COVID-19 Related Lung Ventilation and Perfusion Injury

NCT ID: NCT04549636

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-18

Study Completion Date

2022-01-26

Brief Summary

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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

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Conditions

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Covid-19 Asthma Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy COVID-19+

Individuals who recently recovered from COVID-19 and who have no history of lung disease

V/Q SPECT-CT

Intervention Type OTHER

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)

Intervention Type OTHER

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

Intervention Type OTHER

At visits 1 and 2, dyspnea will be evaluated using the mMRC (Modified Medical Research Council) Dyspnea Scale.

Six-minute walk test (6MWT)

Intervention Type OTHER

At visits 1 and 2, exercise capacity will be evaluated using the six-minute walk test (6MWT).

Spirometry

Intervention Type OTHER

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

Intervention Type OTHER

At visits 1 and 2, plethysmography and the diffusing capacity of the lung for carbon monoxide (DLCO) will be performed.

Airwave Oscillometry

Intervention Type OTHER

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

V/Q SPECT-CT

Intervention Type OTHER

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)

Intervention Type OTHER

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

Intervention Type OTHER

At visits 1 and 2, dyspnea will be evaluated using the mMRC (Modified Medical Research Council) Dyspnea Scale.

Six-minute walk test (6MWT)

Intervention Type OTHER

At visits 1 and 2, exercise capacity will be evaluated using the six-minute walk test (6MWT).

Spirometry

Intervention Type OTHER

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

Intervention Type OTHER

At visits 1 and 2, plethysmography and the diffusing capacity of the lung for carbon monoxide (DLCO) will be performed.

Airwave Oscillometry

Intervention Type OTHER

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

V/Q SPECT-CT

Intervention Type OTHER

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)

Intervention Type OTHER

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

Intervention Type OTHER

At visits 1 and 2, dyspnea will be evaluated using the mMRC (Modified Medical Research Council) Dyspnea Scale.

Six-minute walk test (6MWT)

Intervention Type OTHER

At visits 1 and 2, exercise capacity will be evaluated using the six-minute walk test (6MWT).

Spirometry

Intervention Type OTHER

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

Intervention Type OTHER

At visits 1 and 2, plethysmography and the diffusing capacity of the lung for carbon monoxide (DLCO) will be performed.

Airwave Oscillometry

Intervention Type OTHER

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

V/Q SPECT-CT

Intervention Type OTHER

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)

Intervention Type OTHER

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

Intervention Type OTHER

At visits 1 and 2, dyspnea will be evaluated using the mMRC (Modified Medical Research Council) Dyspnea Scale.

Six-minute walk test (6MWT)

Intervention Type OTHER

At visits 1 and 2, exercise capacity will be evaluated using the six-minute walk test (6MWT).

Spirometry

Intervention Type OTHER

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

Intervention Type OTHER

At visits 1 and 2, plethysmography and the diffusing capacity of the lung for carbon monoxide (DLCO) will be performed.

Airwave Oscillometry

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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).

Intervention Type OTHER

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.

Intervention Type OTHER

Six-minute walk test (6MWT)

At visits 1 and 2, exercise capacity will be evaluated using the six-minute walk test (6MWT).

Intervention Type OTHER

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.

Intervention Type OTHER

Plethysmography & DLCO

At visits 1 and 2, plethysmography and the diffusing capacity of the lung for carbon monoxide (DLCO) will be performed.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Svenningsen, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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FIRH002

Identifier Type: -

Identifier Source: org_study_id

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