Abstract

BackgroundConvalescent plasma (CP) is a potentially important therapy for coronavirus disease 2019 (COVID-19). However, knowledge regarding neutralizing antibody (NAb) titers in donor plasma and their impact in acute COVID-19 patients remains largely undetermined. We measured NAb titers in CP and in acute COVID-19 patients before and after transfusion through the traditional FDA IND pathway.MethodsWe performed a single-arm interventional trial measuring NAb and total antibody titers before and after CP transfusion over a 14-day period in hospitalized patients with laboratory-confirmed severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection. Trial Registration: Clinicaltrials.gov identifier: NCT04434131 (https://clinicaltrials.gov/ct2/show/NCT04434131)ResultsNAb titers in the donor CP units were low (<1:40 to 1:160) and had no effect on recipient neutralizing activity one day after transfusion. NAb titers were detected in 6/12 patients upon enrollment and in 11/12 patients during at least two timepoints. Average titers peaked on day 7 and declined towards day 14 (P=0.004). NAb and IgG titers were correlated in donor plasma units (ρ=0.938, P<0.0001) and in the cumulative patient measures (ρ=0.781, P<0.0001).ConclusionsCP infusion did not alter recipient NAb titers. Pre-screening of CP may be necessary for selecting donors with high levels of neutralizing activity for infusion into patients with COVID-19.

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