COVID-19 Effectiveness Study in the Philippines

NCT ID: NCT05518760

Last Updated: 2022-12-02

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

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-09

Study Completion Date

2024-03-15

Brief Summary

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This is a multi-site, observational, prospective test negative design case-control study which primarily aims to determine the protective effectiveness of 2 doses of an inactivated COVID-19 vaccine at least 14 days after the second dose, against hospitalized virologically-confirmed SARS-CoV-2 infection.

Detailed Description

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Conditions

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COVID-19 Vaccine Effectiveness Against COVID-19 Hospitalized COVID-19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case

A COVID-19 confirmed case is a patient with an acute respiratory illness and RT-PCR confirmation of SARS-CoV-2 infection (i.e. any positive RT-PCR results obtained prior to admission or after enrolment in the study). In case the patient has any inconsistent RT-PCR results (e.g. a positive followed by a negative or a negative followed by a positive result), he/s he/she will be considered as a COVID-19 confirmed case if he/she has at least one positive result during his/her illness under consideration.

no intervention

Intervention Type OTHER

no intervention

Test-negative control

A COVID-19 negative case is a patient with an acute respiratory illness, in whom all RT-PCR tests are negative for SARS-CoV-2

no intervention

Intervention Type OTHER

no intervention

Interventions

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no intervention

no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Written informed consent.
* Aged 18 years of age and above
* Residing in the catchment area of the participating hospital
* Admitted to the participating hospital with an acute respiratory illness
* Able and willing to provide a naso- and oro-pharyngeal swab for RT-PCR testing

Exclusion Criteria

* 6.2.2.1 Refusal to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Coalition for Epidemic Preparedness Innovations

OTHER

Sponsor Role collaborator

Mahidol Oxford Tropical Medicine Research Unit

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role collaborator

University of the Philippines

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacqueline Deen, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

ICHHD, University of the Philippines - National Institutes of Health

Michelle Ylade, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

ICHHD, University of the Philippines - National Institutes of Health

Kristal An C Agrupis, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

ICHHD, University of the Philippines - National Institutes of Health

Maria Vinna Crisostomo, MD

Role: PRINCIPAL_INVESTIGATOR

ICHHD, University of the Philippines - National Institutes of Health

Jedas Veronica Daag, RN, RMT

Role: PRINCIPAL_INVESTIGATOR

ICHHD, University of the Philippines - National Institutes of Health

Locations

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Vicente Sotto Memorial Medical Center

Cebu City, Cebu Province, Philippines

Site Status RECRUITING

Countries

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Philippines

Central Contacts

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Kristal An C Agrupis, MD, MSc

Role: CONTACT

+63 2 8559 0199

Facility Contacts

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Kristal An Agrupis

Role: primary

+639173668540

Other Identifiers

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SJREB-2021-103

Identifier Type: -

Identifier Source: org_study_id

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