Long-term Characterization of Patients With Severe/Critical Infection by COVID-19 Virus

Study Overview
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Brief Summary
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A descriptive study to characterize clinical, radiological, lung function and quality of life alterations in patients who survived a severe or critical disease caused by SARS-COV-2 virus, who were treated in the intensive care unit of a high complexity institution in Cali, Colombia.

Official Title
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Clinical, Radiological, Lung Function, and Quality of Life Characterization of Patients With Severe/Critical Infection by SARS-COV-2 (COVID-19) Virus, After 6 and 12 Months of Hospital Discharge

Conditions
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Covid19

Intervention / Treatment
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* Radiation: chest radiography
* Radiation: thoracic computed tomography scan
* Diagnostic Test: spirometry
* Diagnostic Test: Diffusing capacity of carbon monoxide
* Diagnostic Test: 6 minute walk test
* Diagnostic Test: saint george respiratory questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 19 years old who had a positive test for SARS-COV-2 virus Patients with a severe and critical disease by SARS-COV-2, who were treated at the ICU of Fundación Valle del Lili, and survived Patients with chest radiography or CT scan at admission to the hospital Exclusion Criteria: Patients who do not sign informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Severe and critical COVID-19 survivors<br>Radiological alterations assessed by chest radiography and/or thoracic computed tomography Lung function alterations assessed by spirometry, diffusing capacity for carbon monoxide, 6 minute walk. Quality of life alterations: saint george respiratory questionnaire | Radiation: chest radiography<br>* 6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.<br>Radiation: thoracic computed tomography scan<br>* 6 and 12 months after hospital discharge, if the patient had a CT scan upon admission to the hospital. If the study is normal at 6 months it will not be repeated at 12 months.<br>Diagnostic Test: spirometry<br>* 6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.<br>Diagnostic Test: Diffusing capacity of carbon monoxide<br>* 6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.<br>Diagnostic Test: 6 minute walk test<br>* 6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.<br>Diagnostic Test: saint george respiratory questionnaire<br>* 6 and 12 months after hospital discharge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function | Spirometry in Liters | 6 months after hospital discharge | 
| Lung function | Spirometry in Liters | 12 months after hospital discharge | 
| Lung function | Diffusing capacity of carbon monoxide (% predicted) | 6 months after hospital discharge | 
| Lung function | Diffusing capacity of carbon monoxide (% predicted) | 12 months after hospital discharge | 
| Lung function | 6 min walk test in Meters | 6 months after hospital discharge | 
| Lung function | 6 min walk test in Meters | 12 months after hospital discharge | 
| Radiological alterations | Alterations in chest radiography | 6 months after hospital discharge | 
| Radiological alterations | Alterations in chest radiography | 12 months after hospital discharge | 
| Radiological alterations | Alterations in thoracic CT scan | 6 months after hospital discharge | 
| Radiological alterations | Alterations in thoracic CT scan | 12 months after hospital discharge | 
| Quality of life alterations | Saint George Respiratory questionnaire (from 0 to 100 points, higher levels indicating a major health impairment) | 6 months after hospital discharge | 
| Quality of life alterations | Saint George Respiratory questionnaire (from 0 to 100 points, higher levels indicating a major health impairment) | 12 months after hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covid19, lung function, quality of life