The Canadian Respiratory Research Network Long COVID-19 Study

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05181670
Collaborator
Canadian Institutes of Health Research (CIHR) (Other)
650
12

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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:
    1. Screening:

    Screening for eligibility

    1. Observation Period:

    2. 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.

    3. 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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    650 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Canadian Respiratory Research Network Long COVID-19 Study
    Anticipated Study Start Date :
    May 31, 2022
    Anticipated Primary Completion Date :
    May 31, 2023
    Anticipated Study Completion Date :
    May 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. To determine risk factors for respiratory PASC [At five-12 months post positive PCR test for SARS-CoV-2 infection]

    2. To determine the spectrum of severity of respiratory PASC [At five-12 months post positive PCR test for SARS-CoV-2 infection]

    3. To determine objective physiologic characteristics of respiratory PASC [At five-12 months post positive PCR test for SARS-CoV-2 infection]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Aged ≥18

    • Community dwelling

    • First occurrence of acute SARS-CoV-2 infection (as per the Government of Canada COVID-19 case definitions) 5-12 months previously

    • Experienced symptoms at the time of acute SARS-CoV-2 infection

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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sunnybrook Health Sciences Centre
    • Canadian Institutes of Health Research (CIHR)

    Investigators

    • Principal Investigator: Andrea Gershon, MD, MSc, Sunnybrook Health Sciences Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrea Gershon, Scientist and Respirologist, Sunnybrook Health Sciences Centre
    ClinicalTrials.gov Identifier:
    NCT05181670
    Other Study ID Numbers:
    • 177755
    First Posted:
    Jan 6, 2022
    Last Update Posted:
    May 31, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 31, 2022