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Viral Dynamics of Omicron in Children

Sponsor
The Hospital for Sick Children (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05240183
Collaborator
(none)
100
Enrollment
1
Location
6.8
Anticipated Duration (Months)
14.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Daily SARS-CoV-2 PCR Testing for 10 days

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Viral Dynamics of the SARS-CoV-2 Omicron Variant in Paediatric Patients
Actual Study Start Date :
Feb 4, 2022
Actual Primary Completion Date :
Mar 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Hospital for Sick Children Toronto Ontario Canada M5G 1X8

Sponsors and Collaborators

  • The Hospital for Sick Children

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michelle Science, Infectious Disease Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT05240183
Other Study ID Numbers:
  • 1000079263
First Posted:
Feb 15, 2022
Last Update Posted:
May 12, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of May 12, 2022