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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

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
 (submitted: May 11, 2020)
  • 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
 (submitted: May 11, 2020)
  • 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
 (submitted: May 11, 2020)
  • 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
 (submitted: May 11, 2020)
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 No
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