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临床试验/NCT05240183
NCT05240183已完成不适用

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

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2022年2月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
107
试验地点
1
主要终点
SARS-CoV-2 Viral Load

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

SARS-CoV-2 Viral Load

时间窗: 10 days

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

次要结局

  • Rapid antigen test sensitivity(10 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michelle Science

Infectious Disease Physician

The Hospital for Sick Children

研究点 (1)

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Viral Dynamics of Omicron in Children | 临床试验