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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05181670
Other study ID # 177755
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date August 1, 2022
Est. completion date December 31, 2024

Study information

Verified date April 2024
Source Sunnybrook Health Sciences Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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. The study of COVID-19 infection and its long-term effects is constantly evolving. Over the course of this research study, new knowledge may become available that may lead to changes in the study's outcome measures.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 650
Est. completion date December 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Aged =18 - 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 Exclusion Criteria: - Not able to communicate with our research personnel (themselves or through a translator)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Queen Elizabeth II Health Sciences Centre Halifax Nova Scotia
Canada St. Joseph's Healthcare Hamilton Hamilton Ontario
Canada Kingston Health Sciences Centre Kingston Ontario
Canada The Ottawa Hospital Ottawa Ontario
Canada Institut Universitaire de Cardiologie et de Pneumologie de Québec Québec
Canada St. Michael's Hospital Toronto Ontario
Canada Sunnybrook Health Sciences Centre Toronto Ontario
Canada St. Paul's Hospital Vancouver British Columbia

Sponsors (2)

Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the prevalence of respiratory post-acute sequelae of SARS-CoV-2 (PASC) and PASC At five-12 months post positive PCR test for SARS-CoV-2 infection
Secondary To determine risk factors for respiratory PASC At five-12 months post positive PCR test for SARS-CoV-2 infection
Secondary To determine the spectrum of severity of respiratory PASC At five-12 months post positive PCR test for SARS-CoV-2 infection
Secondary To determine objective physiologic characteristics of respiratory PASC At five-12 months post positive PCR test for SARS-CoV-2 infection
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