Study: Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients (SECR-01)This study uses Study Randomizer. Last updated: 2021-09-27
Link to study information: https://clinicaltrials.gov/ct2/show/NCT04610502
Country: Costa Rica
Start date: 2020-09-06
Publications: Alape-Girón Alberto, Moreira-Soto Andrés, Arguedas Mauricio, Brenes Hebleen, Buján Willem, Corrales-Aguilar Eugenia, Díaz Cecilia, Echeverri Ann, Flores-Díaz Marietta, Gómez Aarón, Hernández Andrés, Herrera María, León Guillermo, Macaya Román, Molina-Mora José Arturo, Mora Javier, Narayanan Aarthi, Sanabria Alfredo, Sánchez Andrés, Sánchez Laura, Segura Álvaro, Segura Eduardo, Solano Daniela, Soto Claudio, Stynoski Jennifer L., Vargas Mariángela, Villalta Mauren, Drexler Jan Felix, Gutiérrez José María "Heterologous Hyperimmune Polyclonal Antibodies Against SARS-CoV-2: A Broad Coverage, Affordable, and Scalable Potential Immunotherapy for COVID-19"; Frontiers in Medicine, Volume 8, Year 2021, page 1517, https://www.frontiersin.org/article/10.3389/fmed.2021.743325 ; DOI 10.3389/fmed.2021.743325.
Abstract: Randomized, Controlled, Double-blind, Multicenter Clinical Study to Compare the Efficacy and Safety of the Administration of Two Hyperimmune Equine Anti-Sars-CoV-2 ("S" and "M") Serum Formulations in Hospitalized Patients With COVID-19. <br>Reports of the use of plasma from convalescent patients and purified immunoglobulin preparations in respiratory infections by various viral agents and SARS-CoV-2 in severely ill patients suggest that specific neutralizing antibodies may benefit their clinical course. During the previous SARS-CoV epidemic in 2003, preparations of hyperimmune equine serum were produced and demonstrated in vitro viral neutralization. These preparations were also successful in several animal models. Taking advantage of the important trajectory of our country in the study and use of equine hyperimmune serums with neutralizing antibodies for snake venom, preparations of hyperimmune serums against recombinant proteins of SARS-CoV-2 were produced through repeated immunization of horses, a first group of animals was inoculated with the "S" (Spike) protein of the virus and the second group with a mixture "M" of the S1 (Spike) proteins, the N (Nucleoprotein) protein and a construct with epitopes of the S1, E (Envelope) and M (Membrane) proteins, generating two different pharmaceutical preparations.Back to the list of studies: Studies overview