Trial document




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  DRKS00021813

Trial Description

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Title

Antibody assesement for COVID-19 prevalence two months after outbreak in the hot spot Region of Tirschenreuth / Bavaria

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Trial Acronym

AK-TIR-COVID-19

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URL of the Trial

http://none

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Brief Summary in Lay Language

Epidemiologic, prospective, monocentre cross sectional study fot seroprevalence of antibodies against SARS-CoV-2 in healthcare workers compared to normal working population.

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Brief Summary in Scientific Language

Blood testing for antibodies vs SARS-CoV-2 in healthcare workers of two hospitals in a hot spot Region Tirschenreuth compared to workers of a medium sized Company. Comparison of different departements.

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

Yes

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Description IPD sharing plan:

IPD and Blood serum anonymised of approximately 2500 participants;
Study protocol can be supplied by August 2020. Written application is necessary, no publication on data platform.

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Organizational Data

  •   DRKS00021813
  •   2020/06/29
  •   [---]*
  •   yes
  •   Approved
  •   2020-1112, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   U07.1, suspicion of COVID-19
  •   J12.8 -  Other viral pneumonia
  •   B97.2 -  Coronavirus as the cause of diseases classified to other chapters
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Interventions/Observational Groups

  •   participant of Kliniken Nordoberpfalz AG: blood sampling to evidence from antibody of SARS-CoV-2 (COVID-19) in blood Serum (once) by clinic participant of the "hotspot"region Tirschenreuth
  •   Particpant of Witron Group: blood sampling to evidence from andibody of SARS-CoV-2 (COVID-19) in blood Serum (once) by participant of Witron Group, a medium sized Company.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prevention
  •   Other
  •   IV
  •   N/A
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Primary Outcome

Seroprevalence of antibodies vs COVID-19 in medical and non-medical working population.

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Secondary Outcome

Seroprevalence of antibodies vs COVID-19 in different departements of hospital Workers.
COVID-vs Non-COVID ward.
Doctors vs nurses.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2020/06/29
  •   2500
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Employee of Kliniken Nordoberpfalz AG or Witron Group.
participants >= 18 years.
In writing, signed and dated Informed consent after verbal Information.

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Exclusion Criteria

<18 years. Subject has not given consent for the clinical Trial.

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Addresses

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    • Kliniken Nordoberpfalz AG
    • Mr.  PD Dr. med.  Thomas  Finkenzeller 
    • Söllnerstr. 16
    • 92637  Weiden
    • Germany
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    • Helmholtz Zentrum für Infektionsforschung
    • Mr.  Prof.  Frank  Klawonn 
    • Inhoffenstrasse 7
    • 38124  Braunschweig
    • Germany
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    • Kliniken Nordoberpfalz AG
    • Mr.  PD Dr. med.  Thomas  Finkenzeller 
    • Söllnerstr. 16
    • 92637  Weiden
    • Germany
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    • Kliniken Nordoberpfalz AG
    • Mr.  PD Dr. med.  Thomas  Finkenzeller 
    • Söllnerstr. 16
    • 92637  Weiden
    • Germany
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Sources of Monetary or Material Support

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    • Kliniken Nordoberpfalz AG, Klinikum Weiden
    • Mr.  Prof. Dr. med.  Theodor  Klotz 
    • Söllnerstr. 16
    • 92637  Weiden
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2020/08/31
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Trial Publications, Results and other Documents

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