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.

Study Overview

• Status: Completed
• Conditions: COVID-19

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:

• '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 (Actual): 59

Contacts and Locations

• Study Contact: Name: Thomas Verstraeten; Phone Number: +352661228822; Email: thomas.verstraeten@p-95.com
• Study Contact Backup: Name: Andres Cordoba; Email: andres.cordoba@p-95.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1131
    • : Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC)
• Colombia
  • Medellín, Colombia
    • Clínica Medellín S.A.S
  • Barranquilla
    • Atlántico, Barranquilla, Colombia
      • Clínica de la Costa Ltda.
• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Hospital General Regional Marcelino Velez Santana
• Peru
  • San Martín De Porres, Peru
    • Instituto de Medicina Tropical Alexander von Humboldt at Universidad Peruana Cayetano Heredia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients 18 years old and older that present to the emergency room ("emergency room visit") or are hospitalized with Severe Acute Respiratory Infection (SARI).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: P95
• Collaborators: Centers for Disease Control and Prevention, China
• Investigators: Principal Investigator: Thomas Verstraeten, P95

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Actual): July 11, 2023
• Study Completion (Actual): July 11, 2023

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PRJ000284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No