An observational study in Coronavirus, COVID-19 and Virus, sponsored by The Hospital for Sick Children. Completed at 2 sites in Canada. Open to participants aged 0 Years to 16 Years. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by The Hospital for Sick Children · Observational
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 1,145 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Cumulative Incidence of COVID-19
To evaluate the cumulative incidence of laboratory-confirmed COVID-19 among healthy children and parents in Toronto, Canada
Time frame: 12 months
Risk Factors for COVID-19
To determine the risk factors for COVID-19 infection in children and parents to inform preventive interventions
Time frame: 12 months
Parent-reported probable case definition of COVID-19
To determine the cumulative incidence of parent-reported probable case definition of COVID-19 among children and parents.
Time frame: 12 months
Dynamics of COVID-19
To determine the dynamics of COVID-19 infection using a susceptible-infected-recovered (SIR) multi-state model.
Time frame: 12 months
Risk to family members
To determine the risk to family members with a laboratory-confirmed COVID-19 infected family member.
Time frame: 12 months
Severity of COVID-19
To determine the severity of laboratory-confirmed COVID-19 in healthy children and parents
Time frame: 12 months
Longer term effects of COVID-19 on physical health
To determine the longer term effects of COVID-19 infection in healthy children and parents on physical health
Time frame: 12 months
Longer term effects of COVID-19 on mental health
To determine the longer term effects of COVID-19 infection in healthy children and parents on mental health
Time frame: 12 months
Longer term effects of COVID-19 on child development
To determine the longer term effects of COVID-19 infection in healthy children and parents on child development
Time frame: 12 months
Longer term effects of COVID-19 on family functioning
To determine the longer term effects of COVID-19 infection in healthy children and parents on family functioning
Time frame: 12 months
Longer term effects of COVID-19 on health behaviours
To determine the longer term effects of COVID-19 infection in healthy children and parents on health behaviours
Time frame: 12 months
Longer term effects of COVID-19 on healthcare utilization
To determine the longer term effects of COVID-19 infection in healthy children and parents on healthcare utilization
Time frame: 12 months
Effects of preventive measures on infection
To determine the effect of preventive measures on COVID-19 infection
Time frame: 12 months
Effects of preventive measures on physical health
To determine the effect of preventive measures on physical health
Time frame: 12 months
Effects of preventive measures on mental health
To determine the effect of preventive measures on mental health
Time frame: 12 months
Effects of preventive measures on child development
To determine the effect of preventive measures on child development
Time frame: 12 months
Effects of preventive measures on family functioning
To determine the effect of preventive measures on family functioning
Time frame: 12 months
Effects of preventive measures on health behaviours
To determine the effect of preventive measures on health behaviours
Time frame: 12 months
Effects of preventive measures on healthcare utilization
To determine the effect of preventive measures on healthcare utilization
Time frame: 12 months
Plan to share: No — There is not a plan to make IPD available.
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children