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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05475704
• Other study ID #: PRJ000284
• Status: Completed
• Start date: May 23, 2022
• Est. completion date: July 11, 2023

Study information

• Verified date: August 2023
• Source: P95
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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:

• '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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: July 11, 2023
• Est. primary completion date: July 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
Argentina	: Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC)	Buenos Aires
Colombia	Clinica de la Costa Ltda.	Atlántico	Barranquilla
Colombia	Clínica Medellín S.A.S	Medellín
Dominican Republic	Hospital General Regional Marcelino Velez Santana	Santo Domingo
Peru	Instituto de Medicina Tropical Alexander von Humboldt at Universidad Peruana Cayetano Heredia	San Martín De Porres

Sponsors (2)

Lead Sponsor	Collaborator
P95	Centers for Disease Control and Prevention, China

Countries where clinical trial is conducted

Argentina,  Colombia,  Dominican Republic,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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