• J. Infect. Dis. · Oct 2020

    Clinical Trial

    Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Antibody Titers in Convalescent Plasma and Recipients in New Mexico: An Open Treatment Study in Patients With Coronavirus Disease 2019.

    • Steven B Bradfute, Ivy Hurwitz, Alexandra V Yingling, Chunyan Ye, Qiuying Cheng, Timothy P Noonan, Jay S Raval, Nestor R Sosa, Gregory J Mertz, Douglas J Perkins, and Michelle S Harkins.
    • Center for Global Health, Department of Internal Medicine, University of New Mexico, Albuquerque, New Mexico, USA.
    • J. Infect. Dis. 2020 Oct 13; 222 (10): 1620-1628.

    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 patients with acute COVID-19 remains largely undetermined. We measured NAb titers in CP and in patients with acute COVID-19 before and after transfusion through the traditional Food and Drug Administration investigational new drug 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 2 infection.ResultsNAb titers in the donor CP units were low (<1:40 to 1:160) and had no effect on recipient neutralizing activity 1 day after transfusion. NAb titers were detected in 6 of 12 patients on enrollment and in 11 of 12 at ≥2 time points. Average titers peaked on day 7 and declined toward day 14 (P = .004). Nab titers and immunoglobulin G levels were correlated in donor plasma units (ρ = 0.938; P < .001) and in the cumulative patient measures (ρ = 0.781; P < .001).ConclusionsCP infusion did not alter recipient NAb titers. Prescreening of CP may be necessary for selecting donors with high titers of neutralizing activity for infusion into patients with COVID-19.Clinical Trials RegistrationNCT04434131.© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

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