Covid-19, Asthma, Healthy
Conditions
Keywords
covid-19, lung ventilation, lung perfusion, V/Q SPECT, lung health, Technegas
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.
Interventions
OTHERV/Q SPECT-CT
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).
OTHERmMRC (Modified Medical Research Council) Dyspnea Scale
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).
OTHERSpirometry
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.
OTHERPlethysmography & DLCO
At visits 1 and 2, plethysmography and the diffusing capacity of the lung for carbon monoxide (DLCO) will be performed.
OTHERAirwave Oscillometry
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.
Sponsors
McMaster University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal change in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - asthmatic | 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. |
| Long-term difference in ventilation defect percent assessed by ventilation SPECT-CT - asthmatic | 6-months post COVID-19 recovery (Visit 2) | The long-term difference in lung ventilation between asthmaticCOVID-19+ and asthmaticCOVID-19- participants |
| Long-term difference in perfusion defect percent assessed by perfusion SPECT-CT - asthmatic | 6-months post COVID-19 recovery (Visit 2) | The long-term difference in lung perfusion between asthmaticCOVID-19+ and asthmaticCOVID-19- participants |
| Long-term difference in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - asthmatic | 6-months post COVID-19 recovery (Visit 2) | The long-term difference in lung ventilation/perfusion mismatch between asthmaticCOVID-19+ and asthmaticCOVID-19- participants |
| Longitudinal change in ventilation defect percent assessed by ventilation SPECT-CT - healthy | 6-months post COVID-19 recovery (Visit 2) | Difference in the 6-month change in lung ventilation between healthyCOVID-19+ and healthyCOVID-19- participants |
| Longitudinal change in perfusion defect percent assessed by perfusion SPECT-CT - healthy | 6-months post COVID-19 recovery (Visit 2) | Difference in the 6-month change in lung perfusion between healthyCOVID-19+ and healthyCOVID-19- participants |
| Longitudinal change in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - healthy | 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 |
| Longitudinal change in ventilation defect percent assessed by ventilation SPECT-CT - asthmatic | 6-months post COVID-19 recovery (Visit 2) | Difference in the 6-month change in lung ventilation between asthmaticCOVID-19+ and asthmaticCOVID-19- participants. |
| Longitudinal change in perfusion defect percent assessed by perfusion SPECT-CT - asthmatic | 6-months post COVID-19 recovery (Visit 2) | Difference in the 6-month change in lung perfusion between asthmaticCOVID-19+ and asthmaticCOVID-19- participants. |
| Short-term difference in ventilation defect percent assessed by ventilation SPECT-CT - healthy | ≤4-weeks post COVID-19 recovery (Visit 1) | The short-term difference in lung ventilation between healthyCOVID-19+ and healthyCOVID-19- participants |
| Short-term difference in perfusion defect percent assessed by perfusion SPECT-CT - healthy | ≤4-weeks post COVID-19 recovery (Visit 1) | The short-term difference in lung perfusion between healthyCOVID-19+ and healthyCOVID-19- participants |
| Short-term difference in lung ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - healthy | ≤4-weeks post COVID-19 recovery (Visit 1) | The short-term difference in lung ventilation/perfusion mismatch between healthyCOVID-19+ and healthyCOVID-19- participants |
| Long-term difference in ventilation defect percent assessed by ventilation SPECT-CT - healthy | 6-months post COVID-19 recovery (Visit 2) | The long-term difference in lung ventilation between healthyCOVID-19+ and healthyCOVID-19- participants |
| Long-term difference in perfusion defect percent assessed by perfusion SPECT-CT - healthy | 6-months post COVID-19 recovery (Visit 2) | The long-term difference in lung perfusion between healthyCOVID-19+ and healthyCOVID-19- participants |
| Long-term difference in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - healthy | 6-months post COVID-19 recovery (Visit 2) | The long-term difference in lung ventilation/perfusion mismatch between healthyCOVID-19+ and healthyCOVID-19- participants |
| Short-term difference in ventilation defect percent assessed by ventilation SPECT-CT - asthmatic | ≤4-weeks post COVID-19 recovery (Visit 1) | The short-term difference in lung ventilation between asthmaticCOVID-19+ and asthmaticCOVID-19- participants |
| Short-term difference in perfusion defect percent assessed by perfusion SPECT-CT - asthmatic | ≤4-weeks post COVID-19 recovery (Visit 1) | The short-term difference in lung perfusion between asthmaticCOVID-19+ and asthmaticCOVID-19- participants |
| Short-term difference in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - asthmatic | ≤4-weeks post COVID-19 recovery (Visit 1) | The short-term difference in lung ventilation/perfusion mismatch between asthmaticCOVID-19+ and asthmaticCOVID-19- participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of lung ventilation with six-minute walk distance (6MWD) ≤4-weeks post COVID-19 recovery | ≤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). |
| 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) | 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). |
| 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) | 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). |
| 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) | 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). |
| Correlation of lung ventilation with six-minute walk distance (6MWD) 6-months post COVID-19 recovery | 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). |
| Correlation of lung ventilation with the forced expiratory volume in one second (FEV1) 6-months post COVID-19 recovery | 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). |
| Correlation of lung ventilation with the diffusing capacity of the lung for carbon monoxide (DLCO) 6-months post COVID-19 recovery | 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). |
| 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) | 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). |
Countries
Canada
Outcome results
None listed