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

Completed
Conditions
SARS-CoV-2
Interventions
Diagnostic Test: Nasopharyngeal swab
Diagnostic Test: Serum testing
Registration Number
NCT04619407
Lead Sponsor
University Medicine Greifswald
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
142
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
teacherSerum testing* 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
childcare educatorsNasopharyngeal swab* 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
pupilsNasopharyngeal swab* 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
childcare educatorsSerum testing* 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
preschoolersNasopharyngeal swab* 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
teacherNasopharyngeal swab* 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
Primary Outcome Measures
NameTimeMethod
Share of participants with SARS-CoV-2 detectable in PCR5 months

Percentage of SARS-CoV-2 PCR positive participants (children and educational staff)

Secondary Outcome Measures
NameTimeMethod
SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life5 months

As assessed by a monthly questionnaire

Seroprevalence of SARS-CoV-2 antibodies5 months

Percentage of Anti-SARS-COV2 S protein IgA and IgA ELISA positive participants (educational staff)

Share of participants with SARS-CoV-2 detectable in PCR4 months

Percentage of SARS-CoV-2 PCR positive participants (children and educational staff)

Trial Locations

Locations (1)

Greifswald University Medicine

🇩🇪

Greifswald, Germany

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