- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05181670
The Canadian Respiratory Research Network Long COVID-19 Study
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.
Study Overview
Status
Detailed 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:
Screening:
Screening for eligibility
Observation Period:
- 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.
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Québec, Canada
- Institut Universitaire de Cardiologie et de Pneumologie de Quebec
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British Columbia
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Vancouver, British Columbia, Canada
- St. Paul's Hospital
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Nova Scotia
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Halifax, Nova Scotia, Canada
- Queen Elizabeth II Health Sciences Centre
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Ontario
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Hamilton, Ontario, Canada
- St. Joseph's Healthcare Hamilton
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Kingston, Ontario, Canada
- Kingston Health Sciences Centre
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Ottawa, Ontario, Canada
- The Ottawa Hospital
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canada
- St. Michael's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To determine the prevalence of respiratory post-acute sequelae of SARS-CoV-2 (PASC) and PASC
Time Frame: At five-12 months post positive PCR test for SARS-CoV-2 infection
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At five-12 months post positive PCR test for SARS-CoV-2 infection
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To determine risk factors for respiratory PASC
Time Frame: At five-12 months post positive PCR test for SARS-CoV-2 infection
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At five-12 months post positive PCR test for SARS-CoV-2 infection
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To determine the spectrum of severity of respiratory PASC
Time Frame: At five-12 months post positive PCR test for SARS-CoV-2 infection
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At five-12 months post positive PCR test for SARS-CoV-2 infection
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To determine objective physiologic characteristics of respiratory PASC
Time Frame: At five-12 months post positive PCR test for SARS-CoV-2 infection
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At five-12 months post positive PCR test for SARS-CoV-2 infection
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Andrea Gershon, MD, MSc, Sunnybrook Health Sciences Centre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Post-Infectious Disorders
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- COVID-19
- Post-Acute COVID-19 Syndrome
Other Study ID Numbers
- 177755
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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