Neurological manifestations in COVID-19 (SARS-CoV-2 infection) patients. Infections and Infestations Sequelae of other specified infectious diseases, COVID-19 (SARS-CoV-2 infection)
Conditions
Interventions
This trial will integrate a mixture of retrospective and prospective data collection, with a follow-up period of 6 months. Patients admitted to the hospital from March 2020 until the start of prospect
peripheral nervous system (PNS) manifestations (taste impairment, smell impairment, vision impairment, and nerve pain)
and skeletal muscular injury manifestations. Impaired consciousness includes the change of consciousness level (somnolence, stupor, and coma) and consciousness content (confusion and delirium).
hence, RT-PCR for COVID-19 will be also performed in the CNS accordingly. In KSA, no autopsies are currently performed according to legislation thus there will be no means to examine any possible brai
Sponsors
King Saud Medical City
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged > 18 years 2. Hospitalized with COVID-19 as per the World Health Organization and Saudi Ministry of Health case definition
Exclusion criteria
Exclusion criteria: 1. Terminally ill receiving palliative care 2. Test negative for COVID-19
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of neurological manifestations in COVID-19 hospitalized patients measured using neurological examination and other pertinent paraclinical examinations, tests, and questionnaires (i.e., total blood count, biochemistry, screening for systemic disorders and hypercoagulable states, imaging such as brain computed tomography scans and magnetic resonance imaging studies, other tests such as cerebrospinal fluid analysis, electromyography, biopsies, etc.) collected from medical records at baseline, on hospital discharge, and 6 months follow-up 2. Range of symptoms of neurological manifestations in COVID-19 hospitalized patients measured using neurological examination and other pertinent paraclinical examinations, tests, and questionnaires collected from medical records at baseline, on hospital discharge, and 6 months follow-up 3. Severity of neurological manifestations in COVID-19 hospitalized patients neurological examination and other pertinent paraclinical studies such as imaging studies (CT, MRI, etc.) collected from medical records at baseline, on hospital discharge, and 6 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Consciousness and neurological picture measured using the GlasgoW Coma Scale (GCS) and neurological examination at baseline, hospital discharge, and at 6 months follow-up 2. Organ function status measured using the Sequential Organ Failure Assessment (SOFA) Score at baseline and hospital discharge 3. Markers of cytokine release syndrome measured through changes in laboratory inflammation markers (lymphocyte count, serum levels of C-reactive protein, lactate dehydrogenase, interleukin-6, ferritin, and d-dimer in addition to other common laboratory markers total blood count, coagulation profile, and biochemistry panel) at baseline and hospital discharge 4. Extent of inflammation measured through changes in laboratory inflammation markers at baseline and hospital discharge 5. Evolution of neurological disorders measured through changes in imaging studies (brain MRI for stroke or encephalitis, and other pertinent tests such as electromyography to measure the evolution of peripheral nervous system disorders) at baseline and hospital discharge 6. ICU length of stay assessed from medical records collected at baseline and ICU discharge 7. Number of days on mechanical ventilation assessed from medical notes collected at 6 months 8. 28 days and 3 months mortality assessed from medical notes collected at 28 days and 3 months 9. Functional outcomes and degree of disability measured using the Glasgow Outcome Score Extended (GOSE) and the Modified Rankin Scale (MRS) at hospital discharge | — |
Countries
Saudi Arabia
Outcome results
None listed