Purpose

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

Conditions

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Cross-Sectional

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Diagnostic Test: Computed Tomography of the Chest
    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
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
  • Diagnostic Test: Computed Tomography of the Chest
    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
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
  • Diagnostic Test: Computed Tomography of the Chest
    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

Recruiting Locations

Tufts Medical Center
Boston, Massachusetts 02111
Contact:
Bipin Malla

More Details

NCT ID
NCT05866952
Status
Recruiting
Sponsor
Tufts Medical Center

Study Contact

Bipin Malla
617-636-6304
tuftsmccorstudy@tuftsmedicalcenter.org

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.