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

AstraZeneca

Status: Completed

Conditions: COVID-19, SARS-CoV-2

Study type: Observational

Funder types: Industry

Identifiers

NCT05282017

D8111R00016

Details and patient eligibility

About

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

Full 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

Enrollment: 792 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

792 participants in 2 patient groups

Case Group

Description:

Meets the COVID-19 like case definition AND Tests positive for at least one SARS-CoV-2 RT-PCR test or Quick-Test (Antigen) with specimens collected between 14 days prior to and including within 24 hours of the day of hospital admission (day 0).

Control Group

Description:

Meets the COVID-19 case definition AND Tests negative for all SARS-CoV-2 RT-PCR or Quick-Test (Antigen) tests with specimens collected between 14 days prior to and including a negative test the day at hospital admission (day 0).