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Artículo

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; Belloso, Waldo H.; Nannini, EstebanIcon ; Colonna, Mariana; Sanguineti, SantiagoIcon ; Zylberman, VanesaIcon ; 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, SantiagoIcon ; Millán, Susana; Kilstein, Yael; Pereiro, Ana; Sued, Omar; Cahn, Pedro; Spatz, Linus; Goldbaum, Fernando AlbertoIcon
Fecha de publicación: 04/2021
Editorial: Lancet Publishing Group
Revista: EClinicalMedicine
ISSN: 2589-5370
Idioma: Inglés
Tipo de recurso: Artículo publicado
Clasificación temática:
Enfermedades Infecciosas

Resumen

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.
Palabras clave: PASSIVE IMMUNOTHERAPY , COVID-19 , EQUINE POLYCLONAL ANTIBODIES , CLINICAL TRIAL
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info:eu-repo/semantics/openAccess Excepto donde se diga explícitamente, este item se publica bajo la siguiente descripción: Creative Commons Attribution-NonCommercial-ShareAlike 2.5 Unported (CC BY-NC-SA 2.5)
Identificadores
URI: http://hdl.handle.net/11336/139002
URL: https://linkinghub.elsevier.com/retrieve/pii/S2589537021001231
DOI: http://dx.doi.org/10.1016/j.eclinm.2021.100843
Colecciones
Articulos(SEDE CENTRAL)
Articulos de SEDE CENTRAL
Articulos(IIBBA)
Articulos de INST.DE INVEST.BIOQUIMICAS DE BS.AS(I)
Citación
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
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