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

Shmuel Shoham, Evan M. Bloch, Arturo Casadevall, Daniel Hanley, Bryan Lau, Kelly Gebo, Edward Cachay, Seble G. Kassaye, James H. Paxton, Jonathan Gerber, Adam C. Levine, Arash Naeim, Judith Currier, Bela Patel, Elizabeth S. Allen, Shweta Anjan, Lawrence Appel, Sheriza Baksh, Paul W. Blair, Anthony BowenPatrick Broderick, Christopher A. Caputo, Valerie Cluzet, Marie Elena Cordisco, Daniel Cruser, Stephan Ehrhardt, Donald Forthal, Yuriko Fukuta, Amy L. Gawad, Thomas Gniadek, Jean Hammel, Moises A. Huaman, Douglas A. Jabs, Anne Jedlicka, Nicky Karlen, Sabra Klein, Oliver Laeyendecker, Karen Lane, Nichol McBee, Barry Meisenberg, Christian Merlo, Giselle Mosnaim, Han Sol Park, Andrew Pekosz, Joann Petrini, William Rausch, David M. Shade, Janna R. Shapiro, J. Robinson Singleton, Catherine Sutcliffe, David L. Thomas, Anusha Yarava, Martin Zand, Jonathan M. Zenilman, Aaron A.R. Tobian, David J. Sullivan

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)E477-E486
JournalClinical Infectious Diseases
Volume76
Issue number3
DOIs
StatePublished - Feb 1 2023

Keywords

  • COVID-19
  • SARS-CoV-2
  • convalescent plasma
  • post-exposure-prophylaxis
  • transfusion

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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