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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04559100
Recruitment Status : Not yet recruiting
First Posted : September 22, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Covid19 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

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Study Type : Observational
Estimated Enrollment : 112 participants
Observational Model: Other
Time Perspective: Prospective
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
Estimated Study Start Date : November 21, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Group/Cohort Intervention/treatment
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
6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.

Radiation: 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.

Diagnostic Test: 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.

Diagnostic Test: 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.

Diagnostic Test: saint george respiratory questionnaire
6 and 12 months after hospital discharge.




Primary Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04559100


Contacts
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Contact: Fernandez 3155006300 liliana.fernandez@fvl.org.co
Contact: Sangiovanni 3152606636 saveria.sangiovanni@fvl.org.co

Sponsors and Collaborators
Fundacion Clinica Valle del Lili
Investigators
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Principal Investigator: Fernandez Fundacion Clinica Valle del Lili
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Responsible Party: Fundacion Clinica Valle del Lili
ClinicalTrials.gov Identifier: NCT04559100    
Other Study ID Numbers: 1631 COVID-LFT
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundacion Clinica Valle del Lili:
covid19
lung function
quality of life
Additional relevant MeSH terms:
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Infection
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs