Trial document




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  DRKS00024434

Trial Description

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Title

Immune-mediated pathogenesis and development of autoimmunity in neurological manifestations of COVID-19

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Trial Acronym

IPEA

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study is to assess the immunpathogenesis and probable upcoming auto-immunity as a reason for neurological symptoms during an acute, subacute and postacute COVID-19 infection as well as the systematical characterization of neuropsychiatric disorders and cognitive deficits during different time points.

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Brief Summary in Scientific Language

Goal of this study is the immunpathogenesis and upcoming auto-immunity as a reason for neurological symptoms during the time frame or after a COVID-19 infection.
Typical neurological symptoms in the acute and subacute phase are anosmia, cyclones, oculomotoric disorder, encephalitis, stroke or intracranial bleeding, seizures or GBS.
After the infection cognitive deficits among with dysaesthesia (polyneuropathia), Fatigue and depression might occur.
Part of the acute and subacute neurological symptoms might be due to a direct infection of the PNS or CNS. The direct proof of viral infection of the CNS has only been shown rarely with SARS COV 2 evidence in the cerebrospinal spinal fluid.
Another possible explanation of neurological symptoms in the disease course of COVID-19 is a viral induced immune activation and inflammation.
Inflammation and tissue damage could cause acute symptoms and might induce autoimmunity initiating prolonged symptoms of the post infectious phase.
Autoimmunity is characterised as the occurrence of auto antibodies produced by auto reactive B-cells and auto reactive T-cells as well as an exuberant immune response.
Aim of this study is a comprehensive and sytemical neurological characterisation of patients with COVID-19 and their association with immunological parameters in blood and cerebrospinal spinal fluid.
Results of this study might be used for better diagnostics (biomarker identification and target oriented immunotherapy).

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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

  •   DRKS00024434
  •   2021/02/05
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  •   yes
  •   Approved
  •   20-1501, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   U07.1 -  Emergency use of U07.1
  •   LONG COVID, cognitive deficits during COVID-19 infection, psychiatric disease after COVID-19 infection, immunological marker and divergence in serum and cerebro spinal fluid during COVID infection
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Interventions/Observational Groups

  •   Depending on the time of presentation of Symptoms: acute onset, post COVID infection
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Characteristics

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

Immunological biomarker and neurocognitive assessment scores

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2021/02/07
  •   150
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Informed consent
no drug or alcohol addiction
german language

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Exclusion Criteria

not able to give informed consent, under-age, no juristical supervisor

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Addresses

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    • University of Cologne
    • Kerpenerstr. 61
    • 50931  Cologne
    • Germany
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    • Charite University Hospital of Berlin
    • Ms.  Dr. med.  Christiana  Franke 
    • Berlin
    • Germany
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    • Uniklinik Köln
    • Mr.  PD Dr. med.  Clemens  Warnke 
    • Kerpenerstr. 61
    • 50931  Köln
    • Germany
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    • Uniklinik Köln Studienbüro Neurologie
    • Ms.  Monika  Höveler 
    • Kerpenerstr.61
    • 50931  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting planned
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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.