COVID19 Neurological Manifestation

Completed

• Conditions: Neurologic Manifestations; SARS-CoV 2

• Registration Number: NCT04496128
• Lead Sponsor: University of Pittsburgh

Brief Summary

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).

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.

Study Timeline

• Study Start: 2020-04-13
• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-30
• Study First Posted: 2020-08-03
• Primary Completion: 2021-03-31
• Status Verified: 2021-04
• Study Completion: 2021-05-30
• Last Update Submitted: 2021-08-13
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States