COVID-19NCT05518760
COVID-19 Effectiveness Study in the Philippines
An observational study of COVID-19 and Vaccine Effectiveness Against COVID-19, run by University of the Philippines at 1 site in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Vaccine Effectiveness Against COVID-19, Hospitalized COVID-19
- How many people
- 3,000 participants
- Where
- 1 sitePhilippines
- Study dates
- 9 Nov 2022to 15 Mar 2024
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients admitted for acute respiratory illness.
Who may be able to join
- 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
Who cannot join
- 6.2.2.1 Refusal to participate
Trial locations and contacts
1 site in 1 country.
Philippines1 site, 1 recruiting
- Recruiting
Vicente Sotto Memorial Medical Center
Cebu City, Cebu Province, 1554
Kristal An Agrupis, +639173668540, kcagrupis@up.edu.ph
About this study
Official title: 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.
- Being tested
- no intervention
- Keywords
- COVID-19, Vaccine effectiveness, hospitalized COVID-19, inactivated COVID-19 vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospitalized virologically-confirmed SARS-CoV-2 infection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start9 Nov 2022
- Primary completion8 Nov 2023 (estimated)
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Philippines
- Sponsor type
- University, hospital or other
- Collaborators
- Coalition for Epidemic Preparedness Innovations, Mahidol Oxford Tropical Medicine Research Unit, Fudan University
- Responsible party
- Sponsor
- Investigators
- Jacqueline Deen, MD, MSc, Principal investigator, ICHHD, University of the Philippines - National Institutes of HealthMichelle Ylade, MD, MSc, Principal investigator, ICHHD, University of the Philippines - National Institutes of HealthKristal An C Agrupis, MD, MSc, Principal investigator, ICHHD, University of the Philippines - National Institutes of HealthMaria Vinna Crisostomo, MD, Principal investigator, ICHHD, University of the Philippines - National Institutes of HealthJedas Veronica Daag, RN, RMT, Principal investigator, ICHHD, University of the Philippines - National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518760
- Sponsor's protocol ID
- SJREB-2021-103
- Status last verified
- Dec 2022
- First submitted
- 25 Aug 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Assess the Effectiveness of an Inactivated COVID-19 Vaccine Against Hospitalized COVID-19
- ClinicalTrials.gov ID
- NCT05518760
- Acronym / sponsor ID
- SJREB-2021-103
- Keywords
- COVID-19, Vaccine effectiveness, hospitalized COVID-19, inactivated COVID-19 vaccine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of the PhilippinesUniversity, hospital or other
- Collaborators
- Coalition for Epidemic Preparedness Innovations, Mahidol Oxford Tropical Medicine Research Unit, Fudan University
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 8 Nov 2023 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: no interventionA 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 | – | Other: no interventionA COVID-19 negative case is a patient with an acute respiratory illness, in whom all RT-PCR tests are negative for SARS-CoV-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted for acute respiratory illness.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 6.2.2.1 Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | Case, Test-negative control |
Primary outcome
Number of hospitalized virologically-confirmed SARS-CoV-2 infection
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Deen, MD, MSc principal investigator
ICHHD, University of the Philippines - National Institutes of Health
Michelle Ylade, MD, MSc principal investigator
ICHHD, University of the Philippines - National Institutes of Health
Kristal An C Agrupis, MD, MSc principal investigator
ICHHD, University of the Philippines - National Institutes of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Vaccine Effectiveness Against COVID-19, 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 5 inclusion and 1 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 2 Dec 2022. 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 Kristal An C Agrupis, MD, MSc (+63 2 8559 0199, kcagrupis@up.edu.ph), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hospitalized virologically-confirmed SARS-CoV-2 infection (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2022.