Clinical trial NCT05234359: The CHILD Cohort COVID-19 Add-On Study
Official title: Rapid Research in the CHILD Cohort to Inform Canada's Response to the COVID-19 Pandemic: Investigating the Prevalence & Predictors of SARS-CoV-2 Infection and the Health & Psychosocial Impact of the COVID-19 Pandemic on Canadian Families.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV Infection
Covid19
Keywords: COVID-19 pandemic
SARS-CoV-@ infection susceptibility and severity
pediatrics
mental health and wellbeing
seroprevalence
immunology
epidemiology
viral infection history
CHILD Cohort Study
data integration
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Research Manitoba
First posted: 2022-02-10
Enrollment: 5385
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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:

1. a panel of innate and adaptive cytokines and chemokines using a commercial multiplex assay,
2. immune cell phenotypes using high dimensional flow cytometry
3. viral antibodies to establish prior/recent infections and cross-reactivity using targeted ELISA assays developed for antibodies to other human beta-coronaviruses

Eligibility criteria: Inclusion Criteria:

* All study participants enrolled in the original CHILD Cohort study are eligible for this add-on study
* Individuals living in the same household as study participants enrolled in the original CHILD Cohort Study are also eligible for this add-on study

Exclusion Criteria:

* CHILD Cohort Study participants who have been previously withdrawn from the study are not eligible for this add-on study
* CHILD Cohort Study participants who have not agreed to future contact by the study team are not eligible for this add-on study
* Participants (with the exception of children) who are not able to provide consent on their own behalf are not eligible for this add-on study
* Participants (with the exception of children) who are not able to read, write and understand English are not eligible for this add-on study
* Participants residing outside of Canada will not be participating in the sample collection component of this study

Primary outcomes:
measure: Real-Time data on SARS-CoV-2 infection, severity, transmission and immune response
timeFrame: Biweekly, up to 70 weeks from Dec 2020 through Mar 2022
measure: Identify biological and sociodemographic predictors of SARS-CoV-2 infection
timeFrame: 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)
measure: Understand the psychosocial, health and equity impacts of the COVID-19 pandemic and its management on CHILD families, and identify equity impacts
timeFrame: 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)
measure: Determine pre-pandemic immune profile of CHILD index children
timeFrame: 12 months
Secondary outcomes:
measure: SARS-CoV-2 infection, severity, transmission and immunity. Prevalence and severity of infection
timeFrame: 12 months
measure: Identify biological, health and sociodemographic predictors of SARS-CoV-2 infection susceptibility and severity
timeFrame: 12 months
measure: Understand the psychosocial, health and equity impacts of the COVID-19 pandemic
timeFrame: 12 months
measure: Sex-and-gender-based analysis
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: SickKids - The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: University of Manitoba
name: Meghan Azad, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Padmaja Subbarao, MD
role: STUDY_DIRECTOR
References: