Outpatient convalescent plasma therapy for high-risk patients with early COVID-19: a randomized placebo-controlled trial.

Autor:	Gharbharan A; Department of Internal Medicine, Section of Infectious Diseases and Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, the Netherlands. Electronic address: a.gharbharan@erasmusmc.nl., Jordans C; Department of Internal Medicine, Section of Infectious Diseases and Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, the Netherlands., Zwaginga L; Department of Haematology, Leiden University Medical Centre, Leiden, The Netherlands and CCTR, Sanquin Blood Supply, Amsterdam, the Netherlands., Papageorgiou G; Department of Biostatistics, Erasmus MC, University Medical Center, Rotterdam, the Netherlands., van Geloven N; Department of Biomedical Data Sciences, Section of Medical Statistics, Leiden University Medical Center, Leiden, the Netherlands., van Wijngaarden P; Department of Internal Medicine, Amphia Hospital, Breda, the Netherlands., den Hollander J; Department of Internal Medicine, Maasstad Ziekenhuis, Rotterdam, the Netherlands., Karim F; Department of Internal Medicine, Groene Hart Hospital, Gouda, the Netherlands., van Leeuwen-Segarceanu E; Department of Internal Medicine, St Antonius Hospital, Nieuwegein, the Netherlands., Soetekouw R; Department of Internal Medicine, Spaarne Gasthuis, Hoofddorp, the Netherlands., Lammers J; Department of Internal Medicine, Isala Hospital, Zwolle, the Netherlands., Postma D; Department of Internal Medicine and Infectious Diseases, Universitair Medisch Centrum Groningen, Groningen, the Netherlands., Kampschreur L; Department of Internal Medicine, Medical Center Leeuwarden, Leeuwarden, the Netherlands., Groeneveld G; Department of Infectious Diseases and Acute Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands., Swaneveld F; Unit of Transfusion Medicine, Sanquin Blood Supply, Amsterdam, the Netherlands., van der Schoot CE; Department of Experimental Immunohematology, Sanquin Research, Amsterdam, the Netherlands., Götz H; Department of Public Health, Public Health Service Rotterdam-Rijnmond, Rotterdam, the Netherlands; Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands., Haagmans B; Department of Viroscience, Erasmus MC, Rotterdam, the Netherlands., Koopmans M; Department of Viroscience, Erasmus MC, Rotterdam, the Netherlands., Bogers S; Department of Viroscience, Erasmus MC, Rotterdam, the Netherlands., Geurtsvankessel C; Department of Viroscience, Erasmus MC, Rotterdam, the Netherlands., Zwaginga JJ; Department of Haematology, Leiden University Medical Centre, Leiden, The Netherlands and CCTR, Sanquin Blood Supply, Amsterdam, the Netherlands., Rokx C; Department of Internal Medicine, Section of Infectious Diseases and Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, the Netherlands., Rijnders B; Department of Internal Medicine, Section of Infectious Diseases and Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, the Netherlands. Electronic address: b.rijnders@erasmusmc.nl.
Jazyk:	angličtina
Zdroj:	Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases [Clin Microbiol Infect] 2023 Feb; Vol. 29 (2), pp. 208-214. Date of Electronic Publication: 2022 Aug 23.
DOI:	10.1016/j.cmi.2022.08.005
Abstrakt:	Objectives: The potential benefit of convalescent plasma (CP) therapy for coronavirus disease 2019 (COVID-19) is highest when administered early after symptom onset. Our objective was to determine the effectiveness of CP therapy in improving the disease course of COVID-19 among high-risk outpatients. Methods: A multicentre, double-blind randomized trial was conducted comparing 300 mL of CP with non-CP. Patients were ≥50 years, were symptomatic for <8 days, had confirmed RT-PCR or antigen test result for COVID-19 and had at least one risk factor for severe COVID-19. The primary endpoint was the highest score on a 5-point ordinal scale ranging from fully recovered (score = 1) or not (score = 2) on day 7, over hospital admission (score = 3), intensive care unit admission (score = 4) and death (score = 5) in the 28 days following randomization. Secondary endpoints were hospital admission, symptom duration and viral RNA excretion. Results: After the enrolment of 421 patients and the transfusion in 416 patients, recruitment was discontinued when the countrywide vaccination uptake in those aged >50 years was 80%. Patients had a median age of 60 years, symptoms for 5 days, and 207 of 416 patients received CP therapy. During the 28 day follow-up, 28 patients were hospitalized and two died. The OR for an improved disease severity score with CP was 0.86 (95% credible interval, 0.59-1.22). The OR was 0.58 (95% CI, 0.33-1.02) for patients with ≤5 days of symptoms. The hazard ratio for hospital admission was 0.61 (95% CI, 0.28-1.34). No difference was found in viral RNA excretion or in the duration of symptoms. Conclusions: In patients with early COVID-19, CP therapy did not improve the 5-point disease severity score. (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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