Viral Dynamics of Omicron in Children

Completed

• Conditions: SARS-CoV2 Infection, COVID-19

• Registration Number: NCT05240183
• Lead Sponsor: The Hospital for Sick Children

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)

Study Timeline

• Study Start: 2022-02-04
• Study First Submitted: 2022-02-04
• Study First Submitted QC: 2022-02-04
• Study First Posted: 2022-02-15
• Primary Completion: 2022-03-31
• Study Completion: 2022-08-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-25
• Last Update Posted: 2022-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SARS-CoV-2 Viral Load	10 days	We will use prospective longitudinal quantitative reverse transcription PCR testing to measure the viral RNA trajectories for individuals in the study.

Secondary Outcome Measures

Name	Time	Method
Rapid antigen test sensitivity	10 days	We will describe the RAT positivity on Days 1 to 10 and evaluate the performance of RAT compared to PCR

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada