Clinical trial NCT06439134: Evaluation Of The Chronic Effects Of Covıd-19 Infection On The Respiratory System
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-COVID-19 Syndrome
COVID-19
Keywords: COVID-19
Post-COVID-19 Syndrome
Pulmonary Ultrasound
Chest X-ray
Respiratory Function Test
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:For the control group;

* 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
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Pulmonary Ultrasound
timeFrame: 1 month
measure: Respiratory Function Test
timeFrame: 1 month
measure: Chest X-ray Evaluation
timeFrame: 1 month
measure: Blood Cytokine Result Analysis
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University
Study officials:
References: