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Coronavirus Disease 2019CORONANCT04386083

Neurologic Manifestations of COVID-19

An observational study of Coronavirus Disease 2019, run by University of the Philippines at 1 site in Philippines.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Coronavirus Disease 2019
How many people
1,342 participants
Where
1 sitePhilippines
Study dates
10 Jun 2020to Mar 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Adult, Older adult

Study population: Adult patients with confirmed COVID-19 disease

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Adrian I Espiritu, MD contact

+639258520341

aiespiritu@up.edu.ph

Roland Dominic G Jamora, MD contact

+639985438062

rgjamora@up.edu.ph

Philippines1 site, 1 recruiting

  • Philippine General Hospital - University of the Philippines Manila

    Manila

    Adrian I Espiritu, MD, +639258520341, aiespiritu@up.edu.ph

    Roland Dominic G Jamora, MD, +639985438062, rgjamora@up.edu.ph

    Recruiting

Other trials in Philippines

About this study

Official title: 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.

Read the 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.

Keywords
COVID-19, neurological manifestations, outcomes, cohort study
Medical subject headings
COVID-19, Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04386083
Study groupRoleWhat they receive
COVID-19 patients with neurologic manifestationsPatients with confirmed COVID-19 disease who presented with neurological symptoms or new-onset neurological disorders/complications
COVID-19 patients without neurologic manifestationsPatients with confirmed COVID-19 disease who did not present with neurological symptoms or new-onset neurological disorders/complications

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality (binary outcome)

    Defined as patients with confirmed COVID-19 who died

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

  2. 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

    Measured: from admission until occurrence of respiratory failure, assessed up to 6 months

Secondary outcomes (2)

  1. Duration of ventilator dependence (continuous outcome)

    Defined as the number of days from initiation of assisted ventilation to extubation

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

  2. Intensive care unit (ICU) admission (binary outcome)

    Defined as the patients with confirmed COVID-19 who are admitted to an ICU or ICU-comparable setting

    Measured: admission to ICU admission, assessed up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2020
  2. Study start10 Jun 2020
  3. Primary completionDec 2020 (estimated)
  4. Study completionMar 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,342 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04386083
Sponsor's protocol ID
RGAO-2020-0348
Acronym
CORONA
Status last verified
Jul 2020
First submitted
4 May 2020
Last updated
28 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 34448930

  • 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.

    PubMed 33257488

Questions about this trial

What is this clinical trial studying?

An observational study of Coronavirus Disease 2019, run by University of the Philippines at 1 site in Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Adrian I Espiritu, MD (+639258520341, aiespiritu@up.edu.ph), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (binary outcome) (time frame: from admission until occurrence of mortality, assessed up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04386083, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.

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