Neurologic Manifestations of COVID-19

Study Overview
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Brief Summary
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This study will determine the neurological profile and predictors of outcomes in patients with COVID-19 disease in the Philippines. It will also evaluate if there is significant difference between COVID-19 patients with neurological manifestations compared to those COVID-19 patients without neurological manifestations in terms of various prespecified clinical outcomes. Furthermore, the likelihood of these outcomes in COVID-19 patients with neurological manifestations compared to those without neurological manifestation will be determined in this study.

Detailed Description
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This quantitative, retrospective, cohort study will determine the following: 1) demographic, clinical and neurological profile of patients with COVID-19 disease in the Philippines; 2) the frequency of neurological symptoms and new-onset neurological disorders/complications in patients with COVID-19 disease; 3) the neurological manifestations that are significant predictors of mortality, respiratory failure, duration of ventilator dependence, intensive care unit (ICU) admission, length of ICU stay, and length of hospital stay; 4) if there is significant difference between COVID-19 patients with neurological manifestations compared to those COVID-19 patients without neurological manifestations in terms of mortality, respiratory failure, duration of ventilator dependence, ICU admission, length of ICU stay and length of hospital stay; and 5) the likelihood of mortality, respiratory failure and ICU admission in COVID-19 patients with neurological manifestations compared to those without neurological manifestations.

Official Title
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COVID-19 Outcomes: A Retrospective Study of Neurological Manifestations and Associated Symptoms (The Philippine CORONA Study)

Conditions
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Coronavirus Disease 2019

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cases confirmed by testing approved patient samples (i.e. nasal swabs, sputum, bronchoalveolar lavage fluid) employing the real-time reverse transcriptase polymerase chain reaction (RT-PCR) from COVID-19 testing centers accredited by the DOH; adult patients at least 19 years of age; male or female; cases with clinical symptoms and signs attributable to COVID-19 disease (i.e. respiratory as well as non-respiratory clinical signs and symptoms), with or without the availability of ancillary tests (i.e. complete blood count, chest x-ray); cases with disposition (i.e. discharged or died) at the end of the study period. Exclusion Criteria: Pediatric patients ≤18 years Cases with conditions of diseases caused by other organisms (i.e. bacteria, other viruses, fungi, etc.) or caused by other pathologies unrelated to COVID-19 disease (i.e., trauma).

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 patients with neurologic manifestations<br>Patients with confirmed COVID-19 disease who presented with neurological symptoms or new-onset neurological disorders/complications | |
| COVID-19 patients without neurologic manifestations<br>Patients with confirmed COVID-19 disease who did not present with neurological symptoms or new-onset neurological disorders/complications | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality (binary outcome) | Defined as patients with confirmed COVID-19 who died | from admission until occurrence of mortality, assessed up to 6 months | 
| Respiratory failure (binary outcome) | Defined as the patient with confirmed COVID-19 who experienced clinical symptoms and signs of respiratory insufficiency. Clinically, this condition may manifest as tachypnea, abnormal blood gases (hypoxemia or hypercapnia), signs of increased work of breathing, and requires oxygen supplementation | from admission until occurrence of respiratory failure, assessed up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of ventilator dependence (continuous outcome) | Defined as the number of days from initiation of assisted ventilation to extubation | day of intubation to day of extubation, assessed up to 6 months | 
| Intensive care unit (ICU) admission (binary outcome) | Defined as the patients with confirmed COVID-19 who are admitted to an ICU or ICU-comparable setting | admission to ICU admission, assessed up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, neurological manifestations, outcomes, cohort study