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

Tufts University

Status: Enrolling

Conditions: Post COVID-19 Condition; Dyspnea; Post-Acute COVID-19; Post Viral Fatigue

Treatments: Diagnostic Test: Computed Tomography of the Chest

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05866952

2337

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 3 patient groups

Post-Acute Sequelae of SARS-CoV-2 (PASC) Group

Description:

Subjects with PASC with a documented history of COVID-19 and persistent symptoms of fatigue, dyspnea, and/or exercise intolerance

Treatment:

Diagnostic Test: Computed Tomography of the Chest

Control: Fully recovered COVID-19

Description:

Subjects with a history of COVID-19 who have fully recovered from COVID-19 with no post-acute sequelae of SARS-Cov-2

Treatment:

Diagnostic Test: Computed Tomography of the Chest

Control: No history of COVID-19

Description:

Healthy subjects without a documented history of COVID-19, no current symptoms, and a normal baseline High resolution CT of the chest

Treatment:

Diagnostic Test: Computed Tomography of the Chest