Abstract
Coronavirus disease 2019 (COVID-19) convalescent plasma has emerged as a promising therapy and has been granted emergency use authorization by the U.S. Food and Drug Administration (FDA) 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 here present results from 60-day follow up of our cohort of 351 transfused hospitalized patients. Prospective determination of ELISA 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 (S/C) ratio of 24.0 for transfused units, a value far exceeding the recently FDA-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 post-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.
Eric Salazar 1, Paul A Christensen 2, Edward A Graviss 3, Duc T Nguyen 4, Brian Castillo 2, Jian Chen 2, Bevin Valdez Lopez 5, Todd N Eagar 1, Xin Yi 1, Picheng Zhao 2, John Rogers 2, Ahmed Shehabeldin 2, David Joseph 2, Faisal Masud 6, Christopher Leveque 2, Randall J Olsen 7, David W Bernard 1, Jimmy Gollihar 8, James M Musser 9PMID: 33157066 DOI: 10.1016/j.ajpath.2020.10.008 Am J Pathol . 2020 Nov 3;S0002-9440(20)30489-2. doi: 10.1016/j.ajpath.2020.10.008. Online ahead of print.
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