German Clinical Trials Register

Acronym/abbreviation of the study

B-FAST Schools and Nurseries

URL of the study

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

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.

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.