Diseases of the Nervous System, Other Specified Viral Diseases
Conditions
Brief 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.
Interventions
OTHERPrimary 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
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
University of Liverpool
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute new-onset neurological disease | Day 30 of admission, or at discharge, or at death, whichever is earlier |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to discharge from hospital | Day 30 of admission, or at discharge, or at death, whichever is earlier | — |
| Severity of stroke using National Institutes of Health Stroke Scale (NIHSS) | 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. |
| Glasgow Outcome Scale Extended | 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). |
| Modified Rankin Score | 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). |
| Admission to a critical (intensive/high dependency) care unit | Day 30 of admission, or at discharge, or at death, whichever is earlier | — |
| Development of new onset neurological sequelae | Discharge (or day 30), 3 months and 9 months | Development of new onset neurological sequelae e.g.epilepsy, new/recurrent stroke, cognitive decline, encephalitis |
| European QoL-5D (EQ-5D-3L) overall health utility quality of life score | 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). |
| Death | In-hospital (up to 30 days from admission), and at 3 months and 9 months | — |
| Montreal Cognitive Assessment (MoCA) | 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 |
Countries
Brazil, India, Malawi
Outcome results
None listed