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

NCT ID: NCT04581889

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2380 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-02

Study Completion Date

2022-07-31

Brief Summary

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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

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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).

Conditions

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Severe Acute Respiratory Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children

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

Diagnostic test

Intervention Type OTHER

Presence of antibodies in saliva

Adult comparator

Adults of unknown status of previous SARSCoV-2 infection.

No interventions assigned to this group

Adult validation

Adults who report a history of SARS-CoV-2 infections between 1. February 2020 and the time point of sampling.

No interventions assigned to this group

Interventions

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Diagnostic test

Presence of antibodies in saliva

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea Kreidenweiss, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tübingen

Jana Held, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tübingen

Locations

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Institute of Tropical Medicine

Tübingen, Deutschland, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 32199864 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32398569 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32353347 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32758454 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32347204 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32047895 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32298676 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31220138 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34533472 (View on PubMed)

Other Identifiers

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Coro-Buddy

Identifier Type: -

Identifier Source: org_study_id