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Neurologic Manifestations of COVID-19 (CORONA)

U

University of the Philippines

Status

Unknown

Conditions

Coronavirus Disease 2019

Study type

Observational

Funder types

Other

Identifiers

NCT04386083
RGAO-2020-0348

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,342 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

1,342 participants in 2 patient groups

COVID-19 patients with neurologic manifestations
Description:
Patients with confirmed COVID-19 disease who presented with neurological symptoms or new-onset neurological disorders/complications
COVID-19 patients without neurologic manifestations
Description:
Patients with confirmed COVID-19 disease who did not present with neurological symptoms or new-onset neurological disorders/complications

Trial contacts and locations

1

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Central trial contact

Adrian I Espiritu, MD; Roland Dominic G Jamora, MD

Data sourced from clinicaltrials.gov

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