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

Dyspnea Clinical Trial

— PASC VQ  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05866952
• Other study ID #: 2337
• Status: Enrolling by invitation
• Start date: June 5, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: July 2023
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Dyspnea
• Fatigue Syndrome, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	4DMedical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measures of regional lung ventilation		1 day
Primary	Measures of blood volume distribution		1 day
Secondary	Dyspnea severity scores		1 day
Secondary	Fatigue severity scores		1 day
Secondary	Quality of life scores		1 day
Secondary	Six-minute walk distance		1 day