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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention, China | OTHER_GOV |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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) |
| 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:
| - 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 |
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Inclusion Criteria
Patients need to fulfill all the following criteria to be eligible for the study:
Exclusion Criteria
Patients that fulfill one or more of the following criteria will not be eligible for the study:
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Patients 18 years old and older that present to the emergency room ("emergency room visit") or are hospitalized with Severe Acute Respiratory Infection (SARI).
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Verstraeten | P95 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| : Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC) | Buenos Aires | 1131 | Argentina | |||
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Clinica de la Costa Ltda. |
| Atlántico |
| Barranquilla |
| Colombia |
| Clínica Medellín S.A.S | Medellín | Colombia |
| Hospital General Regional Marcelino Velez Santana | Santo Domingo | Dominican Republic |
| Instituto de Medicina Tropical Alexander von Humboldt at Universidad Peruana Cayetano Heredia | San Martín de Porres | Peru |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |