Effect of CytoSorb Adsorber on Hemodynamic and Immunological Parameters in Critical Ill Patients With COVID-19 (CYTOCOV-19)

This prospective randomized single Center study investigates to what extent the physical elimination of the inflammatory mediators using the CytoSorb adsorber reduces the morbidity of severely and critically ill patients with Covid-19.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Device: CytoSorb-Therapy

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany
    • University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• confirmed COVID-19 disease
• refractory shock with need for norepinephrine ≥ 0.2 μg/kg/min for MAP ≥ 65 mmHg
• IL6 ≥ 500 ng/l
• Indication for CRRT or ECMO

Exclusion Criteria:

• Liver cirrhosis Child Pugh C
• "do not resuscitate"-order
• expected survival due to comorbidities < 14 days
• pregnancy or breastfeeding
• participation in another interventional trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CytoSorb-Therapy; Therapy of COVID-19 with need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation) using standard of care in Addition with hemoadsorption using CytoSorb-Adsorber	Device: CytoSorb-Therapy; Additional use of Cytosorb-Adsorber in patients with COVID-19 and need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation)
No Intervention: Standard of care; Therapy of COVID-19 with need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation) using standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with a significant stabilization of hemodynamics for at least 24 hours	Percentage of patients with a significant stabilization of hemodynamics ("shock reversal"), defined as a significant reduction of the noradrenaline dose (≤ 0.05 µg/kg/min) while maintaining mean arterial pressure ≥ 65 mmHg for at least 24 hours compared to control group	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in organ dysfunction	Change in organ dysfunction based on "Sequential Organ Failure Assessment" (SOFA) Score The SOFA score is made of 6 variables, each representing an organ system. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure) The worst physiological variables were collected serially every 24 hours of a patient's ICU admission. The "worst" measurement was defined as the measure that correlated to the highest number of points. The SOFA score ranges from 0 to 24.	10 days
Lactate clearance	Improving lactate clearance by lowering serum lactate levels	10 days
Renal replacement therapy	Time with need for renal replacement therapy	10 days
ICU length of stay	ICU length of stay	90 days
Time on mechanical ventilation	Time on mechanical ventilation	10 days
Cumulative catecholamine dose	Cumulative catecholamine dose	10 days
Overall and ICU mortality	Overall and ICU mortality	90 days
Change of plasma Interleukin-6 (IL6) level	Change of plasma Interleukin-6 (IL6) level	10 days
Change of plasma Interleukin-10 (IL10) level	Change of plasma Interleukin-10 (IL10) level	10 days
Change of plasma Procalcitonin (PCT) level	Change of plasma Procalcitonin (PCT) level	10 days
Change of HLA-DR level	Change of HLA-DR (Human Leukocyte Antigen - DR isotype) level of monocytes	10 days
Change of TNF alpha level after ex-vivo stimulation	Change of TNF-alfa level (Tumor Necrosis Factor alpha) level after LPS (Lipopolysaccharides) stimulation as sign of monocytic immunocompetence	10 days
Extracorporeal Membrane Oxygenation	Time with Need for Extracorporeal Membrane Oxygenation	10 days

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Stefan Kluge, MD, University Hospital Hamburg-Eppendorf, Department of Intensive Care Medicine

Publications and helpful links

Helpful Links

• Published trial on PubMed.gov
• DOI

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): April 10, 2021
• Study Completion (Actual): April 28, 2021

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: critically ill; CytoSorb; intensive care medicine; hemoadsorption
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CYTOCOV-19; U1111-1250-2078 (Registry Identifier: UTN); DRKS00021199 (Registry Identifier: DRKS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No