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Registry of CytoSorb Therapy in COVID-19 ICU Patients (CTC REGISTRY)

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ClinicalTrials.gov Identifier: NCT04391920
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : May 20, 2021
Sponsor:
Collaborator:
CytoSorbents Europe GmbH
Information provided by (Responsible Party):
CytoSorbents, Inc

Brief Summary:
The CTC Registry collects patient-level clinical data on CytoSorb hemoadsorption provided to COVID-19 ICU patients via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits. The intent of the registry is to gain understanding on how CytoSorb hemoadsorption provides clinical benefit to COVID-19 ICU patients.

Condition or disease Intervention/treatment
COVID-19 Device: CytoSorb 300 mL device

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 30 Days
Official Title: Registry of CytoSorb Therapy in COVID-19 ICU Patients (CTC REGISTRY): Registry of Patient-level Clinical Data on CytoSorb Hemoadsorption Provided Via Integration of the CytoSorb Device Into Extracorporeal Membrane Oxygenation (ECMO), Continuous Renal Replacement Therapy (CRRT), or Hemoperfusion Extracorporeal Circuits in COVID-19 ICU Patients
Actual Study Start Date : August 28, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : October 2022

Group/Cohort Intervention/treatment
COVID-19 ICU Patients Device: CytoSorb 300 mL device
CytoSorb hemoadsorption provided via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits.




Primary Outcome Measures :
  1. ICU mortality [ Time Frame: From the date of start of CytoSorb use until the date of ICU discharge or date of death, whichever comes first, assessed up to 1 year ]

Secondary Outcome Measures :
  1. Duration of ECMO after start of CytoSorb [ Time Frame: From the date of start of CytoSorb use until the date of cessation of ECMO or date of death, which ever comes first, assessed up to 1 year ]
  2. Duration of mechanical ventilatory support after start of CytoSorb [ Time Frame: From the date of start of CytoSorb use until the date of cessation of mechanical ventilatory support or date of death, which ever comes first, assessed up to 1 year ]
  3. Duration of pharmacologic hemodynamic support after start of CytoSorb [ Time Frame: From the date of start of CytoSorb use until the date of cessation of pharmacologic hemodynamic support or date of death, which ever comes first, assessed up to 1 year ]
  4. Change in serum concentrations of inflammatory biomarkers after start of CytoSorb [ Time Frame: From the day before start of CytoSorb use until the day after cessation of CytoSorb use ]
  5. Change in Pa02/Fi02 ratio after start of CytoSorb [ Time Frame: From the day before start of CytoSorb use until the day after cessation of CytoSorb use ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COVID-19 ICU patients receiving CytoSorb hemoadsorption via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits.
Criteria

Inclusion Criteria:

  1. Confirmed COVID-19
  2. Provision of CytoSorb therapy per Instructions for Use (IFU) of the CytoSorb device.

Exclusion Criteria:

  1. CytoSorb therapy for diseases other than COVID-19
  2. Survival unlikely within 24 hours (for prospectively enrolled patients)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391920


Contacts
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Contact: Jenni Stokes (704) 578-2425 jstokes@cytosorbents.com

Locations
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United States, Colorado
Medical Center of Aurora Recruiting
Aurora, Colorado, United States, 80012
Contact: Jenni Stokes, RN       jstokes@cytosorbents.com   
United States, Illinois
University of Chicago Medicine Recruiting
Chicago, Illinois, United States, 60637
Contact: Jenni Stokes, RN       jstokes@cytosorbents.com   
United States, Indiana
Franciscan Health Indianapolis Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Jenni Stokes, RN       jstokes@cytosorbents.com   
United States, Mississippi
Baptist Memorial Hospital Recruiting
Southaven, Mississippi, United States, 38671
Contact: Jenni Stokes, RN       jstokes@cytosorbents.com   
United States, New York
New York University Medical Center Recruiting
New York, New York, United States, 10016
Contact: Jenni Stokes, RN       jstokes@cytosorbents.com   
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Jenni Stokes, RN       jstokes@cytosorbents.com   
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Jenni Stokes, RN       jstokes@cytosorbents.com   
Sponsors and Collaborators
CytoSorbents, Inc
CytoSorbents Europe GmbH
Investigators
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Study Director: Peter Nelson, MD CytoSorbents Corporation
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Responsible Party: CytoSorbents, Inc
ClinicalTrials.gov Identifier: NCT04391920    
Other Study ID Numbers: 2020-001
FDA EUA ( Other Identifier: FDA )
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: May 20, 2021
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases