Neurologic Manifestations of COVID-19

NCT ID: NCT04386083

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1342 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-10

Study Completion Date

2021-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronavirus Disease 2019

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

COVID-19 patients with neurologic manifestations

Patients with confirmed COVID-19 disease who presented with neurological symptoms or new-onset neurological disorders/complications

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Asian Hospital and Medical Center, Muntinlupa City, Philippines

UNKNOWN

Sponsor Role collaborator

Baguio General Hospital and Medical Center, Baguio City, Philippines

UNKNOWN

Sponsor Role collaborator

Cagayan Valley Medical Center, Tuguegarao City, Philippines

UNKNOWN

Sponsor Role collaborator

Capitol Medical Center, Quezon City, Philippines

UNKNOWN

Sponsor Role collaborator

Cardinal Santos Medical Center, San Juan City, Philippines

UNKNOWN

Sponsor Role collaborator

Chong Hua Hospital, Cebu City, Philippines

UNKNOWN

Sponsor Role collaborator

De La Salle University Medical Center

OTHER

Sponsor Role collaborator

East Avenue Medical Center, Philippines

OTHER_GOV

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

Jose R. Reyes Memorial Medical Center

OTHER_GOV

Sponsor Role collaborator

Lung Center of the Philippines

OTHER

Sponsor Role collaborator

Manila Doctors Hospital, Philippines

UNKNOWN

Sponsor Role collaborator

Manila Medical Center, Philippines

UNKNOWN

Sponsor Role collaborator

Makati Medical Center

OTHER

Sponsor Role collaborator

New Era General Hospital, Philippines

UNKNOWN

Sponsor Role collaborator

Quirino Memorial Medical Center, Philippines

UNKNOWN

Sponsor Role collaborator

Ospital ng Makati, Philippines

UNKNOWN

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

Philippine Heart Center

UNKNOWN

Sponsor Role collaborator

Research Institute for Tropical Medicine, Philippines

OTHER_GOV

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

San Lazaro Hospital, Philippines

UNKNOWN

Sponsor Role collaborator

Southern Isabela Medical Center, Philippines

UNKNOWN

Sponsor Role collaborator

St. Luke's Medical Center, Philippines

OTHER

Sponsor Role collaborator

St Lukes Medical Center, Bonifacio Global City, Philippines

UNKNOWN

Sponsor Role collaborator

Southern Philippines Medical Center

OTHER

Sponsor Role collaborator

The Medical City, Philippines

OTHER

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

University of Santo Tomas Hospital, Philippines

OTHER

Sponsor Role collaborator

Veterans Memorial Medical Center, Philippines

UNKNOWN

Sponsor Role collaborator

Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium

OTHER

Sponsor Role collaborator

Zamboanga City Medical Center, Zamboanga City

UNKNOWN

Sponsor Role collaborator

Western Visayas Medical Center, Iloilo City

UNKNOWN

Sponsor Role collaborator

Northern Mindanao Medical Center, Cagayan de Oro City

UNKNOWN

Sponsor Role collaborator

Vicente Sotto Memorial Medical Center, Cebu City

UNKNOWN

Sponsor Role collaborator

Perpetual Succor Hospital, Cebu City

UNKNOWN

Sponsor Role collaborator

University of the Philippines

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Adrian Espiritu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Adrian I Espiritu, MD

Role: PRINCIPAL_INVESTIGATOR

University of the Philippines

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Philippine General Hospital - University of the Philippines Manila

Manila, , Philippines

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Philippines

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Adrian I Espiritu, MD

Role: CONTACT

+639258520341

Roland Dominic G Jamora, MD

Role: CONTACT

+639985438062

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Adrian I Espiritu, MD

Role: primary

+639258520341

Roland Dominic G Jamora, MD

Role: backup

+639985438062

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34448930 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33257488 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RGAO-2020-0348

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mirroring a Movement
NCT00123448 COMPLETED