COVID-19
Conditions
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).
Interventions
None listed
Sponsors
Centers for Disease Control and Prevention, China
P95
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SARS-CoV-2 detection | 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
| Measure | Time frame | Description |
|---|---|---|
| Level of disease severity | - 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: 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) |
Countries
Argentina, Colombia, Dominican Republic, Peru
Outcome results
None listed