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Treatment of COVID-19 Patients with Two Units of Convalescent Plasma in a Resource-Constrained State
IMPORTANCE: Many therapies are used to treat COVID-19, the disease caused by the virus SARS-CoV-2, including convalescent plasma. The clinical utility of using 2 units of convalescent plasma for COVID-19 hospitalized patients is not fully understood. OBJECTIVE: Many therapies are used to treat COVID...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9278218/ https://www.ncbi.nlm.nih.gov/pubmed/35771890 http://dx.doi.org/10.1093/labmed/lmac055 |
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author | Ipe, Tina S Ugwumba, Blessing Spencer, Horace J Le, Tuan Ridenour, Terry Armitage, John Ryan, Stefanie Pearson, Shanna Kothari, Atul Patil, Naveen Dare, Ryan Crescencio, Juan C R Venkata, Anand Laudadio, Jennifer Mohammad, Khalid Jamal, Naznin Thompson, John McNew, Hailey Gibbs, McKenzie Hennigan, Steve Kellar, Stan Reitzel, Keith Walser, Brandon E Novak, Amanda Quinn, Brian |
author_facet | Ipe, Tina S Ugwumba, Blessing Spencer, Horace J Le, Tuan Ridenour, Terry Armitage, John Ryan, Stefanie Pearson, Shanna Kothari, Atul Patil, Naveen Dare, Ryan Crescencio, Juan C R Venkata, Anand Laudadio, Jennifer Mohammad, Khalid Jamal, Naznin Thompson, John McNew, Hailey Gibbs, McKenzie Hennigan, Steve Kellar, Stan Reitzel, Keith Walser, Brandon E Novak, Amanda Quinn, Brian |
author_sort | Ipe, Tina S |
collection | PubMed |
description | IMPORTANCE: Many therapies are used to treat COVID-19, the disease caused by the virus SARS-CoV-2, including convalescent plasma. The clinical utility of using 2 units of convalescent plasma for COVID-19 hospitalized patients is not fully understood. OBJECTIVE: Many therapies are used to treat COVID-19, the disease caused by the virus SARS-CoV-2, including convalescent plasma. The clinical utility of using 2 units of convalescent plasma for COVID-19 hospitalized patients is not fully understood. Our study aims to determine the safety and efficacy of treating hospitalized COVID-19 patients with 2 units of COVID-19 convalescent plasma (CCP). METHOD: This was a retrospective study of Arkansas patients treated with CCP using the (US) Food and Drug Administration (FDA) emergency Investigational New Drug (eIND) mechanism from April 9, 2020, through August 9, 2020. It was a multicenter, statewide study in a low-resource setting, which are areas that lack funding for health care cost coverage on various levels including individual, family, or social. Adult patients (n = 165, volunteer sample) in Arkansas who were hospitalized with severe or life-threatening acute COVID-19 disease as defined by the FDA criteria were transfused with 2 units of CCP (250 mL/unit) using the FDA eIND mechanism. The primary outcome was 7- and 30-day mortality after the second unit of CCP. RESULTS: Unadjusted mortality was 12.1% at 7 days and 23.0% at 30 days. The unadjusted mortality was reduced to 7.7% if the first CCP unit was transfused on the date of diagnosis, 8.7% if transfused within 3 days of diagnosis, and 32.0% if transfused at or after 4 or more days of diagnosis. The risk of death was higher in patients that received low, negative, or missing titer CCP units in comparison to those that received higher titer units. CONCLUSION: The provision of 2 units of CCP was associated with a reduction in mortality in patients treated with high titer units within 3 days of COVID-19 diagnosis. Given the results, CCP is a viable, low-cost therapy in resource-constrained states and countries. |
format | Online Article Text |
id | pubmed-9278218 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-92782182022-07-18 Treatment of COVID-19 Patients with Two Units of Convalescent Plasma in a Resource-Constrained State Ipe, Tina S Ugwumba, Blessing Spencer, Horace J Le, Tuan Ridenour, Terry Armitage, John Ryan, Stefanie Pearson, Shanna Kothari, Atul Patil, Naveen Dare, Ryan Crescencio, Juan C R Venkata, Anand Laudadio, Jennifer Mohammad, Khalid Jamal, Naznin Thompson, John McNew, Hailey Gibbs, McKenzie Hennigan, Steve Kellar, Stan Reitzel, Keith Walser, Brandon E Novak, Amanda Quinn, Brian Lab Med Science IMPORTANCE: Many therapies are used to treat COVID-19, the disease caused by the virus SARS-CoV-2, including convalescent plasma. The clinical utility of using 2 units of convalescent plasma for COVID-19 hospitalized patients is not fully understood. OBJECTIVE: Many therapies are used to treat COVID-19, the disease caused by the virus SARS-CoV-2, including convalescent plasma. The clinical utility of using 2 units of convalescent plasma for COVID-19 hospitalized patients is not fully understood. Our study aims to determine the safety and efficacy of treating hospitalized COVID-19 patients with 2 units of COVID-19 convalescent plasma (CCP). METHOD: This was a retrospective study of Arkansas patients treated with CCP using the (US) Food and Drug Administration (FDA) emergency Investigational New Drug (eIND) mechanism from April 9, 2020, through August 9, 2020. It was a multicenter, statewide study in a low-resource setting, which are areas that lack funding for health care cost coverage on various levels including individual, family, or social. Adult patients (n = 165, volunteer sample) in Arkansas who were hospitalized with severe or life-threatening acute COVID-19 disease as defined by the FDA criteria were transfused with 2 units of CCP (250 mL/unit) using the FDA eIND mechanism. The primary outcome was 7- and 30-day mortality after the second unit of CCP. RESULTS: Unadjusted mortality was 12.1% at 7 days and 23.0% at 30 days. The unadjusted mortality was reduced to 7.7% if the first CCP unit was transfused on the date of diagnosis, 8.7% if transfused within 3 days of diagnosis, and 32.0% if transfused at or after 4 or more days of diagnosis. The risk of death was higher in patients that received low, negative, or missing titer CCP units in comparison to those that received higher titer units. CONCLUSION: The provision of 2 units of CCP was associated with a reduction in mortality in patients treated with high titer units within 3 days of COVID-19 diagnosis. Given the results, CCP is a viable, low-cost therapy in resource-constrained states and countries. Oxford University Press 2022-06-30 /pmc/articles/PMC9278218/ /pubmed/35771890 http://dx.doi.org/10.1093/labmed/lmac055 Text en © The Author(s) 2022. Published by Oxford University Press on behalf of American Society for Clinical Pathology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com https://academic.oup.com/pages/standard-publication-reuse-rightsThis article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/pages/standard-publication-reuse-rights) |
spellingShingle | Science Ipe, Tina S Ugwumba, Blessing Spencer, Horace J Le, Tuan Ridenour, Terry Armitage, John Ryan, Stefanie Pearson, Shanna Kothari, Atul Patil, Naveen Dare, Ryan Crescencio, Juan C R Venkata, Anand Laudadio, Jennifer Mohammad, Khalid Jamal, Naznin Thompson, John McNew, Hailey Gibbs, McKenzie Hennigan, Steve Kellar, Stan Reitzel, Keith Walser, Brandon E Novak, Amanda Quinn, Brian Treatment of COVID-19 Patients with Two Units of Convalescent Plasma in a Resource-Constrained State |
title | Treatment of COVID-19 Patients with Two Units of Convalescent Plasma in a Resource-Constrained State |
title_full | Treatment of COVID-19 Patients with Two Units of Convalescent Plasma in a Resource-Constrained State |
title_fullStr | Treatment of COVID-19 Patients with Two Units of Convalescent Plasma in a Resource-Constrained State |
title_full_unstemmed | Treatment of COVID-19 Patients with Two Units of Convalescent Plasma in a Resource-Constrained State |
title_short | Treatment of COVID-19 Patients with Two Units of Convalescent Plasma in a Resource-Constrained State |
title_sort | treatment of covid-19 patients with two units of convalescent plasma in a resource-constrained state |
topic | Science |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9278218/ https://www.ncbi.nlm.nih.gov/pubmed/35771890 http://dx.doi.org/10.1093/labmed/lmac055 |
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