Understanding long-term lung effects after COVID-19
Uncover Mechanisms Underlying the Development of Chronic Lung Sequelae Post COVID-19
This study is trying to understand why some people have long-lasting lung problems after recovering from severe COVID-19 by closely monitoring them for a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 67 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | rituximab, chemotherapy, radiation, methotrexate, cyclophosphamide |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06006884 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the mechanisms behind chronic lung issues experienced by some individuals following severe COVID-19 infections. Participants will be monitored over a 12-month period with three scheduled visits at the Mayo Clinic, where they will undergo comprehensive clinical evaluations, pulmonary function tests, and imaging studies. The study will also include bronchoscopy and blood sample collection to analyze immunological and molecular factors contributing to long COVID symptoms. The goal is to identify the underlying causes of persistent respiratory problems in post-acute COVID-19 patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have experienced moderate to critical COVID-19 illness requiring hospitalization.
Not a fit: Patients with pre-existing lung diseases or those who had mild or asymptomatic COVID-19 infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of chronic lung conditions resulting from COVID-19.
How similar studies have performed: Other studies have explored long COVID effects, but this specific approach focusing on chronic lung sequelae is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic Minnesota — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Robert Vassallo, MD — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.