Post-COVID-19 SyndromeNCT06439134
Evaluation Of The Chronic Effects Of Covıd-19 Infection On The Respiratory System
An observational study of Post-COVID-19 Syndrome and COVID-19, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate whether there are chronic effects in the pulmonary system and systemic level in individuals in the post COVID19 period in order to elucidate the involvement of inflammation after recovery. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-COVID-19 Syndrome, COVID-19
- What is being tested?
- Pulmonary Ultrasound, Respiratory Function Test
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 1 Sep 2023
- How long will I take part?
- 1 Year
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The applicants was selected beneath the emplyees of Zonguldak Obstetrics and Gynecology Hospital. The sample was formed by retrospective screening of patient records. (sample size: 372). There are two groups in the study, ones who had COVID-19 infection previously (N:50) and ones who didn't have COVID-19 infection. There was no gender discrimination in randomization.
Who may be able to join
- Age range: 18-60 years old
- Not having had COVID-19 infection
- (For female patients) No pregnancy or puerperium
- Consent for the study
- To be able to complete the pulmonary function test successfully
- Vital signs at the stage of lung ultrasound or pulmonary function testing during the study no change in findings
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- Not having an active infection at the time of the workplace examination
- No abnormal findings in the chest radiograph taken before the study
- Absence of existing autoimmune or rheumatological disorders For the experimental group;
- Age range: Being between 18-60 years old
- Having had COVID-19 infection and post infectious period of 3 months or more to be
- (For female patients) No pregnancy or puerperium
- Consent for the study
- To be able to complete the pulmonary function test successfully
- Vital signs at the stage of lung ultrasound or pulmonary function testing during the study no change in findings
- Not having an active infection at the time of the workplace examination
- Abnormal findings on chest radiography taken in the pre-infectious period before the study absence of
- Absence of existing autoimmune or rheumatological disorders
Who cannot join
- Age range: Being outside the 18-60 age range
- (for the experimental group) COVID-19 infection and 3 days of post infectious period under the month
- (For female patients) Pregnancy or puerperium
- Lack of consent for the study
- Failure to complete the pulmonary function test (dizziness, incompatibility, etc.) reasons)
- Vital signs at the stage of lung ultrasound or pulmonary function testing during the study change in findings
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- Having an active infection at the time of the workplace examination
- Abnormal chest radiographs taken in the pre-infectious period before the study the presence of findings
- Existing autoimmune or rheumatological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Of The Chronic Effects Of Covıd-19 Infection On The Respiratory System By Pulmonary Ultrasound, Pulmonary Function Tests and Cytokine Level Measurement
The aim of this study is to evaluate whether there are chronic effects in the pulmonary system and systemic level in individuals in the post COVID19 period in order to elucidate the involvement of inflammation after recovery. In addition, a perspective on the utility of pulmonary function testing and pulmonary ultrasound in the evaluation of chronic effects and patient follow-up will is aimed to be provided. By measuring the protein levels of inflammatory markers along with the data abovementioned, a foresight regarding the long-term effects of the previous infection at both functional and immunological levels will be obtained, allowing us to evaluate the post-COVID period from different angles.
Volunteers who recovered from COVID-19 and those who didn't have COVID-19 were compared by evaluating chest x-ray scores (CXR), lung ultrasound scores (LUSS), pulmonary function tests and inflammatory cytokine levels (TNF-α, IL-1, IL-6, IL-17A).
Read the detailed description
Objective: The aim of this study is to evaluate whether there are chronic effects in the pulmonary system and systemic level in individuals in the post COVID19 period in order to elucidate the involvement of inflammation after recovery. In addition, a perspective on the utility of pulmonary function testing and pulmonary ultrasound in the evaluation of chronic effects and patient follow-up will is aimed to be provided. By measuring the protein levels of inflammatory markers along with the data abovementioned, a foresight regarding the long-term effects of the previous infection at both functional and immunological levels will be obtained, allowing us to evaluate the post-COVID period from different angles.
Materials and Methods: Volunteers who recovered from COVID-19 infection at least 3 months or more were included in the study, while healthy volunteers who did not have the infection were enrolled as the control group. Two groups were compared by evaluating chest x-ray scores (CXR), lung ultrasound scores (LUSS), pulmonary function tests and inflammatory cytokine levels (TNF-α, IL-1, IL-6, IL-17A).
- Conditions
- Post-COVID-19 Syndrome, COVID-19
- Being tested
- Pulmonary Ultrasound, Respiratory Function Test
- Keywords
- COVID-19, Post-COVID-19 Syndrome, Pulmonary Ultrasound, Chest X-ray, Respiratory Function Test
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Ultrasound, Respiratory Function TestDiagnostic test
Volunteers underwent pulmonary ultrasound and respiratory function test
| Study group | Role | What they receive |
|---|---|---|
| Non-COVID-19 group | The group which consists of volunteers who has not been infected by COVID-19 virus Receives: Diagnostic Test: Pulmonary Ultrasound, Respiratory Function Test | |
| Post COVID-19 group | The group which consists of volunteers who has been infected by COVID-19 virus and has at least 3 months or more post-COVID period Receives: Diagnostic Test: Pulmonary Ultrasound, Respiratory Function Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Ultrasound
Pulmonary Ultrasound is going to be made and evaluated by using LUSS score. LUSS score is an evlatuation score for pulmonary ultrasound. For the study, both hemithoraces of the patient will divided into eight areas in total. The evaluation is going to be performed in the right hemithorax upper anterior, right hemithorax lower anterior, right hemithorax upper lateral, right hemithorax lower lateral, left hemithorax upper anterior, left hemithorax lower anterior, left hemithorax upper lateral, and left hemithorax lower lateral regions, respectively. During the assessment, the researcher is going to be positioned on the right side of the patient for the right hemithorax assessment and on the left side for the left hemithorax assessment. Each area will be scored between 0-3 and for final score, score for each zone will be collected . 24 is the worst score and 0 is the best score.
Measured: 1 month
Respiratory Function Test
Respiratory Function Test results are going to be recorded. The recorded values will be FEV1, FVC, FEV1/FVC, PEF, FRC and TLC values.
Measured: 1 month
Chest X-ray Evaluation
Chest X-ray evaluation is going to be made according to CXR score. During the evaluation of chest radiography, the pulmonary parenchyma is going to be divided into a total of six regions as right/left and apical region/mid region/basal region. Post COVID-19 changes are going to be taken into consideration when scoring criteria is made; 0- No abnormal findings
- Interstitial infiltrates (Septal thickening and focal or extensional opacity)
- Interstitial and alveolar infiltrates (Interstitial predominant)
- Interstitial and alveolar infiltrates (Alveolar predominance) The criteria looked at as A points will be scored. Each zone is going to be evaluated with a score defined as A score and the scores of each zone is going to be summed to obtain a total score. Thus, each radiograph will be given a score between 0-18 by scoring all six defined zones and an evaluation will be made.
Measured: 1 month
Blood Cytokine Result Analysis
Blood Cytokine Result Analysis is going to be made by Cytokine-Bead Array. The measured cytokines will be TNF-α, IL-1, IL-6 and IL-17A
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start1 Jun 2022
- Primary completion1 Jun 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID-19 SyndromeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439134
- Sponsor's protocol ID
- Inflammation and Post COVID-19
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Chronic Effects Of Covıd-19 Infection On The Respiratory System By Pulmonary Ultrasound, Pulmonary Function Tests and Cytokine Level Measurement
- ClinicalTrials.gov ID
- NCT06439134
- Acronym / sponsor ID
- Inflammation and Post COVID-19
- Conditions
- Post-COVID-19 Syndrome, COVID-19
- Keywords
- COVID-19, Post-COVID-19 Syndrome, Pulmonary Ultrasound, Chest X-ray, Respiratory Function Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 3 Jun 2024 (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 aim of this study is to evaluate whether there are chronic effects in the pulmonary system and systemic level in individuals in the post COVID19 period in order to elucidate the involvement of inflammation after recovery. In addition, a perspective on the utility of pulmonary function testing and pulmonary ultrasound in the evaluation of chronic effects and patient follow-up will is aimed to be provided. By measuring the protein levels of inflammatory markers along with the data abovementioned, a foresight regarding the long-term effects of the previous infection at both functional and immunological levels will be obtained, allowing us to evaluate the post-COVID period from different angles.
Volunteers who recovered from COVID-19 and those who didn't have COVID-19 were compared by evaluating chest x-ray scores (CXR), lung ultrasound scores (LUSS), pulmonary function tests and inflammatory cytokine levels (TNF-α, IL-1, IL-6, IL-17A).
Detailed description
Objective: The aim of this study is to evaluate whether there are chronic effects in the pulmonary system and systemic level in individuals in the post COVID19 period in order to elucidate the involvement of inflammation after recovery. In addition, a perspective on the utility of pulmonary function testing and pulmonary ultrasound in the evaluation of chronic effects and patient follow-up will is aimed to be provided. By measuring the protein levels of inflammatory markers along with the data abovementioned, a foresight regarding the long-term effects of the previous infection at both functional and immunological levels will be obtained, allowing us to evaluate the post-COVID period from different angles.
Materials and Methods: Volunteers who recovered from COVID-19 infection at least 3 months or more were included in the study, while healthy volunteers who did not have the infection were enrolled as the control group. Two groups were compared by evaluating chest x-ray scores (CXR), lung ultrasound scores (LUSS), pulmonary function tests and inflammatory cytokine levels (TNF-α, IL-1, IL-6, IL-17A).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-COVID-19 group | – | Diagnostic Test: Pulmonary Ultrasound, Respiratory Function TestThe group which consists of volunteers who has not been infected by COVID-19 virus |
| Post COVID-19 group | – | Diagnostic Test: Pulmonary Ultrasound, Respiratory Function TestThe group which consists of volunteers who has been infected by COVID-19 virus and has at least 3 months or more post-COVID period |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The applicants was selected beneath the emplyees of Zonguldak Obstetrics and Gynecology Hospital. The sample was formed by retrospective screening of patient records. (sample size: 372). There are two groups in the study, ones who had COVID-19 infection previously (N:50) and ones who didn't have COVID-19 infection. There was no gender discrimination in randomization.
Key inclusion criteria (18 listed)
- Age range: 18-60 years old
- Not having had COVID-19 infection
- (For female patients) No pregnancy or puerperium
- Consent for the study
- To be able to complete the pulmonary function test successfully
Key exclusion criteria (9 listed)
- Age range: Being outside the 18-60 age range
- (for the experimental group) COVID-19 infection and 3 days of post infectious period under the month
- (For female patients) Pregnancy or puerperium
- Lack of consent for the study
- Failure to complete the pulmonary function test (dizziness, incompatibility, etc.) reasons)
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 |
|---|---|---|
| Pulmonary Ultrasound, Respiratory Function TestVolunteers underwent pulmonary ultrasound and respiratory function test | Diagnostic test | Non-COVID-19 group, Post COVID-19 group |
Primary outcome
Pulmonary Ultrasound
Time frame: 1 month
Pulmonary Ultrasound is going to be made and evaluated by using LUSS score. LUSS score is an evlatuation score for pulmonary ultrasound. For the study, both hemithoraces of the patient will divided into eight areas in total. The evaluation is going to be performed in the right hemithorax upper anterior, right hemithorax lower anterior, right hemithorax upper lateral, right hemithorax lower lateral, left hemithorax upper anterior, left hemithorax lower anterior, left hemithorax upper lateral, and left hemithorax lower lateral regions, respectively. During the assessment, the researcher is going to be positioned on the right side of the patient for the right hemithorax assessment and on the left side for the left hemithorax assessment. Each area will be scored between 0-3 and for final score, score for each zone will be collected . 24 is the worst score and 0 is the best score.
Respiratory Function Test
Time frame: 1 month
Respiratory Function Test results are going to be recorded. The recorded values will be FEV1, FVC, FEV1/FVC, PEF, FRC and TLC values.
Chest X-ray Evaluation
Time frame: 1 month
Chest X-ray evaluation is going to be made according to CXR score. During the evaluation of chest radiography, the pulmonary parenchyma is going to be divided into a total of six regions as right/left and apical region/mid region/basal region. Post COVID-19 changes are going to be taken into consideration when scoring criteria is made; 0- No abnormal findings 1. Interstitial infiltrates (Septal thickening and focal or extensional opacity) 2. Interstitial and alveolar infiltrates (Interstitial predominant) 3. Interstitial and alveolar infiltrates (Alveolar predominance) The criteria looked at as A points will be scored. Each zone is going to be evaluated with a score defined as A score and the scores of each zone is going to be summed to obtain a total score. Thus, each radiograph will be given a score between 0-18 by scoring all six defined zones and an evaluation will be made.
Blood Cytokine Result Analysis
Time frame: 1 month
Blood Cytokine Result Analysis is going to be made by Cytokine-Bead Array. The measured cytokines will be TNF-α, IL-1, IL-6 and IL-17A
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 3 Jun 2024.
- 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 Post-COVID-19 Syndrome and COVID-19, run by Yeditepe University 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 18 inclusion and 9 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 3 Jun 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 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?
Pulmonary Ultrasound (time frame: 1 month). The study lists 4 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 3 Jun 2024.