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

Completed

• Conditions: COVID-19, SARS-CoV-2

• Registration Number: NCT05282017
• Lead Sponsor: AstraZeneca

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

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-02-18
• Study First Submitted QC: 2022-03-14
• Study First Posted: 2022-03-16
• Primary Completion: 2023-04-19
• Study Completion: 2023-04-19
• Status Verified: 2024-03
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 792

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇵🇦 Panama, Panama