Clinical trial NCT05866952: Ventilatory and Perfusion Abnormalities in Individuals with Post-Acute Sequelae of SARS-CoV-2 Infection
Official title: Quantitative Computed Tomography to Assess Ventilatory and Perfusion Abnormalities in Individuals with Post-Acute Sequelae of SARS-CoV-2 Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-Acute COVID-19
Post COVID-19 Condition
Post Viral Fatigue
Dyspnea
Keywords: Ventilation Perfusion Mismatch
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: 4DMedical
First posted: 2023-05-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Measures of regional lung ventilation
timeFrame: 1 day
measure: Measures of blood volume distribution
timeFrame: 1 day
Secondary outcomes:
measure: Dyspnea severity scores
timeFrame: 1 day
measure: Fatigue severity scores
timeFrame: 1 day
measure: Quality of life scores
timeFrame: 1 day
measure: Six-minute walk distance
timeFrame: 1 day
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
References: