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

University Hospital Tuebingen

Status

Completed

Conditions

Severe Acute Respiratory Syndrome

Treatments

Other: Diagnostic test

Study type

Observational

Funder types

Other

Identifiers

NCT04581889

Coro-Buddy

Details and patient eligibility

About

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.

Full 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).

Enrollment

2,380 patients

Sex

All

Ages

1 to 18 years old

Volunteers

Accepts Healthy Volunteers

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