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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Dyspnea; Post-Acute COVID-19; Post COVID-19 Condition; Post Viral Fatigue
• Intervention / Treatment: Diagnostic test: Computed Tomography of the Chest

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Bipin Malla; Phone Number: 617-636-6304; Email: tuftsmccorstudy@tuftsmedicalcenter.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tufts Medical Center
• Collaborators: 4DMedical

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Ventilation Perfusion Mismatch
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Signs and Symptoms, Respiratory; Encephalomyelitis; Chronic Disease; Neuroinflammatory Diseases; Post-Infectious Disorders; COVID-19; Fatigue Syndrome, Chronic; Dyspnea; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 2337

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No