The CHILD Cohort COVID-19 Add-On Study

University of Manitoba

Status: Completed

Conditions: SARS-CoV Infection; Covid19

Treatments: Diagnostic Test: Stool sample; Diagnostic Test: Serology Testing

Study type: Observational

Funder types: Other

Identifiers

NCT05234359

VR5 - 172658

02207-000, 02205-000 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 5,385 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

5,385 participants in 1 patient group

CHILD Cohort Study

Description:

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

Treatment:

Diagnostic Test: Stool sample

Diagnostic Test: Serology Testing