Predicting The Prognosis Of Covid-19 Patients With Circulating Inflammatory and Coagulation Markers
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Serum PAI-1 levels of Covid-19 patients
研究概览
简要总结
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.
详细描述
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)
- Covid positive patients with mild symptoms who required to be hospitalized,
- Symptomatic (fever, cough, weakness, joint pain, etc.) new patients who apply to the Covid clinic for the first time,
- Patients with stable vital signs and/or SpO2 ≥92% in room air, no radiological signs of lung involvement or mild pneumonia,
- Patients who have not been started on steroid therapy and who have not yet received anticoagulant therapy.
Group 2 (n=20; with moderate symptoms)
- Patients who are positive for Covid 19 and admitted to the covid clinic for the first time;
- Radiologically moderate pneumonia findings and/or SpO2=88-92% in room air,
- Patients who have not been started antiviral, steroid, and anticoagulant treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •Patients may have hypertension disease and type II diabetes mellitus (occurring less than 5 years, diet and/or insulin-regulated).
- •HbA1C levels of all participants (HbA1C < 6.4%) will be studied to confirm if any patient in the study or control groups has unregulated DM or undiagnosed overlooked DM. Diabetic patients with an HbA1C level above 6.4% will be excluded from the study.
- •Enrolled patients have to have a diagnostic chest X-ray and/or HRCT. (Participants will be subjected to radiological classification and scoring according to lung involvement such as ground-glass opacity.)
排除标准
- •Patients who are considered to have previous vascular endothelial damage due to secondary causes such as history of thrombosis, thrombophlebitis and/or thromboembolism,
- •Presence of active cancer, history of chemotherapy, radiotherapy or bone marrow transplantation,
- •Presence or history of autoimmune, connective tissue diseases, vasculitis (autoimmune thyroiditis, Crohn's, ulcerative colitis, SLE, Sjogren's disease, etc.),
- •Familial inherited hereditary diseases (Hemophilia, Mediterranean anemia, FMF, Thalassemia major etc.)
- •Patients with chronic renal failure and/or requiring dialysis,
- •Presence of acquired/congenital immunodeficiency,
- •Patients who are receiving immunosuppressive or biologic drug therapy,
- •Patients receiving treatment with a diagnosis of bronchial asthma,
- •Type 1 or type 2 diabetes mellitus patients with HbA1C levels > 6.4%
- •Patients with diabetes for more than 5 years or currently taking oral insulin-sensitizing drugs (biguanides; metformin)
- •Patients using antithrombotic (Clopidogrel, low-dose aspirin, etc.) and anticoagulant (LMWH, Warfarin, etc.) agents due to comorbid disease at the time of diagnosis.
- •Patients using ACE inhibitors such as lisinopril as an antihypertensive agent
结局指标
主要结局
Serum PAI-1 levels of Covid-19 patients
时间窗: Blood sample collection is limited to up to 32 weeks and laboratory studies will be completed up to one week.
To understand the effects of Covid-19 disease on vascular inflammation and coagulation cascade.
次要结局
- Serum PAI-1 levels of Covid-19 patients(Up to 32 weeks for blood sample collection and up to one week for laboratory analysis.)
研究者
Nazlı ERCAN
Specialist Doctor
Saglik Bilimleri Universitesi