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OpenTrials
Completed

NCT Number: NCT04581889

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

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.

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Tropical Medicine

Tübingen, Deutschland, 72074, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic Test

Other

Presence of antibodies in saliva

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of SARS-CoV-2

    Time frame: 12 months

    Change of incidence of SARS-CoV-2 infection in children during 2020/2021

Other outcomes

  1. SARS-CoV-2 antibody persistence

    Time frame: 12 months

    SARS-CoV-2 antibodies persistence in peripheral blood and saliva

  2. Antibodies presence in saliva samples

    Time frame: 18 months

    Saliva samples as alternative for the detection of antibodies against SARS-CoV-2

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Acronym: Coro-Buddy

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 9, 2020
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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