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

Abstract 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 t...

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Autores principales: Karin Holm, Maria N. Lundgren, Jens Kjeldsen-Kragh, Oskar Ljungquist, Blenda Böttiger, Christian Wikén, Jonas Öberg, Nils Fernström, Ebba Rosendal, Anna K. Överby, Julia Wigren Byström, Mattias Forsell, Mona Landin-Olsson, Magnus Rasmussen
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spelling oai:doaj.org-article:b7713b8a6ec64937b394d31d9f097f2f2021-12-05T12:18:39ZConvalescence plasma treatment of COVID-19: results from a prematurely terminated randomized controlled open-label study in Southern Sweden10.1186/s13104-021-05847-71756-0500https://doaj.org/article/b7713b8a6ec64937b394d31d9f097f2f2021-12-01T00:00:00Zhttps://doi.org/10.1186/s13104-021-05847-7https://doaj.org/toc/1756-0500Abstract 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.Karin HolmMaria N. LundgrenJens Kjeldsen-KraghOskar LjungquistBlenda BöttigerChristian WikénJonas ÖbergNils FernströmEbba RosendalAnna K. ÖverbyJulia Wigren ByströmMattias ForsellMona Landin-OlssonMagnus RasmussenBMCarticleSARS-CoV2COVID-19Convalescent plasmaOxygen therapyDesaturationMedicineRBiology (General)QH301-705.5Science (General)Q1-390ENBMC Research Notes, Vol 14, Iss 1, Pp 1-5 (2021)
institution DOAJ
collection DOAJ
language EN
topic SARS-CoV2
COVID-19
Convalescent plasma
Oxygen therapy
Desaturation
Medicine
R
Biology (General)
QH301-705.5
Science (General)
Q1-390
spellingShingle SARS-CoV2
COVID-19
Convalescent plasma
Oxygen therapy
Desaturation
Medicine
R
Biology (General)
QH301-705.5
Science (General)
Q1-390
Karin Holm
Maria N. Lundgren
Jens Kjeldsen-Kragh
Oskar Ljungquist
Blenda Böttiger
Christian Wikén
Jonas Öberg
Nils Fernström
Ebba Rosendal
Anna K. Överby
Julia Wigren Byström
Mattias Forsell
Mona Landin-Olsson
Magnus Rasmussen
Convalescence plasma treatment of COVID-19: results from a prematurely terminated randomized controlled open-label study in Southern Sweden
description Abstract 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.
format article
author Karin Holm
Maria N. Lundgren
Jens Kjeldsen-Kragh
Oskar Ljungquist
Blenda Böttiger
Christian Wikén
Jonas Öberg
Nils Fernström
Ebba Rosendal
Anna K. Överby
Julia Wigren Byström
Mattias Forsell
Mona Landin-Olsson
Magnus Rasmussen
author_facet Karin Holm
Maria N. Lundgren
Jens Kjeldsen-Kragh
Oskar Ljungquist
Blenda Böttiger
Christian Wikén
Jonas Öberg
Nils Fernström
Ebba Rosendal
Anna K. Överby
Julia Wigren Byström
Mattias Forsell
Mona Landin-Olsson
Magnus Rasmussen
author_sort Karin Holm
title 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_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_sort convalescence plasma treatment of covid-19: results from a prematurely terminated randomized controlled open-label study in southern sweden
publisher BMC
publishDate 2021
url https://doaj.org/article/b7713b8a6ec64937b394d31d9f097f2f
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