The CHILD Cohort COVID-19 Add-On Study

NCT05234359 | Completed

• 2 other identifiers: VR5 - 17265802207-000, 02205-000
• Study Type: observational
• Target: 5,385
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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

  12 months

Secondary Outcomes (4)

• SARS-CoV-2 infection, severity, transmission and immunity. Prevalence and severity of infection

  12 months

• Identify biological, health and sociodemographic predictors of SARS-CoV-2 infection susceptibility and severity

  12 months

• Understand the psychosocial, health and equity impacts of the COVID-19 pandemic

  12 months

• Sex-and-gender-based analysis

  12 months

Study Arms (1)

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

Diagnostic Test: Serology Testing; Diagnostic Test: Stool sample

Interventions

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.

Also known as: Blood samples, Finger stick blood sample

CHILD Cohort Study

Stool sample DIAGNOSTIC_TEST

Stool samples collected for genetic, microbial and viral analysis.

CHILD Cohort Study

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Research Manitoba: collaborator

Study Sites (1)

SickKids - The Hospital for Sick Children

Toronto, Ontario, R3E 3P4, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Blood samples will be taken for SARS-Cov2 lgG serology testing. * Saliva samples collected for genetic and viral analysis and for antibodies, microbiota and hormones. * Stool samples collected for genetic, microbial and viral analysis.

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19; Psychological Well-Being

Interventions

COVID-19 Serological Testing; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Serologic Tests; Immunologic Tests; Investigative Techniques; Immunologic Techniques; Specimen Handling; Punctures; Surgical Procedures, Operative

Study Officials

• Meghan Azad, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Padmaja Subbarao, MD

  University of Toronto

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: February 10, 2022
• Study Start: October 6, 2020
• Primary Completion: April 30, 2022
• Study Completion: October 31, 2022
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Study data will be retained indefinitely.
• Access Criteria: 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).

Locations

CA (1)