Covid-19 Neurological Disease
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Date
2021-06-16
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Kamuzu University of Health Sciences
Abstract
Type of Research
This is a prospective case-control study being conducted in Brazil, India and Malawi. The cases
will be patients with COVID-19 and neurological disease. Controls will have COVID-19 without
neurological disease.
Problem
Neurological manifestations and complications of COVID-19 are being recognised increasingly,
with encephalopathy (mostly delirium) and cerebrovascular disease (predominantly stroke)
being reported most commonly. However, the full spectrum, outcomes, and risks of developing
neurological disease in COVID-19 are poorly understood. This makes the approach to risk
stratification, and pre-emptive or preventative measures, challenging. This study will be
conducted in Brazil, India and Malawi to address this gap in low- and middle-income country
settings, where the impact of neurological disease and emerging infections is often felt
disproportionately.
Objectives
Aim
To describe, and to guide interventions to reduce morbidity from, acute new-onset neurological
disease among hospitalised patients with COVID-19.
Primary Objective
1. To compare characteristics of patients hospitalised with COVID-19 with and without new
onset neurological disease, focusing on stroke, delirium, hypoxia and other potential risk
factors for neurological disease which may be modifiable.
Secondary Objectives
2. To describe the full spectrum of COVID-19 associated neurological disease including its
range and prevalence.
3. To compare outcomes of patients with and without COVID-19 associated neurological
disease, focusing on stroke and delirium.
3.4. To examine prognostic indicators for outcomes in patients with COVID-19
associated neurological disease.
Methodology
The primary objective will be achieved using a case-control design. The cases will be patients
with COVID-19 and neurological disease. Controls will have COVID-19 without neurological
disease.
Secondary objectives will be achieved through a prospective cohort design, including the same
cases and controls with longitudinal follow-up to discharge, and at 3 and 9 months. Hospital
records of adult (≥18 years) patients will be screened for eligibility, and strict predefined case
definitions will be applied by study staff. Consenting patients will have data collected during
their admission up to discharge, and at 3 months and 9 months. This may include additional
clinical investigations for COVID-19, neurological disease and potential risk factors that are
deemed to be indicated and safe by treating clinicians. Final assignment of case vs. control
status of participants will be at 30 days from admission to hospital. “Day 1”, for timing of
variable measurement for the case-control analysis, will be defined for each participant as the
day of presentation with neurological disease in cases, and the day of enrolment in controls.
The target number of cases with all types of neurological disease is 227 (projected breakdown
of 68 with stroke, 136 with delirium, and 23 other), with 454 controls. This will give >95% power
to detect an odds ratio of 2.0 and would give 90% power to detect an odds ratio of 1.6, for the
primary exposure of severe vs. non-severe/no hypoxia for overall participants with any
neurological disease. It would also achieve ≥80% power to detect an odds ratio of 2.0 in both
major disease subgroups of stroke and delirium separately.
Expected Findings and Dissemination
Study results will be presented and discussed at international scientific meetings
and published in open access peer reviewed journals. High impact publications will
be aligned with press releases managed by the University of Liverpool press office
and local institutional press offices in Brazil, India and Malawi (including College of
Medicine-University of Malawi- Research Dissemination Conference, Malawi
Liverpool Wellcome Trust, and Queen Elizabeth Central Hospital).
Description
Keywords
Research Subject Categories::MEDICINE