COVID-19 Effectiveness Study in the Philippines
A Multicenter Study to Assess the Effectiveness of an Inactivated COVID-19 Vaccine Against Hospitalized COVID-19
1 other identifier
observational
3,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2022
CompletedFirst Posted
Study publicly available on registry
August 29, 2022
CompletedStudy Start
First participant enrolled
November 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2024
CompletedDecember 2, 2022
December 1, 2022
12 months
August 25, 2022
December 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of hospitalized virologically-confirmed SARS-CoV-2 infection
1 year
Study Arms (2)
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.
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
Interventions
Eligibility Criteria
Adult patients admitted for acute respiratory illness.
You may qualify if:
- 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
You may not qualify if:
- Refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of the Philippineslead
- Coalition for Epidemic Preparedness Innovationscollaborator
- Mahidol Oxford Tropical Medicine Research Unitcollaborator
- Fudan Universitycollaborator
Study Sites (1)
Vicente Sotto Memorial Medical Center
Cebu City, Cebu Province, 1554, Philippines
Biospecimen
Any remaining oropharyngeal and nasopharyngeal swab samples will be frozen at -70°C and will be kept at ICHHD-NIH-UPM for fifteen years. Consenting participants may rescind their consent at a later date and refuse the use of their samples (which will be destroyed) or data at any time up until the completion of the study. Future studies using the samples and data will undergo appropriate ethical reviews as required. Only the designated study personnel will have access to these specimens.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2022
First Posted
August 29, 2022
Study Start
November 9, 2022
Primary Completion
November 8, 2023
Study Completion
March 15, 2024
Last Updated
December 2, 2022
Record last verified: 2022-12