The CHILD Cohort COVID-19 Add-On Study

Covid19 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05234359
• Other study ID #: VR5 - 172658
• Secondary ID: 02207-000, 02205
• Status: Completed
• Start date: October 6, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: May 2023
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5385
• Est. completion date: October 31, 2022
• Est. primary completion date: April 30, 2022
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Covid19
• Infections
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Diagnostic Test:
• 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.
• Stool sample
Stool samples collected for genetic, microbial and viral analysis.

Locations

Country	Name	City	State
Canada	SickKids - The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Research Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)
Primary	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	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.	12 months
Secondary	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
Secondary	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
Secondary	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