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Korean biotech, GC has applied for an investigational new drug application (IND) to conduct a Phase 2 clinical trial for a COVID-19 plasma therapy known as GC5131A. If authorized by the Korean Ministry of Food and Drug Safety, the study, which is designed to include 60 subjects, will be conducted at five trial sites, including Samsung Medical Center, Asan Medical Center, Chung-ang University Hospital, Korea University Hospital, and Chungnam National University Hospital. The sponsor seeks to establish the correct dose of the therapy and to investigate safety and efficacy.
GC5131A is a hyperimmune globulin-based therapy produced by extracting select active immune antibodies from the plasma of those patients in Korea that have recovered from COVID-19. This investigational product is meant to simplify the development process of delivering plasma-based therapy as hospitals in Korea are already using hyperimmune globulin to treat COVID-19 patients.
