Diseases of the Nervous System Clinical Trial
Official title:
COVID-19 Neurological Disease: A Prospective Study in Brazil, India and Malawi
| Verified date | June 2023 |
| Source | University of Liverpool |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 681 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | March 31, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Cases 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 (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. |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | FioCruz | Recife | |
| India | National Institute of Mental Health and Neurosciences | Bangalore | |
| India | Christian Medical College | Vellore | |
| Malawi | Kamuzu University of Health Sciences | Blantyre | |
| Malawi | Malawi Liverpool Wellcome Clinical Research Programme | Blantyre |
| Lead Sponsor | Collaborator |
|---|---|
| University of Liverpool | 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 |
Brazil, India, Malawi,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Acute new-onset neurological disease | Day 30 of admission, or at discharge, or at death, whichever is earlier | ||
| Secondary | Admission to a critical (intensive/high dependency) care unit | Day 30 of admission, or at discharge, or at death, whichever is earlier | ||
| Secondary | Time to discharge from hospital | Day 30 of admission, or at discharge, or at death, whichever is earlier | ||
| Secondary | 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. | Day 30 of admission, or at discharge, or at death, whichever is earlier | |
| Secondary | Glasgow Outcome Scale Extended | An ordinal scale, from 1 = death (minimum; worst outcome) to 8 = upper good recovery (maximum; best outcome). | Discharge (or day 30), 3 months and 9 months | |
| Secondary | 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). | Discharge (or day 30), 3 months and 9 months | |
| Secondary | 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 | Discharge (or day 30), 3 months and 9 months | |
| Secondary | Development of new onset neurological sequelae | Development of new onset neurological sequelae e.g.epilepsy, new/recurrent stroke, cognitive decline, encephalitis | Discharge (or day 30), 3 months and 9 months | |
| Secondary | 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). | Discharge (or day 30), 3 months and 9 months | |
| Secondary | Death | In-hospital (up to 30 days from admission), and at 3 months and 9 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05013944 -
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