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Convalescence plasma treatment of COVID-19: results from a prematurely terminated randomized controlled open-label study in Southern Sweden

OBJECTIVE: Convalescent plasma has been tried as therapy for various viral infections. Early observational studies of convalescent plasma treatment for hospitalized COVID-19 patients were promising, but randomized controlled studies were lacking at the time. The objective of this study was to invest...

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Autores principales: Holm, Karin, Lundgren, Maria N., Kjeldsen-Kragh, Jens, Ljungquist, Oskar, Böttiger, Blenda, Wikén, Christian, Öberg, Jonas, Fernström, Nils, Rosendal, Ebba, Överby, Anna K., Wigren Byström, Julia, Forsell, Mattias, Landin-Olsson, Mona, Rasmussen, Magnus
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8642769/
https://www.ncbi.nlm.nih.gov/pubmed/34863304
http://dx.doi.org/10.1186/s13104-021-05847-7
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author Holm, Karin
Lundgren, Maria N.
Kjeldsen-Kragh, Jens
Ljungquist, Oskar
Böttiger, Blenda
Wikén, Christian
Öberg, Jonas
Fernström, Nils
Rosendal, Ebba
Överby, Anna K.
Wigren Byström, Julia
Forsell, Mattias
Landin-Olsson, Mona
Rasmussen, Magnus
author_facet Holm, Karin
Lundgren, Maria N.
Kjeldsen-Kragh, Jens
Ljungquist, Oskar
Böttiger, Blenda
Wikén, Christian
Öberg, Jonas
Fernström, Nils
Rosendal, Ebba
Överby, Anna K.
Wigren Byström, Julia
Forsell, Mattias
Landin-Olsson, Mona
Rasmussen, Magnus
author_sort Holm, Karin
collection PubMed
description OBJECTIVE: Convalescent plasma has been tried as therapy for various viral infections. Early observational studies of convalescent plasma treatment for hospitalized COVID-19 patients were promising, but randomized controlled studies were lacking at the time. The objective of this study was to investigate if convalescent plasma is beneficial to hospitalized patients with COVID-19. RESULTS: Hospitalized patients with confirmed COVID-19 and an oxygen saturation below 94% were randomized 1:1 to receive convalescent plasma in addition to standard of care or standard of care only. The primary outcome was number of days of oxygen treatment to keep saturation above 93% within 28 days from inclusion. The study was prematurely terminated when thirty-one of 100 intended patients had been included. The median time of oxygen treatment among survivors was 11 days (IQR 6–15) for the convalescent plasma group and 7 days (IQR 5–9) for the standard of care group (p = 0.4, median difference -4). Two patients in the convalescent plasma group and three patients in the standard of care group died (p = 0.64, OR 0.49, 95% CI 0.08–2.79). Thus no significant differences were observed between the groups. Trial registration ClinicalTrials NCT04600440, retrospectively registered Oct 23, 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13104-021-05847-7.
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spelling pubmed-86427692021-12-06 Convalescence plasma treatment of COVID-19: results from a prematurely terminated randomized controlled open-label study in Southern Sweden Holm, Karin Lundgren, Maria N. Kjeldsen-Kragh, Jens Ljungquist, Oskar Böttiger, Blenda Wikén, Christian Öberg, Jonas Fernström, Nils Rosendal, Ebba Överby, Anna K. Wigren Byström, Julia Forsell, Mattias Landin-Olsson, Mona Rasmussen, Magnus BMC Res Notes Research Note OBJECTIVE: Convalescent plasma has been tried as therapy for various viral infections. Early observational studies of convalescent plasma treatment for hospitalized COVID-19 patients were promising, but randomized controlled studies were lacking at the time. The objective of this study was to investigate if convalescent plasma is beneficial to hospitalized patients with COVID-19. RESULTS: Hospitalized patients with confirmed COVID-19 and an oxygen saturation below 94% were randomized 1:1 to receive convalescent plasma in addition to standard of care or standard of care only. The primary outcome was number of days of oxygen treatment to keep saturation above 93% within 28 days from inclusion. The study was prematurely terminated when thirty-one of 100 intended patients had been included. The median time of oxygen treatment among survivors was 11 days (IQR 6–15) for the convalescent plasma group and 7 days (IQR 5–9) for the standard of care group (p = 0.4, median difference -4). Two patients in the convalescent plasma group and three patients in the standard of care group died (p = 0.64, OR 0.49, 95% CI 0.08–2.79). Thus no significant differences were observed between the groups. Trial registration ClinicalTrials NCT04600440, retrospectively registered Oct 23, 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13104-021-05847-7. BioMed Central 2021-12-04 /pmc/articles/PMC8642769/ /pubmed/34863304 http://dx.doi.org/10.1186/s13104-021-05847-7 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research Note
Holm, Karin
Lundgren, Maria N.
Kjeldsen-Kragh, Jens
Ljungquist, Oskar
Böttiger, Blenda
Wikén, Christian
Öberg, Jonas
Fernström, Nils
Rosendal, Ebba
Överby, Anna K.
Wigren Byström, Julia
Forsell, Mattias
Landin-Olsson, Mona
Rasmussen, Magnus
Convalescence plasma treatment of COVID-19: results from a prematurely terminated randomized controlled open-label study in Southern Sweden
title Convalescence plasma treatment of COVID-19: results from a prematurely terminated randomized controlled open-label study in Southern Sweden
title_full Convalescence plasma treatment of COVID-19: results from a prematurely terminated randomized controlled open-label study in Southern Sweden
title_fullStr Convalescence plasma treatment of COVID-19: results from a prematurely terminated randomized controlled open-label study in Southern Sweden
title_full_unstemmed Convalescence plasma treatment of COVID-19: results from a prematurely terminated randomized controlled open-label study in Southern Sweden
title_short Convalescence plasma treatment of COVID-19: results from a prematurely terminated randomized controlled open-label study in Southern Sweden
title_sort convalescence plasma treatment of covid-19: results from a prematurely terminated randomized controlled open-label study in southern sweden
topic Research Note
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8642769/
https://www.ncbi.nlm.nih.gov/pubmed/34863304
http://dx.doi.org/10.1186/s13104-021-05847-7
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