Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00024635

Trial Description

start of 1:1-Block title

Title

Analyzing the incidence of SARS-Cov-2 infected children and teenager in Western Pomerania

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

Trial Acronym

COVIDKID Vorpommern

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

It is our aim, to analyze the infection rate with SARS-CoV-2 in children and teenager in Western Pomerania by determining SARS-CoV-2-specific antibodies in serum and to identify tempoiral changes as well as risk factors for SRAS-CoV-2-infection. For that, we ask patiens from 6 Months up to 17 years from all children hospitals in Western Pomerania to get an additional blood sample within a regular blood draw and to fill out a questionnaire. Additionally, we ask for permission to collect data from nasopharyngeal swabs for SARS-CoV-2 detection.

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

Brief Summary in Scientific Language

Open, prospective epidemiological study to analyse the incidence of SARS-CoV-2-specific antibodies in Children and teenager in Western Pomerania. Estimation of SARS-CoV-2 infection rate in children and teenager in Western Pomerania over time and impact of major political decisions on transmission rates among children and teenager as well as the identifiaction of major risk factors for SARS-CoV-2 infection in children and teenager. Additionally, the collected data can provide the basis of comparisons between Western Pomerania to cities or highly-populated regions.

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

  •   DRKS00024635
  •   2021/03/09
  •   [---]*
  •   yes
  •   Approved
  •   BB188/20, Ethikkommission an der Medizinischen Fakultät der Ernst-Moritz-Arndt-Universität Greifswald
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 -  Emergency use of U07.1
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Children and teenager from 6 months up to 17 years that live in Western Pomerania are asekd for an additional blood sample within a regular blood draw and to fill out a questionnaire for analysis of incidence of SARS-CoV-2-specific antibodies. Additionally, we ask for permission to collect data from nasopharyngeal swabs for SARS-CoV-2 detection.
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

sample collection (n=4000) within 18 months and analysis of SARS-CoV-2 specific antibodies in serum samples

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

Secondary Outcome

analysis of all samples; data collection from all questionnaires in regard to risk factors and impact of major political decisions; collection of all results from nasopharyngeal swabs

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

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2020/12/10
  •   4000
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   6   Months
  •   17   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

permanent residency in Western Pomerania

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

Exclusion Criteria

permanent residency outside of Western Pomerania, no informed consent

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsmedizin Greifswald
    • 17489  Greifswald
    • 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
    • Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Rheumatologie & Immunologie
    • Ms.  Prof. Dr.med.  Almut  Meyer-Bahlburg 
    • F.-Sauerbruchstraße
    • 17475  Greifswald
    • 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
    • Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Rheumatologie & Immunologie
    • Ms.  Prof. Dr. med.  Almut  Meyer-Bahlburg 
    • F.-Sauerbruchstraße
    • 17475  Greifswald
    • 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
    • Ministerium für Wirtschaft, Arbeit und Gesundheit Mecklenburg-Vorpommern
    • 19048  Schwerin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
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.