Neurologic Manifestations of COVID-19 (CORONA)

July 25, 2020 updated by: Adrian Espiritu, University of the Philippines

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

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

1342

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
      • Manila, Philippines
        • Recruiting
        • Philippine General Hospital - University of the Philippines Manila
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with confirmed COVID-19 disease

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from admission until occurrence of mortality, assessed up to 6 months
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
from admission until occurrence of respiratory failure, assessed up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day of intubation to day of extubation, assessed up to 6 months
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
admission to ICU admission, assessed up to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
ICU admission to ICU discharge, assessed up to 6 months
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
admission to hospital discharge, assessed up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Philippines

Collaborators

St. Luke's Medical Center, Philippines
De La Salle University Medical Center
University of Santo Tomas Hospital, Philippines
Makati Medical Center
Lung Center of the Philippines
Research Institute for Tropical Medicine, Philippines
East Avenue Medical Center, Philippines
Jose R. Reyes Memorial Medical Center
Quirino Memorial Medical Center, Philippines
The Medical City, 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
Jose B. Lingad Memorial Regional Hospital, San Fernando, Pampanga, Philippines
Manila Doctors Hospital, Philippines
Manila Medical Center, Philippines
New Era General Hospital, Philippines
Ospital ng Makati, Philippines
Dr. Pablo O. Torre Memorial Hospital, Bacolod City, Philippines
Philippine Heart Center
San Juan De Dios Educational Foundation Inc. - Hospital, Philippines
San Lazaro Hospital, Philippines
Southern Isabela Medical Center, Philippines
St Lukes Medical Center, Bonifacio Global City, Philippines
Southern Philippines Medical Center
University of the East Ramon Magsaysay Memorial Medical Center, Inc, 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 13, 2020

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 25, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGAO-2020-0348

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Time Frame

Data will be stored for 5 years after completion of the study.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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