COVID-19 Related Lung Ventilation and Perfusion Injury

NCT04549636 | Completed

• 1 other identifier: FIRH002
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

covid-19; lung ventilation; lung perfusion; V/Q SPECT; lung health; Technegas

Outcome Measures

Primary Outcomes (18)

• 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

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

• 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

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

• 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

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

• 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

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

• 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

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

• 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

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

• 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

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

• 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

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

• 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

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

• 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

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

• 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

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

• 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

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

• 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

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

• 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

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

• 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

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

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (8)

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

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

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

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

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

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

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

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

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

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

Study Arms (4)

healthy COVID-19+

Individuals who recently recovered from COVID-19 and who have no history of lung disease

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

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

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

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

Interventions

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.

asthmatic COVID-19+; asthmatic COVID-19-; healthy COVID-19+; healthy COVID-19-

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).

asthmatic COVID-19+; asthmatic COVID-19-; healthy COVID-19+; healthy COVID-19-

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.

asthmatic COVID-19+; asthmatic COVID-19-; healthy COVID-19+; healthy COVID-19-

Six-minute walk test (6MWT) OTHER

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

asthmatic COVID-19+; asthmatic COVID-19-; healthy COVID-19+; healthy COVID-19-

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.

asthmatic COVID-19+; asthmatic COVID-19-; healthy COVID-19+; healthy COVID-19-

Plethysmography & DLCO OTHER

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

asthmatic COVID-19+; asthmatic COVID-19-; healthy COVID-19+; healthy COVID-19-

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.

asthmatic COVID-19+; asthmatic COVID-19-; healthy COVID-19+; healthy COVID-19-

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

community sample

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

COVID-19; Asthma

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sarah Svenningsen, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 16, 2020
• Study Start: October 18, 2020
• Primary Completion: January 26, 2022
• Study Completion: January 26, 2022
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)