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NCT Number: NCT04672590

COVID-19 Neurological Disease: A Prospective Study

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.

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Key information

Conditions

Diseases of the Nervous System Nervous System Diseases Other Specified Viral Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

FioCruz, Recife, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Cases

Inclusion criteria

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

(any of):

  • 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.

Treatment and study plan

Primary exposure is hypoxia (no intervention)

Other

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

Primary outcomes

  1. Acute new-onset neurological disease

    Time frame: Day 30 of admission, or at discharge, or at death, whichever is earlier

Secondary outcomes

  1. Admission to a critical (intensive/high dependency) care unit

    Time frame: Day 30 of admission, or at discharge, or at death, whichever is earlier

  2. Time to discharge from hospital

    Time frame: Day 30 of admission, or at discharge, or at death, whichever is earlier

  3. Severity of stroke using National Institutes of Health Stroke Scale (NIHSS)

    Time frame: 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.

  4. Glasgow Outcome Scale Extended

    Time frame: 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).

  5. Modified Rankin Score

    Time frame: 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).

  6. Montreal Cognitive Assessment (MoCA)

    Time frame: 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

  7. Development of new onset neurological sequelae

    Time frame: Discharge (or day 30), 3 months and 9 months

    Development of new onset neurological sequelae e.g.epilepsy, new/recurrent stroke, cognitive decline, encephalitis

  8. European QoL-5D (EQ-5D-3L) overall health utility quality of life score

    Time frame: 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).

  9. Death

    Time frame: In-hospital (up to 30 days from admission), and at 3 months and 9 months

Sponsors and collaborators

Lead sponsor

University of Liverpool

Other

Collaborators

  • Christian Medical College, Vellore, India
  • Encephalitis Society, UK
  • Instituto Autoimune, Brazil
  • Kamuzu University of Health Sciences
  • National Institute of Mental Health and Neuro Sciences, India
  • Oswaldo Cruz Foundation
  • University College London Hospitals

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Dec 17, 2020
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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