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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06006884
• Other study ID #: 23-001888
• Status: Recruiting
• Start date: January 10, 2024
• Est. completion date: August 2027

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: August 2027
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Procedure:
• 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.

Diagnostic Test:
• 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

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 years