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International Survey of Trials of Convalescent Plasma to Treat COVID-19 Infection
The collection and clinical use of COVID-19 convalescent plasma (CCP) as a therapy for COVID-19 infection is under development and early use in many centers worldwide. We conducted an international survey of centers undertaking studies of CCP to provide understanding of the common themes and differe...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier Inc.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7320682/ https://www.ncbi.nlm.nih.gov/pubmed/32703664 http://dx.doi.org/10.1016/j.tmrv.2020.06.003 |
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author | Murphy, Michael Estcourt, Lise Grant-Casey, John Dzik, Sunny |
author_facet | Murphy, Michael Estcourt, Lise Grant-Casey, John Dzik, Sunny |
author_sort | Murphy, Michael |
collection | PubMed |
description | The collection and clinical use of COVID-19 convalescent plasma (CCP) as a therapy for COVID-19 infection is under development and early use in many centers worldwide. We conducted an international survey of centers undertaking studies of CCP to provide understanding of the common themes and differences between them. Sixty-four studies in 22 countries were identified from clinical trial registries and personal contacts of the authors. Twenty of the 64 centers (31%) from 12 of 22 countries (55%) responded to the survey. Of the 20 studies, 11 were randomized controlled trials (RCTs), and 9 were case series. Only 4 of the RCTs plan to recruit 400 patients or more, and only 3 RCTs were blinded. The majority of studies will study the effect of CCP on sick patients requiring hospitalization and those requiring critical care, and none is examining the role of CCP in non-infected at-risk individuals. A wide variety of primary and secondary outcomes are being used. The donor eligibility criteria among the studies are very similar, and the use of plasmapheresis for the collection of CCP is almost universal. The planned dose of CCP ranges from as little as 200 mL to well over 1 L, but is 400 to 800 mL or 4 mL/kg or greater in all the RCTs. There is considerable variability in donor antibody testing with no consistency regarding the cut-off for antibody titer for acceptance as CCP or the use of pathogen-inactivation. Our survey provides an understanding of the similarities and differences among the studies of CCP, and that by virtue of their design some studies may be more informative than others. |
format | Online Article Text |
id | pubmed-7320682 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Elsevier Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-73206822020-06-29 International Survey of Trials of Convalescent Plasma to Treat COVID-19 Infection Murphy, Michael Estcourt, Lise Grant-Casey, John Dzik, Sunny Transfus Med Rev Article The collection and clinical use of COVID-19 convalescent plasma (CCP) as a therapy for COVID-19 infection is under development and early use in many centers worldwide. We conducted an international survey of centers undertaking studies of CCP to provide understanding of the common themes and differences between them. Sixty-four studies in 22 countries were identified from clinical trial registries and personal contacts of the authors. Twenty of the 64 centers (31%) from 12 of 22 countries (55%) responded to the survey. Of the 20 studies, 11 were randomized controlled trials (RCTs), and 9 were case series. Only 4 of the RCTs plan to recruit 400 patients or more, and only 3 RCTs were blinded. The majority of studies will study the effect of CCP on sick patients requiring hospitalization and those requiring critical care, and none is examining the role of CCP in non-infected at-risk individuals. A wide variety of primary and secondary outcomes are being used. The donor eligibility criteria among the studies are very similar, and the use of plasmapheresis for the collection of CCP is almost universal. The planned dose of CCP ranges from as little as 200 mL to well over 1 L, but is 400 to 800 mL or 4 mL/kg or greater in all the RCTs. There is considerable variability in donor antibody testing with no consistency regarding the cut-off for antibody titer for acceptance as CCP or the use of pathogen-inactivation. Our survey provides an understanding of the similarities and differences among the studies of CCP, and that by virtue of their design some studies may be more informative than others. Elsevier Inc. 2020-07 2020-06-27 /pmc/articles/PMC7320682/ /pubmed/32703664 http://dx.doi.org/10.1016/j.tmrv.2020.06.003 Text en © 2020 Elsevier Inc. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Article Murphy, Michael Estcourt, Lise Grant-Casey, John Dzik, Sunny International Survey of Trials of Convalescent Plasma to Treat COVID-19 Infection |
title | International Survey of Trials of Convalescent Plasma to Treat COVID-19 Infection |
title_full | International Survey of Trials of Convalescent Plasma to Treat COVID-19 Infection |
title_fullStr | International Survey of Trials of Convalescent Plasma to Treat COVID-19 Infection |
title_full_unstemmed | International Survey of Trials of Convalescent Plasma to Treat COVID-19 Infection |
title_short | International Survey of Trials of Convalescent Plasma to Treat COVID-19 Infection |
title_sort | international survey of trials of convalescent plasma to treat covid-19 infection |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7320682/ https://www.ncbi.nlm.nih.gov/pubmed/32703664 http://dx.doi.org/10.1016/j.tmrv.2020.06.003 |
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