Long Term Outcomes of Coronavirus Disease-19 (COVID-19)

Study Overview
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Brief Summary
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The investigators hypothese that lung involvement due to COVID-19 may cause structural changes in the lung in the long term. In this study the effects of structural changes in the lung on pulmonary function tests, exercise capacity and quality of life will be examined.

Detailed Description
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Coronavirus disease-19 (COVID-19) has a clinical spectrum ranging from asymptomatic cases to severe cases requiring intensive care hospitalization due to respiratory failure. The disease mostly infects the lower respiratory tract. Typical computed tomography findings of lung involvement are bilateral, peripherally located ground glass density and consolidations. There is a close relationship between tomography findings and clinical severity. It is not known whether there will be complete recovery in the lungs. Investigators will evaluate pulmonary structures with chest computed tomography, respiratory capacity with pulmonary function tests (PFTs), exercise capacity with six minutes walk test and quality of life with short form-36 (SF-36) im patients who survivors of COVID-19 at least 6 months after hospital discharge.

Official Title
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Long Term Outcomes in Patients With Coronavirus Disease-19 (COVID-19) on Pulmonary Functions, Exercise Capacity, Lung Structure and Quality of Life

Conditions
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Covid19

Intervention / Treatment
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* Diagnostic Test: Chest Computed Tomography
* Diagnostic Test: Pulmonary Function Tests
* Other: Six Minutes Walk Test
* Other: Quality of Life


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who were ≥18 years COVID-19 confirmed by Real-Time PCR At least 6 months after discharge Exclusion Criteria: Patients who were < 18 years Pregnancy Become bedridden after discharge

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients in ICU<br>ICU patients with COVID-19 | Diagnostic Test: Chest Computed Tomography<br>* Evaluation of Lung Structure<br>Diagnostic Test: Pulmonary Function Tests<br>* Respiratory Capacity<br>Other: Six Minutes Walk Test<br>* Exercise Capacity<br>Other: Quality of Life<br>* Physical disability assessment tool<br>* Other names: SF-36;|
| Patients in Hospital Ward<br>Patients with COVID-19 in hospital wards | Diagnostic Test: Chest Computed Tomography<br>* Evaluation of Lung Structure<br>Diagnostic Test: Pulmonary Function Tests<br>* Respiratory Capacity<br>Other: Six Minutes Walk Test<br>* Exercise Capacity<br>Other: Quality of Life<br>* Physical disability assessment tool<br>* Other names: SF-36;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structural Change in Lung | Chest Computed Tomography | up to 6 months after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carbon monoxide diffusion capacity (DLCO) | Carbon monoxide diffusion capacity of the lung | up to 6 months after discharge | 
| Exercise Capacity | Six Minutes Walking Test | up to 6 months after discharge | 
| Short Form Health Survey Score (SF-16) | A 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state | up to 6 months after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid19, Long term outcomes, Chest computed comography, Pulmonary functional tests, Exercise capacity, Quality of life