Screening for COVID-19 in Teachers, Childcare Educators, Pupils and Preschoolers (COKITS)

Screening for SARS-CoV-2-Infections in Teachers, Childcare Educators, Pupils and Preschoolers in the State of Mecklenburg-Vorpommern

The main objectives of this study are

1. to establish the prevalence of SARS-CoV-2 in schools and kindergartens in the State of Mecklenburg-Vorpommern in autumn and winter 2020/2021
2. to monitor the future spread of the disease by assessing serological responses to SARS-CoV-2 in teachers and childcare educators over time

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2
• Intervention / Treatment: Diagnostic test: Nasopharyngeal swab; Diagnostic test: Serum testing

Detailed Description

Detailed Description:

This study aims to collect information on teachers and childcare educators as well as on pupils and preschoolers in the State of Mecklenburg-Vorpommern

Over a 5 month period, 5 study visits per participant are planned. At each visit, nasal/throat swabs (for PCR testing) will be collected and participants will be asked to fill in a questionnaire (asking for SARS-CoV-2 risk factors, perceived risk, and impact of the pandemic on their quality of life). In adults, additional blood samples (for SARS-CoV-2 antibody testing) will be collected at the first and the last study visit. This will help to gain a better understanding of viral load and antibody development over time.

The remaining blood samples will be stored in a repository for future research.

The study is part of a modular SARS-CoV-2-research programme of the University Medicine Greifswald.

• Study Type: Observational
• Enrollment (Actual): 142

Contacts and Locations

Study Locations

• Germany
  • Greifswald, Germany
    • Greifswald University Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 67 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Teachers and childcare educators as well as pupils and preschoolers

Description

Inclusion criteria:

• See cohort descriptions
• Willing to have blood samples stored for future research

Exclusion criteria:

- None

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
teacher; Employed in a school in Mecklenburg-Vorpommern; Age between 18 to 67 years; Willing and able to provide informed consent; Over 5 months: Monthly nasopharyngeal swabs for SARS-CoV-2 PCR, additionally blood samples for SARS-CoV-2 antibody testing will be taken at the beginning and at the end of the study	Diagnostic test: Nasopharyngeal swab; SARS-CoV-2 PCR; Diagnostic test: Serum testing; Anti-SARS-CoV-2 antibody testing (IgA and IgG ELISA)
pupils; Attending school in Mecklenburg-Vorpommern; Age between 6 to 17 years; Agreement to participate; Legal representative willing and able to provide informed consent; Over 5 months: Monthly nasopharyngeal swabs for SARS-CoV-2 PCR	Diagnostic test: Nasopharyngeal swab; SARS-CoV-2 PCR
childcare educators; Employed in a kindergarten in Mecklenburg-Vorpommern; Age between 18 to 67 years; Willing and able to provide informed consent; Over 5 months: Monthly nasopharyngeal swabs for SARS-CoV-2 PCR, additionally blood samples for SARS-CoV-2 antibody testing will be taken at the beginning and at the end of the study	Diagnostic test: Nasopharyngeal swab; SARS-CoV-2 PCR; Diagnostic test: Serum testing; Anti-SARS-CoV-2 antibody testing (IgA and IgG ELISA)
preschoolers; Attending kindergarten in Mecklenburg-Vorpommern; Age between 3 to 6 years; Agreement to participate; Legal representative willing and able to provide informed consent; Over 5 months: Monthly nasopharyngeal swabs for SARS-CoV-2 PCR	Diagnostic test: Nasopharyngeal swab; SARS-CoV-2 PCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Share of participants with SARS-CoV-2 detectable in PCR	Percentage of SARS-CoV-2 PCR positive participants (children and educational staff)	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroprevalence of SARS-CoV-2 antibodies	Percentage of Anti-SARS-COV2 S protein IgA and IgA ELISA positive participants (educational staff)	At study inclusion
Seroprevalence of SARS-CoV-2 antibodies	Percentage of Anti-SARS-COV2 S protein IgA and IgA ELISA positive participants (educational staff)	5 months
SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life	As assessed by a monthly questionnaire	At study inclusion
SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life	As assessed by a monthly questionnaire	1 month
SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life	As assessed by a monthly questionnaire	2 months
SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life	As assessed by a monthly questionnaire	3 months
SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life	As assessed by a monthly questionnaire	4 months
SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life	As assessed by a monthly questionnaire	5 months
Share of participants with SARS-CoV-2 detectable in PCR	Percentage of SARS-CoV-2 PCR positive participants (children and educational staff)	At study inclusion
Share of participants with SARS-CoV-2 detectable in PCR	Percentage of SARS-CoV-2 PCR positive participants (children and educational staff)	1 month
Share of participants with SARS-CoV-2 detectable in PCR	Percentage of SARS-CoV-2 PCR positive participants (children and educational staff)	2 months
Share of participants with SARS-CoV-2 detectable in PCR	Percentage of SARS-CoV-2 PCR positive participants (children and educational staff)	3 months
Share of participants with SARS-CoV-2 detectable in PCR	Percentage of SARS-CoV-2 PCR positive participants (children and educational staff)	4 months

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Collaborators: Ministry of Education, Science and Culture of the State of Mecklenburg-Vorpommern; Ministry of Social Affairs, Integration and Equality of the State of Mecklenburg-Vorpommern; State Office for Health and Social Affairs of the State of Mecklenburg-Vorpommern
• Investigators: Principal Investigator: Nils-Olaf Hübner, Prof. Dr., University Medicine Greifswald; Principal Investigator: Karsten Becker, Prof. Dr., University Medicine Greifswald

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 4, 2020
• Primary Completion (ACTUAL): March 26, 2021
• Study Completion (ACTUAL): March 26, 2021

Study Registration Dates

• First Submitted: November 4, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (ACTUAL): November 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: epidemiology; serology; antibody formation
• Other Study ID Numbers: BB 179/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No