Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00021788

Trial Description

start of 1:1-Block title

Title

Infection rate of Covid-19 among medical staff in GP practices in North Rhine-Westphalia (Germany)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Many healthcare workers worldwide have been infected with SARS-CoV-2. According to a report by the European Center for Disease Prevention and Control (ECDC) on April 23, 2020, the following infection rates were recorded among medical personnel in the healthcare sector: China 3.8%, Italy 10% (up to 20% in the particularly affected region of Lombardy), Spain 20%. To the best of our knowledge, there are no data on this in the outpatient sector in Germany.
In the currently planned cross-sectional study, the SARS-CoV-2 antibody status (IgG) is to be collected from medical staff (doctors, medical assistants) from the existing supra-regional teaching practice pool of the Institute of General Medicine at the University Hospital Essen. In addition, the participants receive questionnaires in order to draw possible causes and relationships from the infection rates.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In the current cross-sectional study, the infection rate of SARS-CoV-2 is to be determined from medical staff (doctors and medical assistants) from the already existing supra-regional teaching practice pool of the Institute of General Medicine at the University Hospital Essen. To realize this, the antibody status (IgG) is raised. If SARS-CoV-2-IgG-Ab is detected, the samples are subjected to a confirmation test by the departement of virology of the University Hospital Essen. If there is a discrepancy between the first test and the confirmation test, a neutralization test is carried out. In addition, participants receive questionnaires to determine possible causes and relationships based on the infection rate.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

No

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00021788
  •   2020/07/14
  •   [---]*
  •   yes
  •   Approved
  •   20-9339-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   U07.1 Covid-19
  •   EMPLOYEES IN THE HEALTH SECTOR
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Medical staff (doctors and medical assistants) in general practices are drawn blood once to test the SARS-CoV-2-IgG antibody status. This is intended to draw conclusions about a recent Covid 19 disease.
    The blood samples with the detection of SARS-CoV-2-IgG are then subjected to a confirmation test in the virology of the University Hospital Essen.
    If the first test and the confirmation test are found to be discrepant, a neutralization test is then carried out.
    In addition, all participants receive questionnaires at the time of blood sampling, which should be used to draw the possible causes and relationships from the infection rates. The participants with evidence of SARS-CoV-2-IgG antibodies will then receive a separate anonymized questionnaire.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Infection rate of SARS-CoV-2 in medical staffl in general practitioners' offices via the SARS-CoV-2 IgG antibody determination

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Identify possible causes and relationships from the infection rate

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2020/06/10
  •   900
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Interest in general medical research,
General medical practice
Communication with the university via email,
Approval for taking blood and answering a questionnaire

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Lack of knowledge of German

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Allgemeinmedizin, Universitätsklinikum Essen
    • Ms.  Dr.  Dorothea  Dehnen 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Institut für Allgemeinmedizin, Universitätsklinikum Essen
    • Ms.  Dr.  Dorothea  Dehnen 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Institut für Allgemeinmedizin des Universitätsklinikums Essen
    • Ms.  Dr.  Dorothea  Dehnen 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Stiftung Universitätsmedizin Essen
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Institut für Allgemeinmedizin, Universitätsklinikum Essen
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.