COVID-19SARIVANCT06162533
Severe Acute Respiratory Syndrome Coronavirus 2 Re-Infection Risk and Vaccine Efficacy in Austria
An observational study of COVID-19, run by Medical University of Graz at 3 sites in Austria.
Trial summary
The coronavirus disease 2019 (COVID-19) pandemic was caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. In this study, we aim to evaluate how strong and how long are individuals in Austria after vaccination and/or infection with SARS-CoV-2 protected against COVID-19 disease. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Vaccination against SARS-CoV-2
- Type of treatment
- Vaccines
- How many people
- 9,090,868 participants
- Where
- 3 sitesAustria
- Study dates
- 1 Jul 2023to 1 Jul 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The national population of Austria
Who may be able to join
- Residency in Austria.
Who cannot join
- None.
Trial locations and contacts
3 sites in 1 country.
Austria3 sites
Medical University of Graz
Graz, 8036
Medical University of Innsbruck
Innsbruck
Austrian Agency for Health and Food Safety
Vienna
About this study
Official title: SARS-CoV-2 Re-Infection Risk and Vaccine Efficacy in Austria: SARIVA Study
The coronavirus disease 2019 (COVID-19) pandemic was caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. In this study, we aim to evaluate how strong and how long are individuals in Austria after vaccination and/or infection with SARS-CoV-2 protected against COVID-19 disease.
In this project, we will analyze national health data from all inhabitants of Austria (about 9 million persons) during the COVID-19 pandemic. The population of Austria will be stratified into different groups according to previous vaccinations against SARS-CoV-2 and previous SARS-CoV-2 infections.
Read more
We primarily evaluate how strong and how long after vaccination against SARS-CoV-2 and/or infection with SARS-CoV-2, the risk for COVID-19 deaths is reduced or altered as compared to less vaccinated and/or infected persons. As secondary study aims, we perform such analyses also for SARS-CoV-2 infections, hospitalizations and intensive care unit (ICU) stays, with or due to SARS-CoV-2. These analyses will be performed during different time periods of the COVID-19 pandemic, and we will also perform various subgroup analyses as for example according to age and gender. Given that antibodies against SARS-CoV-2 are usually detected after vaccination and/or infection, we will use such antibody data from blood donors in Tyrol, to elucidate how well the national health data on SARS-CoV-2 infections and vaccinations match with the respective antibody data, and how well these antibody data indicate risk of COVID-19 deaths and infections.
We will calculate the probability of dying due to a SARS-CoV-2 infection (case/infection fatality rate) for different times of the COVID-19 pandemic, in order to document the health threat due to SARS-CoV-2. Based on all these data, we will calculate how many persons have to be vaccinated against SARS-CoV-2 to prevent one COVID-19 death at different times during this COVID-19 pandemic. We will consider the respective COVID-19 policies such as mask mandates, lock-downs, SARS-CoV-2 test mandates in our analyses and will evaluate the impact of these policies on COVID-19 deaths and diseases. In addition, we will evaluate data on total mortality according to the number of SARS-CoV-2 vaccinations and/or infections, and we will aim to collaborate with other research groups in order to extend our analyses.
In conclusion, the results of this study should provide an overview on the COVID-19 pandemic with respect to protection conferred by vaccinations and previous SARS-CoV-2 infections, as well as the health threat of SARS-CoV-2, in order to provide knowledge for future COVID-19 policy and future pandemics.
- Conditions
- COVID-19
- Being tested
- Vaccination against 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.
Vaccination against SARS-CoV-2Biological
Also called Infection with SARS-CoV-2
Interventions are either a vaccination against SARS-CoV-2 or an infection with SARS-CoV-2
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated against SARS-CoV-2 | Individuals who received a SARS-CoV-2 vaccine but have no record of a previous SARS-CoV-2 infection.
Subgroups will be formed according to the number and type of vaccines against SARS-CoV-2. Receives: Biological: Vaccination against SARS-CoV-2 | |
| Previously SARS-CoV-2 infected | Individuals who were previously infected with SARS-CoV-2 but have not received a SARS-CoV-2 vaccine. Subgroups will be formed according to the number and time period of previous SARS-CoV-2 infections. | |
| Hybrid Immunity against SARS-CoV-2 | Individuals who received a SARS-CoV-2 vaccine and who were previously infected with SARS-CoV-2.
Subgroups will be formed according to the number and time period of previous SARS-CoV-2 infections, the number and type of vaccines against SARS-CoV-2, and according to whether the vaccination or the infection was the first immune conferring event. Receives: Biological: Vaccination against SARS-CoV-2 | |
| No immunity against SARS-CoV-2 | Individuals who have not received a SARS-CoV-2 vaccine and were not previously infected with SARS-CoV-2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 death
Death due to COVID-19
Measured: January 1, 2000 to June 30, 2023
Secondary outcomes (4)
SARS-CoV-2 infection
Documented SARS-CoV-2 infection
Measured: January 1, 2000 to June 30, 2023
ICU stay
ICU stay of COVID-19 patients
Measured: January 1, 2000 to June 30, 2023
Hospitalization
Hospitalization of COVID-19 patients
Measured: January 1, 2000 to June 30, 2023
All-cause mortality
Death due to all-causes
Measured: January 1, 2000 to June 30, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Jul 2023
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9,090,868 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- AGES, Medical University Innsbruck, Austrian Science Fund (FWF)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162533
- Sponsor's protocol ID
- SARIVA 1.0.
- Acronym
- SARIVA
- Status last verified
- Nov 2023
- First submitted
- 30 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participant data of this study are available upon request with approval needed from the Austrian Agency for Health and Food Safety (AGES), Vienna, Austria, and an ethical approval or waiver by the local ethic committee for use of these data. The individual participant data are not publicly available due to restrictions pertaining to contained information that could compromise the privacy of individuals (i.e. potentially allow the identification of certain individuals based on e.g. birthdate, gender and infection or death date). Data are stored at the AGES. The same data availability rules apply to the antibody data (i.e. Anti-SARS-CoV-2 antibodies) from the Medical University of Innsbruck.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 Re-Infection Risk and Vaccine Efficacy in Austria: SARIVA Study
- ClinicalTrials.gov ID
- NCT06162533
- Acronym / sponsor ID
- SARIVA / SARIVA 1.0.
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,090,868 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- AGES, Medical University Innsbruck, Austrian Science Fund (FWF)
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 8 Dec 2023 (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.
The coronavirus disease 2019 (COVID-19) pandemic was caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. In this study, we aim to evaluate how strong and how long are individuals in Austria after vaccination and/or infection with SARS-CoV-2 protected against COVID-19 disease.
In this project, we will analyze national health data from all inhabitants of Austria (about 9 million persons) during the COVID-19 pandemic. The population of Austria will be stratified into different groups according to previous vaccinations against SARS-CoV-2 and previous SARS-CoV-2 infections.
We primarily evaluate how strong and how long after vaccination against SARS-CoV-2 and/or infection with SARS-CoV-2, the risk for COVID-19 deaths is reduced or altered as compared to less vaccinated and/or infected persons. As secondary study aims, we perform such analyses also for SARS-CoV-2 infections, hospitalizations and intensive care unit (ICU) stays, with or due to SARS-CoV-2. These analyses will be performed during different time periods of the COVID-19 pandemic, and we will also perform various subgroup analyses as for example according to age and gender. Given that antibodies against SARS-CoV-2 are usually detected after vaccination and/or infection, we will use such antibody data from blood donors in Tyrol, to elucidate how well the national health data on SARS-CoV-2 infections and vaccinations match with the respective antibody data, and how well these antibody data indicate risk of COVID-19 deaths and infections.
We will calculate the probability of dying due to a SARS-CoV-2 infection (case/infection fatality rate) for different times of the COVID-19 pandemic, in order to document the health threat due to SARS-CoV-2. Based on all these data, we will calculate how many persons have to be vaccinated against SARS-CoV-2 to prevent one COVID-19 death at different times during this COVID-19 pandemic. We will consider the respective COVID-19 policies such as mask mandates, lock-downs, SARS-CoV-2 test mandates in our analyses and will evaluate the impact of these policies on COVID-19 deaths and diseases. In addition, we will evaluate data on total mortality according to the number of SARS-CoV-2 vaccinations and/or infections, and we will aim to collaborate with other research groups in order to extend our analyses.
In conclusion, the results of this study should provide an overview on the COVID-19 pandemic with respect to protection conferred by vaccinations and previous SARS-CoV-2 infections, as well as the health threat of SARS-CoV-2, in order to provide knowledge for future COVID-19 policy and future pandemics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vaccinated against SARS-CoV-2 | – | Biological: Vaccination against SARS-CoV-2Individuals who received a SARS-CoV-2 vaccine but have no record of a previous SARS-CoV-2 infection. Subgroups will be formed according to the number and type of vaccines against SARS-CoV-2. |
| Previously SARS-CoV-2 infected | – | –Individuals who were previously infected with SARS-CoV-2 but have not received a SARS-CoV-2 vaccine. Subgroups will be formed according to the number and time period of previous SARS-CoV-2 infections. |
| Hybrid Immunity against SARS-CoV-2 | – | Biological: Vaccination against SARS-CoV-2Individuals who received a SARS-CoV-2 vaccine and who were previously infected with SARS-CoV-2. Subgroups will be formed according to the number and time period of previous SARS-CoV-2 infections, the number and type of vaccines against SARS-CoV-2, and according to whether the vaccination or the infection was the first immune conferring event. |
| No immunity against SARS-CoV-2 | – | –Individuals who have not received a SARS-CoV-2 vaccine and were not previously infected with SARS-CoV-2. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The national population of Austria
Key inclusion criteria (1 listed)
- Residency in Austria.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccination against SARS-CoV-2Also: Infection with SARS-CoV-2Interventions are either a vaccination against SARS-CoV-2 or an infection with SARS-CoV-2 | Biological | Hybrid Immunity against SARS-CoV-2, Vaccinated against SARS-CoV-2 |
Primary outcome
COVID-19 death
Time frame: January 1, 2000 to June 30, 2023
Death due to COVID-19
4 secondary outcomes
SARS-CoV-2 infection
Time frame: January 1, 2000 to June 30, 2023
ICU stay
Time frame: January 1, 2000 to June 30, 2023
Hospitalization
Time frame: January 1, 2000 to June 30, 2023
All-cause mortality
Time frame: January 1, 2000 to June 30, 2023
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 8 Dec 2023.
- Individual participant dataSharing planned: Undecided. The individual participant data of this study are available upon request with approval needed from the Austrian Agency for Health and Food Safety (AGES), Vienna, Austria, and an ethical approval or waiver by the local ethic committee for use of these data. The individual participant data are not publicly available due to restrictions pertaining to contained information that could compromise the privacy of individuals (i.e. potentially allow the identification of certain individuals based on e.g. birthdate, gender and infection or death date). Data are stored at the AGES. The same data availability rules apply to the antibody data (i.e. Anti-SARS-CoV-2 antibodies) from the Medical University of Innsbruck.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Medical University of Graz at 3 sites in Austria.
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 1 inclusion and 1 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 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria. 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?
COVID-19 death (time frame: January 1, 2000 to June 30, 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2023.