TARGet Kids! COVID-19 Study of Children and Families

September 27, 2021 updated by: Catherine Birken, The Hospital for Sick Children
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

1082

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • The Hospital for Sick Children
        • Contact:
        • Contact:
        • Principal Investigator:
          • Catherine S Birken, MD
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St Michael's Hospital
        • Contact:
        • Principal Investigator:
          • Jonathon Maguire, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will be a prospective longitudinal observational study embedded within the TARGet Kids! cohort study, an ongoing longitudinal observational study enrolling healthy age 0-5 years who receive primary healthcare and following them until adolescence and early adulthood.

Description

Inclusion Criteria:

  • Families with existing participants of the TARGet Kids! cohort with children between the ages of 0-16 years.

Exclusion Criteria:

  • Families who are not participating in the TARGet Kids! cohort or participating families with no children within the age of eligibility.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Incidence of COVID-19
Time Frame: 12 months
To evaluate the cumulative incidence of laboratory-confirmed COVID-19 among healthy children and parents in Toronto, Canada
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk Factors for COVID-19
Time Frame: 12 months
To determine the risk factors for COVID-19 infection in children and parents to inform preventive interventions
12 months
Parent-reported probable case definition of COVID-19
Time Frame: 12 months
To determine the cumulative incidence of parent-reported probable case definition of COVID-19 among children and parents.
12 months
Dynamics of COVID-19
Time Frame: 12 months
To determine the dynamics of COVID-19 infection using a susceptible-infected-recovered (SIR) multi-state model.
12 months
Risk to family members
Time Frame: 12 months
To determine the risk to family members with a laboratory-confirmed COVID-19 infected family member.
12 months
Severity of COVID-19
Time Frame: 12 months
To determine the severity of laboratory-confirmed COVID-19 in healthy children and parents
12 months
Longer term effects of COVID-19 on physical health
Time Frame: 12 months
To determine the longer term effects of COVID-19 infection in healthy children and parents on physical health
12 months
Longer term effects of COVID-19 on mental health
Time Frame: 12 months
To determine the longer term effects of COVID-19 infection in healthy children and parents on mental health
12 months
Longer term effects of COVID-19 on child development
Time Frame: 12 months
To determine the longer term effects of COVID-19 infection in healthy children and parents on child development
12 months
Longer term effects of COVID-19 on family functioning
Time Frame: 12 months
To determine the longer term effects of COVID-19 infection in healthy children and parents on family functioning
12 months
Longer term effects of COVID-19 on health behaviours
Time Frame: 12 months
To determine the longer term effects of COVID-19 infection in healthy children and parents on health behaviours
12 months
Longer term effects of COVID-19 on healthcare utilization
Time Frame: 12 months
To determine the longer term effects of COVID-19 infection in healthy children and parents on healthcare utilization
12 months
Effects of preventive measures on infection
Time Frame: 12 months
To determine the effect of preventive measures on COVID-19 infection
12 months
Effects of preventive measures on physical health
Time Frame: 12 months
To determine the effect of preventive measures on physical health
12 months
Effects of preventive measures on mental health
Time Frame: 12 months
To determine the effect of preventive measures on mental health
12 months
Effects of preventive measures on child development
Time Frame: 12 months
To determine the effect of preventive measures on child development
12 months
Effects of preventive measures on family functioning
Time Frame: 12 months
To determine the effect of preventive measures on family functioning
12 months
Effects of preventive measures on health behaviours
Time Frame: 12 months
To determine the effect of preventive measures on health behaviours
12 months
Effects of preventive measures on healthcare utilization
Time Frame: 12 months
To determine the effect of preventive measures on healthcare utilization
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

Unity Health Toronto

Investigators

  • Principal Investigator: Catherine S Birken, MD, The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2020

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

June 23, 2020

First Submitted That Met QC Criteria

June 25, 2020

First Posted (Actual)

June 29, 2020

Study Record Updates

Last Update Posted (Actual)

October 4, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000069701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe