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OpenTrials
Completed

NCT Number: NCT04496128

COVID19 Neurological Manifestation

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Neurological Complications of COVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 3, 2020
Registry last updated
Aug 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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