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Longitudinal Study of Seroprevalence of SARS-CoV-2 Antibodies and Development of Immunity in School Children (CiaoCorona)

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ClinicalTrials.gov Identifier: NCT04448717
Recruitment Status : Recruiting
First Posted : June 26, 2020
Last Update Posted : July 21, 2020
Sponsor:
Collaborator:
Swiss School of Public Health (SSPH+)
Information provided by (Responsible Party):
Susi Kriemler, University of Zurich

Tracking Information
First Submitted Date June 18, 2020
First Posted Date June 26, 2020
Last Update Posted Date July 21, 2020
Actual Study Start Date June 16, 2020
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 17, 2020)
  • Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies [ Time Frame: at inclusion ]
    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.
  • Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies [ Time Frame: Month 4-5 ]
    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.
  • Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies [ Time Frame: Month 8-9 ]
    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.
Original Primary Outcome Measures
 (submitted: June 25, 2020)
  • Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies [ Time Frame: at inclusion ]
    Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies in randomly selected 5- to 16-year-old population of school-children after the peak phase of the first major wave shortly after re-opening of schools in the canton of Zürich, Switzerland.
  • Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies [ Time Frame: Month 4-5 ]
    Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies in randomly selected 5- to 16-year-old population of school-children after 4-5 after recruitement in the canton of Zürich, Switzerland.
  • Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies [ Time Frame: Month 8-9 ]
    Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies in randomly selected 5- to 16-year-old population of school-children after 8-9 months after recruitment in the canton of Zürich, Switzerland.
Change History
Current Secondary Outcome Measures
 (submitted: July 17, 2020)
  • Presence of self-reported symptoms [ Time Frame: at inclusion ]
    Presence of symptoms (from January 2020) suggestive of a common cold, influenza and similar upper respiratory tract infections prior to the first study visit.
  • Proportion of seropositive children reporting COVID-19 related symptoms from January 2020 [ Time Frame: at inclusion ]
    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.
  • Presence of self-reported symptoms [ Time Frame: within 9 months of follow-up ]
    Presence of symptoms (from January 2020) suggestive of a common cold, influenza and similar upper respiratory tract infections during the follow-up.
  • Incidence of symptoms in initially seropositive participants [ Time Frame: within 9 months of follow-up ]
    Incidence of self-reported symptoms and SARS-CoV-2 infections after the first study visit in initially seropositive participants.
  • Proportion of participants, seronegative at inclusion, with symptoms in the follow-up [ Time Frame: within 9 months of follow-up ]
    Proportion of seronegative participants of the first investigation wave who will self-report symptoms and infection with SARS-CoV-2.
  • Presence of risk factors for infection at inclusion (assessment via custom questionnaire) [ Time Frame: at inclusion ]
    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.
  • Presence of risk factors for infection during follow-up (assessment via custom questionnaire) [ Time Frame: within 9 months of follow-up ]
    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.
  • Self-reported lifestyle changes of participants at inclusion [ Time Frame: 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.
  • Self-reported lifestyle changes of participants during follow-up [ Time Frame: within 9 months of 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.
  • Self-reported mental well-being (KINDL questionnaire) [ Time Frame: within 9 months of follow-up ]
    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.
  • Self-reported mental well-being (HBSC questionnaire) [ Time Frame: within 9 months of follow-up ]
    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.
  • Self-reported quality of life (KINDL questionnaire) [ Time Frame: within 9 months of follow-up ]
    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.
  • Prevalence of seropositive SARS-Cov-2 clusters in schools at inclusion [ Time Frame: at inclusion ]
    Prevalence of clusters of seropositive children, adolescents, and school personnel within schools and classes at baseline.
  • Incidence of seropositive SARS-Cov-2 clusters in schools during the follow-up [ Time Frame: within 9 months of follow-up ]
    Incidence of clusters of seropositive children, adolescents, and school personnel within schools and classes during the follow-up.
  • Change in seropositive participants within school or class, depending on the initial proportion of seropositive participants [ Time Frame: within 9 months of follow-up ]
    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.
  • Effect of risk factors and preventive measures on SARS-CoV-2 infection incidence within schools [ Time Frame: within 9 months of follow-up ]
    Incidence of seropositive children and school personnel according to potential risk factors and preventive measures for SARS-CoV-2 infection within schools.
Original Secondary Outcome Measures
 (submitted: June 25, 2020)
  • Presence of self-reported symptoms [ Time Frame: at inclusion ]
    Presence of symptoms (from January 2020) suggestive of a common cold, influenza and similar upper respiratory tract infections prior to the first study visit.
  • Proportion of seropositive children reporting COVID-19 related symptoms from January 2020 [ Time Frame: at inclusion ]
    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.
  • Presence of self-reported symptoms [ Time Frame: within 9 months of follow-up ]
    Presence of symptoms (from January 2020) suggestive of a common cold, influenza and similar upper respiratory tract infections during the follow-up.
  • Incidence of symptoms in initially seropositive participants [ Time Frame: within 9 months of follow-up ]
    Incidence of self-reported symptoms and SARS-CoV-2 infections after the first study visit in initially seropositive participants.
  • Proportion of participants, seronegative at inclusion, with symptoms in the follow-up [ Time Frame: within 9 months of follow-up ]
    Proportion of seronegative participants of the first investigation wave who will self-report symptoms and infection with SARS-CoV-2.
  • Presence of risk factors for infection at inclusion (assessment via custom questionnaire) [ Time Frame: at inclusion ]
    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.
  • Presence of risk factors for infection during follow-up (assessment via custom questionnaire) [ Time Frame: within 9 months of follow-up ]
    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.
  • Self-reported lifestyle changes of participants at inclusion [ Time Frame: 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).
  • Self-reported lifestyle changes of participants during follow-up [ Time Frame: within 9 months of 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).
  • Self-reported mental well-being (KINDL questionnaire) [ Time Frame: within 9 months of follow-up ]
    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.
  • Self-reported mental well-being (HBSC questionnaire) [ Time Frame: within 9 months of follow-up ]
    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).
  • Self-reported quality of life (KINDL questionnaire) [ Time Frame: within 9 months of follow-up ]
    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.
  • Prevalence of seropositive SARS-Cov-2 clusters in schools at inclusion [ Time Frame: at inclusion ]
    Prevalence of clusters of seropositive children and adolescents within schools and classes at baseline.
  • Incidence of seropositive SARS-Cov-2 clusters in schools during the follow-up [ Time Frame: within 9 months of follow-up ]
    Incidence of clusters of seropositive children and adolescents within schools and classes during the follow-up.
  • Change in seropositive participants within school or class, depending on the initial proportion of seropositive participants [ Time Frame: within 9 months of follow-up ]
    Impact of the number of children/adolescents 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.
  • Effect of risk factors and preventive measures on SARS-CoV-2 infection incidence within schools [ Time Frame: within 9 months of follow-up ]
    Incidence of seropositive children according to potential risk factors and preventive measures for SARS-CoV-2 infection within schools.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Longitudinal Study of Seroprevalence of SARS-CoV-2 Antibodies and Development of Immunity in School Children
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
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.

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 and February/March 2021. 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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Sputum and serum.
Sampling Method Probability 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.

Condition
  • SARS-CoV 2
  • COVID-19
Intervention Diagnostic Test: COVID-19 Antibody testing
COVID-19 Antibody testing in venous blood and/or saliva samples.
Study Groups/Cohorts
  • Children and adolescents
    Children and adolescents in primary and secondary schools (aimed sample size: 2500)
    Intervention: Diagnostic Test: COVID-19 Antibody testing
  • Parents
    Parents of participating children (aimed sample size: 3000)
    Intervention: Diagnostic Test: COVID-19 Antibody testing
  • School personnel
    School personnel (teaching, administrative, maintenance, etc.) (aimed sample size: 2500)
    Intervention: Diagnostic Test: COVID-19 Antibody testing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 17, 2020)
8000
Original Estimated Enrollment
 (submitted: June 25, 2020)
2500
Estimated Study Completion Date March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Susi Kriemler, Prof. +41 44 634 46 10 susi.kriemlerwiget@uzh.ch
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04448717
Other Study ID Numbers 2020-01336
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: 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.
Responsible Party Susi Kriemler, University of Zurich
Study Sponsor University of Zurich
Collaborators Swiss School of Public Health (SSPH+)
Investigators
Principal Investigator: Susi Kriemler, Prof. University of Zurich
PRS Account University of Zurich
Verification Date July 2020