跳至主要内容
临床试验/NCT05181670
NCT05181670已完成不适用

The Canadian Respiratory Research Network Long COVID-19 Study

Sunnybrook Health Sciences Centre8 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2022年8月1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
450
试验地点
8
主要终点
To determine the prevalence of respiratory post-acute sequelae of SARS-CoV-2 (PASC) and PASC

研究概览

简要总结

Preliminary studies suggest that COVID-19 causes long-term lung damage, even in young, otherwise healthy people who did not need to go to hospital or the ICU.

We seek to know how common long-term lung damage after COVID-19 is, who is most affected by it and what the effects of this damage are on other important aspects of people's lives. We plan to study a large sample of people with a history of COVID-19 infection from across Canada-some who needed hospitalization but most who did not. Through online questionnaires, we will determine their respiratory symptoms, quality of life and medical history. Then we will invite them to one of our thirteen Canadian testing centres to have special, thorough breathing tests.

We hypothesize that COVID-19 leaves a significant proportion of people with measurable respiratory impairment.

The information we learn about the effect of COVID-19 on the lungs will help patients and health care providers manage it better. It will also reveal how different COVID-19 variants affect the lungs. We will use this new knowledge to write a formal guide on what respiratory monitoring and testing should be done after COVID-19 infection. This will ensure that people affected by COVID-19 get the care they need to maintain their lung health.

详细描述

We will prospectively recruit a representative, random sample of adult (age ≥ 18), community-dwelling patients, who have had a positive PCR test for COVID-19 infection and symptomatic infection five to 12 months previously.

This cross-sectional, observational study will have two phases:

  1. Screening:

Screening for eligibility 2. Observation Period:

  1. Online / telephone visit: All participants will complete a series of questionnaires (either online or by phone with the assistance of research personnel). In the questionnaires they will be asked about respiratory symptoms (the primary outcome), baseline participant data, burden of respiratory symptoms, overall quality of life, mental health issues as well as physical and psychological trauma from COVID-19.
  2. In-person visit: All participants will complete pulmonary function testing including oscillometry.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • Community dwelling
  • First occurrence of a positive diagnostic test for SARS-CoV-2 infection (i.e., PCR or rapid antigen test, including at-home rapid antigen test) and symptomatic infection 5-12 months previously
  • Consent provided
  • Willing and able to go to study site for pulmonary function testing including oscillometry

排除标准

  • Not able to communicate with our research personnel (themselves or through a translator)

结局指标

主要结局

To determine the prevalence of respiratory post-acute sequelae of SARS-CoV-2 (PASC) and PASC

时间窗: At five-12 months post positive PCR test for SARS-CoV-2 infection

次要结局

  • To determine objective physiologic characteristics of respiratory PASC(At five-12 months post positive PCR test for SARS-CoV-2 infection)
  • To determine the spectrum of severity of respiratory PASC(At five-12 months post positive PCR test for SARS-CoV-2 infection)
  • To determine risk factors for respiratory PASC(At five-12 months post positive PCR test for SARS-CoV-2 infection)

研究者

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

Andrea Gershon

Scientist and Respirologist

Sunnybrook Health Sciences Centre

研究点 (8)

Loading locations...

相似试验