Effectiveness of Chinese COVID-19 Vaccines in Latin America and the Caribbean
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
The vaccines of interest are the following:
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'Sinovac-CoronaVac' (Sinovac Biotech Ltd., Beijing, China),
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'BIBP COVID-19 Vaccine' ('Covilo'; 'BIBP-CorV') (Sinopharm, Beijing Institute of Biological Products, China),
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'Convidecia' ('AD5-nCOV') (CanSino Biologics, Tianjin, China).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Case group 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 |
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| Control group 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 |
Outcome Measures
Primary Outcome Measures
- SARS-CoV-2 detection [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)]
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).
Secondary Outcome Measures
- Level of disease severity [- 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]
Level of disease severity of participants will be characterized according to the WHO COVID-19 Clinical Progression Scale: Ambulatory mild disease, without death Hospitalized (moderate disease) without in-hospital death Hospitalized (ICU, severe disease) without in-hospital death In-hospital death (including death in the ER)
Eligibility Criteria
Criteria
Inclusion Criteria
Patients need to fulfill all the following criteria to be eligible for the study:
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Being 18 years old or older
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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
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ER consultation or hospitalization due to SARI
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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)
Exclusion Criteria
Patients that fulfill one or more of the following criteria will not be eligible for the study:
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Patients vaccinated against COVID-19 but not with the vaccines of interest
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Patients admitted or hospitalized for other condition than SARI
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Patients to whom it is not possible to perform a diagnostic test (antigen or PCR) for SARS-CoV-2
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- P95
- Centers for Disease Control and Prevention, China
Investigators
- Principal Investigator: Thomas Verstraeten, P95
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRJ000284