75 Participants Needed

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

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of 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

Research Team

RV

Robert Vassallo, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

For those in the Sequelae Group, you must meet certain criteria.
The severity of illness is classified as moderate (requiring up to 8L supplemental oxygen during hospitalization), severe (requiring high flow oxygen delivery of at least 8L) or critical (necessitating ICU admission and/or mechanical ventilation).
You are part of the Control Recovery Group.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Evaluation

Comprehensive clinical evaluation and symptom characterization, quantitative lung CT image analysis and pulmonary function testing, and quality of life questionnaires

2-3 months after COVID-19 diagnosis
1 visit (in-person)

Midpoint Evaluation

Continued assessment with clinical evaluations, imaging, and testing, including bronchoscopy with BAL and blood samples

6 months after COVID-19 diagnosis
1 visit (in-person)

Final Evaluation

Final comprehensive evaluation including bronchoscopy with BAL, blood samples, and quality of life assessments

12 months after COVID-19 diagnosis
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Participant Groups
2Treatment groups
Experimental Treatment
Group I: Sequelae groupExperimental Treatment5 Interventions
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)
Group II: Recovery groupExperimental Treatment5 Interventions
Age and gender matched individuals who had mild SARS-CoV-2 infection and experienced complete resolution of symptoms

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+
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