Viral Dynamics of Omicron in Children

November 25, 2022 updated by: Michelle Science, The Hospital for Sick Children

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All children less than 19 years of age with acute SARS-CoV-2 infection

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rapid antigen test sensitivity
Time Frame: 10 days
We will describe the RAT positivity on Days 1 to 10 and evaluate the performance of RAT compared to PCR
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2022

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

February 4, 2022

First Submitted That Met QC Criteria

February 4, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Actual)

November 28, 2022

Last Update Submitted That Met QC Criteria

November 25, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000079263

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on SARS-CoV2 Infection, COVID-19

Clinical Trials on Daily SARS-CoV-2 PCR Testing for 10 days

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe