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COVID-19

Anti-SARS-CoV-2 polyclonal hyperimmune serum (CoviFab®)  

It is an immunotherapy based on equine polyclonal antibodies (EpAbs) with high neutralizing capacity against the SARS-CoV-2 virus.

These EpAbs, which block the virus’ entry into the cells preventing viral replication, are obtained using as an antigen the recombinant receptor-binding domain of the viral Spike glycoprotein produced by biotechnology. The generated antibodies are processed to obtain highly purified F(ab')2 fragments with an excellent safety profile. EpAbs recognize and bind to different regions of the RBD domain of Spike protein blocking the sites of interaction with its human receptor, which reduces the risk of lack of efficacy against new antigenic variants. In addition, EpAbs are relatively quick to produce on large scale.

  • In vitro in vitro proved seroneutralization capacity against several SARS-CoV-2 variants of interest including Omicron, Delta, Gama and Alfa. (1)
  • A Phase 2/3, double-blind, placebo-controlled, multicenter clinical trial analyzed the safety and efficacy of anti-SARS-CoV-2 polyclonal hyperimmune serum in 242 hospitalized adult patients with moderate and severe COVID-19 disease.(2)
  • It was conducted by more than 180 researchers and health professionals, between August and November 2020, in 19 clinical sites of Argentina.
  • On December 22nd 2020, based on the Phase 2/3 clinical trial results, ANMAT issued an emergency use authorization for CoviFab®.
  • A retrospective cohort study, conducted between November 2020 and April 2021, evaluated its safety and effectiveness in 841 adult patients with severe COVID-19.(3)
  • More than 25,000 patients in 221 health institutions were treated with CoviFab® in Argentina.

(1) “Development of a Hyperimmune Equine Serum Therapy for COVID-19 in Argentina”. Zylberman, V., et al. Medicina (Buenos Aires) 2020; Vol. 80 (Supl. III): 1-6.

(2) “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”. G. Lopardo et al. EClinicalMedicine, 34 (2021) 100843.

(3) “Safety and effectiveness of RBD-specific polyclonal equine F(ab´)2 fragments for the treatment of hospitalized patients with severe Covid-19 disease: A retrospective cohort study”. Farizano Salazar DH, Achinelli F, Colonna M, Pérez L, Giménez AA, et al. (2022). PLOS ONE 17(9): e0274796. https://doi.org/10.1371/journal.pone.0274796

CoviFab®

Download prospectus
Distribution: Laboratorio Elea

More information

If you are a health professional and would like more information about this drug candidate and/or the clinical development program, we invite you to contact us at infosalud@inmunova.com.

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