COVID-19 Neurological Disease: A Prospective Study

Completed

• Conditions: Diseases of the Nervous System; Other Specified Viral Diseases
• Interventions: Other: Primary exposure is hypoxia (no intervention)

• Registration Number: NCT04672590
• Lead Sponsor: University of Liverpool

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-17
• Study Start: 2021-04-20
• Primary Completion: 2023-03-31
• Study Completion: 2024-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1017

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Primary exposure is hypoxia (no intervention)	Patients admitted to a study hospital meeting criteria for confirmed or probable acute new-onset neurological disease and confirmed or probable COVID-19.
Controls	Primary exposure is hypoxia (no intervention)	Patients admitted to a study hospital meeting criteria for confirmed or probable COVID-19, without confirmed or probable acute new-onset neurological disease.

Primary Outcome Measures

Name	Time	Method
Acute new-onset neurological disease	Day 30 of admission, or at discharge, or at death, whichever is earlier

Secondary Outcome Measures

Name	Time	Method
Admission to a critical (intensive/high dependency) care unit	Day 30 of admission, or at discharge, or at death, whichever is earlier
Time to discharge from hospital	Day 30 of admission, or at discharge, or at death, whichever is earlier
Modified Rankin Score	Discharge (or day 30), 3 months and 9 months	Modified Rankin Score using a simplified algorithm by Bruno et al 2010. An ordinal scale, from 0 = no symptoms at all (minimum; best outcome) to 6 = dead (maximum; worst outcome).
Montreal Cognitive Assessment (MoCA)	Discharge (or day 30), 3 months and 9 months	Montreal Cognitive Assessment (MoCA), using a full test at discharge (or day 30) and a telephone test at 3 months and 9 months
European QoL-5D (EQ-5D-3L) overall health utility quality of life score	Discharge (or day 30), 3 months and 9 months	A questionnaire scoring 5 domains of quality of life at ordinal levels of 1-3 each (1 = best; 3 = worst), plus an overall health state score from 0 to 100 on a visual analog scale (0 = worst; 100 = best).
Glasgow Outcome Scale Extended	Discharge (or day 30), 3 months and 9 months	An ordinal scale, from 1 = death (minimum; worst outcome) to 8 = upper good recovery (maximum; best outcome).
Severity of stroke using National Institutes of Health Stroke Scale (NIHSS)	Day 30 of admission, or at discharge, or at death, whichever is earlier	A score made up of 11 elements. Total min 0; max 42. Lower is better; 0 can be scored if the person has full function in every element of the assessment.
Development of new onset neurological sequelae	Discharge (or day 30), 3 months and 9 months	Development of new onset neurological sequelae e.g.epilepsy, new/recurrent stroke, cognitive decline, encephalitis
Death	In-hospital (up to 30 days from admission), and at 3 months and 9 months

Trial Locations

Locations (5)

FioCruz; 🇧🇷 Recife, Brazil

Malawi Liverpool Wellcome Clinical Research Programme; 🇲🇼 Blantyre, Malawi

Kamuzu University of Health Sciences; 🇲🇼 Blantyre, Malawi

National Institute of Mental Health and Neurosciences; 🇮🇳 Bangalore, India

Christian Medical College; 🇮🇳 Vellore, India