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Early high antibody titre convalescent plasma for hospitalised COVID-19 patients: DAWn-plasma.
Devos, Timothy; Van Thillo, Quentin; Compernolle, Veerle; Najdovski, Tomé; Romano, Marta; Dauby, Nicolas; Jadot, Laurent; Leys, Mathias; Maillart, Evelyne; Loof, Sarah; Seyler, Lucie; Moonen, Martial; Moutschen, Michel; Van Regenmortel, Niels; Ariën, Kevin K; Barbezange, Cyril; Betrains, Albrecht; Garigliany, Mutien; Engelen, Matthias M; Gyselinck, Iwein; Maes, Piet; Schauwvlieghe, Alexander; Liesenborghs, Laurens; Belmans, Ann; Verhamme, Peter; Meyfroidt, Geert.
  • Devos T; Dept of Hematology, University Hospitals Leuven and Dept of Microbiology and Immunology, Laboratory of Molecular Immunology (Rega Institute), KU Leuven, Leuven, Belgium.
  • Van Thillo Q; Center for Cancer Biology, Vlaams Instituut voor Biotechnologie (VIB) and Center for Human Genetics, KU Leuven, Leuven, Belgium.
  • Compernolle V; Belgian Red Cross, Blood Services, Mechelen, Belgium.
  • Najdovski T; Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.
  • Romano M; Belgian Red Cross, Service du Sang, Namur, Belgium.
  • Dauby N; Immune Response Service, Infectious Diseases in Humans Scientific Directorate, Sciensano, Brussels, Belgium.
  • Jadot L; Dept of Infectious Diseases, CHU Saint-Pierre, School of Public Health, Institute for Medical Immunology, Universite Libre de Bruxelles (ULB), Brussels, Belgium.
  • Leys M; Dept of Anesthesiology and Intensive Care Medicine, and Dept of Infectious Diseases, CHC Mont Legia, Liege, Belgium.
  • Maillart E; Dept of Pulmonary Medicine, AZ Groeninge, Kortrijk, Belgium.
  • Loof S; Dept of Infectious Diseases, Brugmann University Hospital, Brussels, Belgium.
  • Seyler L; Dept of Respiratory Medicine, AZ Maria Middelares Gent, Ghent, Belgium.
  • Moonen M; Dept of Respiratory Medicine, AZ Sint-Vincentius Deinze, Deinze, Belgium.
  • Moutschen M; Dept of Infectious Diseases and Internal Medicine, UZ Brussel Hospital, Brussels, Belgium.
  • Van Regenmortel N; Dept of Internal Medicine and Infectious Diseases, Centre Hospitalier Regional (CHR), Liege, Belgium.
  • Ariën KK; Infectious Diseases and General Internal Medicine, CHU de Liege, Liege, Belgium.
  • Barbezange C; Dept of Intensive Care Medicine, Ziekenhuis Netwerk Antwerpen Campus Stuivenberg, Antwerp, Belgium.
  • Betrains A; Virology Unit, Institute of Tropical Medicine Antwerp, Dept of Biomedical Sciences, University of Antwerp, Antwerp, Belgium.
  • Garigliany M; National Influenza Centre, Sciensano, Brussels, Belgium.
  • Engelen MM; Dept of General Internal Medicine, University Hospitals Leuven, Dept of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.
  • Gyselinck I; Faculty of Veterinary Medicine, Animal Pathology, University of Liege, Liege, Belgium.
  • Maes P; Dept of Cardiovascular Sciences, UZ and KU Leuven, Leuven, Belgium.
  • Schauwvlieghe A; Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Dept CHROMETA, Respiratory Diseases UZ Leuven, Leuven, Belgium.
  • Liesenborghs L; Clinical and Epidemiological Virology, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.
  • Belmans A; Dept of Haematology, Ghent University Hospital, Ghent, Belgium.
  • Verhamme P; Laboratory of Virology and Chemotherapy, Dept of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.
  • Meyfroidt G; I-BioStat, KU Leuven, Leuven, Belgium.
Eur Respir J ; 59(2)2022 02.
Article in English | MEDLINE | ID: covidwho-1376571
ABSTRACT

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 (NT50)) ≥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 21 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 (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)) (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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunization, Passive / COVID-19 / Antibodies, Viral Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Humans Language: English Year: 2022 Document Type: Article Affiliation country: 13993003.01724-2021

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunization, Passive / COVID-19 / Antibodies, Viral Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Humans Language: English Year: 2022 Document Type: Article Affiliation country: 13993003.01724-2021