CoronavirusNCT04449978
TARGet Kids! COVID-19 Study of Children and Families
An observational study of Coronavirus and COVID-19, run by The Hospital for Sick Children at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 0 to 16 years
- Conditions the study is for
- Coronavirus, COVID-19, Virus
- How many people
- 1,145 participants
- Where
- 2 sitesCanada
- Study dates
- 9 Apr 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Families with existing participants of the TARGet Kids! cohort with children between the ages of 0-16 years.
Who cannot join
- Families who are not participating in the TARGet Kids! cohort or participating families with no children within the age of eligibility.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St Michael's Hospital
Toronto, Ontario, M5B 1W8
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
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.
Read the 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
- Medical subject headings
- Coronavirus Infections, COVID-19, Virus Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Incidence of COVID-19
To evaluate the cumulative incidence of laboratory-confirmed COVID-19 among healthy children and parents in Toronto, Canada
Measured: 12 months
Secondary outcomes (18)
Risk Factors for COVID-19
To determine the risk factors for COVID-19 infection in children and parents to inform preventive interventions
Measured: 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.
Measured: 12 months
Dynamics of COVID-19
To determine the dynamics of COVID-19 infection using a susceptible-infected-recovered (SIR) multi-state model.
Measured: 12 months
Risk to family members
To determine the risk to family members with a laboratory-confirmed COVID-19 infected family member.
Measured: 12 months
Severity of COVID-19
To determine the severity of laboratory-confirmed COVID-19 in healthy children and parents
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Effects of preventive measures on infection
To determine the effect of preventive measures on COVID-19 infection
Measured: 12 months
Effects of preventive measures on physical health
To determine the effect of preventive measures on physical health
Measured: 12 months
Effects of preventive measures on mental health
To determine the effect of preventive measures on mental health
Measured: 12 months
Effects of preventive measures on child development
To determine the effect of preventive measures on child development
Measured: 12 months
Effects of preventive measures on family functioning
To determine the effect of preventive measures on family functioning
Measured: 12 months
Effects of preventive measures on health behaviours
To determine the effect of preventive measures on health behaviours
Measured: 12 months
Effects of preventive measures on healthcare utilization
To determine the effect of preventive measures on healthcare utilization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start9 Apr 2020
- Primary completion30 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,145 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto
- Responsible party
- Principal investigator, Catherine Birken, The Hospital for Sick Children
- Investigators
- Catherine S Birken, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449978
- Sponsor's protocol ID
- 1000069701
- Status last verified
- Dec 2024
- First submitted
- 23 Jun 2020
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TARGet Kids! COVID-19 Study of Children and Families
- ClinicalTrials.gov ID
- NCT04449978
- Acronym / sponsor ID
- 1000069701
- Conditions
- Coronavirus, COVID-19, Virus, Family and Household, Infection Viral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,145 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Unity Health Toronto
- Study start
- 9 Apr 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Families with existing participants of the TARGet Kids! cohort with children between the ages of 0-16 years.
Key exclusion criteria (1 listed)
- Families who are not participating in the TARGet Kids! cohort or participating families with no children within the age of eligibility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative Incidence of COVID-19
Time frame: 12 months
To evaluate the cumulative incidence of laboratory-confirmed COVID-19 among healthy children and parents in Toronto, Canada
18 secondary outcomes
Risk Factors for COVID-19
Time frame: 12 months
Parent-reported probable case definition of COVID-19
Time frame: 12 months
Dynamics of COVID-19
Time frame: 12 months
Risk to family members
Time frame: 12 months
Severity of COVID-19
Time frame: 12 months
Longer term effects of COVID-19 on physical health
Time frame: 12 months
Longer term effects of COVID-19 on mental health
Time frame: 12 months
Longer term effects of COVID-19 on child development
Time frame: 12 months
Longer term effects of COVID-19 on family functioning
Time frame: 12 months
Longer term effects of COVID-19 on health behaviours
Time frame: 12 months
Longer term effects of COVID-19 on healthcare utilization
Time frame: 12 months
Effects of preventive measures on infection
Time frame: 12 months
Effects of preventive measures on physical health
Time frame: 12 months
Effects of preventive measures on mental health
Time frame: 12 months
Effects of preventive measures on child development
Time frame: 12 months
Effects of preventive measures on family functioning
Time frame: 12 months
Effects of preventive measures on health behaviours
Time frame: 12 months
Effects of preventive measures on healthcare utilization
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine S Birken, MD principal investigator
The Hospital for Sick Children
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus and COVID-19, run by The Hospital for Sick Children at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence of COVID-19 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.