Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Coalition for Epidemic Preparedness Innovations | OTHER |
| Mahidol Oxford Tropical Medicine Research Unit | OTHER |
| Fudan University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention | Other | no intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of hospitalized virologically-confirmed SARS-CoV-2 infection | 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Adult patients admitted for acute respiratory illness.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristal An C Agrupis, MD, MSc | Contact | +63 2 8559 0199 | kcagrupis@up.edu.ph |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vicente Sotto Memorial Medical Center | Recruiting | Cebu City | Cebu Province | 1554 | Philippines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| 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 | Principal Investigator |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |