Convalescence plasma treatment of COVID-19: results from a prematurely terminated randomized controlled open-label study in Southern Sweden
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
BMC Research Notes, doi:10.1186/s13104-021-05847-7
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.
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Supplementary Information The online version contains supplementary material available at https:// doi. org/ 10. 1186/ s13104-021-05847-7. Additional file 1. SARS-CoV2 antibody detection and microneutralization assay. Authors' contributions KH: study design, inclusion of patients and donors, data collection and analysis, manuscript writing. MNL: study design, transfusion medicine expertise, donor screening and responsible for plasma collection and plasma analysis, data analysis and manuscript writing. JKK: study design, transfusion medicine expertise, data analysis and critical revision of the manuscript. OL, CW, JÖ: inclusion of patients, data collection and analysis, critical revision of the manuscript. NF: study design, inclusion of patients and donors, data collection. BB: study design, responsible for virology sampling and data analysis, critical revision of the manuscript. ER, AKÖ, JWB, MF: responsible for measuring
Declarations Ethics approval and consent to participate The Swedish Ethical Review Authority approved the study (Reference Number #2020-01744, 2020-03595). Written informed consent was required from donors and patients on inclusion.
Consent to publish Not applicable.
Competing interests The authors declare no competing interests.
Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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