NCT04619407

Brief Summary

The main objectives of this study are

  1. 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. 2.to monitor the future spread of the disease by assessing serological responses to SARS-CoV-2 in teachers and childcare educators over time

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

November 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2021

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

November 4, 2020

Last Update Submit

April 13, 2021

Conditions

SARS-CoV-2

Keywords

serologyantibody formationepidemiology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Seroprevalence of SARS-CoV-2 antibodies

    At study inclusion

  • Seroprevalence of SARS-CoV-2 antibodies

    5 months

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

    At study inclusion

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

    1 month

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

    2 months

  • +8 more secondary outcomes

Study Arms (4)

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 swabDiagnostic Test: Serum testing

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

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 swabDiagnostic Test: Serum testing

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

Interventions

Nasopharyngeal swabDIAGNOSTIC_TEST

SARS-CoV-2 PCR

childcare educatorspreschoolerspupilsteacher
Serum testingDIAGNOSTIC_TEST

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

childcare educatorsteacher

Eligibility Criteria

Age3 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Teachers and childcare educators as well as pupils and preschoolers

You may qualify if:

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

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Greifswald University Medicine

Greifswald, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, nasal/throat swabs

Study Officials

  • Nils-Olaf Hübner, Prof. Dr.

    University Medicine Greifswald

    PRINCIPAL INVESTIGATOR

  • Karsten Becker, Prof. Dr.

    University Medicine Greifswald

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 6, 2020

Study Start

November 4, 2020

Primary Completion

March 26, 2021

Study Completion

March 26, 2021

Last Updated

April 14, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)