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

ConditionCOVID-19

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorMayo Clinic

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

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

Disqualifiers

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.

Trial population

COVID-19 patient records from Mayo Clinic, Rochester MN and Mayo Clinic Health System sites will be reviewed for potential enrollment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Bronchoscopies and Bronchoalveolar Lavages (BALs)
Procedure/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

Treatment groups

67 Participants

are divided into 2 treatment groups

Group A: Sequelae group5 interventions

Group B: Recovery group5 interventions

Trial outcomes

Primary outcomes

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

Time frame

4 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

Apply now