NCT04672590

COVID-19 Neurological Disease: A Prospective Study

COVID-19 Neurological Disease: A Prospective Study in Brazil, India and Malawi

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,017 (actual)
• Sponsor: University of Liverpool · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-04-20
• Primary completion: 2023-03-31
• Completion: 2024-12-31
• First posted: 2020-12-17
• Last updated: 2025-04-22

Locations

5 sites across 3 countries: Brazil, India, Malawi