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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

: Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC), Buenos Aires, Argentina

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

SARS-CoV-2 detection

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)

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 outcomes

Level of disease severity

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
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)

Sponsors and collaborators

Lead sponsor

P95

Industry

Collaborators

Centers for Disease Control and Prevention, China

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jul 27, 2022
Registry last updated: Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed