Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 02207-000, 02205-000 | Other Grant/Funding Number | Research Manitoba (Winnipeg) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Research Manitoba | OTHER |
Not provided
Not provided
Not provided
Not provided
The objective of this study is to determine the prevalence and transmission of SARS-CoV-2 infection among Canadian children and parents in the CHILD cohort, identify predictors of infection susceptibility and severity, and understand the health and psychosocial impacts of the COVID-19 pandemic on CHILD families.
Study will leverage the existing CHILD Cohort Study. All household members from each family will be incited to participate. To accommodate institutional physical distancing policies, the study is designed to minimize participant contact and the need for research staff onsite.
Weekly symptom check (by text message): Brief survey will capture COVID-19 signs and symptoms, testing and results, and healthcare utilization. Questions will be aligned with the Government of Canada self-assessment tool and harmonized with international partners.
Quarterly CoRonavIruS Health Impact Survey (CRISIS) (7) and body weight: 10-minute CRISIS survey captures COVID-19 exposure, life changes due to the COVID-19 crisis, daily behaviours, emotions and worries, media use and substance use. Each household member will complete the survey; parents will complete on behalf of younger children. Body weight (measured at home) will also be reported.
Repeated seroprevalence survey: Use of simple home sampling kit containing volumetric absorption micro-sampling devices (Mitra(R) cartridge device, Neoteryx LLC) to collect a fingerstick blood sample (10 ul; a few drops) for SARS-Cov2 IgG serology testing laboratory. Knowledge Users (Public Health authorities) and virology/serology experts will advise on the best available serology assay at the time of testing, and the investigators will consider testing in a public health lab if possible. Kits will be delivered and returned by mail, and an instructional video will be provided. Results will be returned to participants with appropriate explanation of their clinical relevance, and shared in real time with Knowledge Users to inform modeling efforts and pandemic management The timing and frequency of sero-surveys will be guided by our Knowledge Users depending on the progression of the pandemic.
Analysis of recently-collected pre-pandemic bio-samples: To determine the pre-pandemic immune profile of CHILD index children, the investigators will analyze a subset including all cases (asymptomatic and symptomatic) detected by serology and symptom surveys, plus a random subset of uninfected controls (estimated: 400 children in total). The investigators will assess:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHILD Cohort Study | CHILD Cohort Study, a general population cohort of 3500 families (n~12,000) with children born in BC, AB, MB and ON between 2009-12. CHILD has dense longitudinal data (pregnancy to children aged 5-8 years) on physical and mental health, emotional wellbeing, child behaviour problems, and parenting stress, providing the powerful opportunity to identify and study changes in these parameters during the pandemic. CHILD participants have also granted permission for data linkage, providing the opportunity to link study data with administrative health data including clinical diagnoses, hospitalization and medication use. In this grant, the investigators will monitor SARS-CoV-2 seroprevalence among CHILD families and collect information about how they are experiencing the COVID-19 pandemic over the next 12 months. Interventions - Diagnostic Testing via home kit at 2 timepoints: Blood sample, Saliva sample, Stool sample |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serology Testing | Diagnostic Test | A simple home sampling kit containing volumetric absorption microsampling devices (Mitra(R) cartidge device, Neoteryx LLC) will be used by the participants to collect a finger stick blood sample (10 ul; a few drops). Kits will be delivered to participants' homes and returned by mail. An instructional video will be provided. |
| Measure | Description | Time Frame |
|---|---|---|
| Real-Time data on SARS-CoV-2 infection, severity, transmission and immune response | Weekly Symptom check (by text message) Brief survey will capture COVID-19 signs and symptoms, testing and results, and healthcare utilization. Questions will be aligned with the Government of Canada self-assessment tool and harmonized with international partners | Biweekly, up to 70 weeks from Dec 2020 through Mar 2022 |
| Identify biological and sociodemographic predictors of SARS-CoV-2 infection | Quarterly CoRonavIruS Health Impact Survey (CRISIS) (7) and body weight: The 10-minute CRISIS survey captures COVID-19 exposure, life changes due to the COVID-19 crisis, daily behaviours, emotions and worries, media use and substance use. Each household member will complete the survey; parents will complete on behalf of younger children. Body weight (measured at home) will also be reported. | Quarterly (once every 3 months - total duration 12 months), from Dec 2020 through Mar 2022. Baseline survey (Dec - May 2021); Follow-up 1 Survey (July - Aug 2021); Follow-up 2 Survey (Oct - Dec 2021); Follow-up 3 (Jan - Mar 2022) |
| Understand the psychosocial, health and equity impacts of the COVID-19 pandemic and its management on CHILD families, and identify equity impacts | Quarterly CoRonavIruS Health Impact Survey (CRISIS) (7) and body weight: The 10-minute CRISIS survey captures COVID-19 exposure, life changes due to the COVID-19 crisis, daily behaviours, emotions and worries, media use and substance use. Each household member will complete the survey; parents will complete on behalf of younger children. Body weight (measured at home) will also be reported. | Quarterly (once every 3 months - total duration 12 months), from Dec 2020 through Mar 2022. Baseline survey (Dec - May 2021); Follow-up 1 Survey (July - Aug 2021); Follow-up 2 Survey (Oct - Dec 2021); Follow-up 3 (Jan - Mar 2022) |
| Determine pre-pandemic immune profile of CHILD index children | Analysis of recently-collected pre-pandemic bio-samples: To determine the pre-pandemic immune profile of CHILD index children, we will analyze a subset including all cases (asymptomatic and symptomatic) detected by serology and symptom surveys, plus a random subset of uninfected controls (estimated: 400 children in total). The investigators will assess: a) a panel of innate and adaptive cytokines and chemokines using a commercial multiplex assay, b) immune cell phenotypes using high dimensional flow cytometry and c) viral antibodies to establish prior/recent infections and cross-reactivity using targeted ELISA assays developed for antibodies to other human beta-coronaviruses |
| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2 infection, severity, transmission and immunity. Prevalence and severity of infection | Prevalence and severity of infection will be estimated in real-time from weekly reports, and confirmed from serology testing. Severity will be classified as asymptomatic, mild or severe using WHO criteria. Transmission will be assessed using a multilevel modeling approach by province, house, and individual. Persistence of potential immunity will be determined from longitudinal serology testing for SARS-CoV-2 antibodies. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
The study will seek the participation of the original families recruited into the CHILD Cohort Study (child and one or both of their parents or guardians) and any additional interested members from the same household (e.g siblings, grandparents etc). The CHILD Cohort Study is a general population cohort of 3500 families (~12,000 individuals) with children born in BC, Alberta, Manitoba and Ontario. Pregnant mothers were recruited into the study in 2009-2012.
Exclusion criteria for initial recruitment to the CHILD study was mothers pregnant with more than one baby, had in-vitro fertilization (IVF) to become pregnant, baby had severe health problems at birth or was born prior to 35 weeks gestation.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Meghan Azad, PhD | University of Manitoba | Principal Investigator |
| Padmaja Subbarao, MD | University of Toronto | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SickKids - The Hospital for Sick Children | Toronto | Ontario | R3E 3P4 | Canada |
Study data will be entered into REDCap and OpenSpecimen. Questionnaires/forms will only collect de-identified information using the study number. When the questionnaires/ forms collect postal code, the fields will be flagged as containing identifying information. Names and email addresses will be used to send out online questionnaire reminders to participants. All other identifying information will be stored separately from study data, password protected and accessed only by local staff who contact participants. Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be transmitted to and stored at the NCC. This will not include the participant's contact or identifying information. Questionnaire and analyzed data, once cleaned will be de-identified and shared with other approved research team members. At the end of the study, all study databases will be de-identified and archived at the NCC.
Study data will be retained indefinitely.
All IPD will be kept behind two security measures or as per equivalent institutional policy, under the supervision of the site Principal Investigator and will not be transferred outside of the study site. The study monitor, auditor and representatives of the Research Ethics Board (REB) may inspect all documents and records required to be maintained by the Principal Investigator, including but not limited to, medical records for the participants in this study. The study site will permit access to such records. Access to stored samples at the laboratory will be limited to the approved research team. When the study is completed, access to the de-identified, archived study data and/or samples will be provided through the CHILDdb (database).
Not provided
Not provided
| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| D000086382 | COVID-19 |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000087124 | COVID-19 Serological Testing |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D000086742 | COVID-19 Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Stool sample | Diagnostic Test | Stool samples collected for genetic, microbial and viral analysis. |
|
| 12 months |
| 12 months |
| Identify biological, health and sociodemographic predictors of SARS-CoV-2 infection susceptibility and severity | In addition to the new data generated by this grant, the investigators will access existing data from the CHILD database, which contains over 50 million data points including multi-omics measurements from biological samples; indoor exposures including tobacco smoke; longitudinal clinical data on cardiometabolic and respiratory health, anthropometrics and body composition; mental health and psychosocial data; health behaviour data including sleep, physical activity, screen time and diet; and socioeconomic data including ethnicity. CHILD data is also integrated with www.CANUE.ca environmental data including weather, air quality and population density data. The investigators will use two approaches to analyze these data: hypothesis-driven and unbiased machine learning. | 12 months |
| Understand the psychosocial, health and equity impacts of the COVID-19 pandemic | The investigators will identify individuals experiencing a decline in mental or physical health during the pandemic (not due to infection) and identify families and individuals experiencing food insecurity, financial difficulties, domestic violence and substance abuse. The investigators will report the prevalence of these outcomes to our knowledge users monthly. The investigators will use hypothesis-driven and unbiased approaches to identify factors that may predict risk for - or resilience against - these negative impacts of the pandemic. The investigators will also investigate socioeconomic inequities. | 12 months |
| Sex-and-gender-based analysis | Sex differences in COVID-19 severity have been reported in adults (8) and gendered health behaviours are relevant to exposure and transmission. Mental health effects may also vary by sex and gender. It is not known if these differences exist in children, and how they might affect asymptomatic infection and transmission. The investigators will disaggregate all analyses by sex and/or gender in order to address these issues. | 12 months |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D012698 | Serologic Tests |
| D007159 | Immunologic Tests |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D013048 | Specimen Handling |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |