Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation

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.

Conditions

• Coronavirus Infection
• COVID
• SARS-CoV 2
• Respiratory Failure
• Cytokine Storm
• Extracorporeal Membrane Oxygenation

Interventions

DEVICE

vv-ECMO + cytokine adsorption (Cytosorb adsorber)

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

DEVICE

vv-ECMO only (no cytokine adsorption)

COVID-19-diseased treated with vv-ECMO

Sponsors & Collaborators

• Klinikum Ibbenbüren

  collaborator UNKNOWN

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• University Hospital, Saarland

  collaborator OTHER

• Klinikum Ludwigsburg

  collaborator OTHER

• University of Ulm

  collaborator OTHER

• SLK Kliniken Heilbronn GmbH

  collaborator OTHER

• Martin-Luther-Universität Halle-Wittenberg

  collaborator OTHER

• Dr. Alexander Supady

  lead OTHER

Principal Investigators

• Alexander Supady, Dr., MPH · University Clinic Freiburg

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-01

Primary Completion

2021-05-31

Completion

2021-10-31

Countries

• Germany

Study Locations