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The primary aim of our study is to understand the effects of Covid-19 disease on vascular inflammation and coagulation cascade, and secondarily, to investigate its utility in predicting disease prognosis by analyzing serum PAI-1 levels in patients with different severity. The study is planned as a prospective, cross-sectional study that will include patients admitted to Covid-19 services between January 18, 2021, and August 30, 2021. A total of 80 volunteers will be enrolled in the trial whose age, gender, and BMI are planned to be matched.The study will be conducted on four groups. Group 1 (n=20; with mild symptoms), Group 2 (n=20; with moderate symptoms), Group 3 (n=20; with severe symptoms) and Group 4 (n=20; Control group).
All participants who accepted the study will have their sociodemographic data, medical history, and vital signs (respiratory rate, saturation, temperature, and blood pressure values) recorded at the start of the study. The pulmonologist in the study will also classify the patient group's chest X-ray and chest tomography findings and the thymus gland dimensions. After all four groups of patients have given their consent for the study, a sample of 5cc blood will be obtained once for the PAI-1 analysis.
The study is planned as a prospective, cross-sectional study that will include patients admitted to Covid-19 services between January 18, 2021, and August 30, 2021. A total of 80 volunteers will be enrolled in the trial whose age, gender, and BMI are planned to be matched. The study will be conducted on four groups.
Group 1 (n=20; with mild symptoms)
Group 2 (n=20; with moderate symptoms)
Group 3 (n=20; with severe symptoms)
Group 4 (n=20; Control group)
All participants who accepted the study will have their sociodemographic data, medical history, and vital signs (respiratory rate, saturation, temperature, and blood pressure values) recorded at the start of the study. The pulmonologist in the study will also classify the patient group's chest X-ray and chest tomography findings, as well as the thymus gland dimensions. After all four groups of patients have given their consent for the study, a sample of 5cc blood will be obtained once for the PAI-1analysis. The sample will be centrifuged for around 5 minutes at 3000 rpm before being frozen at -70 degrees. The blood sample will be dissolved under proper conditions after a sufficient number of participants has been reached. The researchers will provide the ELISA kits for the study, and laboratory services will be purchased from outside the hospital. Due to Covid-19 disease, white blood cell, neutrophil, lymphocyte, and platelet counts, liver enzymes (AST, ALT, LDH), sodium, total protein, albumin, aPTT, PTZ, INR, D-Dimer, and fibrinogen levels will be recorded in the patient case report form, as well as CRP, IL-6, and ferritin levels, which are routinely requested from patients during their hospitalization. No treatment other than the treatments specified in the Covid-19 guidelines of the Ministry of Health will never be applied to the patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (n=20; with mild symptoms) | Group 1 (n=20; with mild symptoms)
|
| |
| Group 2 (n=20; with moderate symptoms) | Group 2 (n=20; with moderate symptoms)
|
| |
| Group 3 (n=20; with severe symptoms) | Group 3 (n=20; with severe symptoms)
|
| |
| Group 4 (n=20; Control group) | Group 4 (n=20; Control group)
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum PAI-1 alpha analysis. | Other | After all four groups of patients have given their consent for the study, a sample of 5cc blood will be obtained once for the PAI-1 analysis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum PAI-1 levels of Covid-19 patients | To understand the effects of Covid-19 disease on vascular inflammation and coagulation cascade. | Blood sample collection is limited to up to 32 weeks and laboratory studies will be completed up to one week. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum PAI-1 levels of Covid-19 patients | To investigate PAI-1 utility in predicting disease prognosis. | Up to 32 weeks for blood sample collection and up to one week for laboratory analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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Study population: patients who are 20 years of age and older, having Covid-19 PCR positivity in the nasopharyngeal swab and showing symptoms of Covid-19 (fever, cough, dyspnea, joint pain, etc.) with or without involvement in lung imaging. A total of 80 volunteers will be enrolled in the trial whose age, gender, and BMI are planned to be matched.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nazli Ercan, MD | Contact | +905319957255 | drnazliercan@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ozgür Kartal, MD | University of Health Sciences Turkey, Gulhane Research and Training Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences Turkey, Gulhane Research and Training Hospital | Recruiting | Ankara | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32386428 | Result | Kwaan HC. Coronavirus Disease 2019: The Role of the Fibrinolytic System from Transmission to Organ Injury and Sequelae. Semin Thromb Hemost. 2020 Oct;46(7):841-844. doi: 10.1055/s-0040-1709996. Epub 2020 May 9. No abstract available. |
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After all four groups of patients have given their consent for the study, a sample of 5cc blood will be obtained once for the PAI-1 analysis. The sample will be centrifuged for around 5 minutes at 3000 rpm before being frozen at -70 degrees. The blood sample will be dissolved under proper conditions after a sufficient number of participants has been reached. The researchers will provide the ELISA kits for the study, and laboratory services will be purchased from outside the hospital.
|
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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