COVID19 Neurological Manifestation

Neurological Complications of COVID-19

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04496128

Enrollment

300

Registered

2020-08-03

Start date

2020-04-13

Completion date

2021-05-30

Last updated

2021-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurologic Manifestations, SARS-CoV 2

Brief summary

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Prevalence of neurological manifestations	During hospital course, up to 1 month	Proportion of patients with neurological symptoms out of all hospitalized COVID19 patients during study period.
Hospital Mortality	At hospital discharge, approximately 1 month	—
Global functional outcomes using modified Rankin score	At hospital discharge, approximately 1 month	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)

Secondary

Measure	Time frame
Length of ICU stay	At hospital discharge, approximately 1 month
90-day mortality	90 days from the first day of hospitalization
Length of hospital stay (in days)	At hospital discharge, approximately 1 month
30-day mortality	30 days from the first day of hospitalization

Countries

United States

Outcome results