COVID-19, SARS-CoV-2
Conditions
Brief summary
COVID-19 is the infectious disease caused by the novel coronavirus known as SARS-CoV-2, that appeared in 2019. The World Health Organisation (WHO) declared the novel coronavirus a pandemic on 11 March 2020. The evolution of the pandemic is varying across countries, affected in part by different containment strategies ranging from extreme lockdown to relative inaction. As a result, there are regional waves of the disease and pockets of vulnerable populations. Globally, governments have acknowledged that effective vaccines against COVID-19 are the only way to guarantee a safe and sustained exit strategy from repeated lockdowns. The objective of this study is to estimate the vaccine effectiveness against hospitalizations due to circulating COVID-19 VoC among subjects eligible for vaccination with the AstraZeneca or any other COVID-19 vaccine provided in their country as per national/regional immunization recommendations prior to hospital admission. The study design is an observational prospective active-surveillance hospital-based study, with a test-negative case-control design (TNCC) of hospitalized COVID-19 like cases undergoing testing for SARS-CoV-2
Detailed description
LatInamerican Vaccine Effectiveness against hospitalizations due to circulating COVID-19 VoC RWE study is an observational prospective active-surveillance hospital-based study, with a test-negative case-control design (TNCC) of hospitalized COVID-19 like cases undergoing testing for SARS-CoV-2 by RT-PCR or rapid antigen test with the participation of countries from six LatAm Marketing Companies (Argentina, Brazil, Colombia, Costa Rica, Mexico and Panama). This study will generate new information regarding vaccine effectiveness (VE) in the RW setting for populations where evidence is still unavailable
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 18y and older * Ever eligible for vaccination with the AstraZeneca or any other COVID-19 vaccine provided in their country as per national/regional immunization recommendations prior to hospital admission. * Hospitalization due to COVID-19 like case * Willing and able to provide informed consent (or by legal accepted representative if patient are not able to provide their signature by themselves)
Exclusion criteria
* Cannot be swabbed or other conditions that contra-indicate swabbing * COVID-19 hospitalization within 3 months prior to the current admission. Hospital transfers are not considered as a prior hospitalization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of hospitalized patients due COVID-19 like symptoms | From enrollment date until study completion, an average 1 year | The outcome of interest for the primary analysis will be SARS-CoV-2 in patients hospitalized with/because of COVID-19 like symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SARS-CoV-2 variants detection | Through study completion and data analysis, an average of 1.5 year | Include detection of SARS-CoV-2 genetic variants in test-positive cases. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Disease severity (based on WHO severity scale, ICU admission, need of hemodialysis, mechanical ventilation) (Exploratory outcome) | From date of randomization until hospital discharge or date of death from any cause, whichever came first assessed up to 6 months | Severity of hospitalization disease due to laboratory confirmed SARS-CoV-2 disease |
Countries
Brazil, Colombia, Costa Rica, Mexico, Panama
Outcome results
None listed