Trial document





This trial has been registered retrospectively.
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  DRKS00023911

Trial Description

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Title

German research network "Applied Surveillance and Testing" - Workpackage schools and Nurseries (COVID-19)

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Trial Acronym

B-FAST Schools and Nurseries

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URL of the Trial

https://kinderklinik.uk-koeln.de/forschung/b-fast/

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Brief Summary in Lay Language

The long-term goal of this study is to prevent school closures in the SARS-CoV-2 pandemic. To achieve this, study participants at school facilities will be tested closely for SARS-CoV-2 using various methods. The primary objective is to investigate the acceptability of this close-meshed testing.

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Brief Summary in Scientific Language

B-FAST is a project of the National Research Network of University Hospitals in Germany, funded by the German Federal Ministry of Education and Research. The aim of the overall project is to contribute to the management of the SARS-CoV-2 and COVID-19 pandemic.
SARS-CoV-2 and the resulting COVID-19 pandemic pose comprehensive challenges to our society. The role of children and adolescents in the spread of the virus has not yet been conclusively determined; they appear to play a role in the SARS-CoV-2 pandemic as possible carriers and often show mild courses of the disease or may present asymptomatically. Clearance and hygiene rules are difficult to enforce among minors and are inconsistently applied in different states. Moreover, in schools and childcare facilities, many people congregate in a confined space during regular operations. The operation of schools is a risk factor for cluster outbreaks of SARS-CoV-2, and the phenomenon of so-called superspreaders exacerbates this situation. The widespread reopening of schools and daycare centers must not jeopardize further containment of the pandemic. This creates a dilemma with the goal of pandemic control and protection of the vulnerable elderly population on the one hand, and the equally important right to education and care for children on the other. Serious social consequences are to be feared, potentially jeopardizing the acceptance of measures in the context of pandemic plans. The overall effectiveness of school closures is also controversial, depending largely on the timing of their implementation. Nevertheless, models show that school closures alone are not effective interventions and that individual school interventions tend to be both more effective and more cost-efficient. However, no valid data exist on the safety of resuming school operations, and no clear recommendations for action could be derived from previous epidemics in this regard. School closings result in high direct and indirect costs. In addition, together with other quarantine measures, they pose a significant risk for the development of psychiatric disorders. Models suggest that long-term surveillance is urgently required to enable maintenance of social life in the post-pandemic phase of COVID-19. The concept to be investigated in this project is therefore to prevent school closures in the context of cluster outbreaks by providing close virological surveillance of all individuals at community sites over a defined period of time (surveillance). The main focus of this study lies on the feasibility and the acceptance of the provided multiple screenings, in order to not only theoretically plan an already recorded problem area (pandemic plan), but to enable a rapid and broad implementation ('rapid response'). The study will be conducted multicentrally at five sites in Germany (Düsseldorf, Heidelberg, Homburg, Cologne, Munich) . At all sites, the responsible health authority is involved in the planning.

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

Yes

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Description IPD sharing plan:

Data will be shared with the Partners in B-FAST through a Plattform that will be used by B-FAST-Partners only

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Organizational Data

  •   DRKS00023911
  •   2020/12/18
  •   [---]*
  •   yes
  •   Approved
  •   20-1463_1, 20-1463_2, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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

  •   SARS-CoV-2
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Interventions/Observational Groups

  •   Oropharyngeal swab for SARS-CoV-2 on 2 or 3 test days per week, for a period of 3 weeks.
  •   Saliva sample to be tested for SARS-CoV-2, on 2 or 3 days per week, for a period of 3 weeks.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Screening
  •   Factorial
  •   N/A
  •   N/A
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Primary Outcome

acceptance and feasibility of testing for SARS-CoV-2 in schools and nurseries

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Secondary Outcome

Review of child-friendly and everyday sampling methods for the detection and surveillance of SARS-CoV-2 and other respiratory viruses

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/10/18
  •   7500
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Pupils of the participating institution and employees of the participating institution, age > 12 months.

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Exclusion Criteria

age < 12 months

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Addresses

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    • Klinik für Kinder- und Jugendmedizin Universitätsklinikum Köln
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Universitätsklinikum Köln
    • Mr.  Univ.-Prof. Dr.  Jörg  Dötsch 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Universitätsklinikum Köln
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • 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.