Clinical trial NCT04449978: TARGet Kids! COVID-19 Study of Children and Families
Official title: TARGet Kids! COVID-19 Study of Children and Families
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus
COVID-19
Virus
Family and Household
Infection Viral
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
First posted: 2020-06-29
Enrollment: 1145
Sex: ALL
Minimum age (years): 0
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Cumulative Incidence of COVID-19
timeFrame: 12 months
Secondary outcomes:
measure: Risk Factors for COVID-19
timeFrame: 12 months
measure: Parent-reported probable case definition of COVID-19
timeFrame: 12 months
measure: Dynamics of COVID-19
timeFrame: 12 months
measure: Risk to family members
timeFrame: 12 months
measure: Severity of COVID-19
timeFrame: 12 months
measure: Longer term effects of COVID-19 on physical health
timeFrame: 12 months
measure: Longer term effects of COVID-19 on mental health
timeFrame: 12 months
measure: Longer term effects of COVID-19 on child development
timeFrame: 12 months
measure: Longer term effects of COVID-19 on family functioning
timeFrame: 12 months
measure: Longer term effects of COVID-19 on health behaviours
timeFrame: 12 months
measure: Longer term effects of COVID-19 on healthcare utilization
timeFrame: 12 months
measure: Effects of preventive measures on infection
timeFrame: 12 months
measure: Effects of preventive measures on physical health
timeFrame: 12 months
measure: Effects of preventive measures on mental health
timeFrame: 12 months
measure: Effects of preventive measures on child development
timeFrame: 12 months
measure: Effects of preventive measures on family functioning
timeFrame: 12 months
measure: Effects of preventive measures on health behaviours
timeFrame: 12 months
measure: Effects of preventive measures on healthcare utilization
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Catherine S Birken, MD
role: PRINCIPAL_INVESTIGATOR
References: