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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04559100
Other study ID # 1631 COVID-LFT
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date November 15, 2020
Est. completion date December 31, 2022

Study information

Verified date May 2022
Source Fundacion Clinica Valle del Lili
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
chest radiography
6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.
thoracic computed tomography scan
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.
Diagnostic Test:
spirometry
6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.
Diffusing capacity of carbon monoxide
6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.
6 minute walk test
6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.
saint george respiratory questionnaire
6 and 12 months after hospital discharge.

Locations

Country Name City State
Colombia Fundacion Valle del Lili Cali Valle Del Cauca

Sponsors (1)

Lead Sponsor Collaborator
Fundacion Clinica Valle del Lili

Country where clinical trial is conducted

Colombia, 

Outcome

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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