NCT05181670

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

January 4, 2022

Last Update Submit

May 15, 2025

Conditions

Outcome Measures

Primary Outcomes (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 Outcomes (3)

  • To determine risk factors for 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 objective physiologic characteristics of respiratory PASC

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community sample

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Canada

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Andrea Gershon, MD, MSc

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientist and Respirologist

Study Record Dates

First Submitted

January 4, 2022

First Posted

January 6, 2022

Study Start

August 1, 2022

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

May 21, 2025

Record last verified: 2025-05

Locations