COVID-19, SARS-CoV-2LIVENCT05282017
LatInamerican Vaccine Effectiveness Against Hospitalizations Due to Circulating COVID-19 VoC RWE Study
An observational study of COVID-19, SARS-CoV-2, run by AstraZeneca at 9 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COVID-19, SARS-CoV-2
- How many people
- 792 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 1 Feb 2022to 19 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects older than 18y that are hospitalized due COVID-19 like symptoms
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Brazil3 sites
Research Site
Brazil, Rio de Janeiro, 22211-230
Research Site
Brazil, Salvador, 41253-190
Research Site
Brazil, São Paulo, 04501-000
Mexico2 sites
Research Site
Guadalajara, Jalisco, 44280
Research Site
Mérida, Yucatán, 97000
About this study
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
Read the 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
- Conditions
- COVID-19, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment date until study completion, an average 1 year
Secondary outcomes (1)
SARS-CoV-2 variants detection
Include detection of SARS-CoV-2 genetic variants in test-positive cases.
Measured: Through study completion and data analysis, an average of 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Feb 2022
- Primary completion19 Apr 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19, SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 792 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282017
- Sponsor's protocol ID
- D8111R00016
- Acronym
- LIVE
- Status last verified
- Mar 2024
- First submitted
- 18 Feb 2022
- Last updated
- 15 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Lopez-Macias C, Lopez-Medina E, Alves MB, Matos ADR, Hernandez-Villena JV, Aponte-Torres Z, Sarabia LE, Manrique-Ramirez P, Tejado-Gallegos LF, Gutierrez LR, Meeraus W, Furtado BE. Clinical characteristics, SARS-CoV-2 variants, and outcomes of adults hospitalized due to COVID-19 in Latin American countries. Clinics (Sao Paulo). 2025 Apr 23;80:100648. doi: 10.1016/j.clinsp.2025.100648. eCollection 2025.
PubMed 40273490
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LatInamerican Vaccine Effectiveness Against Hospitalizations Due to Circulating COVID-19 VoC RWE Study
- ClinicalTrials.gov ID
- NCT05282017
- Acronym / sponsor ID
- LIVE / D8111R00016
- Conditions
- COVID-19, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 792 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects older than 18y that are hospitalized due COVID-19 like symptoms
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of hospitalized patients due COVID-19 like symptoms
Time frame: 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
1 secondary outcome
SARS-CoV-2 variants detection
Time frame: Through study completion and data analysis, an average of 1.5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Derived from this study: PubMed 40273490Lopez-Macias C, Lopez-Medina E, Alves MB, Matos ADR, Hernandez-Villena JV, Aponte-Torres Z, Sarabia LE, Manrique-Ramirez P, Tejado-Gallegos LF, Gutierrez LR, Meeraus W, Furtado BE. Clinical characteristics, SARS-CoV-2 variants, and outcomes of adults hospitalized due to COVID-19 in Latin American countries. Clinics (Sao Paulo). 2025 Apr 23;80:100648. doi: 10.1016/j.clinsp.2025.100648. eCollection 2025.
- Clinical Study Report (CSR) SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, SARS-CoV-2, run by AstraZeneca at 9 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Brazil, Colombia, Mexico, Costa Rica, Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hospitalized patients due COVID-19 like symptoms (time frame: From enrollment date until study completion, an average 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05282017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.