TARGet Kids! COVID-19 Study of Children and Families

COVID-19 Clinical Trial

Official title:

TARGet Kids! COVID-19 Study of Children and Families

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04449978
• Other study ID #: 1000069701
• Status: Recruiting
• Start date: April 9, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: The Hospital for Sick Children
• Contact: Dalah C Mason, MPH
• Phone: 416-813-7654
• Email: dalah.mason[@]sickkids.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1082
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus
• COVID-19
• Family and Household
• Infection Viral
• Virus
• Virus Diseases

Locations

Country	Name	City	State
Canada	St Michael's Hospital	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Risk Factors for COVID-19	To determine the risk factors for COVID-19 infection in children and parents to inform preventive interventions	12 months
Secondary	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.	12 months
Secondary	Dynamics of COVID-19	To determine the dynamics of COVID-19 infection using a susceptible-infected-recovered (SIR) multi-state model.	12 months
Secondary	Risk to family members	To determine the risk to family members with a laboratory-confirmed COVID-19 infected family member.	12 months
Secondary	Severity of COVID-19	To determine the severity of laboratory-confirmed COVID-19 in healthy children and parents	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	Effects of preventive measures on infection	To determine the effect of preventive measures on COVID-19 infection	12 months
Secondary	Effects of preventive measures on physical health	To determine the effect of preventive measures on physical health	12 months
Secondary	Effects of preventive measures on mental health	To determine the effect of preventive measures on mental health	12 months
Secondary	Effects of preventive measures on child development	To determine the effect of preventive measures on child development	12 months
Secondary	Effects of preventive measures on family functioning	To determine the effect of preventive measures on family functioning	12 months
Secondary	Effects of preventive measures on health behaviours	To determine the effect of preventive measures on health behaviours	12 months
Secondary	Effects of preventive measures on healthcare utilization	To determine the effect of preventive measures on healthcare utilization	12 months