Cytokine adsorption in patients with severe COVID-19 pneumonia requiring extracorporeal membrane oxygenation: protocol for a randomised, controlled, open-label intervention, multicentre trial

BMJ Open. 2021 Jan 17;11(1):e043345. doi: 10.1136/bmjopen-2020-043345.


Introduction: Veno-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 analysis: We 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 dissemination: The 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 numbers: NCT04385771 and DRKS 00021248.

Keywords: COVID-19; adult intensive & critical care; respiratory medicine (see thoracic medicine).

Publication types

  • Clinical Trial Protocol

MeSH terms

  • COVID-19 / therapy*
  • Cytokines / blood
  • Extracorporeal Membrane Oxygenation / methods*
  • Germany
  • Humans
  • Interleukin-6 / blood*
  • Multicenter Studies as Topic
  • Randomized Controlled Trials as Topic
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome


  • Cytokines
  • Interleukin-6

Associated data