COVID-19 Related Lung Ventilation and Perfusion Injury
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Sarah Svenningsen, PhD
- Phone Number: 37313 +1 (905) 522-1155
- Email: svennins@mcmaster.ca
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Healthcare Hamilton
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
healthy COVID-19+
Individuals who recently recovered from COVID-19 and who have no history of lung disease
|
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.
At visits 1 and 2, quality of life will be evaluated using the St. George's Respiratory Questionnaire (SGRQ).
At visits 1 and 2, dyspnea will be evaluated using the mMRC (Modified Medical Research Council) Dyspnea Scale.
At visits 1 and 2, exercise capacity will be evaluated using the six-minute walk test (6MWT).
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.
At visits 1 and 2, plethysmography and the diffusing capacity of the lung for carbon monoxide (DLCO) will be performed.
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+
Individuals who recently recovered from COVID-19 and who have asthma
|
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.
At visits 1 and 2, quality of life will be evaluated using the St. George's Respiratory Questionnaire (SGRQ).
At visits 1 and 2, dyspnea will be evaluated using the mMRC (Modified Medical Research Council) Dyspnea Scale.
At visits 1 and 2, exercise capacity will be evaluated using the six-minute walk test (6MWT).
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.
At visits 1 and 2, plethysmography and the diffusing capacity of the lung for carbon monoxide (DLCO) will be performed.
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.
|
|
healthy COVID-19-
Individuals who have not been diagnosed with COVID-19 and who have no history of lung disease
|
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.
At visits 1 and 2, quality of life will be evaluated using the St. George's Respiratory Questionnaire (SGRQ).
At visits 1 and 2, dyspnea will be evaluated using the mMRC (Modified Medical Research Council) Dyspnea Scale.
At visits 1 and 2, exercise capacity will be evaluated using the six-minute walk test (6MWT).
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.
At visits 1 and 2, plethysmography and the diffusing capacity of the lung for carbon monoxide (DLCO) will be performed.
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-
Individuals who have not been diagnosed with COVID-19 and who have asthma
|
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.
At visits 1 and 2, quality of life will be evaluated using the St. George's Respiratory Questionnaire (SGRQ).
At visits 1 and 2, dyspnea will be evaluated using the mMRC (Modified Medical Research Council) Dyspnea Scale.
At visits 1 and 2, exercise capacity will be evaluated using the six-minute walk test (6MWT).
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.
At visits 1 and 2, plethysmography and the diffusing capacity of the lung for carbon monoxide (DLCO) will be performed.
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
≤4-weeks post COVID-19 recovery (Visit 1)
|
|
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
|
≤4-weeks post COVID-19 recovery (Visit 1)
|
|
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-weeks post COVID-19 recovery (Visit 1)
|
|
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
|
6-months post COVID-19 recovery (Visit 2)
|
|
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-months post COVID-19 recovery (Visit 2)
|
|
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
|
6-months post COVID-19 recovery (Visit 2)
|
|
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
|
≤4-weeks post COVID-19 recovery (Visit 1)
|
|
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
|
≤4-weeks post COVID-19 recovery (Visit 1)
|
|
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
|
≤4-weeks post COVID-19 recovery (Visit 1)
|
|
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
|
6-months post COVID-19 recovery (Visit 2)
|
|
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
|
6-months post COVID-19 recovery (Visit 2)
|
|
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
|
6-months post COVID-19 recovery (Visit 2)
|
|
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
|
6-months post COVID-19 recovery (Visit 2)
|
|
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
|
6-months post COVID-19 recovery (Visit 2)
|
|
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
|
6-months post COVID-19 recovery (Visit 2)
|
|
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.
|
6-months post COVID-19 recovery (Visit 2)
|
|
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.
|
6-months post COVID-19 recovery (Visit 2)
|
|
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.
|
6-months post COVID-19 recovery (Visit 2)
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
≤4-weeks post COVID-19 recovery (Visit 1)
|
|
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).
|
≤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
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-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
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).
|
≤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
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-months post COVID-19 recovery (Visit 2)
|
|
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).
|
6-months post COVID-19 recovery (Visit 2)
|
|
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).
|
6-months post COVID-19 recovery (Visit 2)
|
|
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).
|
6-months post COVID-19 recovery (Visit 2)
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Sarah Svenningsen, PhD, McMaster University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- FIRH002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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