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

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dc.contributor.authorLopardo, Gustavo
dc.contributor.authorBelloso, Waldo H
dc.contributor.authorNannini, Esteban
dc.contributor.authorColonna, Mariana
dc.contributor.authorSanguineti, Santiago
dc.contributor.authorZylberman, Vanesa
dc.contributor.authorMuñoz, Luciana
dc.contributor.authorDobarro, Martín
dc.contributor.authorLebersztein, Gabriel
dc.contributor.authorFarina, Javier
dc.contributor.authorVidiella, Gabriela
dc.contributor.authorBertetti, Anselmo
dc.contributor.authorCrudo, Favio
dc.contributor.authorAlzogaray, Maria Fernanda
dc.contributor.authorBarcelona, Laura
dc.contributor.authorTeijeiro, Ricardo
dc.contributor.authorLambert, Sandra
dc.contributor.authorScublinsky, Darío
dc.contributor.authorIacono, Marisa
dc.contributor.authorStanek, Vanina
dc.contributor.authorSolari, Rubén
dc.contributor.authorCruz, Pablo
dc.contributor.authorCasas, Marcelo Martín
dc.contributor.authorAbusamra, Lorena
dc.contributor.authorLuciardi, Héctor Lucas
dc.contributor.authorCremona, Alberto
dc.contributor.authorCaruso, Diego
dc.contributor.authorde Miguel, Bernardo
dc.contributor.authorLloret, Santiago Perez
dc.contributor.authorMillán, Susana
dc.contributor.authorKilstein, Yael
dc.contributor.authorPereiro, Ana
dc.contributor.authorSued, Omar
dc.contributor.authorCahn, Pedro
dc.contributor.authorSpatz, Linus
dc.contributor.authorGoldbaum, Fernando
dc.date.accessioned2024-04-10T17:34:55Z
dc.date.available2024-04-10T17:34:55Z
dc.date.issued2021-04-11
dc.descriptionFil: Lopardo G. Hospital Municipal Dr. Bernardo Houssay. Provincia de Buenos Aires, Argentina. Fundación del Centro de Estudios Infectológicos (FUNCEI); Ciudad Autónoma de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Belloso WH. Department of Research, Hospital Italiano de Buenos Aires; Ciudad Autónoma de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Nannini E. Departamento de Enfermedades Infecciosas, Sanatorio Británico; Rosario, Santa Fé; Argentina.es_ES
dc.descriptionFil: Colonna M. Inmunova S.A; Villa Lynch, Gral. San Martín; Buenos Aires; Argentinaes_ES
dc.descriptionFil: Sanguineti S. Inmunova S.A; Villa Lynch, Gral. San Martín; Buenos Aires; Argentinaes_ES
dc.descriptionFil: Zylberman V. Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Argentina. Inmunova S.A; Villa Lynch, Gral. San Martín; Buenos Aires; Argentinaes_ES
dc.descriptionFil: Muñoz L. Inmunova S.A; Villa Lynch, Gral. San Martín; Buenos Aires; Argentinaes_ES
dc.descriptionFil: Dobarro M. Sanatorio Sagrado Corazón (OSECAC); Ciudad Autónoma de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Lebersztein G. Sanatorio Sagrado Corazón (OSECAC); Ciudad Autónoma de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Farina J. Hospital de Alta Complejidad Cuenca Alta S.A.M.I.C. Dr. Néstor Carlos Kirchner; Florencio Varela; Provincia de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Vidiella G. Sanatorio Agote; Ciudad Autónoma de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Bertetti A. Sanatorio Güemes; Ciudad Autónoma de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Crudo F. Hospital Municipal Emilio Zerboni; San Antonio de Areco; Provincia de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Alzogaray MF. Instituto Medico Platense; La Plata; Provincia de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Barcelona L. Hospital Municipal Dr. Bernardo Houssay; Florida; Provincia de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Teijeiro R. Hospital General de Agudos Dr. Ignacio Pirovano; Ciudad Autónoma de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Lambert S. Hospital de Alta Complejidad Cuenca Alta S.A.M.I.C. Dr. Néstor Carlos Kirchner; Florencio Varela; Provincia de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Scublinsky D. Clínica Zabala; Ciudad Autónoma de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Iacono M. Hospital Provincial Neuquén Dr. Castro Rendón; Neuquén; Argentinaes_ES
dc.descriptionFil: Stanek V. Sección de Infectología, Servicio de Medicina Interna, Hospital Italiano de Buenos Aires; Ciudad Autónoma de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Solari R. Hospital de Infecciosas Francisco Javier Muñiz; Ciudad Autónoma de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Cruz P. Centro Gallego de Buenos Aires; Ciudad Autónoma de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Casas MM. Clínica Adventista Belgrano; Ciudad Autónoma de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Abusamra L. Hospital Municipal Dr. Diego Thompson; Villa Lynch; Gral. San Martín; Argentinaes_ES
dc.descriptionFil: Luciardi HL. Hospital Centro de Salud Zenón J. Santillán; San Miguel de Tucumán; Tucumán; Argentinaes_ES
dc.descriptionFil: Cremona A. Hospital Italiano La Plata; La Plata; Provincia de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Caruso D. Hospital Español; Ciudad Autónoma de Buenos Aires; Argentinaes_ES
dc.descriptionFil: de Miguel B. mAbxience; Madrid; Españaes_ES
dc.descriptionFil: Lloret SP. Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET); Argentinaes_ES
dc.descriptionFil: Millán S. mAbxience; Madrid; Españaes_ES
dc.descriptionFil: Kilstein Y. PHV LATAM, AES; Ciudad Autónoma de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Pereiro A. Fundación Mundo Sano; Ciudad Autónoma de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Sued O. Fundación Huésped; Ciudad Autónoma de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Cahn P. Fundación Huésped; Ciudad Autónoma de Buenos Aires; Argentinaes_ES
dc.descriptionFil: Spatz L. Inmunova S.A.; Villa Lynch, Gral. San Martín; Buenos Aires; Argentinaes_ES
dc.descriptionFil: Goldbaum F. Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET); Argentinaes_ES
dc.description.abstractBACKGROUND: 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. The primary endpoint was improvement in at least two categories in the 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). The median age was 54 years old, 65.1% were male, and 61% had moderate disease at baseline. The median time from symptom onset to study treatment was 6 days (interquartile range 5 to 8). No statistically significant difference was noted between study groups regarding the primary endpoint (risk difference [95% CI]: 5.28% [-3.95; 14.50]; p = 0.15). The rate of improvement in at least two categories was statistically significantly higher for INM005 at days 14 and 21 of follow-up. The 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% in the INM005 group and 11.4% in the placebo group (risk difference [95% CI]: 0.57 [0.24 to 1.37]). Adverse events of special interest were mild or moderate; no anaphylaxis was reported. INTERPRETATION: Although not having reached the primary endpoint, we found clinical improvement of hospitalized patients with SARS-CoV-2 pneumonia, particularly those with severe disease.es_ES
dc.formatapplication/pdfes_ES
dc.identifier.doihttps://doi.org/10.1016%2Fj.eclinm.2021.100843
dc.identifier.urihttps://repositorio.huesped.org.ar/handle/123456789/953
dc.languageENGes_ES
dc.provenancePublishedes_ES
dc.relation.ispartofseriesEClinicalMedicine;2021 Apr; 34: 100843
dc.rightsopenAccesses_ES
dc.subjectCOVID-19es_ES
dc.subjectInmunoterapiaes_ES
dc.titleRBD-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 triales_ES
dc.typeArticuloes_ES

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