Viral Dynamics of Omicron in Children

NCT ID: NCT05240183

Last Updated: 2022-11-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-04

Study Completion Date

2022-08-31

Brief Summary

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SARS-CoV-2 transmission is dependent on multiple factors, which may be related to either host-virus interaction or the environment. While there have been several studies evaluation viral dynamics and transmission risk in adults, there is limited pediatric data available. The objective of this study is to characterize the period of communicability for children less than 19 years of age with SARS-CoV-2 infection with the Omicron variant.

Detailed Description

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The goal of our study is to assess the viral dynamics of SARS-CoV-2 infection in children \< 19 years with acute infection to inform public health practice.

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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SARS-CoV2 Infection, COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

To be included in the study, the participant must be:

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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Michelle Science

Infectious Disease Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

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.

Reference Type DERIVED
PMID: 38084906 (View on PubMed)

Other Identifiers

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1000079263

Identifier Type: -

Identifier Source: org_study_id

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