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SARS-CoV 2CiaoCoronaNCT04448717

COVID-19: Longitudinal Study of Seroprevalence of SARS-CoV-2 Antibodies and Development of Immunity in School Children

An observational study of SARS-CoV 2 and COVID-19, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 5 years and olderHealthy volunteers can take part
Conditions the study is for
SARS-CoV 2, COVID-19
What is being tested?
COVID-19 Antibody testing
How many people
4,250 participants
Where
1 siteSwitzerland
Study dates
16 Jun 2020to 20 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.
  • In case of confirmed SARS-CoV-2 infection: inclusion at the earliest 21 days from PCR-positive diagnosis after the onset of potential symptoms and no presence of symptoms for at least 48 hours (according to Standard of Care).
  • Informed consent of parents or legal guardians and children, or the adult participant.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich

    Zurich, 8001

Other trials in Switzerland

About this study

Official title: Seroprevalence of SARS-CoV-2 Antibodies and Development of Immunity in a Public School Population - a Population-based Observational Study to Inform Policy Making

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.

Read the detailed description

The role of children and adolescents in the transmission of SARS-CoV-2 remains highly unclear and has been a key question since the early days of the pandemic. It has important consequences for policy decisions, especially concerning the opening of the schools, sport facilities and intergenerational contacts. However, the information on true infection rate and seroprevalence of SARS-CoV-2 is not known in children in Switzerland (and globally), as testing was limited to risk groups and those with SARS-CoV-2 coronavirus disease 2019 (COVID-19) related symptoms. In addition, indications for testing were not uniform and handled heterogeneously. Hence, it is not known whether children are less frequently infected or simply less symptomatic.

This study builds up a system to monitor the seroprevalence of SARS-CoV-2 in children and adolescents who attend school in the canton of Zürich, Switzerland. The investigators aim to assess children of randomly selected primary and secondary schools during the first weeks of re-entering school from all districts of the canton of Zurich in June and July 2020, after the temporary closure due to COVID-19 pandemic, and again in October/November 2020, February/March 2021, November/December 2021, and again in the second half of 2022. The detailed time plan including possible further assessments will be defined depending on the evolution of the pandemic (e.g., 2023). A follow-up capturing health status, symptoms and behaviors over time is important, since it is currently under investigation whether persons may be at risk for reinfection. Thus, a longitudinal assessment is crucial to determine the extent and duration of immunity.

In addition, the seroprevalence of SARS-CoV-2 in the parents of the participating children will be tested in August/September 2020, to examine clusters of infections in households. Seroprevalence of SARS-CoV-2 in school personnel will be tested in August/September 2020 and subsequently in October/November 2020 and February/March 2021, to examine temporal changes in the seroprevalences in the whole school community. Further testing of adults is not planned.

In different subpopulations, further in-depth analysis of immunity markers will be performed in the future.

This study complements the ongoing coordinated efforts of seroprevalence studies in adults in Switzerland, through the Swiss School of Public Health (SSPH+) coordinated CORONA IMMUNITAS studies.

Conditions
SARS-CoV 2, COVID-19
Being tested
COVID-19 Antibody testing
Keywords
Seroprevalence, Seroepidemiology, School children, Switzerland, Schools, Households, Students
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COVID-19 Antibody testingDiagnostic test

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

Study groups in NCT04448717
Study groupRoleWhat they receive
Children and adolescentsChildren and adolescents in primary and secondary schools (aimed sample size: 2500)
Receives: Diagnostic Test: COVID-19 Antibody testing
ParentsParents of participating children (aimed sample size: 3000)
Receives: Diagnostic Test: COVID-19 Antibody testing
School personnelSchool personnel (teaching, administrative, maintenance, etc.) (aimed sample size: 2500)
Receives: Diagnostic Test: COVID-19 Antibody testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at inclusion

  2. 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.

    Measured: Month 4-5

  3. 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.

    Measured: Month 8-9

  4. 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.

    Measured: Month 17-18

  5. 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.

    Measured: Month 24-30

Secondary outcomes (16)
  1. Presence of self-reported symptoms

    Presence of symptoms (from January 2020) suggestive of a common cold, influenza and similar upper respiratory tract infections prior to the first study visit.

    Measured: at inclusion

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

    Proportion of seropositive children reporting symptoms suggestive of a common cold, influenza and similar upper respiratory tract infections between January 2020 and first study visit.

    Measured: at inclusion

  3. Presence of self-reported symptoms

    Presence of symptoms (from January 2020) suggestive of a common cold, influenza and similar upper respiratory tract infections during the follow-up.

    Measured: within 36 months of follow-up

  4. Incidence of symptoms in initially seropositive participants

    Incidence of self-reported symptoms and SARS-CoV-2 infections after the first study visit in initially seropositive participants.

    Measured: within 36 months of follow-up

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

    Proportion of seronegative participants of the first investigation wave who will self-report symptoms and infection with SARS-CoV-2.

    Measured: within 36 months of follow-up

  6. Presence of risk factors for infection at inclusion (assessment via custom questionnaire)

    Potential personal (socioeconomic characteristics, health status, presence of infection in family, personal hygiene and social distancing measures) and school-level (implementation of informational, social distancing and hygiene measures at school) risk and preventive factors for SARS-CoV-2 infection prior to the study. Questionnaire includes HBSC and custom questions.

    Measured: at inclusion

  7. Presence of risk factors for infection during follow-up (assessment via custom questionnaire)

    Potential personal (socioeconomic characteristics, health status, presence of infection in family, personal hygiene and social distancing measures) and school-level (implementation of informational, social distancing and hygiene measures at school) risk and preventive factors for SARS-CoV-2 infection during the follow-up. Questionnaire includes HBSC and custom questions.

    Measured: within 36 months of follow-up

  8. Self-reported lifestyle changes of participants at inclusion

    Changes in lifestyle during the lock-down, compared to prior to it: frequency and duration (in hours, daily) of physical activity, duration (in hours, daily) of sleep, duration of screen-based media-use (in hours, daily). This outcome is measured only in the children population.

    Measured: at inclusion

  9. Self-reported lifestyle changes of participants during follow-up

    Changes in lifestyle after the lock-down and school reopening, compared to during lock-down: frequency and duration (in hours, daily) of physical activity, duration (in hours, daily) of sleep, duration of screen-based media-use (in hours, daily). This outcome is measured only in the children population.

    Measured: within 36 months of follow-up

  10. Self-reported mental well-being (KINDL questionnaire)

    Changes over the study time in mental well-being of the participants during and after the lock-down: frequency scale (never/rarely/sometimes/often/always) of self-reported stress, anxiety, self-confidence feelings in the last 7 days. This outcome is measured only in the children population.

    Measured: within 36 months of follow-up

  11. Self-reported mental well-being (HBSC questionnaire)

    Changes over the study time in mental well-being of the participants during and after the lock-down: frequency scale (daily/weekly/monthly/rarer) of self-reported sadness, anxiety and sleeping problems (HBSC questionnaire question on mental well-being). This outcome is measured only in the children population.

    Measured: within 36 months of follow-up

  12. Self-reported quality of life (KINDL questionnaire)

    Changes over the study time in quality-of-life of the participants during and after the lock-down: frequency scale (never/rarely/sometimes/often/always) assessment of self-reported positive and negative social interactions with family, friends and in the school environment in the last 7 days. This outcome is measured only in the children population.

    Measured: within 36 months of follow-up

  13. Prevalence of seropositive SARS-Cov-2 clusters in schools at inclusion

    Prevalence of clusters of seropositive children, adolescents, and school personnel within schools and classes at baseline.

    Measured: at inclusion

  14. Incidence of seropositive SARS-Cov-2 clusters in schools during the follow-up

    Incidence of clusters of seropositive children, adolescents, and school personnel within schools and classes during the follow-up.

    Measured: within 36 months of follow-up

  15. Change in seropositive participants within school or class, depending on the initial proportion of seropositive participants

    Impact of the number of children/adolescents and school personnel at a specific period (baseline, at the second and third testing date) within a school or class to the subsequent seropositivity within the same group.

    Measured: within 36 months of follow-up

  16. Effect of risk factors and preventive measures on SARS-CoV-2 infection incidence within schools

    Incidence of seropositive children and school personnel according to potential risk factors and preventive measures for SARS-CoV-2 infection within schools.

    Measured: within 36 months of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2020
  2. Study start16 Jun 2020
  3. Primary completion20 Jul 2022
  4. Study completion20 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04448717
Sponsor's protocol ID
2020-01336
Acronym
CiaoCorona
Status last verified
Mar 2025
First submitted
18 Jun 2020
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Sensitive clinical data from vulnerable population (children) will be collected. Therefore, it is not yet decided, if it will be possible to share IPD while preserving participant autonomy and privacy.

Publications

  • 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.

    PubMed 33731327
  • 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.

    PubMed 34264266
  • 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.

    PubMed 35748765
  • 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.

    PubMed 36158782
  • 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.

    PubMed 34485200
  • 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.

    PubMed 33063141
  • 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.

    PubMed 37538234
  • 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.

    PubMed 38411717
  • 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.

    PubMed 36787493
  • 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.

    PubMed 34312201
  • 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.

    PubMed 33796490
  • 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.

    PubMed 38012137
  • 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.

    PubMed 41114667
  • 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.

    PubMed 39389623

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-CoV 2 and COVID-19, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies (time frame: at inclusion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04448717, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

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