Neurologic Manifestations of COVID-19

University of the Philippines1,342 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,342

Conditions

Coronavirus Disease 2019

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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).

Locations (1)

Philippine General Hospital - University of the Philippines Manila

Manila, Philippines

RECRUITING

Outcomes

Primary Outcomes

Mortality (binary outcome)

Defined as patients with confirmed COVID-19 who died

Time frame: 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

Time frame: from admission until occurrence of respiratory failure, assessed up to 6 months

Secondary Outcomes

Duration of ventilator dependence (continuous outcome)

Defined as the number of days from initiation of assisted ventilation to extubation

Time frame: 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

Time frame: admission to ICU admission, assessed up to 6 months

Central Contacts

Adrian I Espiritu, MD

CONTACT

+639258520341 aiespiritu@up.edu.ph

Roland Dominic G Jamora, MD

CONTACT

+639985438062 rgjamora@up.edu.ph

Data from ClinicalTrials.gov

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