Clinical trial NCT04581889: Prevalence of Antibodies Against SARS-CoV-2 Virus That Causes COVID-19 in Tübingen Children
Official title: Prospective, Seroepidemiological, Non-invasive Cohort Study in Tübingen Children Age-stratified by Nursery and School Attendance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Acute Respiratory Syndrome
Keywords: SARS-CoV-2
antibodies
saliva
children
epidemiology
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 2380
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of SARS-CoV-2 infection in infants, children and adolescents
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of SARS-CoV-2
timeFrame: 12 months
Other outcomes:
measure: SARS-CoV-2 antibody persistence
timeFrame: 12 months
measure: Antibodies presence in saliva samples
timeFrame: 18 months
Locations:
city: Tübingen
country: Germany
facility: Institute of Tropical Medicine
state: Deutschland
Study officials:
affiliation: University Hospital Tübingen
name: Andrea Kreidenweiss, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Tübingen
name: Jana Held, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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