A randomized, multicentre, open-label phase II proof-of-concept trial investigating the clinical efficacy and safety of
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A randomized, multicentre, open-label phase II proof-of-concept trial investigating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19: the Donated Antibodies Working against nCoV (DAWn-Plasma) trial Timothy Devos1,2*† , Tatjana Geukens1,2† , Alexander Schauwvlieghe3†, Kevin K. Ariën4, Cyril Barbezange5, Myriam Cleeren1, Veerle Compernolle6, Nicolas Dauby7, Daniël Desmecht8, David Grimaldi9, Bart N. Lambrecht3, Anne Luyten10, Piet Maes11, Michel Moutschen8, Marta Romano5, Lucie Seyler12, Michel Toungouz Nevessignsky13, Katleen Vandenberghe10, Johan van Griensven4, Geert Verbeke14, Erika Vlieghe15, Jean Cyr Yombi16, Laurens Liesenborghs11, Peter Verhamme1 and Geert Meyfroidt1
Abstract Background: The COVID-19 pandemic has imposed an enormous burden on health care systems around the world. In the past, the administration of convalescent plasma of patients having recovered from SARS and severe influenza to patients actively having the disease showed promising effects on mortality and appeared safe. Whether or not this also holds true for the novel SARS-CoV-2 virus is currently unknown. Methods: DAWn-Plasma is a multicentre nation-wide, randomized, open-label, phase II proof-of-concept clinical trial, evaluating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19 in Belgium. Patients hospitalized with a confirmed diagnosis of COVID-19 are eligible when they are symptomatic (i.e. clinical or radiological signs) and have been diagnosed with COVID-19 in the 72 h before study inclusion through a PCR (nasal/nasopharyngeal swab or bronchoalveolar lavage) or a chestCT scan showing features compatible with COVID-19 in the absence of an alternative diagnosis. Patients are (Continued on next page)
* Correspondence: [email protected] † Timothy Devos, Tatjana Geukens and Alexander Schauwvlieghe are co-first authors. 1 University Hospitals Leuven (UZ Leuven), Leuven, Belgium 2 Catholic University of Leuven (KU Leuven), Leuven, Belgium Full list of author information is available at the end of the article © The Author(s). 2020, corrected publication 2020. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this
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