Recruiting

Chronic Lung Sequelae

Sponsor:

Mayo Clinic

Code:

NCT06006884

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bronchoscopies and Bronchoalveolar Lavages (BALs)

Chest Tomography (CT)

Electrocardiogram (ECG)

Pulmonary function tests (PFTs)

6 minute walk test (6MWT)

Study Details

Brief 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

Conditions

COVID-19

Study ID

NCT06006884

Start date

Jan 10, 2024

Status verified date

Apr, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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.

Study Design

Enrollment

67 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

Recovery group

Age and gender matched individuals who had mild SARS-CoV-2 infection and experienced complete resolution of symptoms

Interventions

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.

Chest Tomography (CT)

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

Electrocardiogram (ECG)

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

Pulmonary function tests (PFTs)

Testing to measure how well lungs are working

6 minute walk test (6MWT)

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

Primary outcome measure

  • Decipher clinical, imaging, immune, molecular and/or viral traits underlying post-acute COVID-19 lung sequelae [ Time Frame: 4 years ]

Central Contacts and Locations

Locations

Mayo Clinic Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Chris Roberts

800-753-1606roberts.chris@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

May 7, 2026

Last verified

Apr, 2026

Keywords

  • COVID-19
  • SARS-CoV-2
  • Long COVID
  • chronic lung sequelae
  • post-acute

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-05-07.