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

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ClinicalTrials.gov Identifier: NCT04581889
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Study Description
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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.

Condition or disease Intervention/treatment
Severe Acute Respiratory Syndrome Other: Diagnostic test

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 Design
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Study Type : Observational
Estimated Enrollment : 2380 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Seroepidemiological, Non-invasive Cohort Study in Tübingen Children Age-stratified by Nursery and School Attendance
Actual Study Start Date : July 2, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Children
Children from1 to 18 years, enrolled in kindergartens, primary, or secondary school located in city of Tübingen, Germany.
 Other: Diagnostic test
Presence of antibodies in saliva
Adult comparator
Adults of unknown status of previous SARSCoV-2 infection.
Adult validation
Adults who report a history of SARS-CoV-2 infections between 1. February 2020 and the time point of sampling.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Incidence of SARS-CoV-2 [ Time Frame: 12 months ]
    Change of incidence of SARS-CoV-2 infection in children during 2020/2021


Other Outcome Measures:
  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


Biospecimen Retention:   Samples Without DNA
Saliva, whole blood

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04581889


Contacts
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Contact: Yudi Tatiana Röckl-Pinilla, Dr. 01762844311 tatiana.roeckl-pinilla@uni-tuebingen.de
Contact: Andrea Kreidenweiss, Dr. +4907071 2985569 andrea.kreidenweiss@uni-tuebingen.de@uni-tuebingen.de

Locations
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Germany
Institute of Tropical Medicine Recruiting
Tübingen, Deutschland, Germany, 72074
Contact: Yudi Tatiana Röckl-Pinilla, Dr.    +49070712844311    tatiana.roeckl-pinilla@uni-tuebingen.de   
Contact: Andrea Kreidenweiss, Dr.    +4907071 2585569    andrea.kreidenweiss@uni-tuebingen.de   
Principal Investigator: Andrea Kreidenweiss, Dr.         
Principal Investigator: Jana Held, Dr.         
Principal Investigator: Rolf Fendel, Dr.         
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Andrea Kreidenweiss, Dr. University Hospital Tübingen
Principal Investigator: Jana Held, Dr University Hospital Tübingen
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT04581889    
Other Study ID Numbers: Coro-Buddy
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Tuebingen:
SARS-CoV-2
antibodies
saliva
children
epidemiology
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases