Covid19NCT04559100
Long-term Characterization of Patients With Severe/Critical Infection by COVID-19 Virus
An observational study of Covid19, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Covid19
- What is being tested?
- chest radiography, thoracic computed tomography scan and spirometry
- Type of treatment
- Surgery or procedure
- How many people
- 112 participants
- Where
- 1 siteColombia
- Study dates
- 15 Nov 2020to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥ 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
Who cannot join
- Patients who do not sign informed consent.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundacion Valle del Lili
Cali, Valle del Cauca Department, 760001
About this study
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
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.
- Conditions
- Covid19
- Being tested
- chest radiography, thoracic computed tomography scan, spirometry, Diffusing capacity of carbon monoxide, 6 minute walk test
- Keywords
- covid19, lung function, quality of life
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest radiographyRadiation
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 scanRadiation
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.
spirometryDiagnostic 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 monoxideDiagnostic 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 testDiagnostic 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 questionnaireDiagnostic test
6 and 12 months after hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function
Spirometry in Liters
Measured: 6 months after hospital discharge
Lung function
Spirometry in Liters
Measured: 12 months after hospital discharge
Lung function
Diffusing capacity of carbon monoxide (% predicted)
Measured: 6 months after hospital discharge
Lung function
Diffusing capacity of carbon monoxide (% predicted)
Measured: 12 months after hospital discharge
Lung function
6 min walk test in Meters
Measured: 6 months after hospital discharge
Lung function
6 min walk test in Meters
Measured: 12 months after hospital discharge
Radiological alterations
Alterations in chest radiography
Measured: 6 months after hospital discharge
Radiological alterations
Alterations in chest radiography
Measured: 12 months after hospital discharge
Radiological alterations
Alterations in thoracic CT scan
Measured: 6 months after hospital discharge
Radiological alterations
Alterations in thoracic CT scan
Measured: 12 months after hospital discharge
Quality of life alterations
Saint George Respiratory questionnaire (from 0 to 100 points, higher levels indicating a major health impairment)
Measured: 6 months after hospital discharge
Quality of life alterations
Saint George Respiratory questionnaire (from 0 to 100 points, higher levels indicating a major health impairment)
Measured: 12 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start15 Nov 2020
- Primary completion11 Nov 2021
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinica Valle del Lili
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernandez, Principal investigator, Fundacion Clinica Valle del Lili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559100
- Sponsor's protocol ID
- 1631 COVID-LFT
- Status last verified
- May 2024
- First submitted
- 17 Sep 2020
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04559100
- Acronym / sponsor ID
- 1631 COVID-LFT
- Conditions
- Covid19
- Keywords
- covid19, lung function, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Fundacion Clinica Valle del LiliUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe and critical COVID-19 survivors | – | 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 questionnaireRadiological 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- ≥ 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
Key exclusion criteria (1 listed)
- Patients who do not sign informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chest radiography6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months. | Radiation | Severe and critical COVID-19 survivors |
| thoracic computed tomography scan6 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. | Radiation | Severe and critical COVID-19 survivors |
| spirometry6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months. | Diagnostic test | Severe and critical COVID-19 survivors |
| Diffusing capacity of carbon monoxide6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months. | Diagnostic test | Severe and critical COVID-19 survivors |
| 6 minute walk test6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months. | Diagnostic test | Severe and critical COVID-19 survivors |
| saint george respiratory questionnaire6 and 12 months after hospital discharge. | Diagnostic test | Severe and critical COVID-19 survivors |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernandez principal investigator
Fundacion Clinica Valle del Lili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function (time frame: 6 months after hospital discharge). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.