COVID-19 Neurological Disease: A Prospective Study

NCT ID: NCT04672590

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1017 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-20
• Study Completion Date: 2024-12-31

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.

Conditions

Diseases of the Nervous System; Other Specified Viral Diseases

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Cases

Patients admitted to a study hospital meeting criteria for confirmed or probable acute new-onset neurological disease and confirmed or probable COVID-19.

Primary exposure is hypoxia (no intervention)

Intervention Type: OTHER

The primary exposure, hypoxia, will be defined as severe, non-severe or none for each participant, based on pre-defined criteria.

Controls

Patients admitted to a study hospital meeting criteria for confirmed or probable COVID-19, without confirmed or probable acute new-onset neurological disease.

Primary exposure is hypoxia (no intervention)

Intervention Type: OTHER

The primary exposure, hypoxia, will be defined as severe, non-severe or none for each participant, based on pre-defined criteria.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Confirmed or probable new-onset acute neurological disease (according to study definitions) AND

2. Confirmed or probable COVID-19 (according to study definitions), diagnosed using tests performed no later than 5 days after presentation with neurological disease

Exclusion Criteria

• Age <18 years
• Neurological features are explained fully by a previous neurological disease
• PCR test performed >5 days after admission to hospital, in the absence of clinical illness meeting criteria for suspected COVID-19 (to exclude those with hospital-acquired infection).
• Enrolled on the basis of new-onset acute neurological disease, but subsequently does not meet definition for probable or confirmed COVID-19.

Controls

Two controls with non-neurological COVID-19 will be recruited per case.

They will meet all of the following criteria:

• Adults, no more than 5 years younger or older than the case.
• Enrolled at a similar time since admission to hospital as the case, defined as: <7 days; 7-13 days inclusive; or ≥14 days.
• Hospitalised patients with confirmed or probable COVID-19 (according to study definitions)
• Not meeting criteria for confirmed or probable new-onset acute neurological disease (according to study definitions).

Some potential controls may be reclassified as cases if they develop neurological manifestations at up to 30 days after admission to hospital.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Christian Medical College, Vellore, India

OTHER

Sponsor Role: collaborator

Instituto Autoimune, Brazil

UNKNOWN

Sponsor Role: collaborator

University College London Hospitals

OTHER

Sponsor Role: collaborator

Oswaldo Cruz Foundation

OTHER

Sponsor Role: collaborator

Kamuzu University of Health Sciences

OTHER

Sponsor Role: collaborator

National Institute of Mental Health and Neuro Sciences, India

OTHER

Sponsor Role: collaborator

Encephalitis Society, UK

UNKNOWN

Sponsor Role: collaborator

University of Liverpool

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tom Solomon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Liverpool

Locations

FioCruz

Recife, , Brazil

National Institute of Mental Health and Neurosciences

Bangalore, , India

Christian Medical College

Vellore, , India

Malawi Liverpool Wellcome Clinical Research Programme

Blantyre, , Malawi

Kamuzu University of Health Sciences

Blantyre, , Malawi

Countries

Brazil; India; Malawi

Other Identifiers

UoL001596

Identifier Type: -

Identifier Source: org_study_id