Clinical trial NCT04619407: Screening for COVID-19 in Teachers, Childcare Educators, Pupils and Preschoolers
Official title: Screening for SARS-CoV-2-Infections in Teachers, Childcare Educators, Pupils and Preschoolers in the State of Mecklenburg-Vorpommern
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2
Keywords: serology
antibody formation
epidemiology
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Science and Culture of the State of Mecklenburg-Vorpommern
name: Ministry of Social Affairs, Integration and Equality of the State of Mecklenburg-Vorpommern
name: State Office for Health and Social Affairs of the State of Mecklenburg-Vorpommern
First posted: 2020-11-06
Enrollment: 142
Sex: ALL
Minimum age (years): 3
Maximum age (years): 67
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Teachers and childcare educators as well as pupils and preschoolers

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.

Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

- None

Primary outcomes:
measure: Share of participants with SARS-CoV-2 detectable in PCR
timeFrame: 5 months
Secondary outcomes:
measure: Seroprevalence of SARS-CoV-2 antibodies
timeFrame: At study inclusion
measure: Seroprevalence of SARS-CoV-2 antibodies
timeFrame: 5 months
measure: SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life
timeFrame: At study inclusion
measure: SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life
timeFrame: 1 month
measure: SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life
timeFrame: 2 months
measure: SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life
timeFrame: 3 months
measure: SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life
timeFrame: 4 months
measure: SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life
timeFrame: 5 months
measure: Share of participants with SARS-CoV-2 detectable in PCR
timeFrame: At study inclusion
measure: Share of participants with SARS-CoV-2 detectable in PCR
timeFrame: 1 month
measure: Share of participants with SARS-CoV-2 detectable in PCR
timeFrame: 2 months
measure: Share of participants with SARS-CoV-2 detectable in PCR
timeFrame: 3 months
measure: Share of participants with SARS-CoV-2 detectable in PCR
timeFrame: 4 months
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Greifswald University Medicine
Study officials:
affiliation: University Medicine Greifswald
name: Nils-Olaf Hübner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medicine Greifswald
name: Karsten Becker, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: