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Completed

NCT Number: NCT04549636

COVID-19 Related Lung Ventilation and Perfusion Injury

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.

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Key information

Conditions

COVID-19 Asthma Bronchial Diseases Coronaviridae Infections Coronavirus Infections Healthy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)
  • 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

Exclusion criteria

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
  • 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

Treatment and study plan

V/Q SPECT-CT

Other

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 Scale

Other

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).

Spirometry

Other

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 & DLCO

Other

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

Airwave Oscillometry

Other

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.

Primary outcomes

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Secondary outcomes

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

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

    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).

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

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

    In COVID-19+ participants, the correlation of lung ventilation with six-minute walk distance (6MWD) ≤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

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

    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).

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

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

    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).

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

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

    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).

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

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

    In COVID-19+ participants, the correlation of lung ventilation with six-minute walk distance (6MWD) 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

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

    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).

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

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

    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).

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2020
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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