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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 : Not yet recruiting
First Posted : May 18, 2020
Last Update Posted : May 18, 2020
Sponsor:
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 under the FDA Emergency Use Authorization for this CytoSorb device use. 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 : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : August 2021

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 ]


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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 under the FDA Emergency Use Authorization for this CytoSorb device use.
Criteria

Inclusion Criteria:

  1. Confirmed COVID-19
  2. ICU admission
  3. Confirmed or imminent respiratory failure
  4. CytoSorb hemoadsorption via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits.

Exclusion Criteria:

  1. Platelet counts < 20,000/μL
  2. Any pre-existing contraindication to extracorporeal therapy
  3. Known allergies to extracorporeal circuit components
  4. History of heparin-induced thrombocytopenia
  5. Acute sickle cell crisis
  6. Morbid obesity with BMI ≥ 40 kg/m2
  7. Any pre-existing advanced medical disease with life-expectancy less than 1 month
  8. CytoSorb hemoadsorption deemed clinically futile
  9. Pregnancy

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: Ola Ogunsakin, MD (504) 715-5677 oogunsakin@cytosorbents.com

Sponsors and Collaborators
CytoSorbents, Inc
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 18, 2020
Last Verified: May 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