Trial document




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  DRKS00022259

Trial Description

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Title

Prevalence of SARS-CoV-2 Infections in the employees of the Pius-Hospital Oldenburg, confirmed through virus antibody testing - COVID-19

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Trial Acronym

Co-Kl-Ak

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URL of the Trial

http://nicht zutreffend

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Brief Summary in Lay Language

Testing the workers of the Pius-Hospital Oldenburg for rate of infection with the new Coronavirus through testing blood for built antibodies and documenting the risk factors through a questionnaire.

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Brief Summary in Scientific Language

Monocentric, longtitudinal cohort study determining the prevalence of (past) SARS-CoV-2 Infections in the employees of the Pius-Hosptial in Oldenburg through testing for Virus antibodies in serum and establishing correlation to certain possible risk factors.

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

Yes

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Description IPD sharing plan:

Prevalence values in 3 different chronological points
Correlation percentage for the tested risk factors

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Organizational Data

  •   DRKS00022259
  •   2020/07/10
  •   [---]*
  •   yes
  •   Approved
  •   2020-095, Medizinische Ethikkommission der Carl von Ossietzky Universität Oldenburg
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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

  •   Employees of the Pius-Hospital Oldenburg will have to fill out a questionnaire detailing their potential risk factors and a blood test for Serum Antibodies will be done at 3 different stages in July, September and January.
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Characteristics

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

Percentage of antibody-positive workers in Pius-Hospital.

Questionnaire to document the possible risk factors by each participant plus a blood test for presence of SARS-CoV-2 antibodies, these 2 to be repeated in 3 time intervals in June, September and December 2020 and the results to be statistically analyzed in January 2021.

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Secondary Outcome

n/a

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2020/06/22
  •   1250
  •   Monocenter 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

Employees of the Pius-Hospital with physical presence in the hospital perimeters in the time period between 01/2020 till 12/2020.

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Exclusion Criteria

- Home-Office workers
- Termination of work during the study
- Failure to provide consent
- Illiteracy
- Incompliance
- Withdrawal of Consent

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Addresses

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    • Pius-Hospital Oldenburg
    • Mr.  Professor Dr.  Dirk  Weyhe 
    • Georgstr. 20
    • 26121  Oldenburg
    • Germany
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    • Pius-Hospital Oldenburg
    • Mr.  Haitham  Mansour 
    • Georgstraße 12
    • 26129  Oldenburg
    • Germany
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    • Pius-Hospital Oldenburg
    • Ms.  Dr. rer. nat.  Uslar  Verena 
    • Georgstrasse 20
    • 26121  Oldenburg
    • Germany
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Sources of Monetary or Material Support

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    • Pius-Hospital Oldenburg
    • Mr.  Professor dr.  Dirk  Weyhe 
    • Georgstr. 20
    • 26121  Oldenburg
    • 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.