NCT06006884

A Study of Post COVID-19 Mechanisms for Chronic Lung Sequelae

Uncover Mechanisms Underlying the Development of Chronic Lung Sequelae Post COVID-19

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to understand why some people experience long term effects, such as shortness of breath and fatigue, after a severe COVID-19 infection

Detailed description

Each participant will be in the study for approximately 12 months and will be required to come to Mayo Clinic for 3 visits. These visits will take place approximately 2-3 months after confirmed COVID-19 diagnosis (visit 1), 6 months after diagnosis (visit 2), and 12 months after diagnosis (visit 3). Comprehensive clinical evaluation and symptom characterization, quantitative lung CT image analysis and pulmonary function testing, and quality of life questionnaires will be obtained at each visit. Bronchoscopy with BAL (collected at visits 1 and 3 only) and blood samples (collected at all visits) will dissect the dynamic immunological and molecular signatures in the respiratory tract and in the circulation longitudinally. We will also perform highly sensitive viral reservoir or remnant assays to address the potential contribution of viral factors in regulating chronic lung conditions post-acute COVID-19.

Conditions

• COVID-19

Interventions

Type	Name	Description
PROCEDURE	Bronchoscopies and Bronchoalveolar Lavages (BALs)	Bronchoscopies use a thin, lighted tube, which enters through the mouth or nose and moves down the throat to the airways to look at the lungs. BALs are done during bronchoscopies to collect samples from the lungs for testing. During this procedure, a saline solution is put through the tube to wash the airways and collect a fluid sample.
DIAGNOSTIC_TEST	Chest Tomography (CT)	X-ray to create images of the bones and internal organs of the body
DIAGNOSTIC_TEST	Electrocardiogram (ECG)	Measures the electrical activity of the heart by using sticky pads that are placed on your chest and limbs.
DIAGNOSTIC_TEST	Pulmonary function tests (PFTs)	Testing to measure how well lungs are working
DIAGNOSTIC_TEST	6 minute walk test (6MWT)	Walking test to see how well the lungs function with exercise over 6 minutes

Timeline

• Start date: 2024-01-10
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2023-08-23
• Last updated: 2025-04-27

Locations

1 site across 1 country: United States