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
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 as...
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| Formato: | Artículo |
| Lenguaje: | Inglés |
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Elsevier
2021
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| Acceso en línea: | https://repositorio.uca.edu.ar/handle/123456789/11639 https://doi.org/10.1016/j.eclinm.2021.100843 |
| Aporte de: |
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I33-R139123456789-11639 |
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dspace |
| institution |
Universidad Católica Argentina |
| institution_str |
I-33 |
| repository_str |
R-139 |
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Repositorio Institucional de la Universidad Católica Argentina (UCA) |
| language |
Inglés |
| topic |
COVID-19 INMUNIZACION PASIVA ANTICUERPOS NEUTRALIZANTES NEUMONIA TRATAMIENTO MEDICO |
| spellingShingle |
COVID-19 INMUNIZACION PASIVA ANTICUERPOS NEUTRALIZANTES NEUMONIA TRATAMIENTO MEDICO 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 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 |
| topic_facet |
COVID-19 INMUNIZACION PASIVA ANTICUERPOS NEUTRALIZANTES NEUMONIA TRATAMIENTO MEDICO |
| 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. |
| author2 |
INM005 Study Group |
| author_facet |
INM005 Study Group 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 |
| format |
Artículo |
| author |
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_sort |
Lopardo, Gustavo |
| 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 |
| 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 |
| publisher |
Elsevier |
| publishDate |
2021 |
| url |
https://repositorio.uca.edu.ar/handle/123456789/11639 https://doi.org/10.1016/j.eclinm.2021.100843 |
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