TARGet Kids! COVID-19 Study of Children and Families

NCT ID: NCT04449978

Last Updated: 2024-12-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1145 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-09
• Study Completion Date: 2023-12-31

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Catherine Birken

Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine S Birken, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

St Michael's Hospital

Toronto, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000069701

Identifier Type: -

Identifier Source: org_study_id