Trial document




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  DRKS00021815

Trial Description

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Title

Investigation of the immune status against SARS-CoV-2 of medical professionals in Doctor's Practices in Thuringia (COVID-19 research project)

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Trial Acronym

COVID-PraxImmun

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URL of the Trial

https://www.coronatest-thueringen.de

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Brief Summary in Lay Language

[---]*

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Brief Summary in Scientific Language

Survey, evaluation and monitoring of the immune status against SARS-CoV-2 and correlation with characteristics of exposition and of medical history of medical professionals in Doctor's Practices using a rapid Lateral-Flow-Assay (IgM/IgG) as screening method before highly specific testing with IgA/IgG-ELISA and PCR in case of positive rapid test. Testing is carried out at four defined points within one year.

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

Yes

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Description IPD sharing plan:

External scientists must have the technical requirement to receive the anonymized data body. There may be charges for processing and transmission of data.

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Organizational Data

  •   DRKS00021815
  •   2020/06/05
  •   [---]*
  •   yes
  •   Approved
  •   22860/2020/57, Ethikkommission der Landesärztekammer Thüringen
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Secondary IDs

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

  •   U99.0 -  [---]*
  •   U07.2 -  Emergency use of U07.2
  •   SPECIFIC METHODS OF INVESTIGATION FOR SARSCOV2
  •   COVID19 VIRUS NOT CONFIRMED COVID19 O.N.A.
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Interventions/Observational Groups

  •   Professionals are working in Doctor's Practice in direct contact to patients
  •   Professionals are working in Doctor's Practice without direct contact to patients
  •   Professionals are working out of Doctor's Practice
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Health care system
  •   Factorial
  •   IV
  •   No
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Primary Outcome

Period prevalence of infection with SARS-CoV-2 and of the resulting immune status (proof of IgG-antibodies against SARS-CoV-2 with a Lateral-Flow-Test plus ELISA) over four points of time

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Secondary Outcome

Usability of the proof of IgG-antibodies against SARS-CoV-2 as a marker of the postinfection immunity

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2020/07/28
  •   10000
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

18 years ore more, written consent is signed, inclusion is done by statutory insurance physicians in outpatient medical practices

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Exclusion Criteria

less than 18 years, no written consent, contraindication against blood sampling

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Addresses

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    • Kassenärztliche Vereinigung Thüringen
    • Zum Hospitalgraben 8
    • 99425  Weimar
    • Germany
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    • Zentralinstitut für die kassenärztliche Versorgung in der Bundesrepublik Deutschland
    • Salzufer 8
    • 10587  Berlin
    • Germany
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    • Kassenärztliche Vereinigung Thüringen
    • Mr.  Dr. med.  Thomas  Schröter 
    • Zum Hospitalgraben 8
    • 99425  Weimar
    • Germany
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    • Kassenärztliche Vereinigung Thüringen
    • Ms.  Dr. med.  Anke  Möckel 
    • Zum Hospitalgraben 8
    • 99425  Weimar
    • Germany
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Sources of Monetary or Material Support

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    • Kassenärztliche Vereinigung Thüringen
    • Zum Hospitalgraben 8
    • 99425  Weimar
    • 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.