Viral Dynamics of Omicron in Children

NCT05240183 | Completed

• 1 other identifier: 1000079263
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV2 Infection, COVID-19

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 Viral Load

  We will use prospective longitudinal quantitative reverse transcription PCR testing to measure the viral RNA trajectories for individuals in the study.

  10 days

Secondary Outcomes (1)

• Rapid antigen test sensitivity

  10 days

Interventions

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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• Science M, Orkin J, Maguire B, Bitnun A, Bourns L, Corbeil A, Johnstone J, Macdonald L, Schwartz KL, Bruce Barrett C, Reinprecht J, Heisey A, Nasso S, Juni P, Campigotto A. Viral Dynamics of the SARS-CoV-2 Omicron Variant in Pediatric Patients: A Prospective Cohort Study. Clin Infect Dis. 2024 Jun 14;78(6):1506-1513. doi: 10.1093/cid/ciad740.

  PMID: 38084906 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Infectious Disease Physician

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: February 4, 2022
• Primary Completion: March 31, 2022
• Study Completion: August 31, 2022
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)