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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00023507
Date of registration:	27/11/2020
Prospective Registration:	Yes
Primary sponsor:	Institut für Virologie
Public title:	SARS-CoV-2 Surveillance in childcare facilities
Scientific title:	SARS-CoV-2 Surveillance in childcare facilities - SSC
Date of first enrolment:	29/11/2020
Target sample size:	120
Recruitment status:	Recruiting
URL:	http://drks.de/search/en/trial/DRKS00023507
Study type:	observational
Study design:	Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other
Phase:

Countries of recruitment
Germany

Contacts

Name:	Felix Dewald
Address:	Fürst-Pückler-Strasse 56 50935 Köln Germany
Telephone:	017672184672
Email:	felix.dewald@uk-koeln.de
Affiliation:	Virologie, Uniklinik Köln

Name:	Felix Dewald
Address:	Fürst-Pückler-Straße 56 50935 Köln Germany
Telephone:	017672184672
Email:	felix.dewald@uk-koeln.de
Affiliation:	Institut für Virologie

Key inclusion & exclusion criteria

Inclusion criteria: - Staff or child in one of the childcare facility
- Informed consent (of the legal guardians, with sole custody, the legal guardian)
- Consent of the underaged
Exclusion criteria: rejection of participation (by the legal Guardian(s))

Age minimum: 0 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

U07.1

COVID-19, virus identified

COVID-19
U07.1

Intervention(s)

Group 1: SARS-CoV-2 surveillance is performed in two childcare facilities for 2 weeks (two times in one week). For this purpose, the parents of the children will collect a saliva samples of their children with a regular swab. The swabs will be collected in the day care center and will be transported from there to laboratory. The samples will be tested by pool testing. After validation of the test results, the childcare facilities will be informed. In the case of a positive pool, the children in the positive pool can be tested individually.

Primary Outcome(s)

Assessment of the feasibility of a periodical SARS-CoV-2 surveillance in childcare facilities (2 weeks, two times in one week).

Secondary Outcome(s)

Determination of the turnaround times, determination of the acceptance of the children's sampling, determination of the time and personnel expenditure for the parents and the day-care center staff as well as for the laboratory carrying out the testing (collection of samples, pooling, testing, evaluation, communication of test results)

Secondary ID(s)

Source(s) of Monetary Support

Institut für Virologie

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 28/10/2020
Contact:

gs-ek@uni-koeln.de

Ethikkommission der Medizinischen Fakultät der Universität zu Köln

+49-221-478 82900

gs-ek@uni-koeln.de

Results

Results available:
Date Posted:
Date Completed:
URL:	http://drks.de/search/en/trial/DRKS00023507#studyResults

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