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

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04559100
• Other study ID #: 1631 COVID-LFT
• Status: Enrolling by invitation
• 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
• 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 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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

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