Covid19 Clinical Trial
Official title:
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
Verified date | May 2022 |
Source | Fundacion Clinica Valle del Lili |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 112 |
Est. completion date | December 31, 2022 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 FundaciĆ³n 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. |
Country | Name | City | State |
---|---|---|---|
Colombia | Fundacion Valle del Lili | Cali | Valle Del Cauca |
Lead Sponsor | Collaborator |
---|---|
Fundacion Clinica Valle del Lili |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lung function | Spirometry in Liters | 6 months after hospital discharge | |
Primary | Lung function | Spirometry in Liters | 12 months after hospital discharge | |
Primary | Lung function | Diffusing capacity of carbon monoxide (% predicted) | 6 months after hospital discharge | |
Primary | Lung function | Diffusing capacity of carbon monoxide (% predicted) | 12 months after hospital discharge | |
Primary | Lung function | 6 min walk test in Meters | 6 months after hospital discharge | |
Primary | Lung function | 6 min walk test in Meters | 12 months after hospital discharge | |
Primary | Radiological alterations | Alterations in chest radiography | 6 months after hospital discharge | |
Primary | Radiological alterations | Alterations in chest radiography | 12 months after hospital discharge | |
Primary | Radiological alterations | Alterations in thoracic CT scan | 6 months after hospital discharge | |
Primary | Radiological alterations | Alterations in thoracic CT scan | 12 months after hospital discharge | |
Primary | 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 | |
Primary | 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 |
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