Trial document





This trial has been registered retrospectively.
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  DRKS00023721

Trial Description

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Title

Würzburg Childcare Study during the COVID-19 pandemic: A study into the acceptance of different screening measures for the detection of infections with the novel coronavirus (SARS-CoV-2) in child daycare centres in Würzburg

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Trial Acronym

Wü-KiTa-CoV

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URL of the Trial

https://www.med.uni-wuerzburg.de/wuekitacov

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Brief Summary in Lay Language

The study was designed to establish the best measures for an early detection of infections with the novel coronavirus in daycare children, parents, and daycare staff with regard to their acceptance and efficacy, aiming to prevent lock-downs of daycare centres in Würzburg during the pandemic. Several screening measures (nasal swabs and saliva samples once or twice a week of study participants without symptoms, throat swabs of study participants with cold symptoms) will be compared to each other during a study period of 12 weeks.

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Brief Summary in Scientific Language

Aims: Feasibility study of different screening measures for the surveillance of SARS-CoV-2 infections of daycare children and staff; possible predictors for the acceptance will be determined; psychosocial implications of the surveillance for several months for daycare children, parents, and staff will be evaluated; costs of the surveillance measures will be estimated; seroprevalence data and the number of SARS-CoV-2 infections of daycare children and staff in Würzburg will be collected.
Methods: Surveillance concepts: monitoring of daycare children and staff via nasal swaps once or twice a week, or via collection of saliva samples twice a week; alternatively monitoring of daycare children, staff and their household members due to cold symptoms. All 4 monitoring concepts will be running for 12 weeks.
Additionally, seroprevalence will be determined and parents/guardians, daycare staff and children will be interviewed at defined time points for the collection of sociodemographic data and psychosocial implications; symptomatic household members will be inquired about symptoms of acute respiratory infections and their exposure to SARS-CoV-2.
Laboratory diagnostics: detection of SARS-CoV-2 infections via PCR from nasal swaps or saliva sample (daycare children and staff), or from throat swaps (household members); detection of antibodies (point-of-care- test from finger-prick test, or ELISA from serum).

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

No

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Description IPD sharing plan:

Transfer of data to third parties excluded

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Organizational Data

  •   DRKS00023721
  •   2020/12/15
  •   [---]*
  •   yes
  •   Approved
  •   182/20-me, Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
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Secondary IDs

  •   http://doi.org/10.23728/b2share.0ee3419f9ed84d17a048bd5ab18c040a  (KiCoS (Kinder Corona Studies) kuratiert vom Robert Koch Institut)
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Health Condition or Problem studied

  •   SARS-CoV-2-infection
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Interventions/Observational Groups

  •   Nasal swaps 2x/week for daycare children and staff without symptoms
  •   Nasal swaps 1x/week for daycare children and staff without symptoms
  •   Collection of saliva samples 2x/week for daycare children (≥ 2 years) and staff without symptoms
  •   Throat swaps for symptomatic study participants (daycare children, staff, and their household members) with cold symptoms
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Characteristics

  •   Interventional
  •   [---]*
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Assessment of acceptance rates of various surveillance measures for the detection of SARS-CoV-2 infections in daycare children, staff, and their household members; detection of SARS-CoV-2 infections via PCR from nasal swaps or saliva samples from daycare children and staff; for household members from throat swaps;

Evaluation based on successful participation in all planned samplings during the study period; additionally, survey of parents/guardians, daycare staff and children at defined time points for the collection of sociodemographic data and psychosocial implications, including determination of predictors for the acceptance of the different concepts.

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Secondary Outcome

Collection of basic data of SARS-CoV-2 seroprevalence and the number of SARS-CoV-2 infections in daycare children and staff in Würzburg (point-of-care-test via finger-prick testing or ELISA from serum; rate of positive serological tests and positive PCR tests);

Estimation of the costs of the surveillance measures.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2020/10/01
  •   1000
  •   Multicenter 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

Modules for surveillance of asymptomatic daycare children and staff: daycare children up to 8 years in participating daycare centres or staff employed in participating daycare centre;
For collection of saliva samples children of 2 years of age and older at study start were included.

Modules for surveillance of symptomatic participants: daycare children or staff in participating daycare centres and corresponding household member

Written consent of parents/guardians and daycare staff to participation in the study

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Exclusion Criteria

/

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Addresses

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    • Universität Würzburg
    • Sanderring 2
    • 97070  Würzburg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Kinderklinik und PoliklinikUniversitätsklinikum Würzburg
    • Mr.  Prof. Dr. med., MSc  Johannes  Liese 
    • Josef-Schneider-Str. 2 / D31
    • 97080  Würzburg
    • Germany
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    •   0931-201 27725
    •   [---]*
    •   liese_j at ukw.de
    •   [---]*
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    • Institut für Hygiene und MikrobiologieUniversität Würzburg
    • Mr.  Prof. Dr. med.  Oliver  Kurzai 
    • Josef-Schneider-Str. 2 / E1
    • 97080  Würzburg
    • Germany
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    • Institut für Hygiene und MikrobiologieUniversität Würzburg
    • Studiensekretariat  Wü-KiTa-CoV 
    • Josef-Schneider-Str. 2 / E1
    • 97080  Würzburg
    • 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.