Long-term Characterization of Patients With Severe/Critical Infection by COVID-19 Virus
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| ClinicalTrials.gov Identifier: NCT04559100 |
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Recruitment Status :
Enrolling by invitation
First Posted : September 22, 2020
Last Update Posted : February 11, 2021
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Sponsor:
Fundacion Clinica Valle del Lili
Information provided by (Responsible Party):
Fundacion Clinica Valle del Lili
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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 |
| 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 |
| Actual Study Start Date : | November 15, 2020 |
| Estimated Primary Completion Date : | October 1, 2021 |
| Estimated Study Completion Date : | October 1, 2021 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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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 :
- Lung function [ Time Frame: 6 months after hospital discharge ]Spirometry in Liters
- Lung function [ Time Frame: 12 months after hospital discharge ]Spirometry in Liters
- Lung function [ Time Frame: 6 months after hospital discharge ]Diffusing capacity of carbon monoxide (% predicted)
- Lung function [ Time Frame: 12 months after hospital discharge ]Diffusing capacity of carbon monoxide (% predicted)
- Lung function [ Time Frame: 6 months after hospital discharge ]6 min walk test in Meters
- Lung function [ Time Frame: 12 months after hospital discharge ]6 min walk test in Meters
- Radiological alterations [ Time Frame: 6 months after hospital discharge ]Alterations in chest radiography
- Radiological alterations [ Time Frame: 12 months after hospital discharge ]Alterations in chest radiography
- Radiological alterations [ Time Frame: 6 months after hospital discharge ]Alterations in thoracic CT scan
- Radiological alterations [ Time Frame: 12 months after hospital discharge ]Alterations in thoracic CT scan
- 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)
- 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
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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
Locations
| Colombia | |
| Fundacion Valle del Lili | |
| Cali, Valle Del Cauca, Colombia, 760001 | |
Sponsors and Collaborators
Fundacion Clinica Valle del Lili
Investigators
| Principal Investigator: | Fernandez | Fundacion Clinica Valle del Lili |
| 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: | February 11, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| 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:
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covid19 lung function quality of life |
Additional relevant MeSH terms:
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COVID-19 Infections Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Lung Diseases Respiratory Tract Diseases Carbon Monoxide Antimetabolites Molecular Mechanisms of Pharmacological Action Gasotransmitters Neurotransmitter Agents Physiological Effects of Drugs |