Cytokine adsorption in severe COVID-19 pneumonia requiring extracorporeal membrane oxygenation
Organizational Data
- DRKS-ID:
- DRKS00021300
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2020-04-08
- Last update in DRKS:
- 2021-04-28
- Registration type:
- Retrospective
Acronym/abbreviation of the study
CYCOV
URL of the study
No Entry
Brief summary in lay language
The primary goal is to investigate the efficacy of treatment with a CytoSorb® cytokine adsorber in patients with severe COVID-19 disease requiring venous ECMO over 72 hours after initiation of ECMO.
Brief summary in scientific language
The primary goal is to investigate the efficacy of treatment with a CytoSorb® adsorber in patients with severe COVID-19 disease who require venous ECMO over 72 hours after initiation of ECMO. The primary endpoint is the reduction of interleukin-6 72 hours after initiation of ECMO support. Secondary endpoints include 30-day survival, vasopressor and volume requirements, and lactate.
Health condition or problem studied
- Free text:
- SARS-CoV-2-infection (COVID-19-disease) with severe pneumonia
- ICD10:
- U07.1 - COVID-19, virus identified
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- V-V ECMO with cytokine adsorption using a CytoSorb adsorbers for 72 hours
- Arm 2:
- V-V ECMO without cytokine adsorption
Endpoints
- Primary outcome:
- IL-6 at 72 hours after initiation of V-V ECMO
- Secondary outcome:
- 30d survival, ICU survival, katecholamine dosage, urine output, fluid demand, lactate
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- II-III
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Freiburg im Breisgau
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2020-03-29
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2021-01-27
- Target Sample Size:
- 30
- Final Sample Size:
- 34
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 100 Years
- Additional Inclusion Criteria:
- SARS-CoV-2-infection, vv-ECMO
Exclusion Criteria
pregnancy
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum FreiburgDr., MPH Alexander SupadyHugstetter Strasse 5579106 FreiburgGermany
- Telephone:
- 0761/270-73790
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum FreiburgDr., MPH Alexander SupadyHugstetter Str. 5579106 FreiburgGermany
- Telephone:
- 0761/270-73790
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de
Contact for Public Queries
- Address:
- Universitätsklinikum FreiburgDr., MPH Alexander SupadyHugstetter Str. 5579106 FreiburgGermany
- Telephone:
- 0761/270-73790
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de
Principal Investigator
- Address:
- Universitätsklinikum FreiburgDr., MPH Alexander SupadyHugstetter Str. 5579106 FreiburgGermany
- Telephone:
- 0761/270-73790
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum FreiburgHugstetter Strasse 5579106 FreiburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-03-23
- Ethics committee number:
- 168/20
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-03-27
Further identification numbers
- Other primary registry ID:
- NCT04324528 - clinicaltrials.gov
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- the study protocol and the statistical analysis plan will be published with the publication of the study results
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- DRKS00021248 - Hauptstudie
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry