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

• Conditions: Post-Acute COVID-19; Post COVID-19 Condition; Dyspnea; Post Viral Fatigue
• Interventions: Diagnostic Test: Computed Tomography of the Chest

• Registration Number: NCT05866952
• Lead Sponsor: Tufts Medical Center

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.

Study Timeline

• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-05-18
• Study First Posted: 2023-05-19
• Study Start: 2023-06-05
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-10
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-Acute Sequelae of SARS-CoV-2 (PASC) Group	Computed Tomography of the Chest	Subjects with PASC with a documented history of COVID-19 and persistent symptoms of fatigue, dyspnea, and/or exercise intolerance
Control: No history of COVID-19	Computed Tomography of the Chest	Healthy subjects without a documented history of COVID-19, no current symptoms, and a normal baseline High resolution CT of the chest
Control: Fully recovered COVID-19	Computed Tomography of the Chest	Subjects with a history of COVID-19 who have fully recovered from COVID-19 with no post-acute sequelae of SARS-Cov-2

Primary Outcome Measures

Name	Time	Method
Measures of blood volume distribution	1 day
Measures of regional lung ventilation	1 day

Secondary Outcome Measures

Name	Time	Method
Dyspnea severity scores	1 day
Fatigue severity scores	1 day
Quality of life scores	1 day
Six-minute walk distance	1 day

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States