LatInamerican Vaccine Effectiveness Against Hospitalizations Due to Circulating COVID-19 VoC RWE Study
LIVE
1 other identifier
observational
792
4 countries
7
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2022
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2022
CompletedFirst Submitted
Initial submission to the registry
February 18, 2022
CompletedFirst Posted
Study publicly available on registry
March 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2023
CompletedApril 15, 2024
March 1, 2024
1.2 years
February 18, 2022
April 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of hospitalized patients due COVID-19 like symptoms
The outcome of interest for the primary analysis will be SARS-CoV-2 in patients hospitalized with/because of COVID-19 like symptoms
From enrollment date until study completion, an average 1 year
Secondary Outcomes (1)
SARS-CoV-2 variants detection
Through study completion and data analysis, an average of 1.5 year
Other Outcomes (1)
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
Study Arms (2)
Case Group
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
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).
Eligibility Criteria
Subjects older than 18y that are hospitalized due COVID-19 like symptoms
You may qualify if:
- y 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (9)
Research Site
Brazil, Rio de Janeiro, 22211-230, Brazil
Research Site
Brazil, Salvador, 41253-190, Brazil
Research Site
Brazil, São Paulo, 04501-000, Brazil
Research Site
Bogotá, 1102, Colombia
Research Site
Cali, 760004, Colombia
Research Site
San José, 10108, Costa Rica
Research Site
Guadalajara, Jalisco, 44280, Mexico
Research Site
Mérida, Yucatán, 97000, Mexico
Research Site
Panama City, 0843-01103, Panama
Related Links
Biospecimen
For those participating on the control group (previous positive PCR/antigen test) a new COVID-19 PCR test will be performed to evaluate the type of variant
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2022
First Posted
March 16, 2022
Study Start
February 1, 2022
Primary Completion
April 19, 2023
Study Completion
April 19, 2023
Last Updated
April 15, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.