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Safety and Effectiveness of an Immunobiological Drug in CoViD-19 — INPB001  

Covid19 Clinical Trial

Official title:
Study to Evaluate the Safety and Effectiveness of an Immunobiological Drug (Anti SARS-CoV-2) in the Treatment of Coronavirus Disease 2019 (CoViD-19)

Clinical Trial Summary

The aims of this study is to analyze the efficacy and safety of a passive immunotherapy strategy using hyperimmune equine serum known as Anti-SARS-CoV-2 elaborated by the National Institute for the Production of Biologicals (ANLIS-Malbrán) as an addition to the standard therapeutic approach for hospitalized patients with COVID-19, in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection aged 18 to 80 years.

Clinical Trial Description

This is an adaptive phase II/III study that aims to analyze the efficacy and safety of a immunobiological drug (Anti SARS-CoV-2) in the treatment of CoViD-19. This treatment is a passive immunotherapy strategy developed as a purified F(ab')2 fraction of equine hyperimmune serum (Anti-SARS-CoV-2). The equine serum was generated from antigenic stimulation with the SARS-CoV-2 receptor binding domain (RBD) purified protein. This type of product (equine hyperimmune serum F(ab')2) has been widely used in our country in the last 100 years with satisfactory results and an acceptable safety profile in the treatment of accidents with poisonous animals such as anti-loxosceles, anti -latrodectus, anti-scorpionic, and anti-phoneutria, anti-bothropic, anti-micrurus, and anti-crotalic sera, all developed by the National Institute of Biological Production (ANLIS-Malbrán) and distributed free of charge in public hospitals in the country . In the present study, evaluates the effect and safety of this immunobiological treatment in patients with COVID-19 that require hospitalization. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04913779
Study type Interventional
Source Administracion Nacional de Laboratorios e Institutos de Salud Dr. Carlos G. Malbran
Contact Guillermo A Keller, MD PhD
Phone 011-4961-0943
Email gkeller@anlis.gob.ar
Status Recruiting
Phase Phase 2/Phase 3
Start date June 1, 2021
Completion date December 31, 2021
View Details
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