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Neuro-COVID-19: Neurological Complications of COVID-19 (Neuro-COVID)

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ClinicalTrials.gov Identifier: NCT04418609
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Emanuela Keller, University of Zurich

Tracking Information
First Submitted Date May 28, 2020
First Posted Date June 5, 2020
Last Update Posted Date June 5, 2020
Actual Study Start Date May 1, 2020
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2020)
  • Prevalence of neurological complications [ Time Frame: through study completion, on an average of 3 weeks ]
    Determine the prevalence of neurological complications in hospitalized COVID-19 patients admitted to the intensive care unit.
  • Prevalence and outcome of severe neurological complications [ Time Frame: through study completion, on an average of 3 weeks ]
    Examine if empiric COVID-19 therapies are associated with difference in the prevalence and outcome of severe neurological complications of COVID-19.
  • Impact of neurological complications [ Time Frame: through study completion, on an average of 3 weeks ]
    Determine the impact of neurological complications among COVID-19 patients on mortality, functional outcome, and organizational outcomes (ICU length of stay, hospital length of stay) among patients with confirmed COVID-19.
  • Characteristic patterns in cerebral imaging and electroencephalography (EEG), as well as cerebrospinal fluid (CSF) [ Time Frame: through study completion, on an average of 3 weeks ]
    Analyze characteristic patterns in cerebral imaging and electroencephalography (EEG), as well as cerebrospinal fluid (CSF) of patients, in whom a lumbar puncture has been performed for clinical reasons
  • Brain for pathological changes and histopathological findings (if patient dies). [ Time Frame: through study completion, on an average of 3 weeks ]
    Analyze the brain for pathological changes and histopathological findings, if the patient dies.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neuro-COVID-19: Neurological Complications of COVID-19
Official Title Neuro-COVID-19: Neurological Complications of COVID-19
Brief Summary The prevalence and typical patterns of neurological complications in hospitalized COVID-19 patients admitted to the intensive care units of the University Hospital Zurich will be investigated. The impact of neurological complications among COVID-19 patients on mortality, functional outcome, and organizational outcomes will be analyzed.
Detailed Description This study is a prospective observational cohort study to document prevalence and severity of neurological symptoms among patients requiring critical care admission for confirmed novel coronavirus disease (COVID-19). COVID-19 is classified as severe acute respiratory syndrome 2 (SARS-CoV-2) and shares significant structural and biological similarities with SARS-CoV, which has neuroinvasive properties and brainstem involvement. Early reports of COVID-19 progression indicate presence of severe neurological complications, including seizures, coma, encephalitis, and cerebrovascular events including ischemic stroke, intracranial hemorrhage, and cerebral venous sinus thromboses. In addition, recent data from Zika-virus and H1N1 influenza pandemics reveal a high incidence of neurological complications, including Guillain Barré syndrome and neonatal microcephaly for Zika-virus and narcolepsy with H1N1 infections. Early reports from China suggest neurological symptoms may occur in approximately 36% of SARS-CoV-2 positive patients, with increased prevalence among more severe cases, and fall into three categories: central nervous system symptoms or diseases, peripheral nervous system symptoms, and skeletal muscular symptoms. However, the exact prevalence of these conditions and impact on patient disease severity and outcomes is unknown. As the incidence and severity of COVID-19 infection continues to rapidly rise on an international level, 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients admitted to the Intensive Care Units (ICUs) of the Institute of Intensive Care Medicine, University Hospital of Zurich meeting eligibility criteria during the pandemic will be enrolled.
Condition Neurologic Complication
Intervention Other: further processing of health data
further processing of biological materials and health related personal data for research
Other Name: further processing of biological materials and health related personal data
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 4, 2020)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 30, 2022
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adults (age > 18 years old) treated at ICUs
  • Admitted with confirmed COVID-19 infection
  • Patient exhibiting acute neurological manifestations
  • General consent of the Institute of Intensive Care Medicine available from patient or legal representative

Exclusion Criteria:

  • Pre-existing severe neurologic dysfunction
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Emanuela Keller, Prof. Dr. 0041 44 255 56 71 emanuela.keller@usz.ch
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04418609
Other Study ID Numbers Neuro-COVID-19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Emanuela Keller, University of Zurich
Study Sponsor Emanuela Keller
Collaborators Not Provided
Investigators
Principal Investigator: Emanuela Keller, Prof. Dr. University Hospital, Zürich
PRS Account University of Zurich
Verification Date June 2020