<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04496128</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY20040037</org_study_id>
    <nct_id>NCT04496128</nct_id>
  </id_info>
  <brief_title>COVID19 Neurological Manifestation</brief_title>
  <official_title>Neurological Complications of COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective observational cohort study to document the prevalence and types&#xD;
      of neurological manifestations among hospitalized patients with confirmed or suspected novel&#xD;
      coronavirus infection (COVID-19).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective observational cohort study to document the prevalence and types&#xD;
      of neurological manifestations among hospitalized patients with confirmed or suspected novel&#xD;
      coronavirus infection (COVID-19). Severe acute respiratory syndrome 2 (SARS-CoV-2), the virus&#xD;
      that causes COVID-19, shares significant structural and biological similarities with&#xD;
      SARS-CoV, which is known to be neuroinvasive particularly with brainstem involvement. There&#xD;
      are emerging reports of neurological symptoms associated with COVID-19 infections, including&#xD;
      seizures, coma, encephalitis, Guillan-Barre syndrome, and cerebrovascular events including&#xD;
      ischemic stroke, ICH, and cerebral venous sinus thromboses. However, the exact prevalence of&#xD;
      these conditions and their impact on patient disease severity and outcomes is unknown. As the&#xD;
      incidence and severity of COVID-19 infection continue to rapidly rise globally, it is&#xD;
      imperative to capture prospective data to accurately document prevalence, severity and&#xD;
      clinical characterization of neurological components of COVID 19, the influence of treatment&#xD;
      regimens of neurological complications, and role of these confounders on patient and&#xD;
      organizational outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 13, 2020</start_date>
  <completion_date type="Actual">May 30, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of neurological manifestations</measure>
    <time_frame>During hospital course, up to 1 month</time_frame>
    <description>Proportion of patients with neurological symptoms out of all hospitalized COVID19 patients during study period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital Mortality</measure>
    <time_frame>At hospital discharge, approximately 1 month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Global functional outcomes using modified Rankin score</measure>
    <time_frame>At hospital discharge, approximately 1 month</time_frame>
    <description>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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of ICU stay</measure>
    <time_frame>At hospital discharge, approximately 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay (in days)</measure>
    <time_frame>At hospital discharge, approximately 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day mortality</measure>
    <time_frame>30 days from the first day of hospitalization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90-day mortality</measure>
    <time_frame>90 days from the first day of hospitalization</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">300</enrollment>
  <condition>SARS-CoV 2</condition>
  <condition>Neurologic Manifestations</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to acute care hospital who are suspected and/or confirmed to have COVID&#xD;
        19.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients greater than or equal to 18 years old&#xD;
&#xD;
          -  Admitted with suspected or confirmed COVID19 infection&#xD;
&#xD;
          -  Patient exhibiting acute neurological symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under the age of 18 years old&#xD;
&#xD;
          -  Pre-existing, baseline severe neurologic dysfunction including baseline&#xD;
             coma/vegetative state, baseline quadriparesis, baseline refractory seizure disorder&#xD;
             with frequent breakthrough seizures despite anticonvulsant use&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sherry H Chou, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15261</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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>
    <PMID>32346843</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>32445105</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>August 13, 2021</last_update_submitted>
  <last_update_submitted_qc>August 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Sherry Hsiang-Yi Chou</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurologic Manifestations</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04496128
org study id: STUDY20040037
nct id: NCT04496128
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
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.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of neurological manifestations
time frame: During hospital course, up to 1 month
description: Proportion of patients with neurological symptoms out of all hospitalized COVID19 patients during study period.
measure: Hospital Mortality
time frame: At hospital discharge, approximately 1 month
measure: Global functional outcomes using modified Rankin score
time frame: At hospital discharge, approximately 1 month
description: 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)
measure: Length of ICU stay
time frame: At hospital discharge, approximately 1 month
measure: Length of hospital stay (in days)
time frame: At hospital discharge, approximately 1 month
measure: 30-day mortality
time frame: 30 days from the first day of hospitalization
measure: 90-day mortality
time frame: 90 days from the first day of hospitalization
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sherry H Chou, MD, MSc
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
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.
PMID: 32346843
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.
PMID: 32445105
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Sherry Hsiang-Yi Chou
investigator title: Associate Professor
mesh term: Neurologic Manifestations
sharing ipd: No