SARS-CoV InfectionNCT05234359

The CHILD Cohort COVID-19 Add-On Study

An observational study of SARS-CoV Infection and Covid19, run by University of Manitoba at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Any age
Conditions the study is for: SARS-CoV Infection, Covid19
What is being tested?: Serology Testing and Stool sample
How many people: 5,385 participants
Where: 1 siteCanada
Study dates: 6 Oct 2020to 31 Oct 2022
How long will I take part?: 1 Year
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

CHILD Cohort Study participants who have been previously withdrawn from the study are not eligible for this add-on study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 locations and contacts

1 site in 1 country.

Canada1 site

SickKids - The Hospital for Sick Children
Toronto, Ontario, R3E 3P4

Other trials in Canada

About this 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.

Read the 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:

a panel of innate and adaptive cytokines and chemokines using a commercial multiplex assay,
immune cell phenotypes using high dimensional flow cytometry
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
Being tested: Serology Testing, Stool sample
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
Medical subject headings: Severe Acute Respiratory Syndrome, COVID-19, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Serology TestingDiagnostic test
Also called Blood samples, Finger stick blood sample
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 sampleDiagnostic test
Stool samples collected for genetic, microbial and viral analysis.

Study groups in NCT05234359
Study group	Role	What they receive
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 Receives: Diagnostic Test: Serology Testing; Diagnostic Test: Stool sample

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 months

Secondary outcomes (4)

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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Oct 202031 Oct 2022

First posted10 Feb 2022
Study start6 Oct 2020
Primary completion30 Apr 2022
Study completion31 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
More trials run by University of ManitobaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 5,385 participants (actual)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT05234359
Sponsor's protocol ID: VR5 - 172658
Other IDs: 02207-000, 02205-000
Status last verified: May 2023
First submitted: 10 Jan 2022
Last updated: 26 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Study data will be entered into REDCap and OpenSpecimen. Questionnaires/forms will only collect de-identified information using the study number. When the questionnaires/ forms collect postal code, the fields will be flagged as containing identifying information. Names and email addresses will be used to send out online questionnaire reminders to participants. All other identifying information will be stored separately from study data, password protected and accessed only by local staff who contact participants. Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be transmitted to and stored at the NCC. This will not include the participant's contact or identifying information. Questionnaire and analyzed data, once cleaned will be de-identified and shared with other approved research team members. At the end of the study, all study databases will be de-identified and archived at the NCC.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All SARS-CoV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT05234359
Acronym / sponsor ID: VR5 - 172658
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
Study type: Observational
Recruitment status: Completed
Enrolment: 5,385 participants (actual)
Lead sponsor: University of ManitobaUniversity, hospital or other
Collaborators: Research Manitoba
Study start: 6 Oct 2020 (actual)
Primary completion: 30 Apr 2022 (actual)
Study completion: 31 Oct 2022 (actual)
First posted: 10 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Target follow-up: 1 Year
Number of arms: 1

Arm	Type	Receives
CHILD Cohort Study	–	Diagnostic Test: Serology Testing, Diagnostic Test: Stool sampleCHILD 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

Who may qualify

Sex: All
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Serology TestingAlso: Blood samples, Finger stick blood sampleA 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.	Diagnostic test	CHILD Cohort Study
Stool sampleStool samples collected for genetic, microbial and viral analysis.	Diagnostic test	CHILD Cohort Study

Primary outcome

Real-Time data on SARS-CoV-2 infection, severity, transmission and immune response
Time frame: Biweekly, up to 70 weeks from Dec 2020 through Mar 2022
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
Identify biological and sociodemographic predictors of SARS-CoV-2 infection
Time frame: 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)
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.
Understand the psychosocial, health and equity impacts of the COVID-19 pandemic and its management on CHILD families, and identify equity impacts
Time frame: 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)
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.
Determine pre-pandemic immune profile of CHILD index children
Time frame: 12 months
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

4 secondary outcomes

SARS-CoV-2 infection, severity, transmission and immunity. Prevalence and severity of infection
Time frame: 12 months
Identify biological, health and sociodemographic predictors of SARS-CoV-2 infection susceptibility and severity
Time frame: 12 months
Understand the psychosocial, health and equity impacts of the COVID-19 pandemic
Time frame: 12 months
Sex-and-gender-based analysis
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
Individual participant dataSharing planned: Yes. Study data will be entered into REDCap and OpenSpecimen. Questionnaires/forms will only collect de-identified information using the study number. When the questionnaires/ forms collect postal code, the fields will be flagged as containing identifying information. Names and email addresses will be used to send out online questionnaire reminders to participants. All other identifying information will be stored separately from study data, password protected and accessed only by local staff who contact participants. Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be transmitted to and stored at the NCC. This will not include the participant's contact or identifying information. Questionnaire and analyzed data, once cleaned will be de-identified and shared with other approved research team members. At the end of the study, all study databases will be de-identified and archived at the NCC.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Meghan Azad, PhD principal investigator

University of Manitoba

Padmaja Subbarao, MD study director

University of Toronto

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-CoV Infection and Covid19, run by University of Manitoba at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Real-Time data on SARS-CoV-2 infection, severity, transmission and immune response (time frame: Biweekly, up to 70 weeks from Dec 2020 through Mar 2022). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05234359.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.