Leloir; Argentina Fil: Goldbaum, Fernando. Universidad Nacional de San Martín Campus Miguelete. Centro de Rediseño e Ingeniería en Proteínas; Argentina Fil: Pérez Lloret, Santiago. Consejo Nacional de Investigaciones Científicas y Tecnicas; Argentina Fil: Pérez Lloret, Santiago. Pontificia Universidad Católica Argentina. Facultad de Ciencias Médicas. Departamento de Docencia e Investigación; Argentina Fil: Pérez Lloret, Santiago. Universidad Abierta Interamericana. Centro de Altos Estudios en Ciencias Humanas y de la Salud; Argentina Abstract: 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. |
| description |
Fil: Lopardo, Gustavo. Hospital Municipal Dr. Bernardo Houssay; Argentina |
| publishDate |
2021 |
| dc.date.none.fl_str_mv |
2021 |
| 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 |
https://repositorio.uca.edu.ar/handle/123456789/11639 2589-5370 https://doi.org/10.1016/j.eclinm.2021.100843 33870149 Lopardo, G., 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 [en línea]. Postprint del artículo publicado en: EClinicalMedicine. 2021, 34 (100843). doi:10.1016/j.eclinm.2021.100843. Disponible en: https://repositorio.uca.edu.ar/handle/123456789/11639 |
| url |
https://repositorio.uca.edu.ar/handle/123456789/11639 https://doi.org/10.1016/j.eclinm.2021.100843 |
| identifier_str_mv |
2589-5370 33870149 Lopardo, G., 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 [en línea]. Postprint del artículo publicado en: EClinicalMedicine. 2021, 34 (100843). doi:10.1016/j.eclinm.2021.100843. Disponible en: https://repositorio.uca.edu.ar/handle/123456789/11639 |
| dc.language.none.fl_str_mv |
eng |
| language |
eng |
| dc.rights.none.fl_str_mv |
info:eu-repo/semantics/openAccess https://creativecommons.org/licenses/by-nc-sa/4.0/ |
| eu_rights_str_mv |
openAccess |
| rights_invalid_str_mv |
https://creativecommons.org/licenses/by-nc-sa/4.0/ |
| dc.format.none.fl_str_mv |
application/pdf |
| dc.publisher.none.fl_str_mv |
Elsevier |
| publisher.none.fl_str_mv |
Elsevier |
| dc.source.none.fl_str_mv |
EClinicalMedicine Vol.34, 100843, 2021 reponame:Repositorio Institucional (UCA) instname:Pontificia Universidad Católica Argentina |
| reponame_str |
Repositorio Institucional (UCA) |
| collection |
Repositorio Institucional (UCA) |
| instname_str |
Pontificia Universidad Católica Argentina |
| repository.name.fl_str_mv |
Repositorio Institucional (UCA) - Pontificia Universidad Católica Argentina |
| repository.mail.fl_str_mv |
claudia_fernandez@uca.edu.ar |
| _version_ |
1836638355602800640 |
| score |
12.993085 |