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OpenTrials
Completed

NCT Number: NCT05240183

Viral Dynamics of Omicron in Children

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.

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Key information

Conditions

SARS-CoV2 Infection, COVID-19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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:

  • Describe the kinetics of SARS-CoV-2 viral load in children with acute SARS-CoV-2 infection
  • 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)
  • Estimate the time point at which children are less likely to be infectious
  • Assess the sensitivity of self-collected rapid antigen testing (RAT) in children, compared to PCR (e.g. assess RAT test performance in children)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

  • Less than 19 years of age
  • Have a positive molecular or rapid antigen test in the previous 48 hours
  • If symptomatic, onset of any COVID-19 symptom within last 72 hours.
  • If asymptomatic, evidence to support acute infection (e.g. negative PCR in the last 5 days, known household exposure where index case is clear)
  • Able to collect daily samples

Treatment and study plan

Daily SARS-CoV-2 PCR Testing for 10 days

Diagnostic Test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2022
Registry last updated
Nov 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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