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

NCT04581889 | Completed

• 1 other identifier: Coro-Buddy
• Study Type: observational
• Target: 2,380
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Acute Respiratory Syndrome

Keywords

SARS-CoV-2; antibodies; saliva; children; epidemiology

Outcome Measures

Primary Outcomes (1)

• Incidence of SARS-CoV-2 infection in infants, children and adolescents

  Identification of children that have been infected over different periods of time (summer, before winter and after winter) based on saliva samples

  12 months

Secondary Outcomes (1)

• Incidence of SARS-CoV-2

  12 months

Other Outcomes (2)

• SARS-CoV-2 antibody persistence

  12 months

• Antibodies presence in saliva samples

  18 months

Study Arms (3)

Children

Children from1 to 18 years, enrolled in kindergartens, primary, or secondary school located in city of Tübingen, Germany.

Other: Diagnostic test

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.

Interventions

Diagnostic test OTHER

Presence of antibodies in saliva

Children

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Unwilling to give consent

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

Institute of Tropical Medicine

Tübingen, Deutschland, 72074, Germany

Location

Related Publications (9)

• Hong H, Wang Y, Chung HT, Chen CJ. Clinical characteristics of novel coronavirus disease 2019 (COVID-19) in newborns, infants and children. Pediatr Neonatol. 2020 Apr;61(2):131-132. doi: 10.1016/j.pedneo.2020.03.001. Epub 2020 Mar 10. No abstract available.

  PMID: 32199864 BACKGROUND

• Zimmermann P, Curtis N. COVID-19 in Children, Pregnancy and Neonates: A Review of Epidemiologic and Clinical Features. Pediatr Infect Dis J. 2020 Jun;39(6):469-477. doi: 10.1097/INF.0000000000002700.

  PMID: 32398569 BACKGROUND

• Bi Q, Wu Y, Mei S, Ye C, Zou X, Zhang Z, Liu X, Wei L, Truelove SA, Zhang T, Gao W, Cheng C, Tang X, Wu X, Wu Y, Sun B, Huang S, Sun Y, Zhang J, Ma T, Lessler J, Feng T. Epidemiology and transmission of COVID-19 in 391 cases and 1286 of their close contacts in Shenzhen, China: a retrospective cohort study. Lancet Infect Dis. 2020 Aug;20(8):911-919. doi: 10.1016/S1473-3099(20)30287-5. Epub 2020 Apr 27.

  PMID: 32353347 BACKGROUND

• Macartney K, Quinn HE, Pillsbury AJ, Koirala A, Deng L, Winkler N, Katelaris AL, O'Sullivan MVN, Dalton C, Wood N; NSW COVID-19 Schools Study Team. Transmission of SARS-CoV-2 in Australian educational settings: a prospective cohort study. Lancet Child Adolesc Health. 2020 Nov;4(11):807-816. doi: 10.1016/S2352-4642(20)30251-0. Epub 2020 Aug 3.

  PMID: 32758454 BACKGROUND

• Perera RA, Mok CK, Tsang OT, Lv H, Ko RL, Wu NC, Yuan M, Leung WS, Chan JM, Chik TS, Choi CY, Leung K, Chan KH, Chan KC, Li KC, Wu JT, Wilson IA, Monto AS, Poon LL, Peiris M. Serological assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), March 2020. Euro Surveill. 2020 Apr;25(16):2000421. doi: 10.2807/1560-7917.ES.2020.25.16.2000421.

  PMID: 32347204 BACKGROUND

• To KK, Tsang OT, Yip CC, Chan KH, Wu TC, Chan JM, Leung WS, Chik TS, Choi CY, Kandamby DH, Lung DC, Tam AR, Poon RW, Fung AY, Hung IF, Cheng VC, Chan JF, Yuen KY. Consistent Detection of 2019 Novel Coronavirus in Saliva. Clin Infect Dis. 2020 Jul 28;71(15):841-843. doi: 10.1093/cid/ciaa149.

  PMID: 32047895 BACKGROUND

• Azzi L, Carcano G, Gianfagna F, Grossi P, Gasperina DD, Genoni A, Fasano M, Sessa F, Tettamanti L, Carinci F, Maurino V, Rossi A, Tagliabue A, Baj A. Saliva is a reliable tool to detect SARS-CoV-2. J Infect. 2020 Jul;81(1):e45-e50. doi: 10.1016/j.jinf.2020.04.005. Epub 2020 Apr 14.

  PMID: 32298676 BACKGROUND

• Hettegger P, Huber J, Passecker K, Soldo R, Kegler U, Nohammer C, Weinhausel A. High similarity of IgG antibody profiles in blood and saliva opens opportunities for saliva based serology. PLoS One. 2019 Jun 20;14(6):e0218456. doi: 10.1371/journal.pone.0218456. eCollection 2019.

  PMID: 31220138 BACKGROUND

• Pinilla YT, Friessinger E, Griesbaum JM, Berner L, Heinzel C, Elsner K, Fendel R, Held J, Kreidenweiss A. Prevalence of SARS-CoV-2 Infection in Children by Antibody Detection in Saliva: Protocol for a Prospective Longitudinal Study (Coro-Buddy). JMIR Res Protoc. 2021 Oct 8;10(10):e27739. doi: 10.2196/27739.

  PMID: 34533472 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva, whole blood

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Andrea Kreidenweiss, Dr.

  University Hospital Tübingen

  PRINCIPAL INVESTIGATOR

• Jana Held, Dr

  University Hospital Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 9, 2020
• Study Start: July 2, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2022
• Last Updated: November 29, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)