• Marina Rieder, Fabian Schubach, Claudia Schmoor, Caroline von Spee-Mayer, Tobias Wengenmayer, Jonathan Rilinger, Dawid Staudacher, Christoph Bode, Daniel Duerschmied, and Alexander Supady.
• Department of Medicine III (Interdisciplinary Medical Intensive Care), University of Freiburg, Faculty of Medicine, Freiburg, Baden-Württemberg, Germany.
• BMJ Open. 2021 Jan 17; 11 (1): e043345.

IntroductionVeno-venous extracorporeal membrane oxygenation (V-V ECMO) is a last resort treatment option in patients with severe COVID-19 related acute respiratory distress syndrome (ARDS). Mortality in these critically ill patients is high. Elevated interleukin-6 (IL-6) levels in these severe courses are associated with poor outcome. Extracorporeal cytokine adsorption is an approach to lower elevated IL-6 levels. However, there is no randomised controlled data on the efficacy of cytokine adsorption and its effect on patient outcome in severe COVID-19 related ARDS requiring V-V ECMO support.Methods And AnalysisWe here report the protocol of a 1:1 randomised, controlled, parallel group, open-label intervention, superiority multicentre trial to evaluate the effect of extracorporeal cytokine adsorption using the CytoSorb device in severe COVID-19 related ARDS treated with V-V ECMO. We hypothesise that extracorporeal cytokine adsorption in these patients is effectively reducing IL-6 levels by 75% or more after 72 hours as compared with the baseline measurement and also reducing time to successful V-V ECMO explantation. We plan to include a total of 80 patients at nine centres in Germany.Ethics And DisseminationThe protocol of this study was approved by the ethical committee of the University of Freiburg as the leading institution (EK 285/20). Additional votes will be obtained at all participating centres.Trial Registration NumbersNCT04385771 and DRKS 00021248.© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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