Menu
Recruiting NCT05866952

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Computed Tomography of the Chest.
Who it may be relevant to
Registry conditions: Post-Acute COVID-19, Post COVID-19 Condition, Post Viral Fatigue, Dyspnea. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Measures of regional lung ventilation [Time frame: 1 day]
  • Measures of blood volume distribution [Time frame: 1 day]
Secondary outcome measures (4)
  • Dyspnea severity scores [Time frame: 1 day]
  • Fatigue severity scores [Time frame: 1 day]
  • Quality of life scores [Time frame: 1 day]
  • Six-minute walk distance [Time frame: 1 day]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Tufts Medical Center — Boston

Identifiers

NCT: NCT05866952 · 2337

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗