Trial document




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  DRKS00022359

Trial Description

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Title

Study by DB Fernverkehr AG on corona infections and corona immunity of its employees (COVID-19)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

A representative sample of three occupational groups within the Deutsche Bahn Fernverkehr AG are tested for Covid-19 three times at intervals of three to four months (acute infection and possible sero-conversion).

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Brief Summary in Scientific Language

Prospective longitudinal study to investigate the prevalence and incidence rates of three occupational groups of the Deutsche Bahn Fernverkehr AG.

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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

  •   DRKS00022359
  •   2020/07/17
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  •   no
  •   Approved
  •   Eth.19/20, Ethik-Kommission der Ärztekammer Berlin
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Secondary IDs

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Health Condition or Problem studied

  •   Covid-19
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Interventions/Observational Groups

  •   train attendants; will undergo two SARS-CoV-2 tests at each visit: a PCR-test to identify active SARS-CoV-2 infections as well as an IgG-antibody-test to detect past SARS-CoV-2 infections. Tests will be repeated in autumn and winter 2020/21.
  •   train drivers; will undergo two SARS-CoV-2 tests at each visit: a PCR-test to identify active SARS-CoV-2 infections as well as an IgG-antibody-test to detect past SARS-CoV-2 infections. Tests will be repeated in autumn and winter 2020/21.
  •   craftsmen; will undergo two SARS-CoV-2 tests at each visit: a PCR-test to identify active SARS-CoV-2 infections as well as an IgG-antibody-test to detect past SARS-CoV-2 infections. Tests will be repeated in autumn and winter 2020/21.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Health care system
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

prevalence and incidence of acute Covid-19 infections and seropositivity

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Secondary Outcome

Exploration of infection rates with underlying epidemiological factors

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2020/06/29
  •   1050
  •   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

Railway employees (train attendants / train drivers / craftsmen)

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Exclusion Criteria

none

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Addresses

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    • DB Fernverkehr AG
    • Mr. 
    • Galluspark 15-19
    • 60326  Frankfurt
    • Germany
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    • Charité Resarch Organisation GmbH
    • Mr.  Dr.  Robert  Schultz-Heienbrok 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Deutsche Bahn AG
    • Mr.  Dr.  Christian  Gravert 
    • Potsdamer Platz 2
    • 10785  Berlin
    • Germany
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    • Deutsche Bahn AG
    • Mr.  Dr. med.  Christian  Gravert 
    • Potsdamer Platz 2
    • 10785  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • DB Fernverkehr AG
    • Im Galluspark 15-19
    • 60326  Frankfurt am Main
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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