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

August 26, 2024 updated by: Fundacion Clinica Valle del Lili

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760001
        • Fundacion Valle Del Lili

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lung function
Time Frame: 6 months after hospital discharge
Spirometry in Liters
6 months after hospital discharge
Lung function
Time Frame: 12 months after hospital discharge
Spirometry in Liters
12 months after hospital discharge
Lung function
Time Frame: 6 months after hospital discharge
Diffusing capacity of carbon monoxide (% predicted)
6 months after hospital discharge
Lung function
Time Frame: 12 months after hospital discharge
Diffusing capacity of carbon monoxide (% predicted)
12 months after hospital discharge
Lung function
Time Frame: 6 months after hospital discharge
6 min walk test in Meters
6 months after hospital discharge
Lung function
Time Frame: 12 months after hospital discharge
6 min walk test in Meters
12 months after hospital discharge
Radiological alterations
Time Frame: 6 months after hospital discharge
Alterations in chest radiography
6 months after hospital discharge
Radiological alterations
Time Frame: 12 months after hospital discharge
Alterations in chest radiography
12 months after hospital discharge
Radiological alterations
Time Frame: 6 months after hospital discharge
Alterations in thoracic CT scan
6 months after hospital discharge
Radiological alterations
Time Frame: 12 months after hospital discharge
Alterations in thoracic CT scan
12 months after hospital discharge
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)
6 months after hospital discharge
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)
12 months after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacion Clinica Valle del Lili

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fernandez, Fundacion Clinica Valle del Lili

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 11, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1631 COVID-LFT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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