Trial document




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  DRKS00022729

Trial Description

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Title

SARS-CoV-2 Surveillance in Day Care Centers (COVID-19)

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Trial Acronym

KiTaCoviDD19

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Due to a lack of awareness regarding personal hygiene in toddlers and preschoolers respiratory infection can spread easily in day care centers. However, data on the role of these institutions in the SARS-CoV-2 pandemic and potentially effective protection meassures there is lacking. We aim to better understand this role by conducting repeated antibody tests in parents and teachers and stool examinations in toddlers and preschoolers.

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Brief Summary in Scientific Language

Due to their lack of hygiene awareness and questionable compliance with protective measures, infants represent a critical population in the transmission of respiratory infections. The re-opening of day-care centres according to a structured concept will have an influence on this, but will not be able to completely exclude infection events and transmission chains. A reliable surveillance of the COVID-19 epidemiology in this population is therefore necessary to evaluate the protective measures taken and to carry out appropriate interventions if necessary. However, for ethical reasons, regular blood sampling in this age group is not a feasible option for monitoring the prevalence of COVID-19.
SARS-CoV-2 is also excreted in childhood to a relevant extent via the stool. Excretion takes place 2-4 weeks after infection. Regular stool tests can therefore be used to map the SARS-CoV-2 epidemiology. Reliable data on the spread of SARS-CoV-2 in this population allow risk-adapted control of current isolation measures and are therefore of great relevance to health policy.

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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

  •   DRKS00022729
  •   2020/07/30
  •   [---]*
  •   yes
  •   Approved
  •   BO-EK-179052020, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

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Health Condition or Problem studied

  •   U07.1 COVID-19
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Interventions/Observational Groups

  •   toddler, preschoolers, their parents and teachers in day care Centers in Dresden, Germany
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Characteristics

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

Anti-SARS-CoV-2 antibody seroprevalence in parents and teachers of toddlers and preschoolers

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Secondary Outcome

Transmission dynamics in day care centers

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2020/07/15
  •   750
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

children attending day care Centers in Dresden
at least one Guardian >18 years of Age
children and Guardians live in the same household
teachers in participating day care Centers >18 years of age

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Exclusion Criteria

none

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Addresses

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    • Universitätsklinikum Carl Gustav Carus
    • Mr.  Dr. med.  Jakob  Armann 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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    • Universitätsklinikum Carl Gustav Carus
    • Mr.  Dr. med.  Jakob  Armann 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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    • Universitätsklinikum Carl Gustav Carus
    • Mr.  Dr. med.  Jakob  Armann 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Carl Gustav Carus
    • Fetscherstr. 74
    • 01307  Dresden
    • 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.