NCT04385771

Brief Summary

In December 2019 in the city of Wuhan in China, a series of patients with unclear pneumonia was noticed, some of whom have died of it. In virological analyses of samples from the patients' deep respiratory tract, a novel coronavirus was isolated (SARS-CoV-2). The disease spread rapidly in the city of Wuhan at the beginning of 2020 and soon beyond in China and, in the coming weeks, around the world. Initial studies described numerous severe courses, particularly those associated with increased patient age and previous cardiovascular, metabolic and respiratory diseases. A small number of the particularly severely ill patients required not only highly invasive ventilation therapy but also extracorporeal membrane oxygenation (vv-ECMO) to supply the patient's blood with sufficient oxygen. Even under maximum intensive care treatment, a very high mortality rate of approximately 80-100% was observed in this patient group. In addition, high levels of interleukin-6 (IL-6) could be detected in the blood of these severely ill patients, which in turn were associated with poor outcome. From experience in the therapy of severely ill patients with severe infections and respiratory failure, we know that treatment with a CytoSorb® adsorber can lead to a reduction of the circulating pro- and anti-inflammatory cytokines and thus improve the course of the disease and the outcome of the patients. The aim of the study is to investigate the influence of extracorporeal cytokine adsorption on interleukin-6-levels and time to successful ECMO explantation under controlled conditions in patients with particularly severe COVID-19 disease requiring extracorporeal membrane oxygenation.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

3 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

April 19, 2020

Last Update Submit

March 11, 2021

Conditions

Coronavirus InfectionCOVIDSARS-CoV 2Respiratory FailureCytokine StormExtracorporeal Membrane Oxygenation

Keywords

COVID-19ECMOARDSCytokine Adsorption

Outcome Measures

Primary Outcomes (2)

  • IL-6 reduction by 75% or more after 72 hours as compared to the baseline measurement

    measurement of IL-6 levels in patient blood after 72 hours of cytokine adsorption (in relation to level before initiation of cytokine adsorption)

    72 hours

  • time to successful ECMO-explantation

    time to successful ECMO-explantation within 30 days after randomization

    30 days

Secondary Outcomes (16)

  • Ventilator free days (VFD)

    30 days

  • Time to extubation from ventilation and explantation from ECMO

    30 days

  • Overall survival time

    30 days

  • Days on intensive care unit (ICU)

    30 days

  • Vasopressor dosage

    24, 48, 72 hours

  • +11 more secondary outcomes

Study Arms (2)

vv-ECMO + cytokine adsorption

EXPERIMENTAL

after indication of treatment with vv-ECMO in acute respiratory failure in COVID-19-disease, patients will additionally receive cytokine adsorption using a Cytosorb adsorber

Device: vv-ECMO + cytokine adsorption (Cytosorb adsorber)

vv-ECMO (no cytokine adsorption)

OTHER

treatment with vv-ECMO in acute respiratory failure in COVID-19-disease (standard treatment without additional cytokine adsorption)

Device: vv-ECMO only (no cytokine adsorption)

Interventions

vv-ECMO + cytokine adsorption (Cytosorb adsorber)DEVICE

in COVID-19-diseased vv-ECMO patients additional treatment with cytokine adsorption using a Cytosorb adsorber will be randomized (vs. control group)

vv-ECMO + cytokine adsorption
vv-ECMO only (no cytokine adsorption)DEVICE

COVID-19-diseased treated with vv-ECMO

vv-ECMO (no cytokine adsorption)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • SARS-CoV-2-infection with COVID-pneumonia
  • vv-ECMO therapy

You may not qualify if:

  • known patient will against participation in the study or against the measures applied in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Clinic Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Klinikum Ibbenbueren

Ibbenbueren, 49477, Germany

Location

Klinikum Ludwigsburg

Ludwigsburg, Germany

Location

Related Publications (3)

  • Shekar K, McAuley DF, Brodie D. Cytokine adsorption during ECMO for COVID-19-related ARDS. Lancet Respir Med. 2021 Jul;9(7):680-682. doi: 10.1016/S2213-2600(21)00207-1. Epub 2021 May 14. No abstract available.

    PMID: 34000235DERIVED

  • Rieder M, Duerschmied D, Zahn T, Lang C, Benk C, Lother A, Biever P, Bode C, Wengenmayer T, Staudacher D, Supady A. Cytokine Adsorption in Severe Acute Respiratory Failure Requiring Veno-Venous Extracorporeal Membrane Oxygenation. ASAIO J. 2021 Mar 1;67(3):332-338. doi: 10.1097/MAT.0000000000001302.

    PMID: 33627609DERIVED

  • Rieder M, Schubach F, Schmoor C, von Spee-Mayer C, Wengenmayer T, Rilinger J, Staudacher D, Bode C, Duerschmied D, Supady A. 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.

    PMID: 33455938DERIVED

MeSH Terms

Conditions

Coronavirus InfectionsRespiratory InsufficiencyCytokine Release SyndromeCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRespiration DisordersRespiratory Tract DiseasesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung Diseases

Study Officials

  • Alexander Supady, Dr., MPH

    University Clinic Freiburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trial examining COVID-patients requiring vv-ECMO therapy (+/- cytokine adsorption)
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending Physician - Oberarzt

Study Record Dates

First Submitted

April 19, 2020

First Posted

May 13, 2020

Study Start

September 1, 2020

Primary Completion

May 31, 2021

Study Completion

October 31, 2021

Last Updated

March 15, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)