Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2022
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
_version_ 1784746146329001984
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
work_keys_str_mv AT ipetinas treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT ugwumbablessing treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT spencerhoracej treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT letuan treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT ridenourterry treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT armitagejohn treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT ryanstefanie treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT pearsonshanna treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT kothariatul treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT patilnaveen treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT dareryan treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT crescenciojuancr treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT venkataanand treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT laudadiojennifer treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT mohammadkhalid treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT jamalnaznin treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT thompsonjohn treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT mcnewhailey treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT gibbsmckenzie treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT hennigansteve treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT kellarstan treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT reitzelkeith treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT walserbrandone treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT novakamanda treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate
AT quinnbrian treatmentofcovid19patientswithtwounitsofconvalescentplasmainaresourceconstrainedstate