Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-30 @ 9:03 PM
Study NCT ID:
NCT05475704
Status:
COMPLETED
Last Update Posted:
2023-08-25
First Post:
2022-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Chinese COVID-19 Vaccines in Latin America and the Caribbean
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-24', 'studyFirstSubmitDate': '2022-07-21', 'studyFirstSubmitQcDate': '2022-07-26', 'lastUpdatePostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SARS-CoV-2 detection', 'timeFrame': 'Specimen collected between d-14 and d0, where d0 is the day at ER visit or hospital admission (or specimen collected within 24 hours upon arrival at the hospital)', 'description': 'The outcome of interest for the primary analysis will be the SARS-CoV-2 detection from study participants who present to the ER ("ER visit") or are hospitalized with SARI, as determined through the standard of care diagnostic testing (i.e., antigen test or PCR).'}], 'secondaryOutcomes': [{'measure': 'Level of disease severity', 'timeFrame': '- The Time Frame will be defined as the time from ER/Hospital admission to the date of hospital discharge or date of death at hospital', 'description': 'Level of disease severity of participants will be characterized according to the WHO COVID-19 Clinical Progression Scale:\n\n1. Ambulatory mild disease, without death\n2. Hospitalized (moderate disease) without in-hospital death\n3. Hospitalized (ICU, severe disease) without in-hospital death\n4. In-hospital death (including death in the ER)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This multi-country study seeks to collect real-world evidence (RWE), from Latin American and Caribbean countries, on the effectiveness of China-made COVID-19 vaccines in different populations, against different clinical outcomes, and when administered in different schedules.', 'detailedDescription': "This multi-country study seeks to collect RWE, from Latin American and Caribbean countries, on the effectiveness of China-made COVID-19 vaccines in different populations, against different clinical outcomes and when administered in different schedules.\n\nThe vaccines of interest are the following:\n\n* 'Sinovac-CoronaVac' (Sinovac Biotech Ltd., Beijing, China),\n* 'BIBP COVID-19 Vaccine' ('Covilo'; 'BIBP-CorV') (Sinopharm, Beijing Institute of Biological Products, China),\n* 'Convidecia' ('AD5-nCOV') (CanSino Biologics, Tianjin, China)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients 18 years old and older that present to the emergency room ("emergency room visit") or are hospitalized with Severe Acute Respiratory Infection (SARI).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients need to fulfill all the following criteria to be eligible for the study:\n\n* Being 18 years old or older\n* Ever eligible for vaccination2 with any of the Chinese COVID-19 vaccines provided in their country as per national/regional immunization recommendations prior to hospital admission\n* ER consultation or hospitalization due to SARI\n* Willing and able to provide informed consent (or by a legally accepted representative if the patient is not able to provide a signature by him/herself)\n\nExclusion Criteria\n\nPatients that fulfill one or more of the following criteria will not be eligible for the study:\n\n* Patients vaccinated against COVID-19 but not with the vaccines of interest\n* Patients admitted or hospitalized for other condition than SARI\n* Patients to whom it is not possible to perform a diagnostic test (antigen or PCR) for SARS-CoV-2'}, 'identificationModule': {'nctId': 'NCT05475704', 'briefTitle': 'Effectiveness of Chinese COVID-19 Vaccines in Latin America and the Caribbean', 'organization': {'class': 'INDUSTRY', 'fullName': 'P95'}, 'officialTitle': 'Effectiveness of Chinese COVID-19 Vaccines in Latin America and the Caribbean', 'orgStudyIdInfo': {'id': 'PRJ000284'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case group', 'description': 'Test-positive cases are study participants that meet the SARI case definition AND test positive for at least one SARS-CoV-2 diagnostic test, with specimens collected up to 14 days prior to ER visit or hospitalization or up to 24 hours thereafter'}, {'label': 'Control group', 'description': 'Test-negative controls are study participants that meet the SARI case definition AND test negative for all SARS-CoV-2 diagnostic test with specimens collected up to 14 days prior to ER visit or hospitalization or up to 24 hours thereafter'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1131', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': ': Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC)', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Atlántico', 'state': 'Barranquilla', 'country': 'Colombia', 'facility': 'Clinica de la Costa Ltda.', 'geoPoint': {'lat': 10.45311, 'lon': -74.41424}}, {'city': 'Medellín', 'country': 'Colombia', 'facility': 'Clínica Medellín S.A.S', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Hospital General Regional Marcelino Velez Santana', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'city': 'San Martín de Porres', 'country': 'Peru', 'facility': 'Instituto de Medicina Tropical Alexander von Humboldt at Universidad Peruana Cayetano Heredia', 'geoPoint': {'lat': -8.39936, 'lon': -74.56901}}], 'overallOfficials': [{'name': 'Thomas Verstraeten', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'P95'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'P95', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention, China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}