Diseases of the Nervous SystemNCT04672590
COVID-19 Neurological Disease: A Prospective Study
An observational study of Diseases of the Nervous System and Other Specified Viral Diseases, run by University of Liverpool at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diseases of the Nervous System, Other Specified Viral Diseases
- How many people
- 1,017 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 20 Apr 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cases: Hospitalised patients with acute new-onset neurological disease and COVID-19 Controls: Hospitalised patients with COVID-19, without acute new-onset neurological disease
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
India2 sites
National Institute of Mental Health and Neurosciences
Bangalore
Christian Medical College
Vellore
Malawi2 sites
Malawi Liverpool Wellcome Clinical Research Programme
Blantyre, PO Box 30096
Kamuzu University of Health Sciences
Blantyre, PO Box 360
About this study
Official title: COVID-19 Neurological Disease: A Prospective Study in Brazil, India and Malawi
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.
Read more
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.
- Being tested
- Primary exposure is hypoxia (no intervention)
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients admitted to a study hospital meeting criteria for confirmed or probable acute new-onset neurological disease and confirmed or probable COVID-19. Receives: Other: Primary exposure is hypoxia (no intervention) | |
| Controls | Patients admitted to a study hospital meeting criteria for confirmed or probable COVID-19, without confirmed or probable acute new-onset neurological disease. Receives: Other: Primary exposure is hypoxia (no intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute new-onset neurological disease
Measured: Day 30 of admission, or at discharge, or at death, whichever is earlier
Secondary outcomes (9)
Admission to a critical (intensive/high dependency) care unit
Measured: Day 30 of admission, or at discharge, or at death, whichever is earlier
Time to discharge from hospital
Measured: Day 30 of admission, or at discharge, or at death, whichever is earlier
Severity of stroke using National Institutes of Health Stroke Scale (NIHSS)
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.
Measured: Day 30 of admission, or at discharge, or at death, whichever is earlier
Glasgow Outcome Scale Extended
An ordinal scale, from 1 = death (minimum; worst outcome) to 8 = upper good recovery (maximum; best outcome).
Measured: Discharge (or day 30), 3 months and 9 months
Modified Rankin Score
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).
Measured: Discharge (or day 30), 3 months and 9 months
Montreal Cognitive Assessment (MoCA)
Montreal Cognitive Assessment (MoCA), using a full test at discharge (or day 30) and a telephone test at 3 months and 9 months
Measured: Discharge (or day 30), 3 months and 9 months
Development of new onset neurological sequelae
Development of new onset neurological sequelae e.g.epilepsy, new/recurrent stroke, cognitive decline, encephalitis
Measured: Discharge (or day 30), 3 months and 9 months
European QoL-5D (EQ-5D-3L) overall health utility quality of life score
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).
Measured: Discharge (or day 30), 3 months and 9 months
Death
Measured: In-hospital (up to 30 days from admission), and at 3 months and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start20 Apr 2021
- Primary completion31 Mar 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diseases of the Nervous SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,017 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Christian Medical College, Vellore, India, Instituto Autoimune, Brazil, University College London Hospitals, Oswaldo Cruz Foundation, Kamuzu University of Health Sciences, National Institute of Mental Health and Neuro Sciences, India, Encephalitis Society, UK
- Responsible party
- Sponsor
- Investigators
- Tom Solomon, PhD, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672590
- Sponsor's protocol ID
- UoL001596
- Status last verified
- Apr 2025
- First submitted
- 9 Dec 2020
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Limited dataset
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Neurological Disease: A Prospective Study in Brazil, India and Malawi
- ClinicalTrials.gov ID
- NCT04672590
- Acronym / sponsor ID
- UoL001596
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,017 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Christian Medical College, Vellore, India, Instituto Autoimune, Brazil, University College London Hospitals, Oswaldo Cruz Foundation, Kamuzu University of Health Sciences, National Institute of Mental Health and Neuro Sciences, India, Encephalitis Society, UK
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: 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 | – | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases: Hospitalised patients with acute new-onset neurological disease and COVID-19 Controls: Hospitalised patients with COVID-19, without acute new-onset neurological disease
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Cases, Controls |
Primary outcome
Acute new-onset neurological disease
Time frame: Day 30 of admission, or at discharge, or at death, whichever is earlier
9 secondary outcomes
Admission to a critical (intensive/high dependency) care unit
Time frame: Day 30 of admission, or at discharge, or at death, whichever is earlier
Time to discharge from hospital
Time frame: Day 30 of admission, or at discharge, or at death, whichever is earlier
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
Glasgow Outcome Scale Extended
Time frame: Discharge (or day 30), 3 months and 9 months
Modified Rankin Score
Time frame: Discharge (or day 30), 3 months and 9 months
Montreal Cognitive Assessment (MoCA)
Time frame: Discharge (or day 30), 3 months and 9 months
Development of new onset neurological sequelae
Time frame: Discharge (or day 30), 3 months and 9 months
European QoL-5D (EQ-5D-3L) overall health utility quality of life score
Time frame: Discharge (or day 30), 3 months and 9 months
Death
Time frame: In-hospital (up to 30 days from admission), and at 3 months and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: Yes. Limited dataset
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Solomon, PhD principal investigator
University of Liverpool
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diseases of the Nervous System and Other Specified Viral Diseases, run by University of Liverpool at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India, Malawi, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute new-onset neurological disease (time frame: Day 30 of admission, or at discharge, or at death, whichever is earlier). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.