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Viral Dynamics of Omicron in Children

Viral Dynamics of the SARS-CoV-2 Omicron Variant in Paediatric Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05240183
Enrollment
107
Registered
2022-02-15
Start date
2022-02-04
Completion date
2022-08-31
Last updated
2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV2 Infection, COVID-19

Brief summary

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

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)

Interventions

DIAGNOSTIC_TESTDaily SARS-CoV-2 PCR Testing for 10 days

Each participant will undergo daily SARS-CoV-2 PCR testing to assess viral dynamics

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years

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

Design outcomes

Primary

MeasureTime frameDescription
SARS-CoV-2 Viral Load10 daysWe will use prospective longitudinal quantitative reverse transcription PCR testing to measure the viral RNA trajectories for individuals in the study.

Secondary

MeasureTime frameDescription
Rapid antigen test sensitivity10 daysWe will describe the RAT positivity on Days 1 to 10 and evaluate the performance of RAT compared to PCR

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026