Trial document




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  DRKS00021270

Trial Description

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Title

Prospective molecular biological and serological examination for the detection of SARS-CoV-2 (COVID-19) in employees of a hospital of regular care in Germany

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Trial Acronym

ProCoV

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URL of the Trial

[---]*

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Brief Summary in Lay Language

There is no reliable data on the real spread of SARS-CoV-2 in the population. Representative studies would therefore be necessary.
A representative population group could be all hospital employees, from cleaning staff to administrative staff to nurses and doctors. At least this would be a representative group of employees in the health service. All employees are included in this prospective observational study to detect SARS-CoV-2 by repeated molecular test and repetitive antibody test. This data will be correlated to a daily performed online survey. All data will be evaluated all 3 months to detect spreading pattern.

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Brief Summary in Scientific Language

There is no reliable data on the actual prevalence of SARS-CoV-2 in the population. Representative studies would therefore be necessary.
A representative population group could be all hospital employees, from cleaning staff to administrative staff to nurses and doctors. At least this would be a representative group of healthcare workers. All employees are included in this prospective observational study to demonstrate SARS-CoV-2 through repeated molecular tests and repeated antibody tests. For this purpose, a weekly smear for PCR on SARS-CoV-2 and weekly antibody tests are carried out. In addition, blood samples are preserved for testing for seroconversion. This data is correlated with a daily online survey. All data are evaluated every 3 months to determine the spread pattern.

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

No

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Description IPD sharing plan:

Because of the use of high sensible health data, according to the ICMJE there will be no sharing of individual participant data at all. No other data in particular will be shared. The study protocol will be available. All other data will not be available.

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Organizational Data

  •   DRKS00021270
  •   2020/04/15
  •   [---]*
  •   yes
  •   Approved
  •   038/20 I, Ethikkommission der Ärztekammer Schleswig-Holstein (Ethik-Kommission I)
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Secondary IDs

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

  •   U07.1 -  Emergency use of U07.1
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Interventions/Observational Groups

  •   All employees at Reinbek Hospital are smeared weekly on COVID-19 and a blood sample is taken for the antibody test. At the same time, a daily online survey of the state of health takes place.
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Characteristics

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

How many employees develop a COVID-19 positive test and how many develop antibodies in the sense of a seroconversion?

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Secondary Outcome

Correlation between symptoms and positive test results
Do certain groups show certain symptoms and certain courses?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2020/04/14
  •   900
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Actually working in the study center

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Exclusion Criteria

No informed consent

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Addresses

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    • Krankenhaus Reinbek St. Adolf-Stift
    • Mr.  Björn  Pestinger 
    • Hamburger Straße 41
    • 21465  Reinbek
    • Germany
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    • Krankenhaus Reinbek St. Adolf-Stift
    • Mr.  Prof. Dr. med.  Tim  Strate 
    • Hamburger Straße 41
    • 21465  Reinbek
    • Germany
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    • Krankenhaus Reinbek St. Adolf-Stift
    • Mr.  Dr. med.  Jonas  Herzberg 
    • Hamburger Straße 41
    • 21465  Reinbek
    • Germany
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Sources of Monetary or Material Support

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    • Krankenhaus Reinbek St. Adolf-Stift
    • Mr.  Björn  Pestinger 
    • Hamburger Straße 41
    • 21465  Reinbek
    • 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.