Abstract
Coronavirus disease 2019 (COVID-19) convalescent plasma has emerged as a promising therapy and has been granted Emergency Use Authorization by the US Food and Drug Administration for hospitalized COVID-19 patients. We recently reported results from interim analysis of a propensity score-matched study suggesting that early treatment of COVID-19 patients with convalescent plasma containing high-titer anti-spike protein receptor binding domain (RBD) IgG significantly decreases mortality. We herein present results from a 60-day follow-up of a cohort of 351 transfused hospitalized patients. Prospective determination of enzyme-linked immunosorbent assay anti-RBD IgG titer facilitated selection and transfusion of the highest titer units available. Retrospective analysis by the Ortho VITROS IgG assay revealed a median signal/cutoff ratio of 24.0 for transfused units, a value far exceeding the recent US Food and Drug Administration-required cutoff of 12.0 for designation of high-titer convalescent plasma. With respect to altering mortality, our analysis identified an optimal window of 44 hours after hospitalization for transfusing COVID-19 patients with high-titer convalescent plasma. In the aggregate, the analysis confirms and extends our previous preliminary finding that transfusion of COVID-19 patients soon after hospitalization with high-titer anti-spike protein RBD IgG present in convalescent plasma significantly reduces mortality.
【초록키워드】 COVID-19, convalescent plasma, IgG, Coronavirus disease 2019, therapy, Mortality, Hospitalization, drug, hospitalized patients, Receptor binding domain, Protein, Cohort, RBD, Prospective, early treatment, Follow-up, Anti-spike, food, Analysis, Emergency, COVID-19 patient, Anti-RBD IgG, hospitalized COVID-19 patients, RBD IgG, interim analysis, Cutoff, authorization, aggregate, decrease, Ortho Vitros, enzyme-linked immunosorbent, highest, significantly, reported, median, facilitated, reduce, transfused, 【제목키워드】 COVID-19, SARS-CoV-2, IgG, spike, coronavirus 2, respiratory, Containing, Decreased,