Clinical Trials Logo
  1. Home
  2. SARS-CoV-2
  3. NCT04619407
  4. Details
NCT04619407 Clinical Trial

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

SARS-CoV-2 Clinical Trial

— COKITS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04619407
Other study ID # BB 179/20
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 4, 2020
Est. completion date March 26, 2021

Study information
Verified date April 2021
Source University Medicine Greifswald
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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

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 information / eligibility
Status Completed
Enrollment 142
Est. completion date March 26, 2021
Est. primary completion date March 26, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 67 Years
Eligibility Inclusion criteria: - See cohort descriptions - Willing to have blood samples stored for future research Exclusion criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Nasopharyngeal swab
SARS-CoV-2 PCR
• Serum testing
Anti-SARS-CoV-2 antibody testing (IgA and IgG ELISA)

Locations
Country Name City State
Germany Greifswald University Medicine Greifswald

Sponsors (4)
Lead Sponsor Collaborator
University Medicine Greifswald 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

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Seroprevalence of SARS-CoV-2 antibodies Percentage of Anti-SARS-COV2 S protein IgA and IgA ELISA positive participants (educational staff) At study inclusion
Secondary Seroprevalence of SARS-CoV-2 antibodies Percentage of Anti-SARS-COV2 S protein IgA and IgA ELISA positive participants (educational staff) 5 months
Secondary SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life As assessed by a monthly questionnaire At study inclusion
Secondary SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life As assessed by a monthly questionnaire 1 month
Secondary SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life As assessed by a monthly questionnaire 2 months
Secondary SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life As assessed by a monthly questionnaire 3 months
Secondary SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life As assessed by a monthly questionnaire 4 months
Secondary SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life As assessed by a monthly questionnaire 5 months
Secondary Share of participants with SARS-CoV-2 detectable in PCR Percentage of SARS-CoV-2 PCR positive participants (children and educational staff) At study inclusion
Secondary Share of participants with SARS-CoV-2 detectable in PCR Percentage of SARS-CoV-2 PCR positive participants (children and educational staff) 1 month
Secondary Share of participants with SARS-CoV-2 detectable in PCR Percentage of SARS-CoV-2 PCR positive participants (children and educational staff) 2 months
Secondary Share of participants with SARS-CoV-2 detectable in PCR Percentage of SARS-CoV-2 PCR positive participants (children and educational staff) 3 months
Secondary Share of participants with SARS-CoV-2 detectable in PCR Percentage of SARS-CoV-2 PCR positive participants (children and educational staff) 4 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT04527471 - Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19 Phase 2
Recruiting NCT05584202 - Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants Phase 2
Completed NCT04579549 - Repeat Testing for SARS-CoV-2 N/A
Active, not recruiting NCT05547243 - A Cohort Study of COVID-19 mRNA Vaccine, Bivalent in Participants in China N/A
Recruiting NCT04747574 - Evaluation of the Safety of CD24-Exosomes in Patients With COVID-19 Infection Phase 1
Recruiting NCT04613310 - PCR and Rapid Diagnostic Test on Saliva and Nasopharyngeal Swabs for the Detection of SARS-CoV-2 (COVID-19) N/A
Completed NCT04515147 - A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19 Phase 2
Terminated NCT04447404 - DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury Phase 2
Withdrawn NCT04388709 - Interferon Lambda Therapy for COVID-19 Phase 2
Active, not recruiting NCT05550142 - A Preliminary Exploratory Cohort Study of SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine in Participants Aged 18 Years and Over in China N/A
Completed NCT04620798 - Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students N/A
Active, not recruiting NCT05547256 - A Preliminary Exploratory Cohort Study of COVID-19 mRNA Vaccine, Bivalent in Participants Aged 18 Years and Over in China N/A
Completed NCT04452604 - Multicentric Registry of Patients With Acute Leukemia Infected by COVID-19
Completed NCT04561102 - Evaluation of the COVIDSeq Test in Nasal Swab and Saliva From a COVID-19 Asymptomatic Population
Completed NCT05366322 - A Study to Compare mRNA-1273 Versus BNT162b2 COVID-19 Vaccines Among Immunocompromised Adults
Terminated NCT04958304 - Moderna COVID-19 Vaccine mRNA-1273 Observational Pregnancy Outcome Study
Completed NCT04526769 - Detecting SARS-CoV-2 in Tears
Completed NCT04690413 - NOWDx Test for the Detection of Antibodies to COVID-19 N/A