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

Study Overview
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Brief Summary
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The main objectives of this study are to establish the prevalence of SARS-CoV-2 in schools and kindergartens in the State of Mecklenburg-Vorpommern in autumn and winter 2020/2021 to monitor the future spread of the disease by assessing serological responses to SARS-CoV-2 in teachers and childcare educators over time

Detailed Description
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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.

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

Conditions
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SARS-CoV-2

Intervention / Treatment
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* Diagnostic Test: Nasopharyngeal swab
* Diagnostic Test: Serum testing


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: See cohort descriptions Willing to have blood samples stored for future research Exclusion criteria: - None

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| teacher<br>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<br>* SARS-CoV-2 PCR<br>Diagnostic Test: Serum testing<br>* Anti-SARS-CoV-2 antibody testing (IgA and IgG ELISA)<br>|
| pupils<br>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<br>* SARS-CoV-2 PCR<br>|
| childcare educators<br>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<br>* SARS-CoV-2 PCR<br>Diagnostic Test: Serum testing<br>* Anti-SARS-CoV-2 antibody testing (IgA and IgG ELISA)<br>|
| preschoolers<br>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<br>* SARS-CoV-2 PCR<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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serology, antibody formation, epidemiology