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dc.contributor.author
Lopardo, Gustavo
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Belloso, Waldo H.
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Nannini, Esteban
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Colonna, Mariana
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Sanguineti, Santiago
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Zylberman, Vanesa
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Muñoz, Luciana
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Dobarro, Martín
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Lebersztein, Gabriel
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Farina, Javier
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Vidiella, Gabriela
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Bertetti, Anselmo
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Crudo, Favio
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Alzogaray, Maria Fernanda
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Barcelona, Laura
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Teijeiro, Ricardo
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Lambert, Sandra
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Scublinsky, Darío
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Iacono, Marisa
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Stanek, Vanina
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Solari, Rubén
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Cruz, Pablo
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Casas, Marcelo Martín
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Abusamra, Lorena
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Luciardi, Héctor Lucas
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Cremona, Alberto
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Caruso, Diego
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de Miguel, Bernardo
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Perez Lloret, Santiago
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Millán, Susana
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Kilstein, Yael
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Pereiro, Ana
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Sued, Omar
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Cahn, Pedro
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Spatz, Linus
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Goldbaum, Fernando Alberto
dc.date.available
2021-08-26T16:12:23Z
dc.date.issued
2021-04
dc.identifier.citation
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
dc.identifier.issn
2589-5370
dc.identifier.uri
http://hdl.handle.net/11336/139002
dc.description.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.
dc.format
application/pdf
dc.language.iso
eng
dc.publisher
Lancet Publishing Group
dc.rights
info:eu-repo/semantics/openAccess
dc.rights.uri
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.subject
PASSIVE IMMUNOTHERAPY
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COVID-19
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EQUINE POLYCLONAL ANTIBODIES
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CLINICAL TRIAL
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Enfermedades Infecciosas
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Ciencias de la Salud
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CIENCIAS MÉDICAS Y DE LA SALUD
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
dc.type
info:eu-repo/semantics/article
dc.type
info:ar-repo/semantics/artículo
dc.type
info:eu-repo/semantics/publishedVersion
dc.date.updated
2021-08-25T17:41:15Z
dc.journal.volume
34
dc.journal.pagination
1-11
dc.journal.pais
Reino Unido
dc.journal.ciudad
londres
dc.description.fil
Fil: Lopardo, Gustavo. Municipalidad de Vicente Lopez (buenos Aires). Hospital Municipal Doctor Bernardo Houssay.; Argentina
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Fil: Belloso, Waldo H.. Hospital Italiano; Argentina
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Fil: Nannini, Esteban. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
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Fil: Colonna, Mariana. Inmunova; Argentina
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Fil: Sanguineti, Santiago. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Inmunova; Argentina
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Fil: Zylberman, Vanesa. Inmunova; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
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Fil: Muñoz, Luciana. Inmunova; Argentina
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Fil: Dobarro, Martín. Sanatorio Sagrado Corazón; Argentina
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Fil: Lebersztein, Gabriel. Sanatorio Sagrado Corazón; Argentina
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Fil: Farina, Javier. Gobierno de la Provincia de Buenos Aires. Hospital de Alta Complejidad Cuenca Alta Doctor Nestor Carlos Kirchner.; Argentina
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Fil: Vidiella, Gabriela. Sanatorio Agote. Dr. Luis Agote; Argentina
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Fil: Bertetti, Anselmo. Sanatorio Guemes Sociedad Anonima.; Argentina
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Fil: Crudo, Favio. Universidad Nacional de San Antonio de Areco; Argentina
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Fil: Alzogaray, Maria Fernanda. Instituto Medico Platense.; Argentina
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Fil: Barcelona, Laura. Municipalidad de Vicente Lopez (buenos Aires). Hospital Municipal Doctor Bernardo Houssay.; Argentina
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Fil: Teijeiro, Ricardo. Gobierno de la Ciudad Autónoma de Buenos Aires. Hospital General de Agudos Doctor Ignacio Pirovano; Argentina
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Fil: Lambert, Sandra. Provincia de Buenos Aires. Ministerio de Salud. Hospital Alta Complejidad en Red El Cruce Dr. Néstor Carlos Kirchner Samic; Argentina
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Fil: Scublinsky, Darío. Clinica Zabala.; Argentina
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Fil: Iacono, Marisa. Provincia del Neuquen. Hospital Provincial Neuquen "dr. E. Castro Rendon"; Argentina
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Fil: Stanek, Vanina. Hospital Italiano; Argentina
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Fil: Solari, Rubén. Gobierno de la Ciudad de Buenos Aires. Hospital de Infecciosas "Dr. Francisco Javier Muñiz"; Argentina
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Fil: Cruz, Pablo. No especifíca;
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Fil: Casas, Marcelo Martín. Clinica Adventista Belgrano; Argentina
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Fil: Abusamra, Lorena. Hospital Municipal Dr. Diego Thompson; Argentina
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Fil: Luciardi, Héctor Lucas. Provincia de Tucuman. Ministerio de Salud. Sistema Provincial de Salud. Hosp. Centro de Salud "zenon Santillan"; Argentina
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Fil: Cremona, Alberto. Hospital Italiano de La Plata; Argentina
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Fil: Caruso, Diego. Hospital Español; Argentina
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Fil: de Miguel, Bernardo. No especifíca;
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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
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Fil: Millán, Susana. No especifíca;
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Fil: Kilstein, Yael. No especifíca;
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Fil: Pereiro, Ana. Fundación Mundo Sano; Argentina
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Fil: Sued, Omar. Fundación Huésped; Argentina
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Fil: Cahn, Pedro. Fundación Huésped; Argentina
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Fil: Spatz, Linus. Inmunova; Argentina
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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
dc.journal.title
EClinicalMedicine
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/url/https://linkinghub.elsevier.com/retrieve/pii/S2589537021001231
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.1016/j.eclinm.2021.100843
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