COVID-19 Effectiveness Study in the Philippines

December 1, 2022 updated by: University of the Philippines

A Multicenter Study to Assess the Effectiveness of an Inactivated COVID-19 Vaccine Against Hospitalized COVID-19

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Philippines
    • Cebu Province
      • Cebu City, Cebu Province, Philippines, 1554
        • Recruiting
        • Vicente Sotto Memorial Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients admitted for acute respiratory illness.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: no intervention
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
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of hospitalized virologically-confirmed SARS-CoV-2 infection
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Philippines

Collaborators

Fudan University
Mahidol Oxford Tropical Medicine Research Unit
Coalition for Epidemic Preparedness Innovations

Investigators

  • Principal Investigator: Jacqueline Deen, MD, MSc, ICHHD, University of the Philippines - National Institutes of Health
  • Principal Investigator: Michelle Ylade, MD, MSc, ICHHD, University of the Philippines - National Institutes of Health
  • Principal Investigator: Kristal An C Agrupis, MD, MSc, ICHHD, University of the Philippines - National Institutes of Health
  • Principal Investigator: Maria Vinna Crisostomo, MD, ICHHD, University of the Philippines - National Institutes of Health
  • Principal Investigator: Jedas Veronica Daag, RN, RMT, ICHHD, University of the Philippines - National Institutes of Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 9, 2022

Primary Completion (ANTICIPATED)

November 8, 2023

Study Completion (ANTICIPATED)

March 15, 2024

Study Registration Dates

First Submitted

August 25, 2022

First Submitted That Met QC Criteria

August 25, 2022

First Posted (ACTUAL)

August 29, 2022

Study Record Updates

Last Update Posted (ACTUAL)

December 2, 2022

Last Update Submitted That Met QC Criteria

December 1, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJREB-2021-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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