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

• Sponsor: Tufts Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05866952
• Collaborator: 4DMedical (Industry)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 12.6
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Post-Acute COVID-19; Post COVID-19 Condition; Post Viral Fatigue; Dyspnea	Diagnostic Test: Computed Tomography of the Chest

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Quantitative Computed Tomography to Assess Ventilatory and Perfusion Abnormalities in Individuals With Post-Acute Sequelae of SARS-CoV-2 Infection
• Anticipated Study Start Date: May 12, 2023
• Anticipated Primary Completion Date: May 31, 2024
• Anticipated Study Completion Date: May 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
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; 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	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
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; 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

Outcome Measures

Primary Outcome Measures

1. Measures of regional lung ventilation [1 day]

2. Measures of blood volume distribution [1 day]

Secondary Outcome Measures

1. Dyspnea severity scores [1 day]

2. Fatigue severity scores [1 day]

3. Quality of life scores [1 day]

4. Six-minute walk distance [1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tufts Medical Center	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

• Tufts Medical Center
• 4DMedical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tufts Medical Center
• ClinicalTrials.gov Identifier: NCT05866952
• Other Study ID Numbers: 2337
• First Posted: May 19, 2023
• Last Update Posted: May 19, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tufts Medical Center: Ventilation Perfusion Mismatch
• Additional relevant MeSH terms: COVID-19; Post-Acute COVID-19 Syndrome; Fatigue Syndrome, Chronic; Dyspnea

Study Results

No Results Posted as of May 19, 2023