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NCT Number: NCT06006884

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

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

Recruiting

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bronchoscopies and Bronchoalveolar Lavages (BALs)

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)

Diagnostic Test

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

Electrocardiogram (ECG)

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)

Diagnostic Test

Testing to measure how well lungs are working

6 minute walk test (6MWT)

Diagnostic Test

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

Primary outcomes

  1. Decipher clinical, imaging, immune, molecular and/or viral traits underlying post-acute COVID-19 lung sequelae

    Time frame: 4 years

    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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 23, 2023
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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