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

Completed

• Conditions: Severe Acute Respiratory Syndrome
• Interventions: Other: Diagnostic test

• Registration Number: NCT04581889
• Lead Sponsor: University Hospital Tuebingen

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).

Study Timeline

• Study Start: 2020-07-02
• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-08
• Study First Posted: 2020-10-09
• Primary Completion: 2021-07-31
• Status Verified: 2022-06
• Study Completion: 2022-07-31
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2380

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children	Diagnostic test	Children from1 to 18 years, enrolled in kindergartens, primary, or secondary school located in city of Tübingen, Germany.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of SARS-CoV-2	12 months	Change of incidence of SARS-CoV-2 infection in children during 2020/2021

Trial Locations

Locations (1)

Institute of Tropical Medicine; 🇩🇪 Tübingen, Deutschland, Germany