Trial document




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  DRKS00021300

Trial Description

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Title

Cytokine adsorption in severe COVID-19 pneumonia requiring extracorporeal membrane oxygenation

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Trial Acronym

CYCOV

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URL of the Trial

[---]*

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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.

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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.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

the study protocol and the statistical analysis plan will be published with the publication of the study results

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Organizational Data

  •   DRKS00021300
  •   2020/04/08
  •   2020/03/27
  •   yes
  •   Approved
  •   168/20, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   NCT04324528  (clinicaltrials.gov)
  •   DRKS00021248  (Hauptstudie)
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Health Condition or Problem studied

  •   SARS-CoV-2-infection (COVID-19-disease) with severe pneumonia
  •   U07.1 -  Emergency use of U07.1
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Interventions/Observational Groups

  •   V-V ECMO with cytokine adsorption using a CytoSorb adsorbers for 72 hours
  •   V-V ECMO without cytokine adsorption
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II-III
  •   N/A
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Primary Outcome

IL-6 at 72 hours after initiation of V-V ECMO

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Secondary Outcome

30d survival, ICU survival, katecholamine dosage, urine output, fluid demand, lactate

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/03/29
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

SARS-CoV-2-infection, vv-ECMO

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Exclusion Criteria

pregnancy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg
    • Mr.  Dr., MPH  Alexander  Supady 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Mr.  Dr., MPH  Alexander  Supady 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Mr.  Dr., MPH  Alexander  Supady 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
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  •   2021/01/27
  •   34
  •   34
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.