COVID19 Neurological Manifestation

Neurological Complications of COVID-19

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).

Study Overview

• Status: Completed
• Conditions: Neurologic Manifestations; SARS-CoV 2

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 Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to acute care hospital who are suspected and/or confirmed to have COVID 19.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of neurological manifestations	Proportion of patients with neurological symptoms out of all hospitalized COVID19 patients during study period.	During hospital course, up to 1 month
Hospital Mortality		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)	At hospital discharge, approximately 1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of ICU stay	At hospital discharge, approximately 1 month
Length of hospital stay (in days)	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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Sherry H Chou, MD, MSc, University of Pittsburgh

Publications and helpful links

General Publications

• Needham EJ, Chou SH, Coles AJ, Menon DK. Neurological Implications of COVID-19 Infections. Neurocrit Care. 2020 Jun;32(3):667-671. doi: 10.1007/s12028-020-00978-4.
• Frontera J, Mainali S, Fink EL, Robertson CL, Schober M, Ziai W, Menon D, Kochanek PM, Suarez JI, Helbok R, McNett M, Chou SH; GCS-NeuroCOVID Study. Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID): Study Design and Rationale. Neurocrit Care. 2020 Aug;33(1):25-34. doi: 10.1007/s12028-020-00995-3.

Helpful Links

• NCC COVID-19 Research Opportunities

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2020
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 16, 2021
• Last Update Submitted That Met QC Criteria: August 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations
• Other Study ID Numbers: STUDY20040037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No