Determination of Acute Encephalopathy Predictors in Patients With COVID-19

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].