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

NCT ID: NCT04559100

Last Updated: 2024-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-15

Study Completion Date

2022-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

chest radiography

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

6 and 12 months after hospital discharge.

Interventions

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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.

Intervention Type 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.

Intervention Type RADIATION

spirometry

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

Intervention Type 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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

saint george respiratory questionnaire

6 and 12 months after hospital discharge.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacion Clinica Valle del Lili

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fernandez

Role: PRINCIPAL_INVESTIGATOR

Fundacion Clinica Valle del Lili

Locations

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Fundacion Valle del Lili

Cali, Valle del Cauca Department, Colombia

Site Status

Countries

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Colombia

Other Identifiers

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1631 COVID-LFT

Identifier Type: -

Identifier Source: org_study_id

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