COVID19 Neurological Manifestation

University of Pittsburgh300 enrolled

Overview

This study is a prospective observational cohort study to document the prevalence and types of neurological manifestations among hospitalized patients with confirmed or suspected novel coronavirus infection (COVID-19). Severe acute respiratory syndrome 2 (SARS-CoV-2), the virus that causes COVID-19, shares significant structural and biological similarities with SARS-CoV, which is known to be neuroinvasive particularly with brainstem involvement. There are emerging reports of neurological symptoms associated with COVID-19 infections, including seizures, coma, encephalitis, Guillan-Barre syndrome, and cerebrovascular events including ischemic stroke, ICH, and cerebral venous sinus thromboses. However, the exact prevalence of these conditions and their impact on patient disease severity and outcomes is unknown. As the incidence and severity of COVID-19 infection continue to rapidly rise globally, it is imperative to capture prospective data to accurately document prevalence, severity and clinical characterization of neurological components of COVID 19, the influence of treatment regimens of neurological complications, and role of these confounders on patient and organizational outcomes.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

SARS-CoV 2 Neurologic Manifestations

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients greater than or equal to 18 years old * Admitted with suspected or confirmed COVID19 infection * Patient exhibiting acute neurological symptoms Exclusion Criteria: * Patients under the age of 18 years old * Pre-existing, baseline severe neurologic dysfunction including baseline coma/vegetative state, baseline quadriparesis, baseline refractory seizure disorder with frequent breakthrough seizures despite anticonvulsant use

Locations (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Prevalence of neurological manifestations

Proportion of patients with neurological symptoms out of all hospitalized COVID19 patients during study period.

Time frame: During hospital course, up to 1 month

Hospital Mortality

Time frame: At hospital discharge, approximately 1 month

Global functional outcomes using modified Rankin score

Patients will be assessed on a scale score of 0 (no symptoms at all) to 5 (severe disability; bedridden, incontinent and requiring constant nursing care and attention)

Time frame: At hospital discharge, approximately 1 month

Secondary Outcomes

Length of ICU stay

Time frame: At hospital discharge, approximately 1 month

Length of hospital stay (in days)

Time frame: At hospital discharge, approximately 1 month

30-day mortality

Time frame: 30 days from the first day of hospitalization

90-day mortality

Time frame: 90 days from the first day of hospitalization

Data from ClinicalTrials.gov

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