COVID-19NCT06006884
A Study of Post COVID-19 Mechanisms for Chronic Lung Sequelae
An observational study of COVID-19, run by Mayo Clinic at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Bronchoscopies and Bronchoalveolar Lavages (BALs), Chest Tomography (CT) and Electrocardiogram (ECG)
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2024to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COVID-19 patient records from Mayo Clinic, Rochester MN and Mayo Clinic Health System sites will be reviewed for potential enrollment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
Chris Roberts, 800-753-1606, roberts.chris@mayo.edu
About this study
Official title: 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
Read the 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
- Being tested
- Bronchoscopies and Bronchoalveolar Lavages (BALs), Chest Tomography (CT), Electrocardiogram (ECG), Pulmonary function tests (PFTs), 6 minute walk test (6MWT)
- Keywords
- COVID-19, SARS-CoV-2, Long COVID, chronic lung sequelae, post-acute
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopies and Bronchoalveolar Lavages (BALs)Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) | |
| Recovery group | Age and gender matched individuals who had mild SARS-CoV-2 infection and experienced complete resolution of symptoms Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start10 Jan 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Vassallo, Mayo Clinic
- Investigators
- Robert Vassallo, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006884
- Sponsor's protocol ID
- 23-001888
- Status last verified
- Apr 2026
- First submitted
- 22 Aug 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncover Mechanisms Underlying the Development of Chronic Lung Sequelae Post COVID-19
- ClinicalTrials.gov ID
- NCT06006884
- Acronym / sponsor ID
- 23-001888
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-CoV-2, Long COVID, chronic lung sequelae, post-acute
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequelae group | – | 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)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 | – | 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)Age and gender matched individuals who had mild SARS-CoV-2 infection and experienced complete resolution of symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19 patient records from Mayo Clinic, Rochester MN and Mayo Clinic Health System sites will be reviewed for potential enrollment.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Recovery group, Sequelae group |
| Chest Tomography (CT)X-ray to create images of the bones and internal organs of the body | Diagnostic test | Recovery group, Sequelae group |
| Electrocardiogram (ECG)Measures the electrical activity of the heart by using sticky pads that are placed on your chest and limbs. | Diagnostic test | Recovery group, Sequelae group |
| Pulmonary function tests (PFTs)Testing to measure how well lungs are working | Diagnostic test | Recovery group, Sequelae group |
| 6 minute walk test (6MWT)Walking test to see how well the lungs function with exercise over 6 minutes | Diagnostic test | Recovery group, Sequelae group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Vassallo, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decipher clinical, imaging, immune, molecular and/or viral traits underlying post-acute COVID-19 lung sequelae (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.