<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04448717</url>
  </required_header>
  <id_info>
    <org_study_id>2020-01336</org_study_id>
    <nct_id>NCT04448717</nct_id>
  </id_info>
  <brief_title>COVID-19: Longitudinal Study of Seroprevalence of SARS-CoV-2 Antibodies and Development of Immunity in School Children</brief_title>
  <acronym>CiaoCorona</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swiss School of Public Health (SSPH+)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a lack of knowledge about how many children are infected with SARS-CoV-2, how often&#xD;
      they are asymptomatic, and how long the immunity persists.&#xD;
&#xD;
      The main purpose of this study is to measure antibodies to SARS-CoV-2, symptoms, and risk&#xD;
      factors in a representative cohort of children and adolescents in the canton of Zurich,&#xD;
      Switzerland, shortly after re-opening of the school system and thereafter. The study also&#xD;
      investigates antibodies to SARS-CoV-2 in parents of the children and school personnel.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The role of children and adolescents in the transmission of SARS-CoV-2 remains highly unclear&#xD;
      and has been a key question since the early days of the pandemic. It has important&#xD;
      consequences for policy decisions, especially concerning the opening of the schools, sport&#xD;
      facilities and intergenerational contacts. However, the information on true infection rate&#xD;
      and seroprevalence of SARS-CoV-2 is not known in children in Switzerland (and globally), as&#xD;
      testing was limited to risk groups and those with SARS-CoV-2 coronavirus disease 2019&#xD;
      (COVID-19) related symptoms. In addition, indications for testing were not uniform and&#xD;
      handled heterogeneously. Hence, it is not known whether children are less frequently infected&#xD;
      or simply less symptomatic.&#xD;
&#xD;
      This study builds up a system to monitor the seroprevalence of SARS-CoV-2 in children and&#xD;
      adolescents who attend school in the canton of Zürich, Switzerland. The investigators aim to&#xD;
      assess children of randomly selected primary and secondary schools during the first weeks of&#xD;
      re-entering school from all districts of the canton of Zurich in June and July 2020, after&#xD;
      the temporary closure due to COVID-19 pandemic, and again in October/November 2020,&#xD;
      February/March 2021, November/December 2021, and again in the second half of 2022. The&#xD;
      detailed time plan including possible further assessments will be defined depending on the&#xD;
      evolution of the pandemic (e.g., 2023). A follow-up capturing health status, symptoms and&#xD;
      behaviors over time is important, since it is currently under investigation whether persons&#xD;
      may be at risk for reinfection. Thus, a longitudinal assessment is crucial to determine the&#xD;
      extent and duration of immunity.&#xD;
&#xD;
      In addition, the seroprevalence of SARS-CoV-2 in the parents of the participating children&#xD;
      will be tested in August/September 2020, to examine clusters of infections in households.&#xD;
      Seroprevalence of SARS-CoV-2 in school personnel will be tested in August/September 2020 and&#xD;
      subsequently in October/November 2020 and February/March 2021, to examine temporal changes in&#xD;
      the seroprevalences in the whole school community. Further testing of adults is not planned.&#xD;
&#xD;
      In different subpopulations, further in-depth analysis of immunity markers will be performed&#xD;
      in the future.&#xD;
&#xD;
      This study complements the ongoing coordinated efforts of seroprevalence studies in adults in&#xD;
      Switzerland, through the Swiss School of Public Health (SSPH+) coordinated CORONA IMMUNITAS&#xD;
      studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies</measure>
    <time_frame>at inclusion</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies</measure>
    <time_frame>Month 4-5</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies</measure>
    <time_frame>Month 8-9</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroprevalence of SARS-CoV-2 IgG antibodies</measure>
    <time_frame>Month 17-18</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroprevalence of SARS-CoV-2 IgG antibodies</measure>
    <time_frame>Month 24-30</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of self-reported symptoms</measure>
    <time_frame>at inclusion</time_frame>
    <description>Presence of symptoms (from January 2020) suggestive of a common cold, influenza and similar upper respiratory tract infections prior to the first study visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of seropositive children reporting COVID-19 related symptoms from January 2020</measure>
    <time_frame>at inclusion</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of self-reported symptoms</measure>
    <time_frame>within 36 months of follow-up</time_frame>
    <description>Presence of symptoms (from January 2020) suggestive of a common cold, influenza and similar upper respiratory tract infections during the follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of symptoms in initially seropositive participants</measure>
    <time_frame>within 36 months of follow-up</time_frame>
    <description>Incidence of self-reported symptoms and SARS-CoV-2 infections after the first study visit in initially seropositive participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants, seronegative at inclusion, with symptoms in the follow-up</measure>
    <time_frame>within 36 months of follow-up</time_frame>
    <description>Proportion of seronegative participants of the first investigation wave who will self-report symptoms and infection with SARS-CoV-2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of risk factors for infection at inclusion (assessment via custom questionnaire)</measure>
    <time_frame>at inclusion</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of risk factors for infection during follow-up (assessment via custom questionnaire)</measure>
    <time_frame>within 36 months of follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported lifestyle changes of participants at inclusion</measure>
    <time_frame>at inclusion</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported lifestyle changes of participants during follow-up</measure>
    <time_frame>within 36 months of follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported mental well-being (KINDL questionnaire)</measure>
    <time_frame>within 36 months of follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported mental well-being (HBSC questionnaire)</measure>
    <time_frame>within 36 months of follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported quality of life (KINDL questionnaire)</measure>
    <time_frame>within 36 months of follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of seropositive SARS-Cov-2 clusters in schools at inclusion</measure>
    <time_frame>at inclusion</time_frame>
    <description>Prevalence of clusters of seropositive children, adolescents, and school personnel within schools and classes at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of seropositive SARS-Cov-2 clusters in schools during the follow-up</measure>
    <time_frame>within 36 months of follow-up</time_frame>
    <description>Incidence of clusters of seropositive children, adolescents, and school personnel within schools and classes during the follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in seropositive participants within school or class, depending on the initial proportion of seropositive participants</measure>
    <time_frame>within 36 months of follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of risk factors and preventive measures on SARS-CoV-2 infection incidence within schools</measure>
    <time_frame>within 36 months of follow-up</time_frame>
    <description>Incidence of seropositive children and school personnel according to potential risk factors and preventive measures for SARS-CoV-2 infection within schools.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Evolution of cellular immunity over time</measure>
    <time_frame>within 36 months of follow-up</time_frame>
    <description>Cellular immunity (T &amp; B cells) in a subsample of previously antibody positive and antibody negative (controls) children.</description>
  </other_outcome>
  <other_outcome>
    <measure>Long COVID</measure>
    <time_frame>within 36 months of follow-up</time_frame>
    <description>Self-reported symptoms compatible with Long COVID (i.e., &gt;3months) in seropositive versus seronegative children. Symptoms adapted from International Severe Acute Respiratory and emerging Infection Consortium (ISARIC).</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">8000</enrollment>
  <condition>SARS-CoV 2</condition>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Children and adolescents</arm_group_label>
    <description>Children and adolescents in primary and secondary schools (aimed sample size: 2500)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parents</arm_group_label>
    <description>Parents of participating children (aimed sample size: 3000)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>School personnel</arm_group_label>
    <description>School personnel (teaching, administrative, maintenance, etc.) (aimed sample size: 2500)</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>COVID-19 Antibody testing</intervention_name>
    <description>COVID-19 Antibody testing in venous blood and/or saliva samples.</description>
    <arm_group_label>Children and adolescents</arm_group_label>
    <arm_group_label>Parents</arm_group_label>
    <arm_group_label>School personnel</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Sputum and serum.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        School children, attending grades 1 to 9 in a public or private school in the Canton of&#xD;
        Zurich, Switzerland.&#xD;
&#xD;
        Parents of participating children. School personnel of participating schools.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any school child residing in Switzerland aged 5 years or older and attending a&#xD;
             consenting to participate public or private school that hosts classes of interest&#xD;
             (grade 1 through 9) in the canton of Zürich.&#xD;
&#xD;
          -  Parents of participating children.&#xD;
&#xD;
          -  Personnel employed in the participating schools.&#xD;
&#xD;
          -  No acute respiratory and SARS-CoV-2 infection:&#xD;
&#xD;
               -  In case of unknown respiratory infection, no presence of symptoms for at least 48&#xD;
                  hours.&#xD;
&#xD;
               -  In case of confirmed SARS-CoV-2 infection: inclusion at the earliest 21 days from&#xD;
                  PCR-positive diagnosis after the onset of potential symptoms and no presence of&#xD;
                  symptoms for at least 48 hours (according to Standard of Care).&#xD;
&#xD;
          -  Informed consent of parents or legal guardians and children, or the adult participant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No informed consent by schools or children, or the adult participant.&#xD;
&#xD;
          -  Schools with &lt;40 students in one of the sampled grades (1, 2, 4, 5, 7, or 8).&#xD;
&#xD;
          -  Children of Kindergarten age and younger.&#xD;
&#xD;
          -  Suspicion of acute COVID-19 infection.&#xD;
&#xD;
          -  Special need schools.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susi Kriemler, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Susi Kriemler, Prof.</last_name>
    <phone>+41 44 634 46 10</phone>
    <email>susi.kriemlerwiget@uzh.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8001</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Susi Kriemler, Dr.med.</last_name>
      <phone>+41 44 634 46 10</phone>
      <email>susi.kriemlerwiget@uzh.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>https://www.ciao-corona.ch/</url>
    <description>Study website with information for potential participants and media.</description>
  </link>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>December 9, 2021</last_update_submitted>
  <last_update_submitted_qc>December 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Zurich</investigator_affiliation>
    <investigator_full_name>Susi Kriemler</investigator_full_name>
    <investigator_title>Prof. Dr. med.</investigator_title>
  </responsible_party>
  <keyword>Seroprevalence</keyword>
  <keyword>Seroepidemiology</keyword>
  <keyword>School children</keyword>
  <keyword>Switzerland</keyword>
  <keyword>Schools</keyword>
  <keyword>Households</keyword>
  <keyword>Students</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04448717
org study id: 2020-01336
nct id: NCT04448717
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies
time frame: at inclusion
description: 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.
measure: Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies
time frame: Month 4-5
description: 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.
measure: Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies
time frame: Month 8-9
description: 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.
measure: Seroprevalence of SARS-CoV-2 IgG antibodies
time frame: Month 17-18
description: 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.
measure: Seroprevalence of SARS-CoV-2 IgG antibodies
time frame: Month 24-30
description: 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.
measure: Presence of self-reported symptoms
time frame: at inclusion
description: Presence of symptoms (from January 2020) suggestive of a common cold, influenza and similar upper respiratory tract infections prior to the first study visit.
measure: Proportion of seropositive children reporting COVID-19 related symptoms from January 2020
time frame: at inclusion
description: 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.
measure: Presence of self-reported symptoms
time frame: within 36 months of follow-up
description: Presence of symptoms (from January 2020) suggestive of a common cold, influenza and similar upper respiratory tract infections during the follow-up.
measure: Incidence of symptoms in initially seropositive participants
time frame: within 36 months of follow-up
description: Incidence of self-reported symptoms and SARS-CoV-2 infections after the first study visit in initially seropositive participants.
measure: Proportion of participants, seronegative at inclusion, with symptoms in the follow-up
time frame: within 36 months of follow-up
description: Proportion of seronegative participants of the first investigation wave who will self-report symptoms and infection with SARS-CoV-2.
measure: Presence of risk factors for infection at inclusion (assessment via custom questionnaire)
time frame: at inclusion
description: 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.
measure: Presence of risk factors for infection during follow-up (assessment via custom questionnaire)
time frame: within 36 months of follow-up
description: 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.
measure: Self-reported lifestyle changes of participants at inclusion
time frame: at inclusion
description: 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.
measure: Self-reported lifestyle changes of participants during follow-up
time frame: within 36 months of follow-up
description: 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.
measure: Self-reported mental well-being (KINDL questionnaire)
time frame: within 36 months of follow-up
description: 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.
measure: Self-reported mental well-being (HBSC questionnaire)
time frame: within 36 months of follow-up
description: 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.
measure: Self-reported quality of life (KINDL questionnaire)
time frame: within 36 months of follow-up
description: 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.
measure: Prevalence of seropositive SARS-Cov-2 clusters in schools at inclusion
time frame: at inclusion
description: Prevalence of clusters of seropositive children, adolescents, and school personnel within schools and classes at baseline.
measure: Incidence of seropositive SARS-Cov-2 clusters in schools during the follow-up
time frame: within 36 months of follow-up
description: Incidence of clusters of seropositive children, adolescents, and school personnel within schools and classes during the follow-up.
measure: Change in seropositive participants within school or class, depending on the initial proportion of seropositive participants
time frame: within 36 months of follow-up
description: 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.
measure: Effect of risk factors and preventive measures on SARS-CoV-2 infection incidence within schools
time frame: within 36 months of follow-up
description: Incidence of seropositive children and school personnel according to potential risk factors and preventive measures for SARS-CoV-2 infection within schools.
measure: Evolution of cellular immunity over time
time frame: within 36 months of follow-up
description: Cellular immunity (T & B cells) in a subsample of previously antibody positive and antibody negative (controls) children.
measure: Long COVID
time frame: within 36 months of follow-up
description: Self-reported symptoms compatible with Long COVID (i.e., >3months) in seropositive versus seronegative children. Symptoms adapted from International Severe Acute Respiratory and emerging Infection Consortium (ISARIC).
arm group label: Children and adolescents
description: Children and adolescents in primary and secondary schools (aimed sample size: 2500)
arm group label: Parents
description: Parents of participating children (aimed sample size: 3000)
arm group label: School personnel
description: School personnel (teaching, administrative, maintenance, etc.) (aimed sample size: 2500)
intervention type: Diagnostic Test
intervention name: COVID-19 Antibody testing
description: COVID-19 Antibody testing in venous blood and/or saliva samples.
arm group label: Children and adolescents
arm group label: Parents
arm group label: School personnel
Sputum and serum.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Susi Kriemler, Prof.
role: Principal Investigator
affiliation: University of Zurich
last name: Susi Kriemler, Prof.
phone: +41 44 634 46 10
email: susi.kriemlerwiget@uzh.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
url: https://www.ciao-corona.ch/
description: Study website with information for potential participants and media.
responsible party type: Principal Investigator
investigator affiliation: University of Zurich
investigator full name: Susi Kriemler
investigator title: Prof. Dr. med.
mesh term: COVID-19
mesh term: Antibodies
sharing ipd: Undecided
ipd 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.