<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/NCT04449978</url>
  </required_header>
  <id_info>
    <org_study_id>1000069701</org_study_id>
    <nct_id>NCT04449978</nct_id>
  </id_info>
  <brief_title>TARGet Kids! COVID-19 Study of Children and Families</brief_title>
  <official_title>TARGet Kids! COVID-19 Study of Children and Families</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hospital for Sick Children</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>
      The novel coronavirus (COVID-19) was declared a global pandemic in March 2020. Early research&#xD;
      suggests that children are no more susceptible to COVID-19 infection than adults and that&#xD;
      children with confirmed COVID-19 have generally presented with milder symptoms. However, the&#xD;
      impact of COVID-19 among Canadian children remains unclear. The prevalence of COVID-19 in&#xD;
      children in Canada is currently unknown and no published research exists regarding the risk&#xD;
      factors of COVID-19 in children or its potential long-term health effects on physical health&#xD;
      or development. Using TARGet Kids!, Canada's largest children's cohort study with over 11,000&#xD;
      children involved, the researchers will conduct a longitudinal observational study aimed to&#xD;
      evaluate the cumulative incidence of COVID-19 in children and parents; differences among&#xD;
      infected and uninfected children in terms of age, sex, and income; risk factors of COVID-19;&#xD;
      and longer term health effects of COVID-19 among children. Given the rapid spread of COVID-19&#xD;
      and the unknown health effects of the virus in children, research must be conducted to&#xD;
      determine the extent of infections of COVID-19 in children, disease severity, risk factors&#xD;
      for infection, and how the virus affects children as they become older.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The novel coronavirus (COVID-19) was declared a global pandemic in March 2020. Early research&#xD;
      has suggested that children may experience less severe clinical symptoms than adults, and&#xD;
      infected children with minimal or no symptoms may be an underrecognized source of community&#xD;
      disease transmission. COVID-19 infections in children were occurring very early in the&#xD;
      epidemic but the impact of COVID-19 infection among children remains unclear. The number of&#xD;
      COVID-19 infections in children and parents in Canada is unknown and studies have not&#xD;
      evaluated the symptom severity of COVID-19 in children and parents, risk factors for&#xD;
      infection and severe disease, and whether current preventive efforts are effective. Using&#xD;
      TARGet Kids!, Canada's largest children's cohort study, the researchers will conduct an&#xD;
      observational study to evaluate key epidemiological characteristics of COVID-19 among parents&#xD;
      and children, as well as to determine the spectrum of disease severity, seroprevalence, risk&#xD;
      factors for COVID-19 infection and severe disease, effectiveness of social isolation&#xD;
      recommendations, risk to family members with a COVID-19 infected family member, and potential&#xD;
      new strategies to prevent COVID-19 infection and minimize disease severity. Parents of 1082&#xD;
      existing TARGet Kids! participants will be asked to provide a nasal swab from themselves and&#xD;
      their child during the pandemic in addition to a respiratory tract symptom checklist.&#xD;
      Preventive efforts (e.g. social distancing), parent-reported illness, laboratory-confirmed&#xD;
      infections and healthcare encounters (e.g. emergency department visits, hospitalizations and&#xD;
      ICU care) will be measured. Children will subsequently be followed through the TARGet Kids!&#xD;
      cohort study over the next 6 months and long term, with interim analyses at 3 months. By&#xD;
      understanding every stage of COVID-19 infection from prevention to transmission in the&#xD;
      community and home, to outpatient and hospital care utilization, the researchers will rapidly&#xD;
      develop new interventions to prevent COVID-19 transmission and minimize disease severity&#xD;
      among children and their families. Descriptive statistics will be used to determine the&#xD;
      prevalence of COVID-19 in healthy children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 9, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</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>Cumulative Incidence of COVID-19</measure>
    <time_frame>12 months</time_frame>
    <description>To evaluate the cumulative incidence of laboratory-confirmed COVID-19 among healthy children and parents in Toronto, Canada</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk Factors for COVID-19</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the risk factors for COVID-19 infection in children and parents to inform preventive interventions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent-reported probable case definition of COVID-19</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the cumulative incidence of parent-reported probable case definition of COVID-19 among children and parents.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamics of COVID-19</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the dynamics of COVID-19 infection using a susceptible-infected-recovered (SIR) multi-state model.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk to family members</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the risk to family members with a laboratory-confirmed COVID-19 infected family member.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of COVID-19</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the severity of laboratory-confirmed COVID-19 in healthy children and parents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Longer term effects of COVID-19 on physical health</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the longer term effects of COVID-19 infection in healthy children and parents on physical health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Longer term effects of COVID-19 on mental health</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the longer term effects of COVID-19 infection in healthy children and parents on mental health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Longer term effects of COVID-19 on child development</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the longer term effects of COVID-19 infection in healthy children and parents on child development</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Longer term effects of COVID-19 on family functioning</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the longer term effects of COVID-19 infection in healthy children and parents on family functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Longer term effects of COVID-19 on health behaviours</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the longer term effects of COVID-19 infection in healthy children and parents on health behaviours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Longer term effects of COVID-19 on healthcare utilization</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the longer term effects of COVID-19 infection in healthy children and parents on healthcare utilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of preventive measures on infection</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the effect of preventive measures on COVID-19 infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of preventive measures on physical health</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the effect of preventive measures on physical health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of preventive measures on mental health</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the effect of preventive measures on mental health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of preventive measures on child development</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the effect of preventive measures on child development</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of preventive measures on family functioning</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the effect of preventive measures on family functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of preventive measures on health behaviours</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the effect of preventive measures on health behaviours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of preventive measures on healthcare utilization</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the effect of preventive measures on healthcare utilization</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1082</enrollment>
  <condition>Coronavirus</condition>
  <condition>COVID-19</condition>
  <condition>Virus</condition>
  <condition>Family and Household</condition>
  <condition>Infection Viral</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Nasal swab samples, dried blood spots&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This study will be a prospective longitudinal observational study embedded within the&#xD;
        TARGet Kids! cohort study, an ongoing longitudinal observational study enrolling healthy&#xD;
        age 0-5 years who receive primary healthcare and following them until adolescence and early&#xD;
        adulthood.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Families with existing participants of the TARGet Kids! cohort with children between&#xD;
             the ages of 0-16 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Families who are not participating in the TARGet Kids! cohort or participating&#xD;
             families with no children within the age of eligibility.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine S Birken, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dalah C Mason, MPH</last_name>
    <phone>416-813-7654</phone>
    <phone_ext>302129</phone_ext>
    <email>dalah.mason@sickkids.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Natricha Levy McFarlane, MPhil</last_name>
    <phone>416-813-7654</phone>
    <phone_ext>309441</phone_ext>
    <email>natricha.levymcfarlane@sickkids.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jonathon Maguire, MD</last_name>
      <phone>416-813-7654</phone>
      <phone_ext>309441</phone_ext>
      <email>jonathon.maguire@utoronto.ca</email>
    </contact>
    <investigator>
      <last_name>Jonathon Maguire, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dalah Mason, MPH</last_name>
      <phone>416-813-7654</phone>
      <phone_ext>302129</phone_ext>
      <email>dalah.mason@sickkids.ca</email>
    </contact>
    <contact_backup>
      <last_name>Natricha Levy McFarlane, MPhil</last_name>
      <phone>416-813-7654</phone>
      <phone_ext>309441</phone_ext>
      <email>natricha.levymcfarlane@sickkids.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Catherine S Birken, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>Catherine Birken</investigator_full_name>
    <investigator_title>Senior Scientist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is not a plan to make IPD available.</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/NCT04449978
org study id: 1000069701
nct id: NCT04449978
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The novel coronavirus (COVID-19) was declared a global pandemic in March 2020. Early research
      suggests that children are no more susceptible to COVID-19 infection than adults and that
      children with confirmed COVID-19 have generally presented with milder symptoms. However, the
      impact of COVID-19 among Canadian children remains unclear. The prevalence of COVID-19 in
      children in Canada is currently unknown and no published research exists regarding the risk
      factors of COVID-19 in children or its potential long-term health effects on physical health
      or development. Using TARGet Kids!, Canada's largest children's cohort study with over 11,000
      children involved, the researchers will conduct a longitudinal observational study aimed to
      evaluate the cumulative incidence of COVID-19 in children and parents; differences among
      infected and uninfected children in terms of age, sex, and income; risk factors of COVID-19;
      and longer term health effects of COVID-19 among children. Given the rapid spread of COVID-19
      and the unknown health effects of the virus in children, research must be conducted to
      determine the extent of infections of COVID-19 in children, disease severity, risk factors
      for infection, and how the virus affects children as they become older.
The novel coronavirus (COVID-19) was declared a global pandemic in March 2020. Early research
      has suggested that children may experience less severe clinical symptoms than adults, and
      infected children with minimal or no symptoms may be an underrecognized source of community
      disease transmission. COVID-19 infections in children were occurring very early in the
      epidemic but the impact of COVID-19 infection among children remains unclear. The number of
      COVID-19 infections in children and parents in Canada is unknown and studies have not
      evaluated the symptom severity of COVID-19 in children and parents, risk factors for
      infection and severe disease, and whether current preventive efforts are effective. Using
      TARGet Kids!, Canada's largest children's cohort study, the researchers will conduct an
      observational study to evaluate key epidemiological characteristics of COVID-19 among parents
      and children, as well as to determine the spectrum of disease severity, seroprevalence, risk
      factors for COVID-19 infection and severe disease, effectiveness of social isolation
      recommendations, risk to family members with a COVID-19 infected family member, and potential
      new strategies to prevent COVID-19 infection and minimize disease severity. Parents of 1082
      existing TARGet Kids! participants will be asked to provide a nasal swab from themselves and
      their child during the pandemic in addition to a respiratory tract symptom checklist.
      Preventive efforts (e.g. social distancing), parent-reported illness, laboratory-confirmed
      infections and healthcare encounters (e.g. emergency department visits, hospitalizations and
      ICU care) will be measured. Children will subsequently be followed through the TARGet Kids!
      cohort study over the next 6 months and long term, with interim analyses at 3 months. By
      understanding every stage of COVID-19 infection from prevention to transmission in the
      community and home, to outpatient and hospital care utilization, the researchers will rapidly
      develop new interventions to prevent COVID-19 transmission and minimize disease severity
      among children and their families. Descriptive statistics will be used to determine the
      prevalence of COVID-19 in healthy children.
observational model: Cohort
time perspective: Prospective
measure: Cumulative Incidence of COVID-19
time frame: 12 months
description: To evaluate the cumulative incidence of laboratory-confirmed COVID-19 among healthy children and parents in Toronto, Canada
measure: Risk Factors for COVID-19
time frame: 12 months
description: To determine the risk factors for COVID-19 infection in children and parents to inform preventive interventions
measure: Parent-reported probable case definition of COVID-19
time frame: 12 months
description: To determine the cumulative incidence of parent-reported probable case definition of COVID-19 among children and parents.
measure: Dynamics of COVID-19
time frame: 12 months
description: To determine the dynamics of COVID-19 infection using a susceptible-infected-recovered (SIR) multi-state model.
measure: Risk to family members
time frame: 12 months
description: To determine the risk to family members with a laboratory-confirmed COVID-19 infected family member.
measure: Severity of COVID-19
time frame: 12 months
description: To determine the severity of laboratory-confirmed COVID-19 in healthy children and parents
measure: Longer term effects of COVID-19 on physical health
time frame: 12 months
description: To determine the longer term effects of COVID-19 infection in healthy children and parents on physical health
measure: Longer term effects of COVID-19 on mental health
time frame: 12 months
description: To determine the longer term effects of COVID-19 infection in healthy children and parents on mental health
measure: Longer term effects of COVID-19 on child development
time frame: 12 months
description: To determine the longer term effects of COVID-19 infection in healthy children and parents on child development
measure: Longer term effects of COVID-19 on family functioning
time frame: 12 months
description: To determine the longer term effects of COVID-19 infection in healthy children and parents on family functioning
measure: Longer term effects of COVID-19 on health behaviours
time frame: 12 months
description: To determine the longer term effects of COVID-19 infection in healthy children and parents on health behaviours
measure: Longer term effects of COVID-19 on healthcare utilization
time frame: 12 months
description: To determine the longer term effects of COVID-19 infection in healthy children and parents on healthcare utilization
measure: Effects of preventive measures on infection
time frame: 12 months
description: To determine the effect of preventive measures on COVID-19 infection
measure: Effects of preventive measures on physical health
time frame: 12 months
description: To determine the effect of preventive measures on physical health
measure: Effects of preventive measures on mental health
time frame: 12 months
description: To determine the effect of preventive measures on mental health
measure: Effects of preventive measures on child development
time frame: 12 months
description: To determine the effect of preventive measures on child development
measure: Effects of preventive measures on family functioning
time frame: 12 months
description: To determine the effect of preventive measures on family functioning
measure: Effects of preventive measures on health behaviours
time frame: 12 months
description: To determine the effect of preventive measures on health behaviours
measure: Effects of preventive measures on healthcare utilization
time frame: 12 months
description: To determine the effect of preventive measures on healthcare utilization
Nasal swab samples, dried blood spots
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 0 Years
maximum age: 16 Years
healthy volunteers: No
last name: Catherine S Birken, MD
role: Principal Investigator
affiliation: The Hospital for Sick Children
last name: Dalah C Mason, MPH
phone: 416-813-7654
phone ext: 302129
email: dalah.mason@sickkids.ca
last name: Natricha Levy McFarlane, MPhil
phone: 416-813-7654
phone ext: 309441
email: natricha.levymcfarlane@sickkids.ca
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Catherine Birken
investigator title: Senior Scientist
mesh term: COVID-19
mesh term: Virus Diseases
sharing ipd: No
ipd description: There is not a plan to make IPD available.