COVID-19 Neurological Disease: A Prospective Study

NCT04672590 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1017

Last updated 2025-04-22

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04672590 on ClinicalTrials.gov