COVID19 Neurological Manifestation
Neurological Complications of COVID-19
1 other identifier
observational
300
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 13, 2020
CompletedFirst Submitted
Initial submission to the registry
July 13, 2020
CompletedFirst Posted
Study publicly available on registry
August 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2021
CompletedAugust 16, 2021
April 1, 2021
12 months
July 13, 2020
August 13, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
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
Eligibility Criteria
Patients admitted to acute care hospital who are suspected and/or confirmed to have COVID 19.
You may qualify if:
- Patients greater than or equal to 18 years old
- Admitted with suspected or confirmed COVID19 infection
- Patient exhibiting acute neurological symptoms
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
Related Publications (2)
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.
PMID: 32346843BACKGROUNDFrontera 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.
PMID: 32445105BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sherry H Chou, MD, MSc
University of Pittsburgh
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 13, 2020
First Posted
August 3, 2020
Study Start
April 13, 2020
Primary Completion
March 31, 2021
Study Completion
May 30, 2021
Last Updated
August 16, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share