Prospective Study of Persistent Dyspnea in Recovered COVID-19 Patients

Study Overview
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Brief Summary
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We conducted a national, single center (Hospital Clínico Universitario de Valladolid, Spain, Valladolid), prospective study of patients with prior hospitalization because of COVID-19 who were admitted between March 1st, 2020, and May 15th, 2020. All eligible patients underwent at least at first-time follow-up from the index event. Exclusion criteria were age < 18 years old, pregnant women, terminally ill patients, active SARS-CoV-2 infections, inability to exercise and previous known severe pulmonary or heart disease. Patients underwent a clinical assessment for symptom burden, questionnaire for quality of life (Kansas City Cardiomyopathy Questionnaire and SF-36), venous blood sampling, 6-minute walking test (6-MWT), tests of lung function (spirometry and diffusing capacity of the lungs for carbon monoxide) and treadmill cardio-pulmonary exercise testing (CPET). 48-hours before the test of lung function and the CPET, all patients yielded a negative result in the reverse transcription-polymerase chain reaction (RT-PCR) for SARS-CoV-2. For definitive analysis patients were assigned to the control group if they did not refer dyspnea at the time of the follow-up, a small asymptomatic out-patient control group without prior hospitalization was also included.

Official Title
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Prospective Study of Persistent Dyspnea in Recovered COVID-19 Patients

Conditions
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Covid19, Dyspnea

Intervention / Treatment
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* Diagnostic Test: Cardiopulmonary exercise test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Previous COVID-19 hospitalization with successful discharged Availability of at least one follow up per clinical protocol Exclusion Criteria: pregnant women terminally ill patients active SARS-CoV-2 infections inability to exercise previous known severe pulmonary or heart disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dyspnea<br>Patients with prior hospitalization because of COVID-19, with succesful hospital discharge, who underwent at least a first-time follow-up from the index event, and present persistent dyspnea. | Diagnostic Test: Cardiopulmonary exercise test<br>* Only diagnostic tests<br>* Other names: blood sampling;|
| Control<br>Patients with prior hospitalization because of COVID-19, with succesful hospital discharge, who underwent at least a first-time follow-up from the index event, fully recovered, without persistent dyspnea. | Diagnostic Test: Cardiopulmonary exercise test<br>* Only diagnostic tests<br>* Other names: blood sampling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aerobic capacity | Measured as peak oxygen uptake | 6 months | 
| Total Lung Capacity (TLC) | Pulmonary function test | 6 months | 
| Force Expiratory Volume in 1 second (FEV1) | Pulmonary function test | 6 months | 
| Difussing Lung Capacity of CO (DLCO) | Pulmonary function test | 6 months | 
| Forced Vital Capacity (FVC) | Pulmonary function test | 6 months | 
| Left Ventricular (LV) Function | Left Ventricular (LV) Function (Ecocardiagraphy-measured Cardiac Function) | 6 months | 
| Right Ventricular (RV) Function | Right Ventricular (RV) Function (Ecocardiagraphy-measured Cardiac Function) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form 36 Health Survey (SF-36) | Quality of Life test | 6 months | 
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | Quality of Life test | 6 Months | 
| 6 Minute Walk Test | Walking capacity | 6 months | 
| N-terminal pro hormone B-type natriuretic peptide (NT-proBNP) | Inflammatory and Cardiac Marker | 6 months | 
| Troponin-T | Inflammatory and Cardiac Marker | 6 months | 
| Ferritin | Inflammatory and Cardiac Marker | 6 months | 
| D-Dimer | Inflammatory and Cardiac Marker | 6 months | 
| interleukine-6 | Inflammatory and Cardiac Marker | 6 months | 
| C reactive protein (CRP) | Inflammatory and Cardiac Marker | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyspnea, Covid19, Cardiopulmonary exercise test