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

Completed

• Conditions: Covid19
• Interventions: 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

• Registration Number: NCT04559100
• Lead Sponsor: Fundacion Clinica Valle del Lili

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-22
• Study Start: 2020-11-15
• Primary Completion: 2021-11-11
• Study Completion: 2022-07-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe and critical COVID-19 survivors	chest radiography	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
Severe and critical COVID-19 survivors	spirometry	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
Severe and critical COVID-19 survivors	thoracic computed tomography scan	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
Severe and critical COVID-19 survivors	Diffusing capacity of carbon monoxide	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
Severe and critical COVID-19 survivors	6 minute walk test	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
Severe and critical COVID-19 survivors	saint george respiratory questionnaire	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

Primary Outcome Measures

Name	Time	Method
Radiological alterations	12 months after hospital discharge	Alterations in thoracic CT scan
Lung function	12 months after hospital discharge	6 min walk test in Meters
Quality of life alterations	12 months after hospital discharge	Saint George Respiratory questionnaire (from 0 to 100 points, higher levels indicating a major health impairment)

Trial Locations

Locations (1)

Fundacion Valle del Lili; 🇨🇴 Cali, Valle Del Cauca, Colombia