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| Name | Class |
|---|---|
| 4DMedical | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-Acute Sequelae of SARS-CoV-2 (PASC) Group | Subjects with PASC with a documented history of COVID-19 and persistent symptoms of fatigue, dyspnea, and/or exercise intolerance |
| |
| Control: Fully recovered COVID-19 | Subjects with a history of COVID-19 who have fully recovered from COVID-19 with no post-acute sequelae of SARS-Cov-2 |
| |
| Control: No history of COVID-19 | Healthy subjects without a documented history of COVID-19, no current symptoms, and a normal baseline High resolution CT of the chest |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography of the Chest | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Measures of regional lung ventilation | 1 day | |
| Measures of blood volume distribution | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea severity scores | 1 day | |
| Fatigue severity scores | 1 day | |
| Quality of life scores |
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Inclusion Criteria:
Exclusion Criteria:
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The primary population of interest includes participants with a history of COVID-19 who continue to have symptoms of dyspnea, fatigue, or exercise intolerance 3 months beyond their initial infection. The comparison cohorts will include 2 controls: individuals fully recovered from prior COVID-19 and healthy controls without a history of COVID-19.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bipin Malla | Contact | 617-636-6304 | tuftsmccorstudy@tuftsmedicalcenter.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Recruiting | Boston | Massachusetts | 02111 | United States |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| 1 day |
| Six-minute walk distance | 1 day |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |