COVID-19 Related Lung Ventilation and Perfusion Injury

• Conditions: Healthy; Covid-19; Asthma

• Registration Number: NCT04549636
• Lead Sponsor: McMaster University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-28
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-16
• Study Start: 2020-10-18
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-09
• Last Update Posted: 2021-09-10
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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 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/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
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
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
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
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
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
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/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.
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
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 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 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
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.

Secondary Outcome Measures

Name	Time	Method
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 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 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).
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 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 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).

Trial Locations

Locations (1)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada