A Study to Compare BAL CD8+ TRM Cells and Lung Fibrosis Scores in COVID-19 Infection Survivors
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-004911
About this study
The purpose of this study is to correlate BAL CD8+ TRM cells and quantitative lung fibrosis scores in survivors of moderate-to-severe COVID-19 infection.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria - COVID-19 Cohort:
- Patient age: 60-85 years old.
- SARS-CoV-2 infection confirmed by PCR.
- Need for hospitalization due to COVID-19 pneumonia.
- Need for ≥ 2L supplemental oxygen at any point during hospitalization.
Inclusion Criteria - CONTROL Cohort:
- Patient age: 60-85 years old.
- No pre-existing history of interstitial lung disease or chronic lung disease, except for mild COPD with FEV1 > 80% predicted and FEV1/FVC < 0.7.
- Absence of lung infiltrate, fever or any signs or infection.
- Undergoing bronchoscopy for evaluation of lung nodule or adenopathy.
Exclusion Criteria - COVID-19 and CONTROL Cohorts:
- Unable to provide consent to participate in the study.
- Patient under guardianship or curatorship.
- Pre-existing interstitial lung disease, pulmonary fibrosis or chronic lung disease, except for mild COPD as outlined in “inclusion criteria.”
- Active cigarette smoking, vaping or other inhalation use (former smoker providing quit > 90 days prior to admission acceptable).
- > 20 pack years.
- Immunocompromised host status due to ongoing therapy with methotrexate, cellcept, azathioprine, prednisone dose > 15 mg daily, rituximab, cyclophosphamide or other biologic agents.
- Chemotherapy or Radiation therapy in last 2 years.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Robert Vassallo, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available