NCT04448717

Brief Summary

There is a lack of knowledge about how many children are infected with SARS-CoV-2, how often they are asymptomatic, and how long the immunity persists. The main purpose of this study is to measure antibodies to SARS-CoV-2, symptoms, and risk factors in a representative cohort of children and adolescents in the canton of Zurich, Switzerland, shortly after re-opening of the school system and thereafter. The study also investigates antibodies to SARS-CoV-2 in parents of the children and school personnel.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 26, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2022

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

2.1 years

First QC Date

June 18, 2020

Last Update Submit

March 31, 2025

Conditions

Keywords

SeroprevalenceSeroepidemiologySchool childrenSwitzerlandSchoolsHouseholdsStudents

Outcome Measures

Primary Outcomes (5)

  • Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies

    Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies in randomly selected 5- to 16-year-old population of school-children, their parents, and school personnel, after the peak phase of the first major wave shortly after re-opening of schools in the canton of Zürich, Switzerland.

    at inclusion

  • Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies

    Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies in randomly selected 5- to 16-year-old population of school-children and school personnel after 4-5 after recruitement in the canton of Zürich, Switzerland.

    Month 4-5

  • Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies

    Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies in randomly selected 5- to 16-year-old population of school-children and school personnel after 8-9 months after recruitment in the canton of Zürich, Switzerland.

    Month 8-9

  • Seroprevalence of SARS-CoV-2 IgG antibodies

    Seroprevalence of SARS-CoV-2 IgG antibodies in randomly selected 5- to 16-year-old population of school-children and school personnel after 17-18 months after recruitment in the canton of Zürich, Switzerland.

    Month 17-18

  • Seroprevalence of SARS-CoV-2 IgG antibodies

    Seroprevalence of SARS-CoV-2 IgG antibodies in randomly selected 5- to 16-year-old population of school-children and school personnel after 24-30 months after recruitment in the canton of Zürich, Switzerland.

    Month 24-30

Secondary Outcomes (16)

  • Presence of self-reported symptoms

    at inclusion

  • Proportion of seropositive children reporting COVID-19 related symptoms from January 2020

    at inclusion

  • Presence of self-reported symptoms

    within 36 months of follow-up

  • Incidence of symptoms in initially seropositive participants

    within 36 months of follow-up

  • Proportion of participants, seronegative at inclusion, with symptoms in the follow-up

    within 36 months of follow-up

  • +11 more secondary outcomes

Other Outcomes (2)

  • Evolution of cellular immunity over time

    within 36 months of follow-up

  • Long COVID

    within 36 months of follow-up

Study Arms (3)

Children and adolescents

Children and adolescents in primary and secondary schools (aimed sample size: 2500)

Diagnostic Test: COVID-19 Antibody testing

Parents

Parents of participating children (aimed sample size: 3000)

Diagnostic Test: COVID-19 Antibody testing

School personnel

School personnel (teaching, administrative, maintenance, etc.) (aimed sample size: 2500)

Diagnostic Test: COVID-19 Antibody testing

Interventions

COVID-19 Antibody testing in venous blood and/or saliva samples.

Children and adolescentsParentsSchool personnel

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

School children, attending grades 1 to 9 in a public or private school in the Canton of Zurich, Switzerland. Parents of participating children. School personnel of participating schools.

You may qualify if:

  • Any school child residing in Switzerland aged 5 years or older and attending a consenting to participate public or private school that hosts classes of interest (grade 1 through 9) in the canton of Zürich.
  • Parents of participating children.
  • Personnel employed in the participating schools.
  • No acute respiratory and SARS-CoV-2 infection:
  • In case of unknown respiratory infection, no presence of symptoms for at least 48 hours.
  • Informed consent of parents or legal guardians and children, or the adult participant.

You may not qualify if:

  • No informed consent by schools or children, or the adult participant.
  • Schools with \<40 students in one of the sampled grades (1, 2, 4, 5, 7, or 8).
  • Children of Kindergarten age and younger.
  • Suspicion of acute COVID-19 infection.
  • Special need schools.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich

Zurich, 8001, Switzerland

Location

Related Publications (14)

  • Ulyte A, Radtke T, Abela IA, Haile SR, Berger C, Huber M, Schanz M, Schwarzmueller M, Trkola A, Fehr J, Puhan MA, Kriemler S. Clustering and longitudinal change in SARS-CoV-2 seroprevalence in school children in the canton of Zurich, Switzerland: prospective cohort study of 55 schools. BMJ. 2021 Mar 17;372:n616. doi: 10.1136/bmj.n616.

    PMID: 33731327BACKGROUND
  • Radtke T, Ulyte A, Puhan MA, Kriemler S. Long-term Symptoms After SARS-CoV-2 Infection in Children and Adolescents. JAMA. 2021 Jul 15;326(9):869-71. doi: 10.1001/jama.2021.11880. Online ahead of print.

    PMID: 34264266BACKGROUND
  • Ammann P, Ulyte A, Haile SR, Puhan MA, Kriemler S, Radtke T. Perceptions towards mask use in school children during the SARS-CoV-2 pandemic: descriptive results from the longitudinal Ciao Corona cohort study. Swiss Med Wkly. 2022 Apr 20;152:w30165. doi: 10.4414/smw.2022.w30165. eCollection 2022 Apr 11.

    PMID: 35748765BACKGROUND
  • Peralta GP, Camerini AL, Haile SR, Kahlert CR, Lorthe E, Marciano L, Nussbaumer A, Radtke T, Ulyte A, Puhan MA, Kriemler S. Lifestyle Behaviours of Children and Adolescents During the First Two Waves of the COVID-19 Pandemic in Switzerland and Their Relation to Well-Being: An Observational Study. Int J Public Health. 2022 Sep 8;67:1604978. doi: 10.3389/ijph.2022.1604978. eCollection 2022.

    PMID: 36158782BACKGROUND
  • Blankenberger J, Haile SR, Puhan MA, Berger C, Radtke T, Kriemler S, Ulyte A. Prediction of Past SARS-CoV-2 Infections: A Prospective Cohort Study Among Swiss Schoolchildren. Front Pediatr. 2021 Aug 16;9:710785. doi: 10.3389/fped.2021.710785. eCollection 2021.

    PMID: 34485200BACKGROUND
  • Ulyte A, Radtke T, Abela IA, Haile SR, Braun J, Jung R, Berger C, Trkola A, Fehr J, Puhan MA, Kriemler S. Seroprevalence and immunity of SARS-CoV-2 infection in children and adolescents in schools in Switzerland: design for a longitudinal, school-based prospective cohort study. Int J Public Health. 2020 Dec;65(9):1549-1557. doi: 10.1007/s00038-020-01495-z. Epub 2020 Oct 15.

    PMID: 33063141BACKGROUND
  • Haile SR, Gunz S, Peralta GP, Ulyte A, Raineri A, Rueegg S, Yasenok V, Radtke T, Puhan MA, Kriemler S. Health-Related Quality of Life and Adherence to Physical Activity and Screen Time Recommendations in Schoolchildren: Longitudinal Cohort Ciao Corona. Int J Public Health. 2023 Jul 19;68:1606033. doi: 10.3389/ijph.2023.1606033. eCollection 2023.

    PMID: 37538234BACKGROUND
  • Haile SR, Peralta GP, Raineri A, Rueegg S, Ulyte A, Puhan MA, Radtke T, Kriemler S. Determinants of health-related quality of life in healthy children and adolescents during the COVID-19 pandemic: Results from a prospective longitudinal cohort study. Eur J Pediatr. 2024 May;183(5):2273-2283. doi: 10.1007/s00431-024-05459-w. Epub 2024 Feb 27.

    PMID: 38411717BACKGROUND
  • Haile SR, Raineri A, Rueegg S, Radtke T, Ulyte A, Puhan MA, Kriemler S. Heterogeneous evolution of SARS-CoV-2 seroprevalence in school-age children: Results from the school-based cohort study Ciao Corona in November-December 2021 in the canton of Zurich. Swiss Med Wkly. 2023 Jan 30;153:40035. doi: 10.57187/smw.2023.40035.

    PMID: 36787493BACKGROUND
  • Ulyte A, Radtke T, Abela IA, Haile SR, Blankenberger J, Jung R, Capelli C, Berger C, Frei A, Huber M, Schanz M, Schwarzmueller M, Trkola A, Fehr J, Puhan MA, Kriemler S. Variation in SARS-CoV-2 seroprevalence across districts, schools and classes: baseline measurements from a cohort of primary and secondary school children in Switzerland. BMJ Open. 2021 Jul 26;11(7):e047483. doi: 10.1136/bmjopen-2020-047483.

    PMID: 34312201BACKGROUND
  • Kriemler S, Ulyte A, Ammann P, Peralta GP, Berger C, Puhan MA, Radtke T. Surveillance of Acute SARS-CoV-2 Infections in School Children and Point-Prevalence During a Time of High Community Transmission in Switzerland. Front Pediatr. 2021 Mar 16;9:645577. doi: 10.3389/fped.2021.645577. eCollection 2021.

    PMID: 33796490BACKGROUND
  • Raineri A, Radtke T, Rueegg S, Haile SR, Menges D, Ballouz T, Ulyte A, Fehr J, Cornejo DL, Pantaleo G, Pellaton C, Fenwick C, Puhan MA, Kriemler S. Persistent humoral immune response in youth throughout the COVID-19 pandemic: prospective school-based cohort study. Nat Commun. 2023 Nov 27;14(1):7764. doi: 10.1038/s41467-023-43330-y.

  • Raineri A, Rueegg S, Zimmermann P, Regamey N, Benden C, Haile SR, Ulyte A, Puhan MA, Kriemler S, Radtke T. Long COVID in children and adolescents: results from three cross-sectional school-based cohorts with adjudication. Swiss Med Wkly. 2025 Oct 20;155:4337. doi: 10.57187/s.4337.

  • Haile SR, Peralta GP, Adams M, Bharadwaj AN, Bassler D, Moeller A, Natalucci G, Radtke T, Kriemler S. Health-related quality of life in children and adolescents born very preterm and its correlates: a cross-sectional study. BMJ Paediatr Open. 2024 Oct 10;8(1):e002885. doi: 10.1136/bmjpo-2024-002885.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum and serum.

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Serological Testing

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 TestingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSerologic TestsImmunologic TestsInvestigative TechniquesImmunologic Techniques

Study Officials

  • Susi Kriemler, Prof.

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

June 18, 2020

First Posted

June 26, 2020

Study Start

June 16, 2020

Primary Completion

July 20, 2022

Study Completion

July 20, 2022

Last Updated

April 3, 2025

Record last verified: 2025-03

Locations