[en] BACKGROUND: Several randomised clinical trials have studied convalescent plasma for coronavirus disease 2019 (COVID-19) using different protocols, with different severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralising antibody titres, at different time-points and severities of illness. METHODS: In the prospective multicentre DAWn-plasma trial, adult patients hospitalised with COVID-19 were randomised to 4 units of open-label convalescent plasma combined with standard of care (intervention group) or standard of care alone (control group). Plasma from donors with neutralising antibody titres (50% neutralisation titre (NT(50))) ≥1/320 was the product of choice for the study. RESULTS: Between 2 May 2020 and 26 January 2021, 320 patients were randomised to convalescent plasma and 163 patients to the control group according to a 2:1 allocation scheme. A median (interquartile range) volume of 884 (806-906) mL) convalescent plasma was administered and 80.68% of the units came from donors with neutralising antibody titres (NT(50)) ≥1/320. Median time from onset of symptoms to randomisation was 7 days. The proportion of patients alive and free of mechanical ventilation on day 15 was not different between both groups (convalescent plasma 83.74% (n=267) versus control 84.05% (n=137)) (OR 0.99, 95% CI 0.59-1.66; p=0.9772). The intervention did not change the natural course of antibody titres. The number of serious or severe adverse events was similar in both study arms and transfusion-related side-effects were reported in 19 out of 320 patients in the intervention group (5.94%). CONCLUSIONS: Transfusion of 4 units of convalescent plasma with high neutralising antibody titres early in hospitalised COVID-19 patients did not result in a significant improvement of clinical status or reduced mortality.
Disciplines :
Immunology & infectious disease
Author, co-author :
Devos, Timothy; Dept of Hematology, University Hospitals Leuven and Dept of Microbiology and
Van Thillo, Quentin ; Center for Cancer Biology, Vlaams Instituut voor Biotechnologie (VIB) and Center for
Compernolle, Veerle; Belgian Red Cross, Blood Services, Mechelen, Belgium. ; Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.
Najdovski, Tomé; Belgian Red Cross, Service du Sang, Namur, Belgium.
Dauby, Nicolas ; Dept of Infectious Diseases, CHU Saint-Pierre, School of Public Health, Institute
Jadot, Laurent; Dept of Anesthesiology and Intensive Care Medicine, and Dept of Infectious Diseases,
Leys, Mathias; Dept of Pulmonary Medicine, AZ Groeninge, Kortrijk, Belgium.
Maillart, Evelyne; Dept of Infectious Diseases, Brugmann University Hospital, Brussels, Belgium.
Loof, Sarah; Dept of Respiratory Medicine, AZ Maria Middelares Gent, Ghent, Belgium. ; Dept of Respiratory Medicine, AZ Sint-Vincentius Deinze, Deinze, Belgium.
Seyler, Lucie; Dept of Infectious Diseases and Internal Medicine, UZ Brussel Hospital, Brussels,
Moonen, Martial; Dept of Internal Medicine and Infectious Diseases, Centre Hospitalier Regional
MOUTSCHEN, Michel ; Centre Hospitalier Universitaire de Liège - CHU > > Service des maladies infectieuses - médecine interne
Van Regenmortel, Niels; Dept of Intensive Care Medicine, Ziekenhuis Netwerk Antwerpen Campus Stuivenberg,
Ariën, Kevin K; Virology Unit, Institute of Tropical Medicine Antwerp, Dept of Biomedical Sciences,
Barbezange, Cyril; National Influenza Centre, Sciensano, Brussels, Belgium.
Betrains, Albrecht; Dept of General Internal Medicine, University Hospitals Leuven, Dept of
Garigliany, Mutien-Marie ; Université de Liège - ULiège > Département de morphologie et pathologie (DMP) ; Université de Liège - ULiège > Fundamental and Applied Research for Animals and Health (FARAH) > FARAH: Santé publique vétérinaire ; Université de Liège - ULiège > Département de morphologie et pathologie (DMP) > Pathologie générale et autopsies
Engelen, Matthias M; Dept of Cardiovascular Sciences, UZ and KU Leuven, Leuven, Belgium.
Gyselinck, Iwein ; Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Dept CHROMETA
Maes, Piet; Clinical and Epidemiological Virology, Rega Institute for Medical Research, KU
Schauwvlieghe, Alexander; Dept of Haematology, Ghent University Hospital, Ghent, Belgium.
Liesenborghs, Laurens ; Laboratory of Virology and Chemotherapy, Dept of Microbiology, Immunology and
Belmans, Ann; I-BioStat, KU Leuven, Leuven, Belgium. ; University Hasselt, Hasselt, Belgium.
Verhamme, Peter ; Dept of Cardiovascular Sciences, UZ and KU Leuven, Leuven, Belgium.
Meyfroidt, Geert; Dept of Intensive Care Medicine, University Hospitals Leuven, Dept of Cellular and
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