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Completed

NCT Number: NCT06162533

Severe Acute Respiratory Syndrome Coronavirus 2 Re-Infection Risk and Vaccine Efficacy in Austria

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Residency in Austria.

Exclusion criteria

  • None.

Treatment and study plan

Vaccination against SARS-CoV-2

Biological

Interventions are either a vaccination against SARS-CoV-2 or an infection with SARS-CoV-2

Other names: Infection with SARS-CoV-2

Primary outcomes

  1. COVID-19 death

    Time frame: January 1, 2000 to June 30, 2023

    Death due to COVID-19

Secondary outcomes

  1. SARS-CoV-2 infection

    Time frame: January 1, 2000 to June 30, 2023

    Documented SARS-CoV-2 infection

  2. ICU stay

    Time frame: January 1, 2000 to June 30, 2023

    ICU stay of COVID-19 patients

  3. Hospitalization

    Time frame: January 1, 2000 to June 30, 2023

    Hospitalization of COVID-19 patients

  4. All-cause mortality

    Time frame: January 1, 2000 to June 30, 2023

    Death due to all-causes

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • AGES
  • Austrian Science Fund (FWF)
  • Medical University Innsbruck

Registry information

Official study title

SARS-CoV-2 Re-Infection Risk and Vaccine Efficacy in Austria: SARIVA Study

Acronym: SARIVA

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 8, 2023
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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