The Assessment of the Prevalence, Clinical Course and Treatment of COVID-19 Complications
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Prevalence of COVID-19 complications
研究概览
简要总结
SAR-Cov-2 infection and its clinical manifestation known as COVID-19 beside the respiratory and lung involvement may include the cardiovascular system, the nervous system and the liver. In the acute phase of the disease, all of these conditions may be life-threatened. As a result, after the acute phase of COVID-19, early complications may be observed, including heart, lungs, brain, muscles and liver. A few papers to date have been reported of myocarditis, ventricular arrhythmias, post-inflammatory changes in the lung and liver, as well as ischemic changes in the brain, diseases of skeletal muscle, which may have adverse prognostic effects. Due to the extent of the pandemic, the severity of the complications and the expected high complications' prevalence in the early post-recovery period, a study was designed to determine the extent of the problem of early complications after COVID-19. Complex cardiological, pulmonary, neurological and hepatological diagnostics are planned, including laboratory, imaging and functional tests. The results obtained, in addition to determining the scale of the problem, will allow the selection of studies that optimally identify patients with early complications. The purpose of this procedure is to enable rapid treatment of diseases that are complications of SARS-COV-2 infection. An additional aspect raised in the project will be the issue of psychiatric disorders (anxiety, depression, post traumatic disorders).
The main three purposes of the study include:
- the assessment of prevalence of particular complications after COVID-19.
- identification of the demographic and clinical risk factors of COVID-19 complications
- determining the diagnostic tests which are sufficient to detect early complications of COVID-19
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 120 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SARS-Cov-2 RNA confirmed by the PCR method in the acute phase of disease.
- •Presence of the clinical symptoms associated with COVID-19 in the acute phase of disease
- •Two negative results of SARS-COV-2 PCR test following the 7-day period of quarantine
- •Informed consent
排除标准
- •Any symptoms of infection during the quarantine
- •Lack of patient's consent
- •Lack of possibility of travelling to the hospital for tests
结局指标
主要结局
Prevalence of COVID-19 complications
时间窗: 2 months
Complications include pulmonary, cardio-vascular, neurological, hepatologic and psychiatric disordes that might be linked to the COVID-19. The diagnostic tests: blood tests, transthoracic echocardiography, spirometry, high-resolution computed tomography, neurological examination, liver ultrasonography and elastography, vasular ultrasonography (veins and arteries), psychiatric questionnairies
次要结局
- Assessment of risk factors of COVID-19 complications(2 months)
研究者
Mariusz Gasior
Prof.
Silesian Centre for Heart Diseases
