Neurologic Manifestations of COVID-19 (CORONA)

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ClinicalTrials.gov Identifier: NCT04386083

Recruitment Status : Recruiting

First Posted : May 13, 2020

Last Update Posted : July 28, 2020

See Contacts and Locations

Sponsor:

Collaborators:

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

East Avenue Medical Center, Philippines

Jose B. Lingad Memorial Regional Hospital, San Fernando, Pampanga, Philippines

Jose R. Reyes Memorial Medical Center

Lung Center of the Philippines

Manila Doctors Hospital, Philippines

Manila Medical Center, Philippines

Makati Medical Center

New Era General Hospital, Philippines

Quirino Memorial Medical Center, Philippines

Ospital ng Makati, Philippines

Dr. Pablo O. Torre Memorial Hospital, Bacolod City, Philippines

Philippine Heart Center

Research Institute for Tropical Medicine, Philippines

San Juan De Dios Educational Foundation Inc. - Hospital, Philippines

San Lazaro Hospital, Philippines

Southern Isabela Medical Center, Philippines

St. Luke's Medical Center, Philippines

St Lukes Medical Center, Bonifacio Global City, Philippines

Southern Philippines Medical Center

The Medical City, Philippines

University of the East Ramon Magsaysay Memorial Medical Center, Inc, Philippines

University of Santo Tomas Hospital, Philippines

Veterans Memorial Medical Center, Philippines

Jose N. Rodriguez Memorial Hospital, Caloocan City

Zamboanga City Medical Center, Zamboanga City

Western Visayas Medical Center, Iloilo City

Northern Mindanao Medical Center, Cagayan de Oro City

Vicente Sotto Memorial Medical Center, Cebu City

Perpetual Succor Hospital, Cebu City

Information provided by (Responsible Party):

Adrian Espiritu, University of the Philippines

Tracking Information

First Submitted Date

May 4, 2020

First Posted Date

May 13, 2020

Last Update Posted Date

July 28, 2020

Actual Study Start Date

June 10, 2020

Estimated Primary Completion Date

December 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

Mortality (binary outcome) [ Time Frame: from admission until occurrence of mortality, assessed up to 6 months ]
Defined as patients with confirmed COVID-19 who died
Respiratory failure (binary outcome) [ Time Frame: 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

Original Primary Outcome Measures

Same as current

Change History

Current Secondary Outcome Measures

Duration of ventilator dependence (continuous outcome) [ Time Frame: 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) [ Time Frame: 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

Original Secondary Outcome Measures

Same as current

Current Other Pre-specified Outcome Measures

Length of ICU stay (continuous outcome) [ Time Frame: 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) [ Time Frame: admission to hospital discharge, assessed up to 6 months ]
Defined as the number of days from admission to discharge

Original Other Pre-specified Outcome Measures

Same as current

Descriptive Information

Brief Title

Neurologic Manifestations of COVID-19

Official Title

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

Study Type

Observational

Study Design

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Adult patients with confirmed COVID-19 disease

Condition

Coronavirus Disease 2019

Intervention

Not Provided

Study Groups/Cohorts

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

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Recruiting

Estimated Enrollment

1342

Original Estimated Enrollment

Same as current

Estimated Study Completion Date

March 2021

Estimated Primary Completion Date

December 2020 (Final data collection date for primary outcome measure)

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).

Sex/Gender

Sexes Eligible for Study:

All

Ages

19 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Not Provided

Contacts

Contact: Adrian I Espiritu, MD	+639258520341	aiespiritu@up.edu.ph
Contact: Roland Dominic G Jamora, MD	+639985438062	rgjamora@up.edu.ph

Listed Location Countries

Philippines

Removed Location Countries

Administrative Information

NCT Number

NCT04386083

Other Study ID Numbers

RGAO-2020-0348

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement

Plan to Share IPD:	Yes
Plan Description:	Researchers may be able to request data through an official letter addressed to the Steering Committee of the "The Philippine CORONA Study" e-mailed to coronastudyph@gmail.com.
Supporting Materials:	Study Protocol
Time Frame:	Data will be stored for 5 years after completion of the study.
Access Criteria:	Data may be requested through an official letter addressed to the Steering Committee of the "The Philippine CORONA Study" e-mailed to coronastudyph@gmail.com.

Responsible Party

Adrian Espiritu, University of the Philippines

Study Sponsor

University of the Philippines

Collaborators

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

Investigators

Principal Investigator:

Adrian I Espiritu, MD

University of the Philippines

PRS Account

University of the Philippines

Verification Date

July 2020

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