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

NCT04324528 | Completed

• 1 other identifier: CYCOV
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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. Our primary goal is to investigate the efficacy of treatment with a CytoSorb® adsorber in patients with severe COVID-19 disease requiring venous ECMO over 72 hours after initiation of ECMO. The primary endpoint is the reduction of plasma interleukin-6 levels 72 hours after initiation of ECMO support. As secondary endpoints we investigate 30-day survival, vasopressor and volume requirements, lactate in terms of lactate and platelet function. As safety variables, we further investigate the levels of the applied antibiotics (usually ampicillin and sulbactam).

Conditions

Coronavirus; COVID-19; SARS-CoV Infection; Respiratory Failure; Cytokine Storm

Outcome Measures

Primary Outcomes (1)

• interleukin-6 (IL-6) level after 72 hours

  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

Secondary Outcomes (4)

• 30-day-survival

  72 hours

• vasopressor dosage

  72 hours

• fluid balance

  72 hours

• lactate

  72 hours

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)

control-arm: 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

control-arm: vv-ECMO (no cytokine adsorption)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pregnancy, breastfeeding

Sponsors & Collaborators

• Dr. Alexander Supady: lead

Study Sites (1)

University Clinic Freiburg

Freiburg im Breisgau, 79108, Germany

Location

Related Publications (1)

• Supady A, Weber E, Rieder M, Lother A, Niklaus T, Zahn T, Frech F, Muller S, Kuhl M, Benk C, Maier S, Trummer G, Flugler A, Kruger K, Sekandarzad A, Stachon P, Zotzmann V, Bode C, Biever PM, Staudacher D, Wengenmayer T, Graf E, Duerschmied D. Cytokine adsorption in patients with severe COVID-19 pneumonia requiring extracorporeal membrane oxygenation (CYCOV): a single centre, open-label, randomised, controlled trial. Lancet Respir Med. 2021 Jul;9(7):755-762. doi: 10.1016/S2213-2600(21)00177-6. Epub 2021 May 14.

  PMID: 34000236 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; COVID-19; Severe Acute Respiratory Syndrome; Respiratory Insufficiency; Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

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: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician - Oberarzt

Model Details: randomized controlled trial examining COVID-patients requiring vv-ECMO therapy (+/- cytokine adsorption)

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 27, 2020
• Study Start: March 27, 2020
• Primary Completion: January 27, 2021
• Study Completion: January 27, 2021
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)