NCT04386083

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,342

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

June 10, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

May 4, 2020

Last Update Submit

July 25, 2020

Conditions

Coronavirus Disease 2019

Keywords

COVID-19neurological manifestationsoutcomescohort study

Outcome Measures

Primary Outcomes (2)

  • Mortality (binary outcome)

    Defined as patients with confirmed COVID-19 who died

    from admission until occurrence of mortality, assessed up to 6 months

  • 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 Outcomes (2)

  • Duration of ventilator dependence (continuous outcome)

    day of intubation to day of extubation, assessed up to 6 months

  • Intensive care unit (ICU) admission (binary outcome)

    admission to ICU admission, assessed up to 6 months

Other Outcomes (2)

  • Length of ICU stay (continuous outcome)

    ICU admission to ICU discharge, assessed up to 6 months

  • Length of hospital stay (continuous outcome)

    admission to hospital discharge, assessed up to 6 months

Study Arms (2)

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

Eligibility Criteria

Age19 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with confirmed COVID-19 disease

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philippine General Hospital - University of the Philippines Manila

Manila, Philippines

RECRUITING

Related Publications (2)

  • Espiritu AI, Sy MCC, Anlacan VMM, Jamora RDG; Philippine CORONA Study Group Investigators. COVID-19 outcomes of 10,881 patients: retrospective study of neurological symptoms and associated manifestations (Philippine CORONA Study). J Neural Transm (Vienna). 2021 Nov;128(11):1687-1703. doi: 10.1007/s00702-021-02400-5. Epub 2021 Aug 27.

    PMID: 34448930DERIVED

  • 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.

    PMID: 33257488DERIVED

MeSH Terms

Conditions

COVID-19Neurologic Manifestations

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Adrian I Espiritu, MD

    University of the Philippines

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrian I Espiritu, MD

CONTACT

+639258520341aiespiritu@up.edu.ph

Roland Dominic G Jamora, MD

CONTACT

+639985438062rgjamora@up.edu.ph

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 13, 2020

Study Start

June 10, 2020

Primary Completion

December 1, 2020

Study Completion

March 1, 2021

Last Updated

July 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
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.

Locations

PH(1)