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Early high antibody-titre convalescent plasma for hospitalised COVID-19 patients: DAWn-plasma

Department of Hematology, University Hospitals Leuven and Department of Microbiology and Immunology, Laboratory of Molecular Immunology (Rega Institute), KU Leuven, Leuven, Belgium. Center for Cancer Biology, Vlaams Instituut voor Biotechnologie (VIB), Leuven and Center for Human Genetics, KU Leuven, Leuven, Belgium. Belgian Red Cross, Blood Services, Mechelen, Belgium. Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium. Belgian Red Cross, Service du Sang, Namur, Belgium. Immune Response Service; Infectious Diseases in Humans Scientific Directorate, Sciensano, Brussels, Belgium. Department of Infectious Diseases, CHU Saint-Pierre, Universite Libre de Bruxelles (ULB), School of Public Health, Universite Libre de Bruxelles (ULB), Institute for Medical Immunology, Universite Libre de Bruxelles (ULB), Belgium. Department of Anesthesiology and Intensive Care Medicine, and Department of Infectious diseases, CHC Mont Legia, Liege, Belgium. Department of Pulmonary Medicine, AZ Groeninge, Kortrijk, Belgium. Department of Infectious Diseases, Brugmann University Hospital, Brussels, Belgium. Department of Respiratory Medicine, AZ Maria Middelares Gent, Ghent, Belgium. Department of Respiratory Medicine, AZ Sint-Vincentius Deinze, Deinze, Belgium. Department of Infectious Diseases and Internal Medicine, UZ Brussel Hospital, Brussels, Belgium. Department of Internal Medicine and Infectious Diseases, Centre Hospitalier Regional (CHR), Liege, Belgium. Infectious Diseases and General Internal Medicine, CHU de Liege, ULiege, Belgium. Department of Intensive Care Medicine, Ziekenhuis Netwerk Antwerpen Campus Stuivenberg, Antwerp, Belgium. Virology Unit, Institute of Tropical Medicine Antwerp, Antwerp and Department of Biomedical Sciences, University of Antwerp, Antwerp, Belgium. National Influenza Centre, Sciensano, Brussels, Belgium. Department of General Internal Medicine, University Hospitals Leuven, Leuven and Department of Microbiology, Immunology, and Transplantation, KU Leuven, Leuven, Belgium. University of Liege, Faculty of Veterinary Medicine, Animal Pathology, Liege, Belgium. Department of Cardiovascular Sciences, UZ and KU Leuven, Belgium. Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department CHROMETA, KU Leuven, Respiratory Diseases UZ Leuven, Leuven, Belgium. KU Leuven, Rega Institute for Medical Research, Clinical and Epidemiological Virology, Leuven, Belgium. Department of Haematology, Ghent University Hospital, Ghent, Belgium. Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium. I-BioStat, KU Leuven, Leuven, Belgium and University Hasselt, Hasselt, Belgium. Department of Intensive Care Medicine, University Hospitals Leuven, and Department of Cellular and Molecular Medicine, Laboratory of Intensive Care Medicine, KU Leuven, Leuven, Belgium.

The European Respiratory Journal. 2021
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Abstract
BACKGROUND Several randomised clinical trials have studied convalescent plasma (CP) for COVID-19 using different protocols, with different 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 (NT50) ≥1/320 was the product of choice for the study. RESULTS Between May 2nd, 2020 and January 26th, 2021, 320 patients were randomised to convalescent plasma and 163 patients to the control group according to a 2:1 allocation scheme. A median volume of 884 mL convalescent plasma (IQR 806-906 mL) was administered, and 80.68% of the units came from donors with neutralising-antibody-titres (NT50) ≥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) - Odds ratio 0.99 (0.59-1.66) - p-value=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 19/320 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 the clinical status, or a reduced mortality.
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Language : eng
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