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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
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

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.

Condition or disease
Coronavirus Disease 2019

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.

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Study Type : Observational
Estimated Enrollment : 1342 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: COVID-19 Outcomes: A Retrospective Study of Neurological Manifestations and Associated Symptoms (The Philippine CORONA Study)
Actual Study Start Date : June 10, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Other Outcome Measures:
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with confirmed COVID-19 disease
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04386083


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

Locations
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Philippines
Philippine General Hospital - University of the Philippines Manila Recruiting
Manila, Philippines
Contact: Adrian I Espiritu, MD    +639258520341    aiespiritu@up.edu.ph   
Contact: Roland Dominic G Jamora, MD    +639985438062    rgjamora@up.edu.ph   
Sponsors and Collaborators
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
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
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Principal Investigator: Adrian I Espiritu, MD University of the Philippines
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Adrian Espiritu, Principal Investigator, University of the Philippines
ClinicalTrials.gov Identifier: NCT04386083    
Other Study ID Numbers: RGAO-2020-0348
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adrian Espiritu, University of the Philippines:
COVID-19
neurological manifestations
outcomes
cohort study
Additional relevant MeSH terms:
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Coronavirus Infections
Neurologic Manifestations
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Nervous System Diseases