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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; 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.
Affiliation
  • Shoham S; Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
  • Bloch EM; Department of Pathology, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
  • Casadevall A; Department of Molecular Microbiology and Immunology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  • Hanley D; Department of Neurology, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
  • Lau B; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  • Gebo K; Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
  • Cachay E; Department of Medicine, Division of Infectious Diseases, University of California, San Diego, San Diego, California, USA.
  • Kassaye SG; Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington D.C, USA.
  • Paxton JH; Department of Emergency Medicine, Wayne State University, Detroit, Michigan, USA.
  • Gerber J; Department of Medicine, Division of Hematology and Oncology, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA.
  • Levine AC; Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, Rhode Island, USA.
  • Naeim A; Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, California, USA.
  • Currier J; Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, California, USA.
  • Patel B; Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, Texas, USA.
  • Allen ES; Department of Pathology, University of California, San Diego, San Diego, California, USA.
  • Anjan S; Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Appel L; Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
  • Baksh S; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  • Blair PW; Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
  • Bowen A; Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
  • Broderick P; Department of Emergency Medicine, Danbury Hospital, Danbury, Connecticut, USA.
  • Caputo CA; Department of Molecular Microbiology and Immunology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  • Cluzet V; Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, New York, USA.
  • Cordisco ME; Office of Clinical Trials, Nuvance Health, University of Vermont, Danbury, Connecticut, USA.
  • Cruser D; Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
  • Ehrhardt S; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  • Forthal D; Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, California, USA.
  • Fukuta Y; Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, Texas, USA.
  • Gawad AL; Department of Neurology, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
  • Gniadek T; Department of Pathology, Northshore University Health System, Evanston, Illinois, USA.
  • Hammel J; Department of Emergency Medicine, Norwalk Hospital, Norwalk, Connecticut, USA.
  • Huaman MA; Department of Medicine, Division of Infectious Diseases, University of Cincinnati, Cincinnati, Ohio, USA.
  • Jabs DA; Department of Ophthalmology, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
  • Jedlicka A; Department of Molecular Microbiology and Immunology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  • Karlen N; Mosaic Consulting Ltd., Israel.
  • Klein S; Department of Molecular Microbiology and Immunology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  • Laeyendecker O; Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Baltimore, Maryland, USA.
  • Lane K; Department of Neurology, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
  • McBee N; Department of Neurology, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
  • Meisenberg B; Department of Medicine, Luminis Health, Annapolis, Maryland, USA.
  • Merlo C; Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
  • Mosnaim G; Division of Allergy and Immunology, Department of Medicine, Northshore University Health System, Evanston, Illinois, USA.
  • Park HS; Department of Molecular Microbiology and Immunology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  • Pekosz A; Department of Molecular Microbiology and Immunology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  • Petrini J; Office of Clinical Trials, Nuvance Health, University of Vermont, Danbury, Connecticut, USA.
  • Rausch W; Office of Clinical Trials, Nuvance Health, University of Vermont, Danbury, Connecticut, USA.
  • Shade DM; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  • Shapiro JR; Department of Molecular Microbiology and Immunology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  • Singleton JR; Department of Neurology, University of Utah, Salt Lake City, Utah, USA.
  • Sutcliffe C; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Clin Infect Dis ; 76(3): e477-e486, 2023 02 08.
Article in En | MEDLINE | ID: mdl-35579509
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 (≥1320 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.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Clinical_trials Limits: Adolescent / Adult / Humans Language: En Journal: Clin Infect Dis Journal subject: DOENCAS TRANSMISSIVEIS Year: 2023 Type: Article Affiliation country: United States
Fulltext
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PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Clinical_trials Limits: Adolescent / Adult / Humans Language: En Journal: Clin Infect Dis Journal subject: DOENCAS TRANSMISSIVEIS Year: 2023 Type: Article Affiliation country: United States