SARS-CoV-2COKITSNCT04619407
Screening for COVID-19 in Teachers, Childcare Educators, Pupils and Preschoolers
An observational study of SARS-CoV-2, run by University Medicine Greifswald at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Nasopharyngeal swab and Serum testing
- How many people
- 142 participants
- Where
- 1 siteGermany
- Study dates
- 4 Nov 2020to 26 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 67 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Teachers and childcare educators as well as pupils and preschoolers
Who may be able to join
- See cohort descriptions
- Willing to have blood samples stored for future research
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for SARS-CoV-2-Infections in Teachers, Childcare Educators, Pupils and Preschoolers in the State of Mecklenburg-Vorpommern
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
Read the 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.
- Conditions
- SARS-CoV-2
- Being tested
- Nasopharyngeal swab, Serum testing
- Keywords
- serology, antibody formation, epidemiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal swabDiagnostic test
SARS-CoV-2 PCR
Serum testingDiagnostic test
Anti-SARS-CoV-2 antibody testing (IgA and IgG ELISA)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Nasopharyngeal swab; Diagnostic 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 Receives: 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 Receives: Diagnostic Test: Nasopharyngeal swab; Diagnostic 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 Receives: Diagnostic Test: Nasopharyngeal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Share of participants with SARS-CoV-2 detectable in PCR
Percentage of SARS-CoV-2 PCR positive participants (children and educational staff)
Measured: 5 months
Secondary outcomes (13)
Seroprevalence of SARS-CoV-2 antibodies
Percentage of Anti-SARS-COV2 S protein IgA and IgA ELISA positive participants (educational staff)
Measured: At study inclusion
Seroprevalence of SARS-CoV-2 antibodies
Percentage of Anti-SARS-COV2 S protein IgA and IgA ELISA positive participants (educational staff)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 5 months
Share of participants with SARS-CoV-2 detectable in PCR
Percentage of SARS-CoV-2 PCR positive participants (children and educational staff)
Measured: 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)
Measured: 1 month
Share of participants with SARS-CoV-2 detectable in PCR
Percentage of SARS-CoV-2 PCR positive participants (children and educational staff)
Measured: 2 months
Share of participants with SARS-CoV-2 detectable in PCR
Percentage of SARS-CoV-2 PCR positive participants (children and educational staff)
Measured: 3 months
Share of participants with SARS-CoV-2 detectable in PCR
Percentage of SARS-CoV-2 PCR positive participants (children and educational staff)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start4 Nov 2020
- Primary completion26 Mar 2021
- Study completion26 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or 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
- Responsible party
- Sponsor
- Investigators
- Nils-Olaf Hübner, Prof. Dr., Principal investigator, University Medicine GreifswaldKarsten Becker, Prof. Dr., Principal investigator, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619407
- Sponsor's protocol ID
- BB 179/20
- Acronym
- COKITS
- Status last verified
- Apr 2021
- First submitted
- 4 Nov 2020
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for SARS-CoV-2-Infections in Teachers, Childcare Educators, Pupils and Preschoolers in the State of Mecklenburg-Vorpommern
- ClinicalTrials.gov ID
- NCT04619407
- Acronym / sponsor ID
- COKITS / BB 179/20
- Conditions
- SARS-CoV-2
- Keywords
- serology, antibody formation, epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or 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
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| teacher | – | Diagnostic Test: Nasopharyngeal swab, Diagnostic Test: Serum 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 |
| pupils | – | Diagnostic Test: Nasopharyngeal 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 educators | – | Diagnostic Test: Nasopharyngeal swab, Diagnostic Test: Serum 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 |
| preschoolers | – | Diagnostic Test: Nasopharyngeal 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 |
Who may qualify
- Ages
- 3 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Teachers and childcare educators as well as pupils and preschoolers
Key inclusion criteria (2 listed)
- See cohort descriptions
- Willing to have blood samples stored for future research
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasopharyngeal swabSARS-CoV-2 PCR | Diagnostic test | childcare educators, preschoolers, pupils, teacher |
| Serum testingAnti-SARS-CoV-2 antibody testing (IgA and IgG ELISA) | Diagnostic test | childcare educators, teacher |
Primary outcome
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)
13 secondary outcomes
Seroprevalence of SARS-CoV-2 antibodies
Time frame: At study inclusion
Seroprevalence of SARS-CoV-2 antibodies
Time frame: 5 months
SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life
Time frame: At study inclusion
SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life
Time frame: 1 month
SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life
Time frame: 2 months
SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life
Time frame: 3 months
SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life
Time frame: 4 months
SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life
Time frame: 5 months
Share of participants with SARS-CoV-2 detectable in PCR
Time frame: At study inclusion
Share of participants with SARS-CoV-2 detectable in PCR
Time frame: 1 month
Share of participants with SARS-CoV-2 detectable in PCR
Time frame: 2 months
Share of participants with SARS-CoV-2 detectable in PCR
Time frame: 3 months
Share of participants with SARS-CoV-2 detectable in PCR
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nils-Olaf Hübner, Prof. Dr. principal investigator
University Medicine Greifswald
Karsten Becker, Prof. Dr. principal investigator
University Medicine Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Share of participants with SARS-CoV-2 detectable in PCR (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.