Clinical trial NCT04496128: COVID19 Neurological Manifestation
Official title: Neurological Complications of COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV 2
Neurologic Manifestations
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to acute care hospital who are suspected and/or confirmed to have COVID 19.

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.

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

Primary outcomes:
measure: Prevalence of neurological manifestations
timeFrame: During hospital course, up to 1 month
measure: Hospital Mortality
timeFrame: At hospital discharge, approximately 1 month
measure: Global functional outcomes using modified Rankin score
timeFrame: At hospital discharge, approximately 1 month
Secondary outcomes:
measure: Length of ICU stay
timeFrame: At hospital discharge, approximately 1 month
measure: Length of hospital stay (in days)
timeFrame: At hospital discharge, approximately 1 month
measure: 30-day mortality
timeFrame: 30 days from the first day of hospitalization
measure: 90-day mortality
timeFrame: 90 days from the first day of hospitalization
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sherry H Chou, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.