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

ClinicalTrials.gov ID NCT04581889
Sponsor University Hospital Tuebingen
Information provided by University Hospital Tuebingen (Responsible Party)
Last Update Posted 2023-11-29
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Study Overview

Brief Summary
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.
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).
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Official Title
Prospective, Seroepidemiological, Non-invasive Cohort Study in Tübingen Children Age-stratified by Nursery and School Attendance
Conditions
Severe Acute Respiratory Syndrome
Intervention / Treatment
  • Other: Diagnostic test
  • Other: Diagnostic test
Other Study ID Numbers
  • Coro-Buddy
Study Start (Actual)
2020-07-02
Primary Completion (Actual)
2021-07-31
Study Completion (Actual)
2022-07-31
Enrollment (Actual)
2380
Study Type
Observational

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 1 location
Germany
Deutschland Locations
Tübingen, Deutschland, Germany, 72074

Institute of Tropical Medicine
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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.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
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
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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.

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Ages Eligible for Study
1 Year to 18 Years (ChildAdult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample

Study Plan

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

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Design Details
Observational Model : Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples Without DNA
Biospecimen Description: Saliva, whole blood

Groups and Interventions

Groups/Cohorts Intervention/Treatment
Groups/Cohorts Children
Children from1 to 18 years, enrolled in kindergartens, primary, or secondary school located in city of Tübingen, Germany.
Intervention/Treatment Other: Diagnostic test
  • Presence of antibodies in saliva

Groups/Cohorts Adult comparator
Adults of unknown status of previous SARSCoV-2 infection.
Intervention/Treatment
Groups/Cohorts Adult validation
Adults who report a history of SARS-CoV-2 infections between 1. February 2020 and the time point of sampling.
Intervention/Treatment
Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Incidence of SARS-CoV-2 infection in infants, children and adolescentsIdentification of children that have been infected over different periods of time (summer, before winter and after winter) based on saliva samples12 months
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Incidence of SARS-CoV-2Change of incidence of SARS-CoV-2 infection in children during 2020/202112 months
Other Outcome Measures
Outcome Measure Measure Description Time Frame
SARS-CoV-2 antibody persistenceSARS-CoV-2 antibodies persistence in peripheral blood and saliva12 months
Antibodies presence in saliva samplesSaliva samples as alternative for the detection of antibodies against SARS-CoV-218 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

General

These publications are provided voluntarily by the person who enters information about the study and may be about anything related to the study.

From PubMed

These publications come from PubMed, a public database of scientific and medical articles. This list is automatically created by ClinicalTrials.gov Identifier (NCT Number), and these articles may or may not be about the study.

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 Registration Dates
First Submitted
2020-10-07
First Submitted that Met QC Criteria
2020-10-08
First Posted
2020-10-09
Study Record Updates
Last Update Submitted that met QC Criteria
2023-11-28
Last Update Posted
2023-11-29
Last Verified
2022-06

More Information

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Keywords Provided by University Hospital Tuebingen
Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
No