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Completed

NCT Number: NCT04619407

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

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

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Key information

Conditions

SARS-CoV-2

Age range

3 year–67 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Greifswald University Medicine

Greifswald, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Nasopharyngeal swab

Diagnostic Test

SARS-CoV-2 PCR

Serum testing

Diagnostic Test

Anti-SARS-CoV-2 antibody testing (IgA and IgG ELISA)

Primary outcomes

  1. Share of participants with SARS-CoV-2 detectable in PCR

    Time frame: 5 months

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

Secondary outcomes

  1. Seroprevalence of SARS-CoV-2 antibodies

    Time frame: At study inclusion

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

  2. Seroprevalence of SARS-CoV-2 antibodies

    Time frame: 5 months

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

  3. SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life

    Time frame: At study inclusion

    As assessed by a monthly questionnaire

  4. SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life

    Time frame: 1 month

    As assessed by a monthly questionnaire

  5. SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life

    Time frame: 2 months

    As assessed by a monthly questionnaire

  6. SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life

    Time frame: 3 months

    As assessed by a monthly questionnaire

  7. SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life

    Time frame: 4 months

    As assessed by a monthly questionnaire

  8. SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life

    Time frame: 5 months

    As assessed by a monthly questionnaire

  9. Share of participants with SARS-CoV-2 detectable in PCR

    Time frame: At study inclusion

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

  10. Share of participants with SARS-CoV-2 detectable in PCR

    Time frame: 1 month

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

  11. Share of participants with SARS-CoV-2 detectable in PCR

    Time frame: 2 months

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

  12. Share of participants with SARS-CoV-2 detectable in PCR

    Time frame: 3 months

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

  13. Share of participants with SARS-CoV-2 detectable in PCR

    Time frame: 4 months

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

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

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

Registry information

Official study title

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

Acronym: COKITS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 6, 2020
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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