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COVID19 Neurological Manifestation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04496128
Recruitment Status : Enrolling by invitation
First Posted : August 3, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Sherry Hsiang-Yi Chou, University of Pittsburgh

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).

Condition or disease
SARS-CoV 2 Neurologic Manifestations

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurological Complications of COVID-19
Actual Study Start Date : April 13, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021



Primary Outcome Measures :
  1. 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.

  2. Hospital Mortality [ Time Frame: At hospital discharge, approximately 1 month ]
  3. 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)


Secondary Outcome Measures :
  1. Length of ICU stay [ Time Frame: At hospital discharge, approximately 1 month ]
  2. Length of hospital stay (in days) [ Time Frame: At hospital discharge, approximately 1 month ]
  3. 30-day mortality [ Time Frame: 30 days from the first day of hospitalization ]
  4. 90-day mortality [ Time Frame: 90 days from the first day of hospitalization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to acute care hospital who are suspected and/or confirmed to have COVID 19.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04496128


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Sherry H Chou, MD, MSc University of Pittsburgh
Additional Information:
Publications:
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Responsible Party: Sherry Hsiang-Yi Chou, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04496128    
Other Study ID Numbers: STUDY20040037
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neurologic Manifestations
Nervous System Diseases