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Clinical Trials/NCT05866952
NCT05866952
Recruiting
Not Applicable

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

Tufts Medical Center1 site in 1 country40 target enrollmentJune 5, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-Acute COVID-19
Sponsor
Tufts Medical Center
Enrollment
40
Locations
1
Primary Endpoint
Measures of blood volume distribution
Status
Recruiting
Last Updated
9 months ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
June 5, 2023
End Date
December 31, 2026
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Measures of blood volume distribution

Time Frame: 1 day

Measures of regional lung ventilation

Time Frame: 1 day

Secondary Outcomes

  • Fatigue severity scores(1 day)
  • Quality of life scores(1 day)
  • Six-minute walk distance(1 day)
  • Dyspnea severity scores(1 day)

Study Sites (1)

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