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临床试验/NCT04453748
NCT04453748Unknown不适用

The Assessment of the Prevalence, Clinical Course and Treatment of COVID-19 Complications

Silesian Centre for Heart Diseases1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年6月8日最近更新:
适应症

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:

  1. the assessment of prevalence of particular complications after COVID-19.
  2. identification of the demographic and clinical risk factors of COVID-19 complications
  3. 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

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

发起方
Silesian Centre for Heart Diseases
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariusz Gasior

Prof.

Silesian Centre for Heart Diseases

研究点 (1)

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