Cytokine adsorption in patients with severe COVID-19 pneumonia requiring extracorporeal membrane oxygenation (CYCOV): a single centre, open-label, randomised, controlled trial
MD, M Rieder MD, A Lother MD Alexander Supady, PhD, E Graf PhD Enya Weber, Marina Rieder, Achim Lother, Tim Niklaus, Timm Zahn, Franziska Frech, Sissi Müller, Moritz Kuhl, Christoph Benk, MSc Sven Maier, MD Georg Trummer, MD, K Krüger MD, A Sekandarzad MD, P Stachon MD Annabelle Flügler, Kirsten Krüger, Asieb Sekandarzad, Peter Stachon, Prof Viviane Zotzmann, Prof Christoph Bode, Paul M Biever, MD Dawid Staudacher, Tobias Wengenmayer, Medical Center (E Weber Erika Graf, Daniel Duerschmied
The Lancet Respiratory Medicine, doi:10.1016/s2213-2600(21)00177-6
Background We sought to clarify the benefit of cytokine adsorption in patients with COVID-19 supported with venovenous extracorporeal membrane oxygenation (ECMO).
Methods We did a single-centre, open-label, randomised, controlled trial to investigate cytokine adsorption in adult patients with severe COVID-19 pneumonia requiring ECMO. Patients with COVID-19 selected for ECMO at the Freiburg University Medical Center (Freiburg, Germany) were randomly assigned (1:1) to receive cytokine adsorption using the CytoSorb device or not. Randomisation was computer-generated, allocation was concealed by opaque, sequentially numbered sealed envelopes. The CytoSorb device was incorporated into the ECMO circuit before connection to the patient circuit, replaced every 24 h, and removed after 72 h. The primary endpoint was serum interleukin-6 (IL-6) concentration 72 h after initiation of ECMO analysed by intention to treat. Secondary endpoints included 30-day survival. The trial is registered with ClinicalTrials.gov (NCT04324528) and the German Clinical Trials Register (DRKS00021300) and is closed. Findings From March 29, 2020, to Dec 29, 2020, of 34 patients assessed for eligibility, 17 (50%) were treated with cytokine adsorption and 17 (50%) without. Median IL-6 decreased from 357•0 pg/mL to 98•6 pg/mL in patients randomly assigned to cytokine adsorption and from 289•0 pg/mL to 112•0 pg/mL in the control group after 72 h. One patient in each group died before 72 h. Adjusted mean log IL-6 concentrations after 72 h were 0•30 higher in the cytokine adsorption group (95% CI -0•70 to 1•30, p=0•54). Survival after 30 days was three (18%) of 17 with cytokine adsorption and 13 (76%) of 17 without cytokine adsorption (p=0•0016). Interpretation Early initiation of cytokine adsorption in patients with severe COVID-19 and venovenous ECMO did not reduce serum IL-6 and had a negative effect on survival. Cytokine adsorption should not be used during the first days of ECMO support in COVID-19.
Contributors ASu was principal investigator of the trial, he wrote the study protocol, designed and supervised the trial, and wrote the first draft of the manuscript. ASu and DD accessed and verified the data. Statistical analyses were done by EW, EG, and AS. MR, AL, TN, TZ, FF, SMü, MK, CBe, SMa, GT, AF, KK, ASe, PS, VZ, CBo, PMB, DS, TW, and DD supported acquisition, analysis, and interpretation of the data. All authors had full access to all the data and the corresponding author had final responsibility for the decision to submit for publication. All authors read and approved the final manuscript.
Declarations of interests All authors have completed the ICMJE form (available on request from the corresponding author). ASu reports research grants and lecture fees from CytoSorbents and lecture fees from Abiomed, both outside of the submitted work. MR reports funding by the IMM-PACT-Programme for Clinician Scientists, Department of Medicine II, Medical Center, University of Freiburg and Faculty of Medicine, funded by the Deutsche Forschungsgemeinschaft (German Research Foundation)-413517907 and financial support from CytoSorbents for attending a scientific meeting. AL reports a research grant from the German Center for infectious diseases, outside of the submitted work and is a member of SFB1425, funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation #422681845). SMa reports honoraria from CytoSorbents for a presentation during a scientific workshop...
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