Clinical trial NCT04386083: Neurologic Manifestations of COVID-19
Official title: COVID-19 Outcomes: A Retrospective Study of Neurological Manifestations and Associated Symptoms (The Philippine CORONA Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Disease 2019
Keywords: COVID-19
neurological manifestations
outcomes
cohort study
Lead sponsor: University of the Philippines
Sponsor class: OTHER
Collaborators: name: Asian Hospital and Medical Center, Muntinlupa City, Philippines
name: Baguio General Hospital and Medical Center, Baguio City, Philippines
name: Cagayan Valley Medical Center, Tuguegarao City, Philippines
name: Capitol Medical Center, Quezon City, Philippines
name: Cardinal Santos Medical Center, San Juan City, Philippines
name: Chong Hua Hospital, Cebu City, Philippines
name: De La Salle University Medical Center
name: East Avenue Medical Center, Philippines
name: Jose B. Lingad Memorial Regional Hospital, San Fernando, Pampanga, Philippines
name: Jose R. Reyes Memorial Medical Center
name: Lung Center of the Philippines
name: Manila Doctors Hospital, Philippines
name: Manila Medical Center, Philippines
name: Makati Medical Center
name: New Era General Hospital, Philippines
name: Quirino Memorial Medical Center, Philippines
name: Ospital ng Makati, Philippines
name: Dr. Pablo O. Torre Memorial Hospital, Bacolod City, Philippines
name: Philippine Heart Center
name: Research Institute for Tropical Medicine, Philippines
name: San Juan De Dios Educational Foundation Inc. - Hospital, Philippines
name: San Lazaro Hospital, Philippines
name: Southern Isabela Medical Center, Philippines
name: St. Luke's Medical Center, Philippines
name: St Lukes Medical Center, Bonifacio Global City, Philippines
name: Southern Philippines Medical Center
name: The Medical City, Philippines
name: University of the East Ramon Magsaysay Memorial Medical Center, Inc, Philippines
name: University of Santo Tomas Hospital, Philippines
name: Veterans Memorial Medical Center, Philippines
name: Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium
name: Zamboanga City Medical Center, Zamboanga City
name: Western Visayas Medical Center, Iloilo City
name: Northern Mindanao Medical Center, Cagayan de Oro City
name: Vicente Sotto Memorial Medical Center, Cebu City
name: Perpetual Succor Hospital, Cebu City
First posted: 2020-05-13
Enrollment: 1342
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with confirmed COVID-19 disease

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Mortality (binary outcome)
timeFrame: from admission until occurrence of mortality, assessed up to 6 months
measure: Respiratory failure (binary outcome)
timeFrame: from admission until occurrence of respiratory failure, assessed up to 6 months
Secondary outcomes:
measure: Duration of ventilator dependence (continuous outcome)
timeFrame: day of intubation to day of extubation, assessed up to 6 months
measure: Intensive care unit (ICU) admission (binary outcome)
timeFrame: admission to ICU admission, assessed up to 6 months
Other outcomes:
measure: Length of ICU stay (continuous outcome)
timeFrame: ICU admission to ICU discharge, assessed up to 6 months
measure: Length of hospital stay (continuous outcome)
timeFrame: admission to hospital discharge, assessed up to 6 months
Locations:
city: Manila
country: Philippines
facility: Philippine General Hospital - University of the Philippines Manila
Study officials:
affiliation: University of the Philippines
name: Adrian I Espiritu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Espiritu AI, Sy MCC, Anlacan VMM, Jamora RDG; Philippine CORONA Study Group Investigators. COVID-19 outcomes of 10,881 patients: retrospective study of neurological symptoms and associated manifestations (Philippine CORONA Study). J Neural Transm (Vienna). 2021 Nov;128(11):1687-1703. doi: 10.1007/s00702-021-02400-5. Epub 2021 Aug 27.
citation: Espiritu AI, Sy MCC, Anlacan VMM, Jamora RDG. The Philippine COVID-19 Outcomes: a Retrospective study Of Neurological manifestations and Associated symptoms (The Philippine CORONA study): a protocol study. BMJ Open. 2020 Nov 30;10(11):e040944. doi: 10.1136/bmjopen-2020-040944.