Contributors: Gyselinck, Iwein/0000-0002-4068-7228; Barbezange; Cyril/0000-0001-9606-2983; Dauby, Nicolas/0000-0002-7697-6849; Liesenborghs, Laurens/0000-0001-5616-8548; Devos , Timothy; Van Thillo, Quentin; Compernolle, Veerle; Najdovski, Tome; Romano, Marta; Dauby, Nicolas; Jadot, Laurent; Leys, Mathias; Maillart, Evelyne; Loof, Sarah; Seyler , Lucie; Moonen , Martial; Moutschen, Michel; Van Regenmortel, Niels; Arien, 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
نبذة مختصرة : 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 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 (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. ; This work was supported by Fonds Wetenschappelijk Onderzoek (grant: 1843118N) and Belgian Health Care Knowledge Centre (KCE). Funding information for this article has been deposited with the Crossref Funder ...
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