Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
107 participants
OBSERVATIONAL
2022-02-04
2022-08-31
Brief Summary
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Detailed Description
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Specific Aims:
1. Describe the kinetics of SARS-CoV-2 viral load in children with acute SARS-CoV-2 infection
2. Assess the impact of various host factors on viral dynamics, including age (\<1 year, 1-4 years, 5-11 years, 12-18 years), symptoms, clinical severity (hospitalization vs. outpatient), comorbidities (immunocompromised vs. not immunocompromised), vaccination (none, 1 dose, 2 doses)
3. Estimate the time point at which children are less likely to be infectious
4. Assess the sensitivity of self-collected rapid antigen testing (RAT) in children, compared to PCR (e.g. assess RAT test performance in children)
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Daily SARS-CoV-2 PCR Testing for 10 days
Each participant will undergo daily SARS-CoV-2 PCR testing to assess viral dynamics
Eligibility Criteria
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Inclusion Criteria
1. Less than 19 years of age
2. Have a positive molecular or rapid antigen test in the previous 48 hours
3. If symptomatic, onset of any COVID-19 symptom within last 72 hours.
4. If asymptomatic, evidence to support acute infection (e.g. negative PCR in the last 5 days, known household exposure where index case is clear)
5. Able to collect daily samples
18 Years
ALL
No
Sponsors
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The Hospital for Sick Children
OTHER
Responsible Party
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Michelle Science
Infectious Disease Physician
Locations
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The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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References
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Science M, Orkin J, Maguire B, Bitnun A, Bourns L, Corbeil A, Johnstone J, Macdonald L, Schwartz KL, Bruce Barrett C, Reinprecht J, Heisey A, Nasso S, Juni P, Campigotto A. Viral Dynamics of the SARS-CoV-2 Omicron Variant in Pediatric Patients: A Prospective Cohort Study. Clin Infect Dis. 2024 Jun 14;78(6):1506-1513. doi: 10.1093/cid/ciad740.
Other Identifiers
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1000079263
Identifier Type: -
Identifier Source: org_study_id
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