Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05866952
Other study ID # 2337
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 5, 2023
Est. completion date May 31, 2024

Study information

Verified date July 2023
Source Tufts Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 40
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Tufts Medical Center Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Tufts Medical Center 4DMedical

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measures of regional lung ventilation 1 day
Primary Measures of blood volume distribution 1 day
Secondary Dyspnea severity scores 1 day
Secondary Fatigue severity scores 1 day
Secondary Quality of life scores 1 day
Secondary Six-minute walk distance 1 day
See also
  Status Clinical Trial Phase
Recruiting NCT04688905 - Diagnosing Heart Failure With Preserved Ejection Fraction in Patients With Unexplained Dyspnea (Diagnose-HFpEF)
Completed NCT03679312 - The Effect of Inhaled Nitric Oxide on Dyspnea and Exercise Tolerance in COPD Phase 1/Phase 2
Recruiting NCT04868357 - Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program N/A
Active, not recruiting NCT03604822 - Music Therapy Protocol to Support Bulbar and Respiratory Functions in ALS N/A
Completed NCT03626519 - Effects of Menthol on Dyspnoea in COPD Patients N/A
Completed NCT02638649 - Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
Completed NCT02248831 - Evaluation of Cardiopulmonary Diseases by Ultrasound N/A
Terminated NCT02269761 - Chest Ultrasound of ER Patients With Cough or SOB
Completed NCT02538770 - Rapid Viral Diagnostics in Adults to Reduce Antimicrobial Consumption and Duration of Hospitalization N/A
Recruiting NCT01655199 - Sensitivity of the Step Test to Detect Improvement in Dyspnea Following Bronchodilation in Patients With Chronic Obstructive Pulmonary Disease N/A
Active, not recruiting NCT01440764 - Aerosol Inhalation Treatment for Dyspnea Phase 1/Phase 2
Completed NCT01577407 - Non Opioid Treatment for Experimental Dyspnea Phase 3
Completed NCT01193998 - Impact of Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department N/A
Recruiting NCT04327882 - Point-of-care Ultrasound Interest in Dyspneic Emergency Department Patients: an Observational Bicentric Study
Completed NCT05029986 - Preventing Dyspnea During Speech in Older Speakers N/A
Recruiting NCT04615065 - Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
Completed NCT04305639 - The Reliability and Validity of Turkish Version of ''The Dyspnea-ALS-Scale (DALS-15)"
Completed NCT04370990 - Automated Oxygen Administration -Rethinking Interventions Alleviating Dyspnea in Patients With COPD N/A
Completed NCT04375917 - Is Reduced Hypoxia Through a Robot Intervention, Associated With Sensory and Emotional Descriptions of Dyspnea, Anxiety, Depression, Symptom Burden and Anxiolytics N/A
Completed NCT04186754 - Study of an Integral Respiratory Rehabilitation Program in Oncological Patient With Disney N/A