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

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Mayo Clinic

Status

Enrolling

Conditions

COVID-19

Treatments

Diagnostic Test: Pulmonary function tests (PFTs)
Diagnostic Test: Chest Tomography (CT)
Diagnostic Test: 6 minute walk test (6MWT)
Diagnostic Test: Electrocardiogram (ECG)
Procedure: Bronchoscopies and Bronchoalveolar Lavages (BALs)

Study type

Observational

Funder types

Other

Identifiers

NCT06006884
23-001888

Details and patient eligibility

About

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

Full 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.

Enrollment

75 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

75 participants in 2 patient groups

Sequelae group
Description:
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)
Treatment:
Procedure: Bronchoscopies and Bronchoalveolar Lavages (BALs)
Diagnostic Test: Electrocardiogram (ECG)
Diagnostic Test: 6 minute walk test (6MWT)
Diagnostic Test: Chest Tomography (CT)
Diagnostic Test: Pulmonary function tests (PFTs)
Recovery group
Description:
Age and gender matched individuals who had mild SARS-CoV-2 infection and experienced complete resolution of symptoms
Treatment:
Procedure: Bronchoscopies and Bronchoalveolar Lavages (BALs)
Diagnostic Test: Electrocardiogram (ECG)
Diagnostic Test: 6 minute walk test (6MWT)
Diagnostic Test: Chest Tomography (CT)
Diagnostic Test: Pulmonary function tests (PFTs)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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