Neurological Complications of COVID-19
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- SARS-CoV 2
- Sponsor
- University of Pittsburgh
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Global functional outcomes using modified Rankin score
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Sherry Hsiang-Yi Chou
Associate Professor
University of Pittsburgh
Eligibility Criteria
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
Outcomes
Primary Outcomes
Global functional outcomes using modified Rankin score
Time Frame: 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
Time Frame: During hospital course, up to 1 month
Proportion of patients with neurological symptoms out of all hospitalized COVID19 patients during study period.
Hospital Mortality
Time Frame: At hospital discharge, approximately 1 month
Secondary Outcomes
- Length of ICU stay(At hospital discharge, approximately 1 month)
- 30-day mortality(30 days from the first day of hospitalization)
- Length of hospital stay (in days)(At hospital discharge, approximately 1 month)
- 90-day mortality(90 days from the first day of hospitalization)