Ventilatory and Perfusion Abnormalities in Individuals With Post-Acute Sequelae of SARS-CoV-2 Infection

Study Overview
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Brief Summary
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Prospective cohort study to evaluate the utility of quantitative CT analysis to assess ventilation and perfusion defects in patients with Post-acute Sequelae of SARS-CoV-2 (PASC) and functional limitations

Detailed Description
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This is a study to describe the overall pattern of lung ventilation and perfusion defects in individuals with PASC. Subjects with PASC with a documented history of COVID-19 and persistent symptoms of fatigue, dyspnea, and/or exercise intolerance will complete questionnaires, and undergo pulmonary function tests, 6-minute walk tests, and a low dose CT chest to describe the overall pattern of lung regional ventilation and blood distribution and to compare this pattern to asymptomatic controls with and without prior COVID-19.

Official Title
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Quantitative Computed Tomography to Assess Ventilatory and Perfusion Abnormalities in Individuals With Post-Acute Sequelae of SARS-CoV-2 Infection

Conditions
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Post-Acute COVID-19, Post COVID-19 Condition, Post Viral Fatigue, Dyspnea

Intervention / Treatment
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* Diagnostic Test: Computed Tomography of the Chest


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Self-reported or documented SARS-CoV-2 infection by RT-PCR or Antigen testing > 3 months ago or no previous history of SARS-CoV-2 infection (control group only) Normal or mild abnormalities on baseline Pulmonary Function Tests (PFTs) New or worsening symptoms of chronic fatigue, dyspnea or exercise intolerance after COVID-19 with otherwise unclear etiology (PASC group only) Exclusion Criteria: SARS-CoV-2 infection by RT-PCR or Antigen testing within the last 3 months Inability to provide consent or non-English speaking Pregnancy Any respiratory infection in last 4 weeks PFT relative contraindications History of major cardiovascular, pulmonary, renal, hepatic, autoimmune or neuromuscular disease including asthma, COPD, interstitial lung disease, heart failure, pulmonary arterial hypertension, or prior pulmonary embolism Active malignancy undergoing treatment or history of malignancy involving the lung

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post-Acute Sequelae of SARS-CoV-2 (PASC) Group<br>Subjects with PASC with a documented history of COVID-19 and persistent symptoms of fatigue, dyspnea, and/or exercise intolerance | Diagnostic Test: Computed Tomography of the Chest<br>* Quantitative Computed Tomography of the chest in the inspiratory and expiratory phases will be performed to assess regional lung ventilation as well as pulmonary vascular volume and distribution<br>|
| Control: Fully recovered COVID-19<br>Subjects with a history of COVID-19 who have fully recovered from COVID-19 with no post-acute sequelae of SARS-Cov-2 | Diagnostic Test: Computed Tomography of the Chest<br>* Quantitative Computed Tomography of the chest in the inspiratory and expiratory phases will be performed to assess regional lung ventilation as well as pulmonary vascular volume and distribution<br>|
| Control: No history of COVID-19<br>Healthy subjects without a documented history of COVID-19, no current symptoms, and a normal baseline High resolution CT of the chest | Diagnostic Test: Computed Tomography of the Chest<br>* Quantitative Computed Tomography of the chest in the inspiratory and expiratory phases will be performed to assess regional lung ventilation as well as pulmonary vascular volume and distribution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of regional lung ventilation |  | 1 day | 
| Measures of blood volume distribution |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea severity scores |  | 1 day | 
| Fatigue severity scores |  | 1 day | 
| Quality of life scores |  | 1 day | 
| Six-minute walk distance |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventilation Perfusion Mismatch