Registry of CytoSorb Therapy in COVID-19 ICU Patients (CTC REGISTRY)
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ClinicalTrials.gov Identifier: NCT04391920 |
Recruitment Status :
Completed
First Posted : May 18, 2020
Last Update Posted : January 21, 2022
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Condition or disease | Intervention/treatment |
---|---|
COVID-19 | Device: CytoSorb 300 mL device |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 138 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 |
Actual Primary Completion Date : | January 20, 2022 |
Actual Study Completion Date : | January 20, 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. |
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 |
Inclusion Criteria:
- Confirmed COVID-19
- Provision of CytoSorb therapy per Instructions for Use (IFU) of the CytoSorb device.
Exclusion Criteria:
- CytoSorb therapy for diseases other than COVID-19
- Survival unlikely within 24 hours (for prospectively enrolled patients)

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
United States, Colorado | |
Medical Center of Aurora | |
Aurora, Colorado, United States, 80012 | |
United States, Illinois | |
University of Chicago Medicine | |
Chicago, Illinois, United States, 60637 | |
United States, Indiana | |
Franciscan Health Indianapolis | |
Indianapolis, Indiana, United States, 46237 | |
United States, Mississippi | |
Baptist Memorial Hospital | |
Southaven, Mississippi, United States, 38671 | |
United States, New York | |
New York University Medical Center | |
New York, New York, United States, 10016 | |
United States, West Virginia | |
West Virginia University | |
Morgantown, West Virginia, United States, 26506 | |
United States, Wisconsin | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 |
Study Director: | Peter Nelson, MD | CytoSorbents Corporation |
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: | January 21, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
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 |