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https://repositorio.uca.edu.ar/handle/123456789/11639
Campo DC | Valor | Lengua/Idioma |
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dc.contributor.author | Lopardo, Gustavo | es |
dc.contributor.author | Belloso, Waldo H. | es |
dc.contributor.author | Nannini, Esteban | es |
dc.contributor.author | Colonna, Mariana | es |
dc.contributor.author | Sanguineti, Santiago | es |
dc.contributor.author | Zylberman, Vanesa | es |
dc.contributor.author | Munoz, Luciana | es |
dc.contributor.author | Dobarro, Martín | es |
dc.contributor.author | Lebersztein, Gabriel | es |
dc.contributor.author | Farina, Javier | es |
dc.contributor.author | Vidiella, Gabriela | es |
dc.contributor.author | Bertetti, Anselmo | es |
dc.contributor.author | Crudo, Favio | es |
dc.contributor.author | Alzogaray, Maria Fernanda | es |
dc.contributor.author | Barcelona, Laura | es |
dc.contributor.author | Teijeiro, Ricardo | es |
dc.contributor.author | Lambert, Sandra | es |
dc.contributor.author | Scublinsky, Darío | es |
dc.contributor.author | Iacono, Marisa | es |
dc.contributor.author | Stanek, Vanina | es |
dc.contributor.author | Solari, Ruben | es |
dc.contributor.author | Cruz, Pablo | es |
dc.contributor.author | Casas, Marcelo Martín | es |
dc.contributor.author | Abusamra, Lorena | es |
dc.contributor.author | Luciardi, Hector Lucas | es |
dc.contributor.author | Cremona, Alberto | es |
dc.contributor.author | Caruso, Diego | es |
dc.contributor.author | Miguel, Bernardo de | es |
dc.contributor.author | Millan, Susana | es |
dc.contributor.author | Kilstein, Yael | es |
dc.contributor.author | Pereiro, Ana | es |
dc.contributor.author | Sued, Omar | es |
dc.contributor.author | Cahn, Pedro | es |
dc.contributor.author | Spatz, Linus | es |
dc.contributor.author | Goldbaum, Fernando | es |
dc.contributor.author | Pérez Lloret, Santiago | es |
dc.contributor.other | INM005 Study Group | es |
dc.date.accessioned | 2021-06-16T15:04:49Z | - |
dc.date.available | 2021-06-16T15:04:49Z | - |
dc.date.issued | 2021 | - |
dc.identifier.citation | 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 | es |
dc.identifier.issn | 2589-5370 | - |
dc.identifier.uri | https://repositorio.uca.edu.ar/handle/123456789/11639 | - |
dc.description.abstract | 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. | es |
dc.format | application/pdf | es |
dc.language.iso | eng | es |
dc.publisher | Elsevier | es |
dc.rights | Acceso abierto | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-sa/4.0/ | * |
dc.source | EClinicalMedicine Vol.34, 100843, 2021 | es |
dc.subject | COVID-19 | es |
dc.subject | INMUNIZACION PASIVA | es |
dc.subject | ANTICUERPOS NEUTRALIZANTES | es |
dc.subject | NEUMONIA | es |
dc.subject | TRATAMIENTO MEDICO | es |
dc.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 | es |
dc.type | Artículo | es |
dc.identifier.doi | https://doi.org/10.1016/j.eclinm.2021.100843 | - |
dc.identifier.pmid | 33870149 | - |
uca.disciplina | MEDICINA | es |
uca.issnrd | 1 | es |
uca.affiliation | Fil: Lopardo, Gustavo. Hospital Municipal Dr. Bernardo Houssay; Argentina | es |
uca.affiliation | Fil: Lopardo, Gustavo. Fundación del Centro de Estudios Infectológicos; Argentina | es |
uca.affiliation | Fil: Belloso, Waldo H. Hospital Italiano de Buenos Aires. Department of Research; Argentina | es |
uca.affiliation | Fil: Nannini, Esteban. Sanatorio Británico. Departamento de Enfermedades Infecciosas; Argentina | es |
uca.affiliation | Fil: Nannini, Esteban. Consejo Nacional de Investigaciones Científicas y Tecnicas; Argentina | es |
uca.affiliation | Fil: Colonna, Mariana. Inmunova S.A; Argentina | es |
uca.affiliation | Fil: Sanguineti, Santiago. Inmunova S.A; Argentina | es |
uca.affiliation | Fil: Zylberman, Vanesa. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina | es |
uca.affiliation | Fil: Zylberman, Vanesa. Inmunova S.A; Argentina | es |
uca.affiliation | Fil: Munoz, Luciana. Inmunova S.A; Argentina | es |
uca.affiliation | Fil: Dobarro, Martín. Sanatorio Sagrado Corazón; Argentina | es |
uca.affiliation | Fil: Lebersztein, Gabriel. Sanatorio Sagrado Corazón; Argentina | es |
uca.affiliation | Fil: Farina, Javier. Hospital de Alta Complejidad Cuenca Alta Néstor Kirchner; Argentina | es |
uca.affiliation | Fil: Vidiella, Gabriela. Sanatorio Agote; Argentina | es |
uca.affiliation | Fil: Bertetti, Anselmo. Sanatorio Güemes; Argentina | es |
uca.affiliation | Fil: Crudo, Favio. Hospital Municipal Emilio Zerboni; Argentina | es |
uca.affiliation | Fil: Crudo, Favio. Universidad Nacional de San Antonio de Areco; Argentina | es |
uca.affiliation | Fil: Alzogaray, María Fernanda. Instituto Medico Platense; Argentina | es |
uca.affiliation | Fil: Barcelona, Laura. Hospital Municipal Dr. Bernardo Houssay; Argentina | es |
uca.affiliation | Fil: Teijeiro, Ricardo. Hospital General de Agudos Dr. Ignacio Pirovano; Argentina | es |
uca.affiliation | Fil: Lambert, Sandra. Hospital de Alta Complejidad El Cruce Néstor Kirchner; Argentina | es |
uca.affiliation | Fil: Scublinsky, Darío. Clínica Zabala; Argentina | es |
uca.affiliation | Fil: Iacono, Marisa. Hospital Provincial Neuquén Dr. Castro Rendón; Argentina | es |
uca.affiliation | Fil: Stanek, Vanina. Hospital Italiano de Buenos Aires. Servicio de Medicina Interna. Sección de Infectología; Argentina | es |
uca.affiliation | Fil: Solari, Ruben. Hospital de Infecciosas Francisco Javier Muñiz; Argentina | es |
uca.affiliation | Fil: Cruz, Pablo. Centro Gallego de Buenos Aires; Argentina | es |
uca.affiliation | Fil: Casas, Marcelo Martín. Clínica Adventista Belgrano; Argentina | es |
uca.affiliation | Fil: Abusamra, Lorena. Hospital Municipal Dr. Diego Thompson; Argentina | es |
uca.affiliation | Fil: Luciardi, Hector Lucas. Hospital Centro de Salud Zenón J. Santillán; Argentina | es |
uca.affiliation | Fil: Cremona, Alberto. Hospital Italiano La Plata; Argentina | es |
uca.affiliation | Fil: Caruso, Diego. Hospital Español; Argentina | es |
uca.affiliation | Fil: Miguel, Bernardo de. mAbxience; España | es |
uca.affiliation | Fil: Millan, Susana. mAbxience; España | es |
uca.affiliation | Fil: Kilstein, Yael. Hospital Municipal Dr. Bernardo Houssay; Argentina | es |
uca.affiliation | Fil: Kilstein, Yael. Hospital Italiano de Buenos Aires. Department of Research; Argentina | es |
uca.affiliation | Fil: Pereiro, Ana. Hospital Municipal Dr. Bernardo Houssay; Argentina | es |
uca.affiliation | Fil: Pereiro, Ana. Sanatorio Británico. Departamento de Enfermedades Infecciosas; Argentina | es |
uca.affiliation | Fil: Sued, Omar. Hospital Municipal Dr. Bernardo Houssay; Argentina | es |
uca.affiliation | Fil: Sued, Omar. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina | es |
uca.affiliation | Fil: Cahn, Pedro. Hospital Municipal Dr. Bernardo Houssay; Argentina | es |
uca.affiliation | Fil: Cahn, Pedro. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina | es |
uca.affiliation | Fil: Spatz, Linus. Inmunova S.A.; Argentina | es |
uca.affiliation | Fil: Goldbaum, Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones Bioquímicas de Buenos Aires; Argentina | es |
uca.affiliation | Fil: Goldbaum, Fernando. Inmunova S.A.; Argentina | es |
uca.affiliation | Fil: Goldbaum, Fernando. Fundación Instituto Leloir; Argentina | es |
uca.affiliation | Fil: Goldbaum, Fernando. Universidad Nacional de San Martín Campus Miguelete. Centro de Rediseño e Ingeniería en Proteínas; Argentina | es |
uca.affiliation | Fil: Pérez Lloret, Santiago. Consejo Nacional de Investigaciones Científicas y Tecnicas; Argentina | es |
uca.affiliation | Fil: Pérez Lloret, Santiago. Pontificia Universidad Católica Argentina. Facultad de Ciencias Médicas. Departamento de Docencia e Investigación; Argentina | es |
uca.affiliation | Fil: Pérez Lloret, Santiago. Universidad Abierta Interamericana. Centro de Altos Estudios en Ciencias Humanas y de la Salud; Argentina | es |
uca.version | publishedVersion | es |
item.fulltext | With Fulltext | - |
item.grantfulltext | open | - |
item.languageiso639-1 | en | - |
crisitem.author.dept | Laboratorio de Neurobiología Molecular | - |
crisitem.author.dept | Consejo Nacional de Investigaciones Científicas y Técnicas | - |
crisitem.author.orcid | 0000-0001-9069-6512 | - |
crisitem.author.parentorg | Instituto de Investigaciones Biomédicas - BIOMED | - |
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