Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-31 @ 4:02 PM
Study NCT ID:
NCT05518760
Status:
UNKNOWN
Last Update Posted:
2022-12-02
First Post:
2022-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 Effectiveness Study in the Philippines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-01', 'studyFirstSubmitDate': '2022-08-25', 'studyFirstSubmitQcDate': '2022-08-25', 'lastUpdatePostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of hospitalized virologically-confirmed SARS-CoV-2 infection', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Vaccine effectiveness', 'hospitalized COVID-19', 'inactivated COVID-19 vaccine'], 'conditions': ['COVID-19', 'Vaccine Effectiveness Against COVID-19', 'Hospitalized COVID-19']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients admitted for acute respiratory illness.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent.\n* Aged 18 years of age and above\n* Residing in the catchment area of the participating hospital\n* Admitted to the participating hospital with an acute respiratory illness\n* Able and willing to provide a naso- and oro-pharyngeal swab for RT-PCR testing\n\nExclusion Criteria:\n\n* 6.2.2.1 Refusal to participate'}, 'identificationModule': {'nctId': 'NCT05518760', 'briefTitle': 'COVID-19 Effectiveness Study in the Philippines', 'organization': {'class': 'OTHER', 'fullName': 'University of the Philippines'}, 'officialTitle': 'A Multicenter Study to Assess the Effectiveness of an Inactivated COVID-19 Vaccine Against Hospitalized COVID-19', 'orgStudyIdInfo': {'id': 'SJREB-2021-103'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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.', 'interventionNames': ['Other: no intervention']}, {'label': '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', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['Case', 'Test-negative control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1554', 'city': 'Cebu City', 'state': 'Cebu Province', 'status': 'RECRUITING', 'country': 'Philippines', 'contacts': [{'name': 'Kristal An Agrupis', 'role': 'CONTACT', 'email': 'kcagrupis@up.edu.ph', 'phone': '+639173668540'}], 'facility': 'Vicente Sotto Memorial Medical Center', 'geoPoint': {'lat': 10.31672, 'lon': 123.89071}}], 'centralContacts': [{'name': 'Kristal An C Agrupis, MD, MSc', 'role': 'CONTACT', 'email': 'kcagrupis@up.edu.ph', 'phone': '+63 2 8559 0199'}], 'overallOfficials': [{'name': 'Jacqueline Deen, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICHHD, University of the Philippines - National Institutes of Health'}, {'name': 'Michelle Ylade, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICHHD, University of the Philippines - National Institutes of Health'}, {'name': 'Kristal An C Agrupis, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICHHD, University of the Philippines - National Institutes of Health'}, {'name': 'Maria Vinna Crisostomo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICHHD, University of the Philippines - National Institutes of Health'}, {'name': 'Jedas Veronica Daag, RN, RMT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICHHD, University of the Philippines - National Institutes of Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of the Philippines', 'class': 'OTHER'}, 'collaborators': [{'name': 'Coalition for Epidemic Preparedness Innovations', 'class': 'OTHER'}, {'name': 'Mahidol Oxford Tropical Medicine Research Unit', 'class': 'OTHER'}, {'name': 'Fudan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}