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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-10

Study Completion Date

2027-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lung Structure-Function In Survivors of Mild and Severe COVID-19 Infection

NCT04584671

Covid19

ACTIVE_NOT_RECRUITING

Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs

NCT04628039

COVID-19 Chronic Lung Diseases

COMPLETED

Breath Analysis Based Disease Biomarkers

NCT04341012

Liver Diseases Liver Cancer COVID19

COMPLETED

Pulmonary and Extrapulmonary Impairments in Patients With Post COVID-19

NCT05381727

COVID-19

COMPLETED

Post COVID-19 Interstitial Lung Disease: A Study of Genetic and Environmental Interactions

NCT04987606

Pulmonary Fibrosis COVID-19 Pneumonia

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Bronchoscopies and Bronchoalveolar Lavages (BALs)

Intervention Type PROCEDURE

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.

Chest Tomography (CT)

Intervention Type DIAGNOSTIC_TEST

X-ray to create images of the bones and internal organs of the body

Electrocardiogram (ECG)

Intervention Type DIAGNOSTIC_TEST

Measures the electrical activity of the heart by using sticky pads that are placed on your chest and limbs.

Pulmonary function tests (PFTs)

Intervention Type DIAGNOSTIC_TEST

Testing to measure how well lungs are working

6 minute walk test (6MWT)

Intervention Type DIAGNOSTIC_TEST

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

Bronchoscopies and Bronchoalveolar Lavages (BALs)

Intervention Type PROCEDURE

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.

Chest Tomography (CT)

Intervention Type DIAGNOSTIC_TEST

X-ray to create images of the bones and internal organs of the body

Electrocardiogram (ECG)

Intervention Type DIAGNOSTIC_TEST

Measures the electrical activity of the heart by using sticky pads that are placed on your chest and limbs.

Pulmonary function tests (PFTs)

Intervention Type DIAGNOSTIC_TEST

Testing to measure how well lungs are working

6 minute walk test (6MWT)

Intervention Type DIAGNOSTIC_TEST

Walking test to see how well the lungs function with exercise over 6 minutes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Chest Tomography (CT)

X-ray to create images of the bones and internal organs of the body

Intervention Type DIAGNOSTIC_TEST

Electrocardiogram (ECG)

Measures the electrical activity of the heart by using sticky pads that are placed on your chest and limbs.

Intervention Type DIAGNOSTIC_TEST

Pulmonary function tests (PFTs)

Testing to measure how well lungs are working

Intervention Type DIAGNOSTIC_TEST

6 minute walk test (6MWT)

Walking test to see how well the lungs function with exercise over 6 minutes

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No