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

NCT ID: NCT05866952

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-05

Study Completion Date

2026-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

Computed Tomography of the Chest

Intervention Type 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

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

Computed Tomography of the Chest

Intervention Type 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: 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

Computed Tomography of the Chest

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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4DMedical

INDUSTRY

Sponsor Role collaborator

Tufts Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tufts Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bipin Malla

Role: CONTACT

617-636-6304

Facility Contacts

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Bipin Malla

Role: primary

Other Identifiers

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2337

Identifier Type: -

Identifier Source: org_study_id

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