Cytokine adsorption in patients with severe COVID-19 pneumonia requiring extracorporeal membrane oxygenation – randomized, controlled, open-label intervention, multi-center trial

Cytokine adsorption in patients with severe COVID-19 pneumonia requiring extracorporeal membrane oxygenation – randomized, controlled, open-label intervention, multi-center trial - CYCOV-II

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00021248

Enrollment

Registered

2020-05-22

Start date

2020-10-19

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

U07.1

Interventions

Group 1: V-V ECMO with cytokine adsorption using a CytoSorb adsorber for 72 hours Group 2: V-V ECMO without cytokine adsorption

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patient (= 18 years), initiation of vv-ECMO, SARS-CoV-2-infection

Exclusion criteria

Exclusion criteria: Known or presumed patient will against participation in the study or against the measures applied in the study, a decision (made prior to inclusion of the patient into this trial) to terminate the treatment within the next 24 hours

Design outcomes

Primary

Measure	Time frame
(1) IL-6 reduction by 75 % or more after 72 hours as compared to the baseline measurement, (2) time to successful ECMO-explantation within 30 days after randomization.	—

Secondary

Measure	Time frame
• Ventilator free days (VFD) in the first 30 days after randomization, where invasive mechanical ventilation (IMV), non-invasive ventilation (NIV) and ECMO are defined as ventilator days. VFD=0, if the patient dies in the first 30 days after randomization • Time to extubation from ventilation and explantation from ECMO. Death under ventilation and/or ECMO will be analyzed as a competing event. • Overall survival time, defined as time from randomization to death. • Days on intensive care unit (ICU) • Vasopressor dosage of adrenaline, noradrenaline, vasopressin, and dobutamine at 24, 48, 72 h • Fluid substitution and fluid balance at 24, 48, 72 h • Serum lactate at 24, 48, 72 h • Urine output at 24, 48, 72 h • Willebrand factor at 24, 48, 72 h • d-dimers at 24, 48, 72 h • interleukin-6 levels at 24, 48, 72 h • SOFA-score at 24, 48, 72 h • Adverse events of special interest (AESI) as defined in the clinical trial protocol	—

Measure

Time frame

• Ventilator free days (VFD) in the first 30 days after randomization, where invasive mechanical ventilation (IMV), non-invasive ventilation (NIV) and ECMO are defined as ventilator days. VFD=0, if the patient dies in the first 30 days after randomization • Time to extubation from ventilation and explantation from ECMO. Death under ventilation and/or ECMO will be analyzed as a competing event. • Overall survival time, defined as time from randomization to death. • Days on intensive care unit (ICU) • Vasopressor dosage of adrenaline, noradrenaline, vasopressin, and dobutamine at 24, 48, 72 h • Fluid substitution and fluid balance at 24, 48, 72 h • Serum lactate at 24, 48, 72 h • Urine output at 24, 48, 72 h • Willebrand factor at 24, 48, 72 h • d-dimers at 24, 48, 72 h • interleukin-6 levels at 24, 48, 72 h • SOFA-score at 24, 48, 72 h • Adverse events of special interest (AESI) as defined in the clinical trial protocol

—

Countries

Germany

Contacts

Public ContactAlexander Supady

Universitätsklinikum Freiburg, Klinik für Innere Medizin III

alexander.supady@universitaets-herzzentrum.de0761 270-73790

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026