ClinicalTrials.gg
Status unknownNCT05518760Updated Dec 2, 2022

COVID-19 Effectiveness Study in the Philippines

An observational study in COVID-19, Vaccine Effectiveness Against COVID-19 and Hospitalized COVID-19, sponsored by University of the Philippines. Status unknown at 1 site in Philippines. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-02.

Sponsored by University of the Philippines · Observational

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
3,000
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

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

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Keywords

  • COVID-19
  • Vaccine effectiveness
  • hospitalized COVID-19
  • inactivated COVID-19 vaccine
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In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University of the Philippines is the lead sponsor of 26 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Adult patients admitted for acute respiratory illness.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Written .
  • 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

Exclusion Criteria:

  • 6.2.2.1 Refusal to participate
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • 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

Interventions

  • Otherno intervention

    no intervention

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What researchers measure

Primary outcomes

  1. Number of hospitalized virologically-confirmed SARS-CoV-2 infection

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Vicente Sotto Memorial Medical Center
    Cebu City, Cebu Province 1554, Philippines
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2022 (actual). Primary completion is estimated for Nov 2023, 11 months after the start.

Of 1,640 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's planned 11 months is below that.

Counting every sponsor, half of 1,774 studies reached it within 13 months; a quarter within 5 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2022
First posted
Aug 29, 2022
StartActual
Nov 9, 2022
Primary completionEst.
Nov 8, 2023
CompletionEst.
Mar 15, 2024
Last update
Dec 2, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05518760
Lead sponsor
University of the Philippines
Collaborators
Coalition for Epidemic Preparedness Innovations, Mahidol Oxford Tropical Medicine Research Unit, Fudan University
Responsible party
Sponsor
First posted
Aug 29, 2022
Start date
Nov 9, 2022
Primary completion
Nov 8, 2023 (estimated)
Completion
Mar 15, 2024 (estimated)
Last update
Dec 2, 2022

Study contacts

Kristal An C Agrupis, MD, MSc
Contact
kcagrupis@up.edu.ph
+63 2 8559 0199
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
Maria Vinna Crisostomo, MD
principal investigator · ICHHD, University of the Philippines - National Institutes of Health
Jedas Veronica Daag, RN, RMT
principal investigator · ICHHD, University of the Philippines - National Institutes of Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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