Trial document




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  DRKS00022380

Trial Description

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Title

Clinical translational and epidemiological research project on SARS coronavirus 2 infection in during the COVID 19 pandemic children in Bavaria

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Trial Acronym

COVID Kids Bavaria

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URL of the Trial

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Brief Summary in Lay Language


COVID KIDS BAVARIA is a Bavaria-wide study in which six children's hospitals from Bavarian universities take part. The aim of the study is to examine the role of children in the spread of COVID-19, the effects of school and kindergarten closings on the spread and the psychological effects of these interventions on toddlers and children in Bavaria. Kindergartens and schools are contacted and all children are invited to participate. Participation includes a detailed questionnaire and, in some of the subjects, a swab from the nasopharynx.

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Brief Summary in Scientific Language

COVID KIDS BAVARIA is a prospective multicenter observational study with the aim to access the role of children in disease spread, the effect of school and kindergarden closures and the psychological impact of those interventions on infant and children in Bavaria.

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

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00022380
  •   2020/07/07
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  •   yes
  •   Approved
  •   20-538, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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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

  •   Epidemiological, prospective, multicenter study. Examination of the spread of COVID-19 in primary schools and kindergartens in Bavaria. Examining the impact of prevention measures on the well being of children.
    Pilot phase with questionnaire and nasopharynx swab (COVID-19 PCR). Then phase 1-3 from September 2021 to April 2021 with questionnaire and nasopharynx swab (COVID-19 PCR). Final (4th) phase with testing of blood for SARS-CoV-2 antibodies for pupil and teacher of primary schools plus short questionnaire
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Characteristics

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

Spread of COVID-19 in primary schools and childcare

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Secondary Outcome


Impact of school and childcare closings on children's health

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/07/21
  •   14000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   0   Years
  •   10   Years
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Additional Inclusion Criteria


Caregiver or child in one of the selected institutions

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Exclusion Criteria

People who do not belong to the selected institutions

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Addresses

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    • Dr. von Haunersches KinderspitalLMU Klinikum
    • Mr.  Prof. Dr.  Christoph  Klein 
    • Lindwurmstr. 4
    • 80337  München
    • Germany
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    • Dr. von Haunersches Kinderspital, LMU Klinikum
    • Ms.  Dr. med.  Nicole  Maison 
    • Lindwurmstr. 4
    • 80337  München
    • Germany
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    • Dr. von Haunersches Kinderspital, LMU Klinikum
    • Ms.  Dr. med.  Anna  Kern 
    • Lindwurmstr. 4
    • 80337  München
    • Germany
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Sources of Monetary or Material Support

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    • Bayerisches Staatsministerium für Wissenschaft und Kunst
    • 80327  München
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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