Determination of Acute Encephalopathy Predictors in Patients With COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- The percentage of patients who have developed encephalopathy
研究概览
简要总结
The SARS-CoV-2 infection was detected in December 2019 in Wuhan City, China. The infection affects all age groups, although childhood is the lowest proportion of those affected.
The main clinical manifestations that require hospitalization of infected patients are SARS pneumonia, which may require treatment in the intensive care unit (27%) and its progression into acute respiratory distress syndrome (67%) with life-threatening conditions in almost 25% of patients diagnosed with "SARS-CoV-2 infection".
Nervous system damage with SARS-CoV-2 infection has been practically not investigated, but neurological disorders have been reported in 36% of these patients.
Finally, the mortality rate associated with the new virus is high in patients who require treatment in intensive care units (62% of cases).
Therefore, we are conducting a prospective study to identify acute encephalopathy predictors in patients with COVID-19.
详细描述
This is a prospective, cohort-based, adaptive design study that aims to identify acute encephalopathy predictors in patients with COVID-19. Patients with community-acquired pneumonia and confirmed pulmonary tissue infiltration will be enrolled in the study based on CT data with changes corresponding to the medium and high probability of coronavirus pneumonia (CO-RADS 4-5) and lesion of at least 25% of one lung.
Each patient will be examined at least twice (2 visits): P1 - on admission to hospital; P2 - in 10±5 days.
In the further course of the disease patients will be divided into 2 groups (cohorts). Group 1 - patients who have developed acute encephalopathy. Group 2 - patients who at the moment of discharge have no acute encephalopathy.
The study will collect clinical exam ( including neurological signs), neurophysiological data (including electroencephalography (EEG) and evoked potential (EP)), comprehensive laboratory tests, CT-scan and all standards of care to identify predictors of acute encephalopathy.
The study will consist of two phases:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 to 60 years
- •Out-of-hospital pneumonia with confirmed pulmonary tissue infiltration according to CT with changes corresponding to the average and high probability of coronavirus pneumonia (4-5 levels by CO-RADS classification) and the loss of more than 25% of one of the lungs.
- •The patient has read the information sheet and signed the informed consent form.
排除标准
- •Negative PCR test for coronavirus infection.
- •The presence in the anamnesis of data for myocardial infarction or stroke.
- •Verified thrombophilia.
- •Pregnancy.
- •Patients with malignant tumors (including anamnesis), including postoperative period in the background of chemo and/or radiation therapy.
- •Acute stroke.
- •Dropout Criteria:
- •Patient's refusal to participate further in the study.
- •Negative PCR result for coronavirus infection.
结局指标
主要结局
The percentage of patients who have developed encephalopathy
时间窗: 10 days
The percentage of patients who have developed encephalopathy
次要结局
未报告次要终点
研究者
Oleg Vinogradov
MD, PhD
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia