Registry of CytoSorb Therapy in COVID-19 ICU Patients

COVID-19 Clinical Trial

— CTC REGISTRY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04391920
• Other study ID #: 2020-001
• Secondary ID: FDA EUA
• Status: Completed
• Start date: August 28, 2020
• Est. completion date: January 20, 2022

Study information

• Verified date: January 2022
• Source: CytoSorbents, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: January 20, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19

Intervention

Device:
• CytoSorb 300 mL device
CytoSorb hemoadsorption provided via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits.

Locations

Country	Name	City	State
United States	Medical Center of Aurora	Aurora	Colorado
United States	University of Chicago Medicine	Chicago	Illinois
United States	Franciscan Health Indianapolis	Indianapolis	Indiana
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	West Virginia University	Morgantown	West Virginia
United States	New York University Medical Center	New York	New York
United States	Baptist Memorial Hospital	Southaven	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
CytoSorbents, Inc	CytoSorbents Europe GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU mortality		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	Duration of ECMO after start of CytoSorb		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
Secondary	Duration of mechanical ventilatory support after start of CytoSorb		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
Secondary	Duration of pharmacologic hemodynamic support after start of CytoSorb		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
Secondary	Change in serum concentrations of inflammatory biomarkers after start of CytoSorb		From the day before start of CytoSorb use until the day after cessation of CytoSorb use
Secondary	Change in Pa02/Fi02 ratio after start of CytoSorb		From the day before start of CytoSorb use until the day after cessation of CytoSorb use