Clinical trial NCT05475704: Effectiveness of Chinese COVID-19 Vaccines in Latin America and the Caribbean
Official title: Effectiveness of Chinese COVID-19 Vaccines in Latin America and the Caribbean
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: P95
Sponsor class: INDUSTRY
Collaborators: name: Centers for Disease Control and Prevention, China
First posted: 2022-07-27
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: SARS-CoV-2 detection
timeFrame: 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:
measure: Level of disease severity
timeFrame: - 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
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: : Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC)
city: Atlántico
country: Colombia
facility: Clinica de la Costa Ltda.
state: Barranquilla
city: Medellín
country: Colombia
facility: Clínica Medellín S.A.S
city: Santo Domingo
country: Dominican Republic
facility: Hospital General Regional Marcelino Velez Santana
city: San Martín De Porres
country: Peru
facility: Instituto de Medicina Tropical Alexander von Humboldt at Universidad Peruana Cayetano Heredia
Study officials:
affiliation: P95
name: Thomas Verstraeten
role: PRINCIPAL_INVESTIGATOR
References: