TARGet Kids! COVID-19 Study of Children and Families

NCT04449978 | Completed

• 1 other identifier: 1000069701
• Study Type: observational
• Target: 1,145
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Coronavirus; COVID-19; Virus; Family and Household; Infection Viral

Outcome Measures

Primary Outcomes (1)

• Cumulative Incidence of COVID-19

  To evaluate the cumulative incidence of laboratory-confirmed COVID-19 among healthy children and parents in Toronto, Canada

  12 months

Secondary Outcomes (18)

• Risk Factors for COVID-19

  12 months

• Parent-reported probable case definition of COVID-19

  12 months

• Dynamics of COVID-19

  12 months

• Risk to family members

  12 months

• Severity of COVID-19

  12 months

Eligibility Criteria

• Age: 0 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Unity Health Toronto: collaborator

Study Sites (2)

St Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasal swab samples, dried blood spots

MeSH Terms

Conditions

Coronavirus Infections; COVID-19; Virus Diseases

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Catherine S Birken, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 29, 2020
• Study Start: April 9, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 31, 2023
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)