Determination of Acute Encephalopathy Predictors in Patients With COVID-19
Condition: Encephalopathy; COVID
MeSH terms: Brain Diseases
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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:

        1. The pilot phase - inclusion of the first 60 patients, followed by an interim analysis on
           the basis of which will be clarified:

             -  sample size;

             -  clinical, laboratory and instrumental parameters to be analyzed;

             -  terms and frequency of the EEG and EP.

        2. The main phase - further patient recruitment and all procedures required by the
           protocol.

      The intermediate and final analysis will include both patients who have developed acute
      encephalopathy (main group) and patients who have not developed acute encephalopathy (control
      group).

      Acute encephalopathy will be defined as recently stated :

        1. The term acute encephalopathy refers to a rapidly developing (over less than 4 weeks,
           but usually within hours to a few days) pathobiological process in the brain. This is a
           preferred term

        2. Acute encephalopathy can lead to a clinical presentation of subsyndromal delirium,
           delirium, or in case of a severely decreased level of consciousness, coma; all
           representing a change from baseline cognitive status

        3. The term delirium refers to a clinical state characterized by a combination of features
           defined by diagnostic systems such as the DSM-5.

      Delirium according to the DSM-5 is defined if criterium A-E are fulfilled:

      A. Disturbance in attention (i.e., reduced ability to direct, focus, sustain, and shift
      attention) and awareness (reduced orientation to the environment).

      B. The disturbance develops over a short period of time (usually hours to a few days)
      represents a change from baseline attention and awareness, and tends to fluctuate in severity
      during the course of the day.

      C. An additional disturbance in cognition (e.g., memory deficit, disorientation, language,
      visuospatial ability, or perception).

      D. The disturbances in criteria A and C are not explained by another pre-existing,
      established, or evolving neurocognitive disorder, and do not occur in the context of a
      severely reduced level of arousal, such as coma.

      E. There is evidence from the history, physical examination, or laboratory findings that the
      disturbance is a direct physiologic consequence of another medical condition, substance
      intoxication or withdrawal (i.e. because of a drug of abuse medication), or exposure to a
      toxin, or is because of multiple etiologies [1].
    

Intervention name(s): CT-scan; EEG; EP; Pulse oximetry; Blood tests
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): chest CT-scan; Electroencephalography; Evoked potential; Pulse oximetry; Blood tests
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic