COVID-19 Related Lung Ventilation and Perfusion Injury

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04549636
• Other study ID #: FIRH002
• Status: Recruiting
• Start date: October 18, 2020
• Est. completion date: December 2021

Study information

• Verified date: September 2021
• Source: McMaster University
• Contact: Sarah Svenningsen, PhD
• Phone: +1 (905) 522-1155
• Email: svennins[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Covid-19
• Healthy

Intervention

Other:
• V/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.
• St. George's Respiratory Questionnaire (SGRQ)
At visits 1 and 2, quality of life will be evaluated using the St. George's Respiratory Questionnaire (SGRQ).
• mMRC (Modified Medical Research Council) Dyspnea Scale
At visits 1 and 2, dyspnea will be evaluated using the mMRC (Modified Medical Research Council) Dyspnea Scale.
• Six-minute walk test (6MWT)
At visits 1 and 2, exercise capacity will be evaluated using the six-minute walk test (6MWT).
• Spirometry
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.
• Plethysmography & DLCO
At visits 1 and 2, plethysmography and the diffusing capacity of the lung for carbon monoxide (DLCO) will be performed.
• Airwave 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.

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Cyclomedica Australia Pty Ltd, Research St. Joseph's - Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Correlation of lung ventilation with the St. George's Respiratory Questionnaire (SGRQ) score =4-weeks post COVID-19 recovery	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)
Secondary	Correlation of lung ventilation with six-minute walk distance (6MWD) =4-weeks post COVID-19 recovery	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)
Secondary	Correlation of lung ventilation with the forced expiratory volume in one second (FEV1) =4-weeks post COVID-19 recovery	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)
Secondary	Correlation of lung ventilation with the diffusing capacity of the lung for carbon monoxide (DLCO) =4-weeks post COVID-19 recovery	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)
Secondary	Correlation of lung ventilation with the St. George's Respiratory Questionnaire (SGRQ) score 6-months post COVID-19 recovery	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)
Secondary	Correlation of lung ventilation with six-minute walk distance (6MWD) 6-months post COVID-19 recovery	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)
Secondary	Correlation of lung ventilation with the forced expiratory volume in one second (FEV1) 6-months post COVID-19 recovery	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)
Secondary	Correlation of lung ventilation with the diffusing capacity of the lung for carbon monoxide (DLCO) 6-months post COVID-19 recovery	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)