Neurologic Manifestations of COVID-19

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04386083

Acronym

CORONA

Enrollment

1342

Registered

2020-05-13

Start date

2020-06-10

Completion date

2021-03-31

Last updated

2020-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Disease 2019

Keywords

COVID-19, neurological manifestations, outcomes, cohort study

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame	Description
Mortality (binary outcome)	from admission until occurrence of mortality, assessed up to 6 months	Defined as patients with confirmed COVID-19 who died
Respiratory failure (binary outcome)	from admission until occurrence of respiratory failure, assessed up to 6 months	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

Secondary

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

Other

Measure	Time frame	Description
Length of ICU stay (continuous outcome)	ICU admission to ICU discharge, assessed up to 6 months	Defined as the number of days admitted in the ICU or ICU-comparable setting
Length of hospital stay (continuous outcome)	admission to hospital discharge, assessed up to 6 months	Defined as the number of days from admission to discharge

Countries

Philippines

Contacts

Primary ContactAdrian I Espiritu, MD

aiespiritu@up.edu.ph+639258520341

Backup ContactRoland Dominic G Jamora, MD

rgjamora@up.edu.ph+639985438062

Outcome results