Therapy Areas: Infectious Diseases
CoVIg-19 Plasma Alliance reports disappointing topline results from NIH-Sponsored Clinical Trial of CoVIg-19
5 April 2021 -

The CoVIg-19 Plasma Alliance disclosed on Friday that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints to show efficacy in adults hospitalized with COVID-19, with no serious safety signals.

According to the alliance, the hyperimmune globulin, known as CoVIg-19, is a high-quality pharmaceutical product that contains purified, consistent and concentrated levels of convalescent antibodies. The antibodies in the H-Ig come from the liquid portion of blood, or plasma, donated by healthy people who have recovered from COVID-19. The analysis remain ongoing and full trial results will be published soon.

This Phase 3 global, multi-centre, double-blind, placebo-controlled, randomized trial tested the safety, tolerability and efficacy of a combination treatment regimen of the antiviral remdesivir along with an anti-coronavirus hyperimmune intravenous immunoglobulin (H-Ig), which contains a highly concentrated solution of antibodies that neutralize SARS-CoV-2, disclosed the alliance.

Co-founded by CSL Behring and Takeda, the alliance includes BioPharma Plasma, Biotest, GC Pharma, LFB, National Bioproducts Institute, Octapharma and Sanquin. The Bill & Melinda Gates Foundation provided advisory support. Microsoft provided technology including the Alliance website and the Plasma Bot for donor recruitment. Pall and Uber Health made in-kind contributions to the Alliance.

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