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LatInamerican Vaccine Effectiveness Against Hospitalizations Due to Circulating COVID-19 VoC RWE Study

NCT05282017

CompletedN/A

Sponsor: AstraZeneca

Conditions: COVID-19, SARS-CoV-2

Countries: Brazil, Colombia, Costa Rica, Mexico, Panama

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

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (9)

Brazil, Rio de Janeiro, Brazil
Brazil, Salvador, Brazil
Brazil, São Paulo, Brazil
Bogotá, Colombia
Cali, Colombia
San José, Costa Rica
Guadalajara, Jalisco, Mexico
Mérida, Yucatán, Mexico
Panama City, Panama