COVID-19 Effectiveness Study in the Philippines

University of the Philippines

Status: Enrolling

Conditions: COVID-19; Vaccine Effectiveness Against COVID-19; Hospitalized COVID-19

Treatments: Other: no intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05518760

SJREB-2021-103

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,000 participants in 2 patient groups

Case

Description:

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.

Treatment:

Other: no intervention

Test-negative control

Description:

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

Treatment:

Other: no intervention