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Covid-19NCT04549636

COVID-19 Related Lung Ventilation and Perfusion Injury

An observational study of Covid-19 and Asthma, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Little is currently known about the immediate and long-term effect of COVID-19 on lung ventilation (delivery of air to the lungs) and lung perfusion (delivery of blood to the lungs). Some people who survive COVID-19 may have lung ventilation and/or perfusion injury that persists following COVID-19 recovery. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Covid-19, Asthma, Healthy
What is being tested?
V/Q SPECT-CT, St. George's Respiratory Questionnaire (SGRQ) and mMRC (Modified Medical Research Council) Dyspnea Scale
How many people
42 participants
Where
1 siteCanada
Study dates
18 Oct 2020to 26 Jan 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: community sample

Who may be able to join

  • For all participants:
  • Males and females ≥ 18 years of age
  • Individuals able and willing to provide written informed consent
  • Individuals able and willing to comply with the study protocol
  • For participants with asthma:
  • Individuals with physician confirmed asthma (12% bronchodilator reversibility or PC20 methacholine less than 8mg/ml)
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  • Individuals treated with inhaled corticosteroids, oral corticosteroids and/or anti-T2 biologics
  • For participants who recently recovered from covid-19:
  • Individuals previously diagnosed with covid-19 confirmed by FLOQswab test
  • Individuals who recently (≤4-weeks) recovered from covid-19

Who cannot join

  • For all participants:
  • Males and females < 18 years of age
  • Individuals who are unable to read and/or understand English
  • Individuals who are pregnant or breastfeeding
  • Individuals who currently smoke or are an ex-smoker with ≥10 pack-year smoking history
  • Individuals who in the opinion of the investigator, are mentally or legally incapacitated, preventing informed consent from being obtained
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  • Individuals who are unable to complete one or more study manoeuvres
  • For participants with no history of lung disease:
  • Individuals with a history of respiratory infection or disease
  • For participants who have not been diagnosed with covid-19:
  • Individuals who have previously had covid-19 confirmed by FLOQswab test

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

Other trials in Canada

About this study

Official title: Prospective Longitudinal Study to Characterize and Understand the Clinical Relevance of SARS-CoV2 Related Ventilation and Perfusion Injury Evaluated by V/Q SPECT-CT in an Asthmatic and Healthy Population

Little is currently known about the immediate and long-term effect of COVID-19 on lung ventilation (delivery of air to the lungs) and lung perfusion (delivery of blood to the lungs). Some people who survive COVID-19 may have lung ventilation and/or perfusion injury that persists following COVID-19 recovery. This lung injury may be related to inflammation in the lung, breathlessness, exercise limitation and reduced quality of life. Therefore, towards the goal of understanding the effects of COVID-19 on lung health, the purpose of this study is to characterize and understand the clinical relevance of COVID-19 related lung ventilation and perfusion injury and associated inflammatory status, ≤4 weeks and 6-months following COVID-19 recovery in an asthmatic and healthy population. To do this, an asthmatic and healthy population who have, and have not, been previously diagnosed with COVID-19 will be studied.

Conditions
Covid-19, Asthma, Healthy
Being tested
V/Q SPECT-CT, St. George's Respiratory Questionnaire (SGRQ), mMRC (Modified Medical Research Council) Dyspnea Scale, Six-minute walk test (6MWT), Spirometry
Keywords
covid-19, lung ventilation, lung perfusion, V/Q SPECT, lung health, Technegas
Medical subject headings
COVID-19, Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • V/Q SPECT-CTOther

    At visits 1 and 2, ventilation will be assessed by 99mTc Technegas SPECT ventilation scan and perfusion will be assessed by 99mTc Macroaggregated Albumin SPECT perfusion scan.

  • St. George's Respiratory Questionnaire (SGRQ)Other

    At visits 1 and 2, quality of life will be evaluated using the St. George's Respiratory Questionnaire (SGRQ).

  • mMRC (Modified Medical Research Council) Dyspnea ScaleOther

    At visits 1 and 2, dyspnea will be evaluated using the mMRC (Modified Medical Research Council) Dyspnea Scale.

  • Six-minute walk test (6MWT)Other

    At visits 1 and 2, exercise capacity will be evaluated using the six-minute walk test (6MWT).

  • SpirometryOther

    At visits 1 and 2, spirometry will be performed to quantify the forced expiratory volume in one second (FEV1), the forced vital capacity (FVC) and FEV1/FVC.

  • Plethysmography & DLCOOther

    At visits 1 and 2, plethysmography and the diffusing capacity of the lung for carbon monoxide (DLCO) will be performed.

  • Airwave OscillometryOther

    At visits 1 and 2, airwave oscillometry will be performed to obtain resistance (R) and reactance (X) at 5 Hz (R5) and 19 Hz (R19). The resonance frequency (fres), area above the reactance curve (AX) and the heterogeneity of obstruction (R5-19) will be derived from R and X.

Study groups in NCT04549636
Study groupRoleWhat they receive
healthy COVID-19+Individuals who recently recovered from COVID-19 and who have no history of lung disease
Receives: Other: V/Q SPECT-CT; Other: St. George's Respiratory Questionnaire (SGRQ); Other: mMRC (Modified Medical Research Council) Dyspnea Scale; Other: Six-minute walk test (6MWT); Other: Spirometry; Other: Plethysmography & DLCO; Other: Airwave Oscillometry
asthmatic COVID-19+Individuals who recently recovered from COVID-19 and who have asthma
Receives: Other: V/Q SPECT-CT; Other: St. George's Respiratory Questionnaire (SGRQ); Other: mMRC (Modified Medical Research Council) Dyspnea Scale; Other: Six-minute walk test (6MWT); Other: Spirometry; Other: Plethysmography & DLCO; Other: Airwave Oscillometry
healthy COVID-19-Individuals who have not been diagnosed with COVID-19 and who have no history of lung disease
Receives: Other: V/Q SPECT-CT; Other: St. George's Respiratory Questionnaire (SGRQ); Other: mMRC (Modified Medical Research Council) Dyspnea Scale; Other: Six-minute walk test (6MWT); Other: Spirometry; Other: Plethysmography & DLCO; Other: Airwave Oscillometry
asthmatic COVID-19-Individuals who have not been diagnosed with COVID-19 and who have asthma
Receives: Other: V/Q SPECT-CT; Other: St. George's Respiratory Questionnaire (SGRQ); Other: mMRC (Modified Medical Research Council) Dyspnea Scale; Other: Six-minute walk test (6MWT); Other: Spirometry; Other: Plethysmography & DLCO; Other: Airwave Oscillometry

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Short-term difference in ventilation defect percent assessed by ventilation SPECT-CT - healthy

    The short-term difference in lung ventilation between healthyCOVID-19+ and healthyCOVID-19- participants

    Measured: ≤4-weeks post COVID-19 recovery (Visit 1)

  2. Short-term difference in perfusion defect percent assessed by perfusion SPECT-CT - healthy

    The short-term difference in lung perfusion between healthyCOVID-19+ and healthyCOVID-19- participants

    Measured: ≤4-weeks post COVID-19 recovery (Visit 1)

  3. Short-term difference in lung ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - healthy

    The short-term difference in lung ventilation/perfusion mismatch between healthyCOVID-19+ and healthyCOVID-19- participants

    Measured: ≤4-weeks post COVID-19 recovery (Visit 1)

  4. Long-term difference in ventilation defect percent assessed by ventilation SPECT-CT - healthy

    The long-term difference in lung ventilation between healthyCOVID-19+ and healthyCOVID-19- participants

    Measured: 6-months post COVID-19 recovery (Visit 2)

  5. Long-term difference in perfusion defect percent assessed by perfusion SPECT-CT - healthy

    The long-term difference in lung perfusion between healthyCOVID-19+ and healthyCOVID-19- participants

    Measured: 6-months post COVID-19 recovery (Visit 2)

  6. Long-term difference in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - healthy

    The long-term difference in lung ventilation/perfusion mismatch between healthyCOVID-19+ and healthyCOVID-19- participants

    Measured: 6-months post COVID-19 recovery (Visit 2)

  7. Short-term difference in ventilation defect percent assessed by ventilation SPECT-CT - asthmatic

    The short-term difference in lung ventilation between asthmaticCOVID-19+ and asthmaticCOVID-19- participants

    Measured: ≤4-weeks post COVID-19 recovery (Visit 1)

  8. Short-term difference in perfusion defect percent assessed by perfusion SPECT-CT - asthmatic

    The short-term difference in lung perfusion between asthmaticCOVID-19+ and asthmaticCOVID-19- participants

    Measured: ≤4-weeks post COVID-19 recovery (Visit 1)

  9. Short-term difference in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - asthmatic

    The short-term difference in lung ventilation/perfusion mismatch between asthmaticCOVID-19+ and asthmaticCOVID-19- participants

    Measured: ≤4-weeks post COVID-19 recovery (Visit 1)

  10. Long-term difference in ventilation defect percent assessed by ventilation SPECT-CT - asthmatic

    The long-term difference in lung ventilation between asthmaticCOVID-19+ and asthmaticCOVID-19- participants

    Measured: 6-months post COVID-19 recovery (Visit 2)

  11. Long-term difference in perfusion defect percent assessed by perfusion SPECT-CT - asthmatic

    The long-term difference in lung perfusion between asthmaticCOVID-19+ and asthmaticCOVID-19- participants

    Measured: 6-months post COVID-19 recovery (Visit 2)

  12. Long-term difference in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - asthmatic

    The long-term difference in lung ventilation/perfusion mismatch between asthmaticCOVID-19+ and asthmaticCOVID-19- participants

    Measured: 6-months post COVID-19 recovery (Visit 2)

  13. Longitudinal change in ventilation defect percent assessed by ventilation SPECT-CT - healthy

    Difference in the 6-month change in lung ventilation between healthyCOVID-19+ and healthyCOVID-19- participants

    Measured: 6-months post COVID-19 recovery (Visit 2)

  14. Longitudinal change in perfusion defect percent assessed by perfusion SPECT-CT - healthy

    Difference in the 6-month change in lung perfusion between healthyCOVID-19+ and healthyCOVID-19- participants

    Measured: 6-months post COVID-19 recovery (Visit 2)

  15. Longitudinal change in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - healthy

    Difference in the 6-month change in lung ventilation/perfusion mismatch between healthyCOVID-19+ and healthyCOVID-19- participants

    Measured: 6-months post COVID-19 recovery (Visit 2)

  16. Longitudinal change in ventilation defect percent assessed by ventilation SPECT-CT - asthmatic

    Difference in the 6-month change in lung ventilation between asthmaticCOVID-19+ and asthmaticCOVID-19- participants.

    Measured: 6-months post COVID-19 recovery (Visit 2)

  17. Longitudinal change in perfusion defect percent assessed by perfusion SPECT-CT - asthmatic

    Difference in the 6-month change in lung perfusion between asthmaticCOVID-19+ and asthmaticCOVID-19- participants.

    Measured: 6-months post COVID-19 recovery (Visit 2)

  18. Longitudinal change in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - asthmatic

    Difference in the 6-month change in lung ventilation/perfusion mismatch between asthmaticCOVID-19+ and asthmaticCOVID-19- participants.

    Measured: 6-months post COVID-19 recovery (Visit 2)

Secondary outcomes (8)
  1. Correlation of lung ventilation with the St. George's Respiratory Questionnaire (SGRQ) score ≤4-weeks post COVID-19 recovery

    In COVID-19+ participants, the correlation of lung ventilation with the St. George's Respiratory Questionnaire (SGRQ) score ≤4-weeks post COVID-19 recovery (Visit 1).

    Measured: ≤4-weeks post COVID-19 recovery (Visit 1)

  2. Correlation of lung ventilation with six-minute walk distance (6MWD) ≤4-weeks post COVID-19 recovery

    In COVID-19+ participants, the correlation of lung ventilation with six-minute walk distance (6MWD) ≤4-weeks post COVID-19 recovery (Visit 1).

    Measured: ≤4-weeks post COVID-19 recovery (Visit 1)

  3. Correlation of lung ventilation with the forced expiratory volume in one second (FEV1) ≤4-weeks post COVID-19 recovery

    In COVID-19+ participants, the correlation of lung ventilation with the forced expiratory volume in one second (FEV1) ≤4-weeks post COVID-19 recovery (Visit 1).

    Measured: ≤4-weeks post COVID-19 recovery (Visit 1)

  4. Correlation of lung ventilation with the diffusing capacity of the lung for carbon monoxide (DLCO) ≤4-weeks post COVID-19 recovery

    In COVID-19+ participants, the correlation of lung ventilation with the diffusing capacity of the lung for carbon monoxide (DLCO) ≤4-weeks post COVID-19 recovery (Visit 1).

    Measured: ≤4-weeks post COVID-19 recovery (Visit 1)

  5. Correlation of lung ventilation with the St. George's Respiratory Questionnaire (SGRQ) score 6-months post COVID-19 recovery

    In COVID-19+ participants, the correlation of lung ventilation with the St. George's Respiratory Questionnaire (SGRQ) score 6-months post COVID-19 recovery (Visit 2).

    Measured: 6-months post COVID-19 recovery (Visit 2)

  6. Correlation of lung ventilation with six-minute walk distance (6MWD) 6-months post COVID-19 recovery

    In COVID-19+ participants, the correlation of lung ventilation with six-minute walk distance (6MWD) 6-months post COVID-19 recovery (Visit 2).

    Measured: 6-months post COVID-19 recovery (Visit 2)

  7. Correlation of lung ventilation with the forced expiratory volume in one second (FEV1) 6-months post COVID-19 recovery

    In COVID-19+ participants, the correlation of lung ventilation with the forced expiratory volume in one second (FEV1) 6-months post COVID-19 recovery (Visit 2).

    Measured: 6-months post COVID-19 recovery (Visit 2)

  8. Correlation of lung ventilation with the diffusing capacity of the lung for carbon monoxide (DLCO) 6-months post COVID-19 recovery

    In COVID-19+ participants, the correlation of lung ventilation with the diffusing capacity of the lung for carbon monoxide (DLCO) 6-months post COVID-19 recovery (Visit 2).

    Measured: 6-months post COVID-19 recovery (Visit 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2020
  2. Study start18 Oct 2020
  3. Primary completion26 Jan 2022
  4. Study completion26 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04549636
Sponsor's protocol ID
FIRH002
Status last verified
Aug 2025
First submitted
28 Aug 2020
Last updated
14 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared with other researchers.

Questions about this trial

What is this clinical trial studying?

An observational study of Covid-19 and Asthma, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short-term difference in ventilation defect percent assessed by ventilation SPECT-CT - healthy (time frame: ≤4-weeks post COVID-19 recovery (Visit 1)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.

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