NCT04418609

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2022

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

2.1 years

First QC Date

May 28, 2020

Last Update Submit

August 3, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • Prevalence of neurological complications

    Determine the prevalence of neurological complications in hospitalized COVID-19 patients admitted to the intensive care unit.

    through study completion, on an average of 3 weeks

  • Prevalence and outcome of severe neurological complications

    Examine if empiric COVID-19 therapies are associated with difference in the prevalence and outcome of severe neurological complications of COVID-19.

    through study completion, on an average of 3 weeks

  • Impact of neurological complications

    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.

    through study completion, on an average of 3 weeks

  • Characteristic patterns in cerebral imaging and electroencephalography (EEG), as well as cerebrospinal fluid (CSF)

    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

    through study completion, on an average of 3 weeks

  • Brain for pathological changes and histopathological findings (if patient dies).

    Analyze the brain for pathological changes and histopathological findings, if the patient dies.

    through study completion, on an average of 3 weeks

Interventions

further processing of biological materials and health related personal data for research

Also known as: further processing of biological materials and health related personal data

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Pre-existing severe neurologic dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Study Officials

  • Emanuela Keller, Prof. Dr.

    University Hospital, Zürich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. Emanuela Keller

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 5, 2020

Study Start

May 1, 2020

Primary Completion

June 9, 2022

Study Completion

June 9, 2022

Last Updated

August 4, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations