Background: This study assesses the feasibility of producing hyperimmune anti-COVID-19 intravenously administrable immunoglobulin (C-IVIG) from pooled convalescent plasma (PCP) to provide a safe and effective passive immunization treatment option for COVID-19. Materials & methods: PCP was fractionated by modified caprylic acid precipitation followed by ultrafiltration/diafiltration to produce hyperimmune C-IVIG. Results: In C-IVIG, the mean SARS-CoV-2 antibody level was found to be threefold (104 ± 30 cut-off index) that of the PCP (36 ± 8.5 cut-off index) and mean protein concentration was found to be 46 ± 3.7 g/l, comprised of 89.5% immunoglobulins. Conclusion: The current method of producing C-IVIG is feasible as it uses locally available PCP and simpler technology and yields a high titer of SARS-CoV-2 antibody. The safety and efficacy of C-IVIG will be evaluated in a registered clinical trial (NCT 04521309).
【저자키워드】 convalescent plasma, passive immunization, SARS-CoV-2, Immunotherapy, Intravenous immunoglobulins, Ultrafiltration, anti-COVID-19 IVIG, pooled plasma, caprylic acid, diafiltration, 【초록키워드】 COVID-19, Treatment, Efficacy, clinical trial, feasibility, immunoglobulins, immunization, SARS-CoV-2 antibody, Immunoglobulin, Safe, material, cut-off, intravenously, protein concentration, effective, hyperimmune, evaluated, feasible, producing, 【제목키워드】 COVID-19, Production, Intravenous immunoglobulin, anti-SARS-CoV-2, hyperimmune,