COVID19 Neurological Manifestation

SARS-CoV 2 Clinical Trial

Official title:

Neurological Complications of COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04496128
• Other study ID #: STUDY20040037
• Status: Completed
• Start date: April 13, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: April 2021
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurologic Manifestations
• SARS-CoV 2

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Hospital Mortality		At hospital discharge, approximately 1 month
Primary	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	Length of ICU stay		At hospital discharge, approximately 1 month
Secondary	Length of hospital stay (in days)		At hospital discharge, approximately 1 month
Secondary	30-day mortality		30 days from the first day of hospitalization
Secondary	90-day mortality		90 days from the first day of hospitalization

External Links

•   NCC COVID-19 Research Opportunities