Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00022032

Trial Description

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Title

Study on the Evaluation of the Infectious Process of SARS-CoV-2 in Teachers and Students in Saxony (COVID-19)

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Trial Acronym

SchuCo

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URL of the Trial

http://life-child.de

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Brief Summary in Lay Language

The study aims to observe the actual extent of the spread of Sars-CoV-2 in Saxon schools during the course of the reopening. Within the framework of the study, at three points in time - at the beginning of June 2020, at the beginning of September 2020 and at the end of October / beginning of November 2020 - at 18 schools in Saxony, students of 2 class levels each, as well as the teaching staff are asked to have tests carried out for an acute infection or the presence of antibodies against Sars-CoV-2 on the basis of a throat swab and a blood sample.

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Brief Summary in Scientific Language

The aim of the study is to estimate the prevalence and sero-prevalence among teachers and students of Saxon general education schools to support decision makers in the gradual opening of general education schools (possibly stratified by age groups) and to determine the effect of infection control measures or their relaxation on the incidence rates in the target population. The target population are teachers and pupils of Saxon schools. The Dresdner/Zwickauer/Leipziger general education schools are suitable as sampling frames for the study population stratified by school type; the regions of Dresden, Zwickau and Leipzig as well as Werdau were chosen as rural areas because they represent areas with relatively low or high prevalence.

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

No

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Description IPD sharing plan:

The study results are the aggregated numbers of the prevalence of Sars-CoV-2 infections or antibodies, which are published in coordination with the sponsor of the study. A provision of the data on individual level is not planned as no additional clinical data will be collected.

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Organizational Data

  •   DRKS00022032
  •   2020/06/30
  •   [---]*
  •   yes
  •   Approved
  •   260/20-ek, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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

  •   infection and antibody status for Sars-CoV-2
  •   COVID-19
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Interventions/Observational Groups

  •   A throat-swab and a blood sample are taken, and tests for antibodies (IgG) and an acute infection are performed.
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Characteristics

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

Infection with Sars-CoV-2 (RT-PCR tasts of throat swab), presence of antibodies (IgG) in the blood sample

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
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Recruitment

  •   Actual
  •   2020/05/27
  •   4000
  •   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

Teacher or student at one of the selected saxon schools / class levels.

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Exclusion Criteria

unable to attend school

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Addresses

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    • Universität Leipzig
    • Ms.  Prof. Dr.  Beate  Schücking 
    • Ritterstraße 26
    • 04109  Leipzig
    • Germany
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    • Universität Leipzig
    • Mr.  Prof. Dr.  Wieland  Kiess 
    • Liebigstraße 27, Haus E
    • 04103  Leipzig
    • Germany
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    • Universität Leipzig
    • Ms.  Anne  Jurkutat 
    • Philipp-Rosenthal-Str. 27
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Sächsisches Staatsministerium für Kultus
    • Carolaplatz 1
    • 01097  Dresden
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Enrolling by invitation
  •   [---]*
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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.