THE KOREA HERALD/ANN – GC Pharma, a blood plasma-derived medicine company, said yesterday that it has administered its COVID-19 plasma treatment GC5131A to the first domestic patient for a phase 2 clinical trial.
In Korea, professor Chung Jin-won of the division of infectious diseases at Chung-Ang University Hospital was the first to take on GC Pharma’s GC5131A pipeline for treatment on Saturday. This phase 2 trial will determine the right dosage for safe and efficacious use of GC5131A.
It targets 60 seriously ill COVID-19 patients who are elderly, with pneumonia or underlying diseases, who are most vulnerable to the coronavirus, GC Pharma said.
It had taken the company a month since the Ministry of Food and Drug Safety approved its clinical design on August 20, because it had taken time to secure and register the right candidates. GC Pharma is still seeking more candidates to fulfill the planned head count of 60, per its trial design.
Six medical institutions will carry out GC Pharma’s phase 2 trial: Chung-Ang University Hospital, Samsung Medical Center, Asan Medical Center, Korea University Ansan Hospital, Severance Hospital of Yonsei University and Chungnam National University Hospital.
Apart from Chungnam National University Hospital, which is located in Daejeon, others are based in Seoul.
All in all, GC Pharma anticipates to have the results from this phase 2 trial by year-end, and is simultaneously proceeding with the application of therapeutic use of the drug prior to final drug authorisation.