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

NCT05866952 | Recruiting

• 1 other identifier: 2337
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Keywords

Ventilation Perfusion Mismatch

Outcome Measures

Primary Outcomes (2)

• Measures of regional lung ventilation

  1 day

• Measures of blood volume distribution

  1 day

Secondary Outcomes (4)

• Dyspnea severity scores

  1 day

• Fatigue severity scores

  1 day

• Quality of life scores

  1 day

• Six-minute walk distance

  1 day

Study Arms (3)

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

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

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

Interventions

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

Control: Fully recovered COVID-19; Control: No history of COVID-19; Post-Acute Sequelae of SARS-CoV-2 (PASC) Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead
• 4DMedical: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Dyspnea

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

Bipin Malla

CONTACT

617-636-6304; tuftsmccorstudy@tuftsmedicalcenter.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 19, 2023
• Study Start: June 5, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

US (1)