Covid19NCT04715919
Long Term Outcomes of Coronavirus Disease-19 (COVID-19)
An observational study of Covid19, run by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators hypothese that lung involvement due to COVID-19 may cause structural changes in the lung in the long term. In this study the effects of structural changes in the lung on pulmonary function tests, exercise capacity and quality of life will be examined. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Covid19
- What is being tested?
- Chest Computed Tomography, Pulmonary Function Tests and Six Minutes Walk Test
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2021to 1 Jun 2021
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Survivors of COVID-19 aged over 18 years old who had been admitted in University of Health Sciences, Dr. Suat Seren Chest Disease and Surgery Training and Research Hospital for COVID-19 patients in İzmir, Turkey.
Who may be able to join
- Patients who were ≥18 years
- COVID-19 confirmed by Real-Time PCR
- At least 6 months after discharge
Who cannot join
- Patients who were < 18 years
- Pregnancy
- Become bedridden after discharge
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
1University of Health Sciences Turkey, Dr Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Intensive Care Unit
Izmir, 35110
About this study
Official title: Long Term Outcomes in Patients With Coronavirus Disease-19 (COVID-19) on Pulmonary Functions, Exercise Capacity, Lung Structure and Quality of Life
The investigators hypothese that lung involvement due to COVID-19 may cause structural changes in the lung in the long term. In this study the effects of structural changes in the lung on pulmonary function tests, exercise capacity and quality of life will be examined.
Read the detailed description
Coronavirus disease-19 (COVID-19) has a clinical spectrum ranging from asymptomatic cases to severe cases requiring intensive care hospitalization due to respiratory failure. The disease mostly infects the lower respiratory tract. Typical computed tomography findings of lung involvement are bilateral, peripherally located ground glass density and consolidations. There is a close relationship between tomography findings and clinical severity. It is not known whether there will be complete recovery in the lungs.
Investigators will evaluate pulmonary structures with chest computed tomography, respiratory capacity with pulmonary function tests (PFTs), exercise capacity with six minutes walk test and quality of life with short form-36 (SF-36) im patients who survivors of COVID-19 at least 6 months after hospital discharge.
- Conditions
- Covid19
- Being tested
- Chest Computed Tomography, Pulmonary Function Tests, Six Minutes Walk Test, Quality of Life
- Keywords
- Covid19, Long term outcomes, Chest computed comography, Pulmonary functional tests, Exercise capacity, 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 Computed TomographyDiagnostic test
Evaluation of Lung Structure
Pulmonary Function TestsDiagnostic test
Respiratory Capacity
Six Minutes Walk TestOther
Exercise Capacity
Quality of LifeOther
Also called SF-36
Physical disability assessment tool
| Study group | Role | What they receive |
|---|---|---|
| Patients in ICU | ICU patients with COVID-19 Receives: Diagnostic Test: Chest Computed Tomography; Diagnostic Test: Pulmonary Function Tests; Other: Six Minutes Walk Test; Other: Quality of Life | |
| Patients in Hospital Ward | Patients with COVID-19 in hospital wards Receives: Diagnostic Test: Chest Computed Tomography; Diagnostic Test: Pulmonary Function Tests; Other: Six Minutes Walk Test; Other: Quality of Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural Change in Lung
Chest Computed Tomography
Measured: up to 6 months after discharge
Secondary outcomes (3)
Carbon monoxide diffusion capacity (DLCO)
Carbon monoxide diffusion capacity of the lung
Measured: up to 6 months after discharge
Exercise Capacity
Six Minutes Walking Test
Measured: up to 6 months after discharge
Short Form Health Survey Score (SF-16)
A 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state
Measured: up to 6 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start15 Jan 2021
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turkish Respiratory Society
- Responsible party
- Principal investigator, Cenk Kirakli, M.D., Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715919
- Sponsor's protocol ID
- 195/ADF14
- Status last verified
- Sep 2021
- First submitted
- 28 Dec 2020
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcomes in Patients With Coronavirus Disease-19 (COVID-19) on Pulmonary Functions, Exercise Capacity, Lung Structure and Quality of Life
- ClinicalTrials.gov ID
- NCT04715919
- Acronym / sponsor ID
- 195/ADF14
- Conditions
- Covid19
- Keywords
- Covid19, Long term outcomes, Chest computed comography, Pulmonary functional tests, Exercise capacity, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research HospitalUniversity, hospital or other
- Collaborators
- Turkish Respiratory Society
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 20 Jan 2021 (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.
The investigators hypothese that lung involvement due to COVID-19 may cause structural changes in the lung in the long term. In this study the effects of structural changes in the lung on pulmonary function tests, exercise capacity and quality of life will be examined.
Detailed description
Coronavirus disease-19 (COVID-19) has a clinical spectrum ranging from asymptomatic cases to severe cases requiring intensive care hospitalization due to respiratory failure. The disease mostly infects the lower respiratory tract. Typical computed tomography findings of lung involvement are bilateral, peripherally located ground glass density and consolidations. There is a close relationship between tomography findings and clinical severity. It is not known whether there will be complete recovery in the lungs.
Investigators will evaluate pulmonary structures with chest computed tomography, respiratory capacity with pulmonary function tests (PFTs), exercise capacity with six minutes walk test and quality of life with short form-36 (SF-36) im patients who survivors of COVID-19 at least 6 months after hospital discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients in ICU | – | Diagnostic Test: Chest Computed Tomography, Diagnostic Test: Pulmonary Function Tests, Other: Six Minutes Walk Test, Other: Quality of LifeICU patients with COVID-19 |
| Patients in Hospital Ward | – | Diagnostic Test: Chest Computed Tomography, Diagnostic Test: Pulmonary Function Tests, Other: Six Minutes Walk Test, Other: Quality of LifePatients with COVID-19 in hospital wards |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Survivors of COVID-19 aged over 18 years old who had been admitted in University of Health Sciences, Dr. Suat Seren Chest Disease and Surgery Training and Research Hospital for COVID-19 patients in İzmir, Turkey.
Key inclusion criteria (3 listed)
- Patients who were ≥18 years
- COVID-19 confirmed by Real-Time PCR
- At least 6 months after discharge
Key exclusion criteria (3 listed)
- Patients who were < 18 years
- Pregnancy
- Become bedridden after discharge
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 Computed TomographyEvaluation of Lung Structure | Diagnostic test | Patients in Hospital Ward, Patients in ICU |
| Pulmonary Function TestsRespiratory Capacity | Diagnostic test | Patients in Hospital Ward, Patients in ICU |
| Six Minutes Walk TestExercise Capacity | Other | Patients in Hospital Ward, Patients in ICU |
| Quality of LifeAlso: SF-36Physical disability assessment tool | Other | Patients in Hospital Ward, Patients in ICU |
Primary outcome
Structural Change in Lung
Time frame: up to 6 months after discharge
Chest Computed Tomography
3 secondary outcomes
Carbon monoxide diffusion capacity (DLCO)
Time frame: up to 6 months after discharge
Exercise Capacity
Time frame: up to 6 months after discharge
Short Form Health Survey Score (SF-16)
Time frame: up to 6 months after discharge
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 14 Sep 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital at 1 site in Turkey (Türkiye).
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 3 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 14 Sep 2021. 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 Turkey (Türkiye). 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?
Structural Change in Lung (time frame: up to 6 months after discharge). 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 14 Sep 2021.