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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.
J Infect Dis. 2020 10 13; 222(10):1620-1628.JI

Abstract

BACKGROUND

Convalescent 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.

METHODS

We 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.

RESULTS

NAb 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).

CONCLUSIONS

CP 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 REGISTRATION

NCT04434131.

Authors+Show Affiliations

Center for Global Health, Department of Internal Medicine, University of New Mexico, Albuquerque, New Mexico, USA.Center for Global Health, Department of Internal Medicine, University of New Mexico, Albuquerque, New Mexico, USA.Center for Global Health, Department of Internal Medicine, University of New Mexico, Albuquerque, New Mexico, USA.Center for Global Health, Department of Internal Medicine, University of New Mexico, Albuquerque, New Mexico, USA.Center for Global Health, Department of Internal Medicine, University of New Mexico, Albuquerque, New Mexico, USA.Division of Infectious Diseases, Department of Internal Medicine, University of New Mexico, Albuquerque, New Mexico, USA.Department of Pathology, School of Medicine, University of New Mexico, Albuquerque, New Mexico, USA.Division of Infectious Diseases, Department of Internal Medicine, University of New Mexico, Albuquerque, New Mexico, USA.Center for Global Health, Department of Internal Medicine, University of New Mexico, Albuquerque, New Mexico, USA.Center for Global Health, Department of Internal Medicine, University of New Mexico, Albuquerque, New Mexico, USA.Division of Pulmonary, Critical Care and Sleep, Department of Internal Medicine, University of New Mexico, Albuquerque, New Mexico, USA.

Pub Type(s)

Clinical Trial
Journal Article

Language

eng

PubMed ID

32779705

Citation

Bradfute, Steven B., et al. "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." The Journal of Infectious Diseases, vol. 222, no. 10, 2020, pp. 1620-1628.
Bradfute SB, Hurwitz I, Yingling AV, et al. 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. J Infect Dis. 2020;222(10):1620-1628.
Bradfute, S. B., Hurwitz, I., Yingling, A. V., Ye, C., Cheng, Q., Noonan, T. P., Raval, J. S., Sosa, N. R., Mertz, G. J., Perkins, D. J., & Harkins, M. S. (2020). 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. The Journal of Infectious Diseases, 222(10), 1620-1628. https://doi.org/10.1093/infdis/jiaa505
Bradfute SB, et al. 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. J Infect Dis. 2020 10 13;222(10):1620-1628. PubMed PMID: 32779705.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Bradfute,Steven B, AU - Hurwitz,Ivy, AU - Yingling,Alexandra V, AU - Ye,Chunyan, AU - Cheng,Qiuying, AU - Noonan,Timothy P, AU - Raval,Jay S, AU - Sosa,Nestor R, AU - Mertz,Gregory J, AU - Perkins,Douglas J, AU - Harkins,Michelle S, PY - 2020/07/10/received PY - 2020/08/04/accepted PY - 2020/8/12/pubmed PY - 2020/11/3/medline PY - 2020/8/12/entrez KW - SARS-CoV-2 KW - antibodies KW - convalescent KW - coronavirus KW - neutralizing KW - plasma SP - 1620 EP - 1628 JF - The Journal of infectious diseases JO - J Infect Dis VL - 222 IS - 10 N2 - BACKGROUND: Convalescent 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. METHODS: We 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. RESULTS: NAb 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). CONCLUSIONS: CP 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 REGISTRATION: NCT04434131. SN - 1537-6613 UR - https://www.unboundmedicine.com/medline/citation/32779705/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_ L2 - https://academic.oup.com/jid/article-lookup/doi/10.1093/infdis/jiaa505 DB - PRIME DP - Unbound Medicine ER -