Trial document





This trial has been registered retrospectively.
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  DRKS00022941

Trial Description

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Title

"COVID-19: Hotspot hospital?- Epidemiological analysis time shifted antibody tests of hospital employees

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Our hospital St. Vincenz Hospital Datteln got access to an antibody test against the new corona virus SARS-CoV-2. There was great interest in this laboratory test among hospital employees so that we decided to offer the test for free. This offer is also valid for employees of the hospitals St. Laurentius Stift Waltrop, Vestische Klinik für Kinder- und Jugendmedizin Datteln and for employees of retirement and nursing homes belonging to our sponsoring organization. We want to collect data anonymised.
Results of this study should be evaluated scientifically and published within a PhD. Besides the test result for each participant we see the aim of our study in the infectepidemiological context of the actual pandemic situation.
We plan 200 -400 test per months for 1 year, i.e. from June 2020 to June 2021. Data evaluation should be finished until the end of 2021.

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

Yes

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Description IPD sharing plan:

Will individual participant data be available: Yes.
What data in particular will be shared? Names of participant will be anonymized after the end of the testperiod and evaluation. We plan to publish anonymized data that underlie the results. The personnel data which stay visible are in the main: laboratory number, testdate, date of birth, institution, if necessary hospital ward, test result.
What other documents will be available? Statistical protocols, laboratory protocols.
When will data be available? Immediately following publication. No end date.
With whom? Anyone who wishes to access data.
For what types of analyses? Any purpose.
By what mechanism will data be made available? Data will be composed as additional material and made indefinitely available with a link to a website.

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Organizational Data

  •   DRKS00022941
  •   2020/08/28
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  •   yes
  •   Approved
  •   2020-478-f-S , Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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Health Condition or Problem studied

  •   SARS-CoV-2 antibodies
  •   U07 -  Emergency use of U07
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Interventions/Observational Groups

  •   We take one Serum sample from each voluntary participant. Everybody will get a personally report with the test result. It is possible to take part in the study repeatedly during the test period.
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Characteristics

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

What?: We detect antibodies against SARS-CoV-2. The result will be positive or negative.
When?: The period of time for taking part in the study is from June 2020 to June 2021. Each participant can decide the test time independently. It is also possible to be tested repeatedly.
How?: We use the antibody test oft he Roche company.

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2020/06/15
  •   3000
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

employees of the participating institutions

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Exclusion Criteria

none

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Addresses

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    • St. Vincenz Krankenhaus Datteln
    • Wolfgang  Mueller 
    • Rottstr. 11
    • 45711  Datteln
    • Germany
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    • Institut für Mikrobiologie und Hygiene Abteilung für Medizinische Mikrobiologie MAFO 01 Süd / Fachnr. 21
    • Mr.  Prof.  Sören  Gatermann 
    • Universitätsstraße 150
    • 44801  Bochum
    • Germany
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    • St. Vincenz Krankenhaus Datteln Klinik für Innere Medizin I
    • Ms.  PD Dr.  Anke  Hildebrandt 
    • Rottstr. 11
    • 45711  Datteln
    • Germany
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    • St. Vincenz Krankenhaus Datteln Klinik für Innere Medizin I
    • Ms.  PD Dr.  Anke  Hildebrandt 
    • Rottstr. 11
    • 45711  Datteln
    • Germany
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Sources of Monetary or Material Support

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    • St. Vincenz Krankenhaus Datteln
    • Wolfgang  Mueller 
    • Rottstr. 11
    • 45711  Datteln
    • Germany
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Status

  •   Recruiting ongoing
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