Neurologic Manifestations of COVID-19

Coronavirus Disease 2019 Clinical Trial

— CORONA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04386083
• Other study ID #: RGAO-2020-0348
• Status: Recruiting
• Start date: June 10, 2020
• Est. completion date: March 2021

Study information

• Verified date: July 2020
• Source: University of the Philippines
• Contact: Adrian I Espiritu, MD
• Phone: +639258520341
• Email: aiespiritu[@]up.edu.ph
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1342
• Est. completion date: March 2021
• Est. primary completion date: December 2020
• Gender: All
• Age group: 19 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Coronavirus Disease 2019
• Coronavirus Infections
• Neurologic Manifestations

Locations

Country	Name	City	State
Philippines	Philippine General Hospital - University of the Philippines Manila	Manila

Sponsors (37)

Lead Sponsor

Collaborator

University of the Philippines

Asian Hospital and Medical Center, Muntinlupa City, Philippines, Baguio General Hospital and Medical Center, Baguio City, Philippines, Cagayan Valley Medical Center, Tuguegarao City, Philippines, Capitol Medical Center, Quezon City, Philippines, Cardinal Santos Medical Center, San Juan City, Philippines, Chong Hua Hospital, Cebu City, Philippines, De La Salle University Medical Center, Dr. Pablo O. Torre Memorial Hospital, Bacolod City, Philippines, East Avenue Medical Center, Philippines, Jose B. Lingad Memorial Regional Hospital, San Fernando, Pampanga, Philippines, Jose N. Rodriguez Memorial Hospital, Caloocan City, Jose R. Reyes Memorial Medical Center, Lung Center of the Philippines, Makati Medical Center, Manila Doctors Hospital, Philippines, Manila Medical Center, Philippines, New Era General Hospital, Philippines, Northern Mindanao Medical Center, Cagayan de Oro City, Ospital ng Makati, Philippines, Perpetual Succor Hospital, Cebu City, Philippine Heart Center, Quirino Memorial Medical Center, Philippines, Research Institute for Tropical Medicine, Philippines, San Juan De Dios Educational Foundation Inc. - Hospital, Philippines, San Lazaro Hospital, Philippines, Southern Isabela Medical Center, Philippines, Southern Philippines Medical Center, St Lukes Medical Center, Bonifacio Global City, Philippines, St. Luke's Medical Center, Philippines, The Medical City, Philippines, University of Santo Tomas Hospital, Philippines, University of the East Ramon Magsaysay Memorial Medical Center, Inc, Philippines, Veterans Memorial Medical Center, Philippines, Vicente Sotto Memorial Medical Center, Cebu City, Western Visayas Medical Center, Iloilo City, Zamboanga City Medical Center, Zamboanga City

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of ICU stay (continuous outcome)	Defined as the number of days admitted in the ICU or ICU-comparable setting	ICU admission to ICU discharge, assessed up to 6 months
Other	Length of hospital stay (continuous outcome)	Defined as the number of days from admission to discharge	admission to hospital discharge, assessed up to 6 months
Primary	Mortality (binary outcome)	Defined as patients with confirmed COVID-19 who died	from admission until occurrence of mortality, assessed up to 6 months
Primary	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	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
Secondary	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