COVID-19 Neurological Disease: A Prospective Study
NCT04672590 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1017
Last updated 2025-04-22
Summary
Background: Recent reports increasingly recognize neurological manifestations in COVID-19 patients. However, the full spectrum of the disease and risk factors are not well understood.
Aim: To describe the full spectrum of neurological manifestations in COVID-19 and assess the clinical characteristics, risks and prognostic factors.
Outcomes: Identification of COVID-19 associated neurological disease is the primary outcome while requirement for admission to critical care unit, mortality, length of hospital stay, quality of life, and neurological disability are the secondary outcomes.
Participants: Patients above Age more than 18 years enrolled based on new-onset acute neurological disease and COVID19 positive will serve as cases while patient with confirmed COVID-19 without neurological manifestation will serve as controls.
Design and Procedures: The study is prospective case control in design and is divided into three phases in India, Brazil and Malawi ; the first phase will address role of hypoxia in causation of neurological diseases, the second phase will compare characteristics of patients hospitalized with COVID-19 with and without neurological disease and the third phase will assess the long-term follow up (at 3 months and 9 months) of cases.
Conditions
- Diseases of the Nervous System
- Other Specified Viral Diseases
Interventions
- OTHER
-
Primary exposure is hypoxia (no intervention)
The primary exposure, hypoxia, will be defined as severe, non-severe or none for each participant, based on pre-defined criteria.
Sponsors & Collaborators
-
Christian Medical College, Vellore, India
collaborator OTHER -
Instituto Autoimune, Brazil
collaborator UNKNOWN -
University College London Hospitals
collaborator OTHER -
Oswaldo Cruz Foundation
collaborator OTHER -
Kamuzu University of Health Sciences
collaborator OTHER -
National Institute of Mental Health and Neuro Sciences, India
collaborator OTHER -
Encephalitis Society, UK
collaborator UNKNOWN -
University of Liverpool
lead OTHER
Principal Investigators
-
Tom Solomon, PhD · University of Liverpool
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-20
- Primary Completion
- 2023-03-31
- Completion
- 2024-12-31
Countries
- Brazil
- India
- Malawi
Study Locations
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