The CHILD Cohort COVID-19 Add-On Study

NCT ID: NCT05234359

Last Updated: 2023-05-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5385 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-06
• Study Completion Date: 2022-10-31

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

Conditions

SARS-CoV Infection; Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

Serology Testing

Intervention Type: 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.

Stool sample

Intervention Type: DIAGNOSTIC_TEST

Stool samples collected for genetic, microbial and viral analysis.

Interventions

Serology Testing

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.

Intervention Type: DIAGNOSTIC_TEST

Stool sample

Stool samples collected for genetic, microbial and viral analysis.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Blood samples; Finger stick blood sample

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Manitoba

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meghan Azad, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Padmaja Subbarao, MD

Role: STUDY_DIRECTOR

University of Toronto

Locations

SickKids - The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

02207-000, 02205-000

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

VR5 - 172658

Identifier Type: -

Identifier Source: org_study_id