Transfusing Convalescent Plasma as Post-Exposure Prophylaxis Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Double-Blinded, Phase 2 Randomized, Controlled Trial
Shoham, Shmuel ; Bloch, Evan M ; Casadevall, Arturo ; Hanley, Daniel ; Lau, Bryan ; Gebo, Kelly ; Cachay, Edward ; Kassaye, Seble G ; Paxton, James H ; Gerber, Jonathan M ... show 10 more
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Authors
Bloch, Evan M
Casadevall, Arturo
Hanley, Daniel
Lau, Bryan
Gebo, Kelly
Cachay, Edward
Kassaye, Seble G
Paxton, James H
Gerber, Jonathan M
Levine, Adam C
Naeim, Arash
Currier, Judith
Patel, Bela
Allen, Elizabeth S
Anjan, Shweta
Appel, Lawrence
Baksh, Sheriza
Blair, Paul W
Bowen, Anthony
Broderick, Patrick
Caputo, Christopher A
Cluzet, Valerie
Cordisco, Marie Elena
Cruser, Daniel
Ehrhardt, Stephan
Forthal, Donald
Fukuta, Yuriko
Gawad, Amy L
Gniadek, Thomas
Hammel, Jean
Huaman, Moises A
Jabs, Douglas A
Jedlicka, Anne
Karlen, Nicky
Klein, Sabra
Laeyendecker, Oliver
Lane, Karen
McBee, Nichol
Meisenberg, Barry
Merlo, Christian
Mosnaim, Giselle
Park, Han-Sol
Pekosz, Andrew
Petrini, Joann
Rausch, William
Shade, David M
Shapiro, Janna R
Singleton, J Robinson
Sutcliffe, Catherine
Thomas, David L
Yarava, Anusha
Zand, Martin
Zenilman, Jonathan M
Tobian, Aaron A R
Sullivan, David J
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UMass Chan Affiliations
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Abstract
Background: The efficacy of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) convalescent plasma (CCP) for preventing infection in exposed, uninfected individuals is unknown. CCP might prevent infection when administered before symptoms or laboratory evidence of infection.
Methods: This double-blinded, phase 2 randomized, controlled trial (RCT) compared the efficacy and safety of prophylactic high titer (≥1:320 by Euroimmun ELISA) CCP with standard plasma. Asymptomatic participants aged ≥18 years with close contact exposure to a person with confirmed coronavirus disease 2019 (COVID-19) in the previous 120 hours and negative SARS-CoV-2 test within 24 hours before transfusion were eligible. The primary outcome was new SARS-CoV-2 infection.
Results: In total, 180 participants were enrolled; 87 were assigned to CCP and 93 to control plasma, and 170 transfused at 19 sites across the United States from June 2020 to March 2021. Two were excluded for screening SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) positivity. Of the remaining 168 participants, 12/81 (14.8%) CCP and 13/87 (14.9%) control recipients developed SARS-CoV-2 infection; 6 (7.4%) CCP and 7 (8%) control recipients developed COVID-19 (infection with symptoms). There were no COVID-19-related hospitalizations in CCP and 2 in control recipients. Efficacy by restricted mean infection free time (RMIFT) by 28 days for all SARS-CoV-2 infections (25.3 vs 25.2 days; P = .49) and COVID-19 (26.3 vs 25.9 days; P = .35) was similar for both groups.
Conclusions: Administration of high-titer CCP as post-exposure prophylaxis, although appearing safe, did not prevent SARS-CoV-2 infection.
Clinical trials registration: NCT04323800.
Source
Shoham S, Bloch EM, Casadevall A, Hanley D, Lau B, Gebo K, Cachay E, Kassaye SG, Paxton JH, Gerber J, Levine AC, Naeim A, Currier J, Patel B, Allen ES, Anjan S, Appel L, Baksh S, Blair PW, Bowen A, Broderick P, Caputo CA, Cluzet V, Cordisco ME, Cruser D, Ehrhardt S, Forthal D, Fukuta Y, Gawad AL, Gniadek T, Hammel J, Huaman MA, Jabs DA, Jedlicka A, Karlen N, Klein S, Laeyendecker O, Lane K, McBee N, Meisenberg B, Merlo C, Mosnaim G, Park HS, Pekosz A, Petrini J, Rausch W, Shade DM, Shapiro JR, Singleton JR, Sutcliffe C, Thomas DL, Yarava A, Zand M, Zenilman JM, Tobian AAR, Sullivan DJ. Transfusing Convalescent Plasma as Post-Exposure Prophylaxis Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Double-Blinded, Phase 2 Randomized, Controlled Trial. Clin Infect Dis. 2023 Feb 8;76(3):e477-e486. doi: 10.1093/cid/ciac372. PMID: 35579509; PMCID: PMC9129191.