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

P9559 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

COVID-19

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

: Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC)

Buenos Aires, Argentina

Clinica de la Costa Ltda.

Atlántico, Barranquilla, Colombia

Clínica Medellín S.A.S

Medellín, Colombia

Hospital General Regional Marcelino Velez Santana

Santo Domingo, Dominican Republic

Outcomes

Primary Outcomes

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).

Time frame: 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 Outcomes

Level of disease severity

Level of disease severity of participants will be characterized according to the WHO COVID-19 Clinical Progression Scale: 1. Ambulatory mild disease, without death 2. Hospitalized (moderate disease) without in-hospital death 3. Hospitalized (ICU, severe disease) without in-hospital death 4. In-hospital death (including death in the ER)

Time frame: - 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

Data from ClinicalTrials.gov

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