Shmuel Shoham1, Evan M Bloch2, Arturo Casadevall3, Daniel Hanley4, Bryan Lau5, Kelly Gebo1, Edward Cachay6, Seble G Kassaye7, James H Paxton8, Jonathan Gerber9, Adam C Levine10, Arash Naeim11, Judith Currier11, Bela Patel12, Elizabeth S Allen13, Shweta Anjan14, Lawrence Appel1, Sheriza Baksh5, Paul W Blair1, Anthony Bowen1, Patrick Broderick15, Christopher A Caputo3, Valerie Cluzet16, Marie Cordisco Elena17, Daniel Cruser, Stephan Ehrhardt5, Donald Forthal18, Yuriko Fukuta19, Amy L Gawad4, Thomas Gniadek20, Jean Hammel21, Moises A Huaman22, Douglas A Jabs23, Anne Jedlicka3, Nicky Karlen1, Sabra Klein3, Oliver Laeyendecker24, Lane Karen4, Nichol McBee4, Barry Meisenberg25, Christian Merlo1, Giselle Mosnaim26, Han-Sol Park3, Andrew Pekosz3, Joann Petrini24, William Rausch24, David M Shade5, Janna R Shapiro3, Robinson J Singleton27, Catherine Sutcliffe5, David L Thomas1, Anusha Yarava4, Martin Zand28, Jonathan M Zenilman1, Aaron A R Tobian2, David J Sullivan3. 1. Department of Medicine. 2. Department of Pathology. 3. Department of Molecular Microbiology and Immunology. 4. Department of Neurology, and the. 5. Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA, Mosaic Consulting Ltd., Israel. 6. Department of Medicine, Division of Infectious Diseases. 7. Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC, USA. 8. Department of Emergency Medicine Wayne State University, Detroit, Michigan, USA. 9. Department of Medicine, Division of Hematology and Oncology, University of Massachusetts Chan Medical School, Worchester, Massachusetts, USA. 10. Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, Rhode Island, USA. 11. Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, California, USA. 12. Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, Texas, USA. 13. Department of Pathology, University of California, San Diego, San Diego, California, USA. 14. Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, Florida, USA. 15. Danbury Hospital. 16. Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, New York, USA. 17. University of Vermont, Nuvance Health, Danbury, Connecticut, USA. 18. Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, California, USA. 19. Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, Texas, USA. 20. Department of Pathology, Northshore University Health System, Evanston, Illinois, USA. 21. Norwalk Hospital. 22. Department of Medicine, Division of Infectious Diseases, University of Cincinnati, Cincinnati, Ohio, USA. 23. Department of Ophthalmology, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. 24. Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Baltimore, Maryland, USA. 25. Luminis Health, Annapolis, Maryland, USA. 26. Division of Allergy and Immunology, Department of Medicine. 27. Department of Neurology, University of Utah, Salt Lake City, Utah, USA. 28. Department of Medicine, University of Rochester, Rochester, New York, USA.
Abstract
BACKGROUND: The efficacy of 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 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: 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 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 = 0·49) and COVID-19 (26·3 vs. 25·9 days; p = 0·35) was similar for both groups. CONCLUSIONS: Administration of high-titer CCP as post-exposure prophylaxis, while appearing safe, did not prevent SARS-CoV-2 infection.
BACKGROUND: The efficacy of 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 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: 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 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 = 0·49) and COVID-19 (26·3 vs. 25·9 days; p = 0·35) was similar for both groups. CONCLUSIONS: Administration of high-titer CCP as post-exposure prophylaxis, while appearing safe, did not prevent SARS-CoV-2 infection.
Authors: Evan M Bloch; Aaron A R Tobian; Shmuel Shoham; Daniel F Hanley; Thomas J Gniadek; Edward R Cachay; Barry R Meisenberg; Kimberly Kafka; Christi Marshall; Sonya L Heath; Aarthi Shenoy; James H Paxton; Adam Levine; Donald Forthal; Yuriko Fukuta; Moises A Huaman; Alyssa Ziman; Jill Adamski; Jonathan Gerber; Daniel Cruser; Seble G Kassaye; Giselle S Mosnaim; Bela Patel; Ryan A Metcalf; Shweta Anjan; Ronald B Reisler; Anusha Yarava; Karen Lane; Nichol McBee; Amy Gawad; Jay S Raval; Martin Zand; Matthew Abinante; Patrick B Broderick; Arturo Casadevall; David Sullivan; Kelly A Gebo Journal: Transfusion Date: 2022-04-04 Impact factor: 3.337
Authors: Lise J Estcourt; Claudia S Cohn; Monica B Pagano; Claire Iannizzi; Nina Kreuzberger; Nicole Skoetz; Elizabeth S Allen; Evan M Bloch; Gregory Beaudoin; Arturo Casadevall; Dana V Devine; Farid Foroutan; Thomas J Gniadek; Ruchika Goel; Jed Gorlin; Brenda J Grossman; Michael J Joyner; Ryan A Metcalf; Jay S Raval; Todd W Rice; Beth H Shaz; Ralph R Vassallo; Jeffrey L Winters; Aaron A R Tobian Journal: Ann Intern Med Date: 2022-08-16 Impact factor: 51.598
Authors: Arwa Z Al-Riyami; Lise Estcourt; Naomi Rahimi-Levene; Evan M Bloch; Ruchika Goel; Pierre Tiberghien; Jean-Baptiste Thibert; Mie Topholm Bruun; Dana V Devine; Richard R Gammon; Silvano Wendel; Michel Toungouz Nevessignsky; Rada M Grubovic Rastvorceva; Adaeze Oreh; Iñigo Romon; Karin van den Berg; Junichi Kitazawa; Gopal Patidar; Cynthia So-Osman; Erica M Wood Journal: Vox Sang Date: 2022-09-14 Impact factor: 2.996