Clinical trial NCT04549636: COVID-19 Related Lung Ventilation and Perfusion Injury
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
Asthma
Healthy
Keywords: covid-19
lung ventilation
lung perfusion
V/Q SPECT
lung health
Technegas
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Research St. Joseph's - Hamilton
name: Cyclomedica Australia Pty Ltd
First posted: 2020-09-16
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

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.


Eligibility criteria: 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

Primary outcomes:
measure: Short-term difference in ventilation defect percent assessed by ventilation SPECT-CT - healthy
timeFrame: ≤4-weeks post COVID-19 recovery (Visit 1)
measure: Short-term difference in perfusion defect percent assessed by perfusion SPECT-CT - healthy
timeFrame: ≤4-weeks post COVID-19 recovery (Visit 1)
measure: Short-term difference in lung ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - healthy
timeFrame: ≤4-weeks post COVID-19 recovery (Visit 1)
measure: Long-term difference in ventilation defect percent assessed by ventilation SPECT-CT - healthy
timeFrame: 6-months post COVID-19 recovery (Visit 2)
measure: Long-term difference in perfusion defect percent assessed by perfusion SPECT-CT - healthy
timeFrame: 6-months post COVID-19 recovery (Visit 2)
measure: Long-term difference in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - healthy
timeFrame: 6-months post COVID-19 recovery (Visit 2)
measure: Short-term difference in ventilation defect percent assessed by ventilation SPECT-CT - asthmatic
timeFrame: ≤4-weeks post COVID-19 recovery (Visit 1)
measure: Short-term difference in perfusion defect percent assessed by perfusion SPECT-CT - asthmatic
timeFrame: ≤4-weeks post COVID-19 recovery (Visit 1)
measure: Short-term difference in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - asthmatic
timeFrame: ≤4-weeks post COVID-19 recovery (Visit 1)
measure: Long-term difference in ventilation defect percent assessed by ventilation SPECT-CT - asthmatic
timeFrame: 6-months post COVID-19 recovery (Visit 2)
measure: Long-term difference in perfusion defect percent assessed by perfusion SPECT-CT - asthmatic
timeFrame: 6-months post COVID-19 recovery (Visit 2)
measure: Long-term difference in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - asthmatic
timeFrame: 6-months post COVID-19 recovery (Visit 2)
measure: Longitudinal change in ventilation defect percent assessed by ventilation SPECT-CT - healthy
timeFrame: 6-months post COVID-19 recovery (Visit 2)
measure: Longitudinal change in perfusion defect percent assessed by perfusion SPECT-CT - healthy
timeFrame: 6-months post COVID-19 recovery (Visit 2)
measure: Longitudinal change in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - healthy
timeFrame: 6-months post COVID-19 recovery (Visit 2)
measure: Longitudinal change in ventilation defect percent assessed by ventilation SPECT-CT - asthmatic
timeFrame: 6-months post COVID-19 recovery (Visit 2)
measure: Longitudinal change in perfusion defect percent assessed by perfusion SPECT-CT - asthmatic
timeFrame: 6-months post COVID-19 recovery (Visit 2)
measure: Longitudinal change in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - asthmatic
timeFrame: 6-months post COVID-19 recovery (Visit 2)
Secondary outcomes:
measure: Correlation of lung ventilation with the St. George's Respiratory Questionnaire (SGRQ) score ≤4-weeks post COVID-19 recovery
timeFrame: ≤4-weeks post COVID-19 recovery (Visit 1)
measure: Correlation of lung ventilation with six-minute walk distance (6MWD) ≤4-weeks post COVID-19 recovery
timeFrame: ≤4-weeks post COVID-19 recovery (Visit 1)
measure: Correlation of lung ventilation with the forced expiratory volume in one second (FEV1) ≤4-weeks post COVID-19 recovery
timeFrame: ≤4-weeks post COVID-19 recovery (Visit 1)
measure: Correlation of lung ventilation with the diffusing capacity of the lung for carbon monoxide (DLCO) ≤4-weeks post COVID-19 recovery
timeFrame: ≤4-weeks post COVID-19 recovery (Visit 1)
measure: Correlation of lung ventilation with the St. George's Respiratory Questionnaire (SGRQ) score 6-months post COVID-19 recovery
timeFrame: 6-months post COVID-19 recovery (Visit 2)
measure: Correlation of lung ventilation with six-minute walk distance (6MWD) 6-months post COVID-19 recovery
timeFrame: 6-months post COVID-19 recovery (Visit 2)
measure: Correlation of lung ventilation with the forced expiratory volume in one second (FEV1) 6-months post COVID-19 recovery
timeFrame: 6-months post COVID-19 recovery (Visit 2)
measure: Correlation of lung ventilation with the diffusing capacity of the lung for carbon monoxide (DLCO) 6-months post COVID-19 recovery
timeFrame: 6-months post COVID-19 recovery (Visit 2)
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: Sarah Svenningsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: