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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

Organizational Data

DRKS-ID:
DRKS00023721
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2020-12-15
Last update in DRKS:
2022-11-03
Registration type:
Retrospective

Acronym/abbreviation of the study

Wü-KiTa-CoV

URL of the study

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

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.

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).

Health condition or problem studied

Free text:
SARS-CoV-2-infection
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Nasal swaps 2x/week for daycare children and staff without symptoms
Arm 2:
Nasal swaps 1x/week for daycare children and staff without symptoms
Arm 3:
Collection of saliva samples 2x/week for daycare children (≥ 2 years) and staff without symptoms
Arm 4:
Throat swaps for symptomatic study participants (daycare children, staff, and their household members) with cold symptoms

Endpoints

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.
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.

Study Design

Purpose:
Other
Allocation:
Non-randomized controlled study
Control:
  • Other
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Other Kinderbetreuungseinrichtungen Würzburg

Recruitment period and number of participants

Planned study start date:
2020-10-01
Actual study start date:
2020-10-01
Planned study completion date:
No Entry
Actual Study Completion Date:
2022-09-30
Target Sample Size:
1000
Final Sample Size:
592

Inclusion Criteria

Sex:
All
Minimum Age:
no minimum age
Maximum Age:
no maximum age
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

Exclusion Criteria

/

Addresses

Primary Sponsor

Universität Würzburg
Sanderring 2
97070 Würzburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Institut für Hygiene und MikrobiologieUniversität Würzburg
Prof. Dr. med. Oliver Kurzai
Josef-Schneider-Str. 2 / E1
97080 Würzburg
Germany
Telephone:
0931/31 88007
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Institut für Hygiene und MikrobiologieUniversität Würzburg
Studiensekretariat Wü-KiTa-CoV
Josef-Schneider-Str. 2 / E1
97080 Würzburg
Germany
Telephone:
0931-31 87592
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Institut für Hygiene und MikrobiologieUniversität Würzburg
Prof. Dr. med. Oliver Kurzai
Josef-Schneider-Str. 2 / E1
97080 Würzburg
Germany
Telephone:
0931/31 88007
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Bundesministerium für Bildung und Forschung Dienstsitz Berlin
Friedrichstraße 130 B
10117 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.bmbf.de

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Universität Würzburg, Institut für Pharmakologie und Toxikologie
Versbacher Str. 9
97078 Würzburg
Germany
Telephone:
+49-931-3148315
Fax:
+49-931-3187520
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2020-08-03
Ethics committee number:
182/20-me
Vote of the Ethics Committee:
Approved
Date of the vote:
2020-08-20

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
Other secondary IDs:
No Entry
Other secondary IDs:
http://doi.org/10.23728/b2share.0ee3419f9ed84d1... - KiCoS (Kinder Corona Studies) kuratiert vom Robert Koch Institut
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
Transfer of data to third parties excluded

Study protocol and other study documents

Study protocols:
Study protocoll
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
forster_2022_JAMA_OpenNetworks
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry