Prevalence of Antibodies Against SARS-CoV-2 Virus That Causes COVID-19 in Tübingen Children (Coro-Buddy)

November 28, 2023 updated by: University Hospital Tuebingen

Prospective, Seroepidemiological, Non-invasive Cohort Study in Tübingen Children Age-stratified by Nursery and School Attendance

This is a prospective, longitudinal study to determine the incidence of SARS-COV-2 infection in children and adolescents by measuring specific antibodies in non-invasive saliva sampled in kindergartens and schools in a defined city area. The study includes an additional arm to validate the ELISA for anti-SARS-COV-2 reactive antibody measurements in saliva compared against blood collected in adult volunteers in a bimonthly follow-up period for 12 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The world is confronting Coronavirus Disease-2019 (COVID-19) pandemic caused by SARS-CoV-2 virus, which is causing many deaths and burden on intensive care facilities. Data regarding epidemiologic characteristics in children and young adults is limited, especially in the context of educational settings. Due to mild symptoms or even asymptomatic cases in children, the rate of SARS-CoV-2 infected children is underestimated. Therefore, the present study aims to determine the incidence of SARS-CoV-2 infection in children at 3 timepoints during 12 months expressed as seroconversion measured in non-invasive saliva sampling in Tübingen, a defined study area. Children and adolescents (N = 1850) in the age of 1 to 17 years will be recruited via child-care, kindergarten and primary and secondary schools and followed-up for 12 months: shortly after release of lock-down measures in summer 2020, before winter and after the winter. An adult cohort (adult comparator group) is sampled at the same time points for incidence comparisons. To validate the ELISA for SARS-CoV-2 antibody measurements in saliva compared to blood, and to understand the half-life of SARS-CoV-2 antibodies in respective body fluids, peripheral blood and in saliva will be sampled every 2 months in an additional adult group (adult validation group).

Study Type

Observational

Enrollment (Actual)

2380

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Deutschland
      • Tübingen, Deutschland, Germany, 72074
        • Institute of Tropical Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Group A: Kita cohort (any age, usually 1-3 years): N = 350 Group B: Kindergarten cohort (any age, usually 3-6 years): N = 350 Group C: Primary school cohort (any age, usually, 6-10 years): N = 350 Group D: Secondary school, young cohort (class 5-8, any age, usually 10 - 14 years): N =400 Group E: Secondary school, adolescent cohort (class 9-12, any age, usually 14 - 18 years): N = 400 Group F: Tübinger adults (> 18 years): N = 400 (adult comparator group)

Adults (n = 80). Specifically, 40 adult individuals who had a previous confirmed SARS-CoV-2 infection as well as 40 adults without previous SARS-CoV-2 infection at the start of the study.

Description

Inclusion Criteria:

  • Children from 1 months to 18 years
  • Written informed consent of the parent/legal guardian (study population is minor)
  • Written assent when children are ≥ 12 years
  • Enrolled in a kita, kindergarden, primary, or secondary school located in Tübingen

Adult population:

  • Individuals >18 years who recovered from a confirmed SARS-CoV-2 infection.
  • Or individuals > 18 years with an unknown status of previous SARS-CoV-2 infection

Exclusion Criteria:

  • Unwilling to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children
Children from1 to 18 years, enrolled in kindergartens, primary, or secondary school located in city of Tübingen, Germany.
Other: Diagnostic test
Presence of antibodies in saliva
Adult comparator
Adults of unknown status of previous SARSCoV-2 infection.
Adult validation
Adults who report a history of SARS-CoV-2 infections between 1. February 2020 and the time point of sampling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of SARS-CoV-2 infection in infants, children and adolescents
Time Frame: 12 months
Identification of children that have been infected over different periods of time (summer, before winter and after winter) based on saliva samples
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of SARS-CoV-2
Time Frame: 12 months
Change of incidence of SARS-CoV-2 infection in children during 2020/2021
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV-2 antibody persistence
Time Frame: 12 months
SARS-CoV-2 antibodies persistence in peripheral blood and saliva
12 months
Antibodies presence in saliva samples
Time Frame: 18 months
Saliva samples as alternative for the detection of antibodies against SARS-CoV-2
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Andrea Kreidenweiss, Dr., University Hospital Tübingen
  • Principal Investigator: Jana Held, Dr, University Hospital Tübingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2020

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

July 31, 2022

Study Registration Dates

First Submitted

October 7, 2020

First Submitted That Met QC Criteria

October 8, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Coro-Buddy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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