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

NCT04559100 | Completed DMC

• 1 other identifier: 1631 COVID-LFT
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

covid19; lung function; quality of life

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (1)

Severe and critical COVID-19 survivors

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; 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

Interventions

chest radiography RADIATION

6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.

Severe and critical COVID-19 survivors

thoracic computed tomography scan RADIATION

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.

Severe and critical COVID-19 survivors

spirometry DIAGNOSTIC_TEST

6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.

Severe and critical COVID-19 survivors

Diffusing capacity of carbon monoxide DIAGNOSTIC_TEST

6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.

Severe and critical COVID-19 survivors

6 minute walk test DIAGNOSTIC_TEST

6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.

Severe and critical COVID-19 survivors

saint george respiratory questionnaire DIAGNOSTIC_TEST

6 and 12 months after hospital discharge.

Severe and critical COVID-19 survivors

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a severe or critical disease caused by SARS-COV-2 infection who were treated at the ICU of Fundación Valle del Lili and were alive at 6 months of hospital discharge.

You may qualify if:

• ≥ 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

You may not qualify if:

• Patients who do not sign informed consent.

Sponsors & Collaborators

• Fundacion Clinica Valle del Lili: lead

Study Sites (1)

Fundacion Valle del Lili

Cali, Valle del Cauca Department, 760001, Colombia

Location

MeSH Terms

Conditions

COVID-19

Interventions

X-Rays; Spirometry; Walk Test

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Exercise Test; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Fernandez

  Fundacion Clinica Valle del Lili

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 22, 2020
• Study Start: November 15, 2020
• Primary Completion: November 11, 2021
• Study Completion: July 1, 2022
• Last Updated: August 28, 2024

Record last verified: 2024-05

Locations

CO (1)