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OpenTrials
Completed

NCT Number: NCT04559100

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundacion Valle del Lili

Cali, Valle del Cauca Department, 760001, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

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.

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.

saint george respiratory questionnaire

Diagnostic Test

6 and 12 months after hospital discharge.

Primary outcomes

  1. Lung function

    Time frame: 6 months after hospital discharge

    Spirometry in Liters

  2. Lung function

    Time frame: 12 months after hospital discharge

    Spirometry in Liters

  3. Lung function

    Time frame: 6 months after hospital discharge

    Diffusing capacity of carbon monoxide (% predicted)

  4. Lung function

    Time frame: 12 months after hospital discharge

    Diffusing capacity of carbon monoxide (% predicted)

  5. Lung function

    Time frame: 6 months after hospital discharge

    6 min walk test in Meters

  6. Lung function

    Time frame: 12 months after hospital discharge

    6 min walk test in Meters

  7. Radiological alterations

    Time frame: 6 months after hospital discharge

    Alterations in chest radiography

  8. Radiological alterations

    Time frame: 12 months after hospital discharge

    Alterations in chest radiography

  9. Radiological alterations

    Time frame: 6 months after hospital discharge

    Alterations in thoracic CT scan

  10. Radiological alterations

    Time frame: 12 months after hospital discharge

    Alterations in thoracic CT scan

  11. Quality of life alterations

    Time frame: 6 months after hospital discharge

    Saint George Respiratory questionnaire (from 0 to 100 points, higher levels indicating a major health impairment)

  12. Quality of life alterations

    Time frame: 12 months after hospital discharge

    Saint George Respiratory questionnaire (from 0 to 100 points, higher levels indicating a major health impairment)

Sponsors and collaborators

Lead sponsor

Fundacion Clinica Valle del Lili

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 22, 2020
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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