Emergent BioSolutions’ COVID-19 Human Immune Globulin Product Candidate to be Included in NIH-Sponsored Phase 3 Clinical Trial of Hyperimmune Intravenous Immunoglobulin to Treat COVID-19

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Emergent BioSolutions Inc. is carrying out the Phase 3 clinical trial that is evaluating plasma-derived therapy COVID-HIG as a potential treatment for hospitalized patients with coronavirus disease (COVID-19). The INSIGHT-013 clinical study called “Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC),” is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The study is evaluating the safety, tolerability, and efficacy of hyperimmune globulin products derived from plasma of individuals who have recovered from COVID-19 and have developed neutralizing antibodies to SARS-CoV-2, the virus that causes COVID-19. The randomized controlled clinical trial assigns participants to receive infusions of either a placebo or one of four hyperimmune globulin products, which includes Emergent’s COVID-HIG, with a background therapy of remdesivir in all groups.

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