Trial document




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  DRKS00024376

Trial Description

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Title

CRP apheresis registry for COVID-19

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Trial Acronym

CACOV-registry

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URL of the Trial

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Brief Summary in Lay Language

The CACOV registry is a non-interventional study (observational study) to investigate the reduction of C-reactive protein (CRP) by therapeutic apheresis (CRP apheresis) in patients with COVID-19.
The term therapeutic apheresis generally refers to medical procedures whose therapeutic effect is based on the elimination of components of the blood to which a pathogenic function is attributed in the context of disease processes. The elimination takes place in adsorbers outside the body in an extracorporeal circuit. To remove the pathogenic substances, plasma is separated from the blood (circulation) and passed through the adsorber. The purified plasma is then recombined with the solid blood components and returned to the patient.
The "PentraSorb® CRP" adsorber used for CRP apheresis is CE-certified for the selective removal of C-reactive protein from human plasma.

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Brief Summary in Scientific Language

The CACOV registry is being conducted on a multicenter basis.
It offers the possibility to systematically record CRP apheresis, a new treatment option for the targeted reduction of CRP levels in COVID-19. Apheresis treatments will be performed in parallel to therapy according to S2k guideline - recommendations for inpatient therapy of patients with COVID-19 of DGIIN, DIVI and DGP.
In CRP apheresis, CRP is selectively removed from plasma in an extracorporeal circuit using an adsorber. The frequency and intervals of the treatments depend on the initial CRP concentration. In general, 1.5 - 2.5 times the plasma volume is processed at a time.

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

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00024376
  •   2021/05/04
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  •   no
  •   Approved
  •   Eth-28/21, Ethik-Kommission der Ärztekammer Berlin
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Secondary IDs

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Health Condition or Problem studied

  •   U07.1 COVID-19
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Interventions/Observational Groups

  •   CRP apheresis according to the instructions for use of the adsorber PentraSorb CRP in patients with COVID-19
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

CRP progression

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Secondary Outcome

Length of stay in hospital
- Length of stay in the intensive care unit
- Days of mandatory ventilation
- mortality
- Pulmonary tissue damage
- Myocardial tissue damage
- Inflammation markers
- Incidence of adverse effects of CRP apheresis

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2021/05/14
  •   1000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

COVID-19, CRP-apheresis

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Exclusion Criteria

none

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Addresses

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    • Pentracor GmbH
    • Neuendorfstr. 23 b/d
    • 16761  Hennigsdorf
    • Germany
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    • Pentracor GmbH
    • Mr.  Dr.  Burghard  Thiesen 
    • Neuendorfstr. 23 b/d
    • 16761  Hennigsdorf
    • Germany
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    • Pentracor GmbH
    • Mr.  Dr.  Burghard  Thiesen 
    • Neuendorfstr. 23 b/d
    • 16761  Hennigsdorf
    • Germany
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Sources of Monetary or Material Support

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    • Pentracor GmbH
    • Neuendorfstr. 23 b/d
    • 16761  Hennigsdorf
    • Germany
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Status

  •   Recruiting ongoing
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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.