The Effect of miRNA and Epigenetic Modifications on Prognosis in Covid-19 Infection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Determination of the relationship between the severity of disease and epigenetic factors in COVID 19
研究概览
简要总结
The necessity for early detection and hence improving the outcome of treatment of pneumonia is critical especially SARS-CoV-2 induced cases. This work was designed to evaluate the potential application of measuring circulating epigenetic markers namely, miR-744, miR-24, miR-124, miR-155, miR-19a, miR-122, miR-21, miR-223, let-7f, miR-146, miR-196, miR-136, P13-K, miR-9 expression, and DNA methylation profiling of the ACE2, TMPRSS2, PARP, HOX1 genes in Coronavirus disease 2019 (COVID-19) due to SARS-CoV-2 with/without pneumonia and severe acute respiratory syndrome (SARS) patients as an attempt to evaluate the potential benefits of these new circulating, prognostic, epigenetic markers for Turkish patients.
详细描述
The objectives of this observational study are 1) To investigate why COVID-19 infection causes different biological behavioral patterns in individuals, 2) To determine the role of epigenetic mechanisms here to detect the difference between individuals, 3)To determine the effectiveness of this behavior model and mechanisms on clinical treatment and to ensure that the results obtained are a step for further treatment studies, 4) To evaluate whether the data obtained in MicroRNA analysis is a predictive marker on prognosis. Material and methods Study design This is an observational prospective cohort study. In the power analysis performed with the G * power 3.1 programs related to our study, the effect size for the lymphocyte percentage and C-reactive protein was found to be 0.57 (Effective Treatment of Severe COVID-19 Patients with Tocilizumab) (alpha probability of error = 0.05); in the sample width analysis, taking the power value 0.80, the total number of patients to be collected was 105 (105/3 = 35 for each group).
Patient's criteria This study was approved by the Clinical Research Ethics Committee (2011- CREC-40) at Bakırköy Dr.Sadi Konuk Training and Research Hospital and informed consent will be obtained from all patients according to the rules of the Declaration of Helsinki. Approval of the local ethical committee number is 2020/143 (2011-CREC-40). Patients enrolled in this study will be admitted to the Infectious Diseases and Clinical Microbiology Department and the Intensive Care Department from May 2020 to September 2020. Diagnosis of COVID 19 will be depending upon the presence of specific lesions in lungs confirmed by computed tomography (CT), and/or laboratory findings according to the Republic of Turkey Ministry of Health diagnostic criteria.
Inclusion criteria All patients between the ages of 18 and 65 included will suffer from COVID 19, and specific treatment should not yet be initiated. COVID 19 diagnosis of patients will be based on full medical history, thorough clinical examination, radiological imaging, laboratory assessment, and SARS-CoV-2 analysis by RT-PCR.
Exclusion criteria
- People with chronic lung disease or previous AC surgery
- People with immune deficiency or cancer patients
- Patients receiving immunosuppressive therapy for autoimmune disease
- People with neurological diseases affecting the respiratory muscles, such as hypotonia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients between the ages of 18 and 65 included will suffer from COVID 19, and specific treatment should not yet be initiated.
- •COVID 19 diagnosis of patients will be based on full medical history, thorough clinical examination, radiological imaging, laboratory assessment, and SARS-CoV-2 analysis by RT-PCR.
排除标准
- •People with chronic lung disease or previous AC surgery
- •People with immune deficiency or cancer patients
- •Patients receiving immunosuppressive therapy for autoimmune disease
- •People with neurological diseases affecting the respiratory muscles, such as hypotonia.
结局指标
主要结局
Determination of the relationship between the severity of disease and epigenetic factors in COVID 19
时间窗: Seven months
Analysis of pathway-related micro RNAs in patients with mild, moderate and severe Covid 19 clinics
次要结局
未报告次要终点
研究者
Gokhan Tolga Adas
Faculty Member
Bakirkoy Dr. Sadi Konuk Research and Training Hospital