Effectiveness of Chinese COVID-19 Vaccines in Latin America and the Caribbean

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 'Sinovac-CoronaVac' (Sinovac Biotech Ltd., Beijing, China), 'BIBP COVID-19 Vaccine' ('Covilo'; 'BIBP-CorV') (Sinopharm, Beijing Institute of Biological Products, China), 'Convidecia' ('AD5-nCOV') (CanSino Biologics, Tianjin, China).

Official Title
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Effectiveness of Chinese COVID-19 Vaccines in Latin America and the Caribbean

Conditions
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COVID-19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients need to fulfill all the following criteria to be eligible for the study: Being 18 years old or older 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 ER consultation or hospitalization due to SARI 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: Patients vaccinated against COVID-19 but not with the vaccines of interest Patients admitted or hospitalized for other condition than SARI Patients to whom it is not possible to perform a diagnostic test (antigen or PCR) for SARS-CoV-2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case group<br>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 | |
| Control group<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 detection | 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). | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of disease severity | 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) | - 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 |