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

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

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

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Procedure: Bronchoscopies and Bronchoalveolar Lavages (BALs); Diagnostic test: Chest Tomography (CT); Diagnostic test: Electrocardiogram (ECG); Diagnostic test: Pulmonary function tests (PFTs); Diagnostic test: 6 minute walk test (6MWT)

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.

• Study Type: Observational
• Enrollment (Estimated): 67

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Minnesota
      • Contact: Chris Roberts; Phone Number: 800-753-1606; Email: roberts.chris@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

COVID-19 patient records from Mayo Clinic, Rochester MN and Mayo Clinic Health System sites will be reviewed for potential enrollment.

Description

Inclusion Criteria:

For the Sequelae Group

• Age ≥18 years at screening, PCR confirmed COVID19 illness (+PCR defines day 0 of illness), hospitalization for COVID-19, absence of pre-existing history of interstitial lung disease, or significant other lung disease.
• Severity of illness will be categorized as moderate disease (supplemental oxygen need 1-8L at any time during hospitalization), severe disease (need for high flow oxygen delivery ≥8L at any time during hospitalization) and critical illness (need for ICU admission or mechanical ventilation).

Control Recovery Group

• Age ≥18 years at screening
• PCR confirmed COVID-19 cases who had nonsymptomatic or mild acute infection that do not require hospitalization 7,48,49
• Absence of pre-existing history of interstitial lung disease, or significant other lung disease, absence of any ongoing respiratory and systemic symptoms.

Exclusion Criteria:

• Inability to provide informed consent, evidence of pre-existing interstitial lung disease or chronic lung disease;
• Active cigarette smoking, vaping or other inhalation use.
• Immunocompromised host status due to ongoing therapy with methotrexate, CellCept, azathioprine, rituximab, cyclophosphamide or other biologic agents;
• > 20 pack year smoking history.
• History of chemotherapy or radiation therapy in the last two years; and pregnancy.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sequelae group; COVID-19 convalescents that recover from prior severe acute diseases requiring hospitalization and who will be at high risk of chronic lung sequelae (with an estimate of >50% having moderate to severe sequelae based on current literature)	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
Recovery group; Age and gender matched individuals who had mild SARS-CoV-2 infection and experienced complete resolution of symptoms	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decipher clinical, imaging, immune, molecular and/or viral traits underlying post-acute COVID-19 lung sequelae	This study will expand on prior observations from a previous study and discover potential drivers and targets for therapy of post-acute COVID-19 lung disease by recruiting a larger group of COVID-19 convalescents, following up longitudinally up to 12 months after acute infection. This longitudinal approach will allow for assess immune dysregulation and establish the etiology of lung sequelae of COVID-19	4 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Robert Vassallo, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Long COVID; post-acute; chronic lung sequelae
• Additional Relevant MeSH Terms: Post-Infectious Disorders; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; COVID-19; Post-Acute COVID-19 Syndrome; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy; Diagnostic Techniques, Respiratory System; Diagnostic Techniques, Cardiovascular; Thoracic Surgical Procedures; Heart Function Tests; Electrodiagnosis; Therapeutic Irrigation; Pulmonary Surgical Procedures; Exercise Test; Respiratory Function Tests; Electrocardiography; Bronchoalveolar Lavage; Walk Test; Bronchoscopy
• Other Study ID Numbers: 23-001888

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No