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| Name | Class |
|---|---|
| The Chancellor, Masters and Scholars of the University of Oxford | UNKNOWN |
This is a retrospective cohort study to assess the real world effectiveness of the Oxford/AstraZeneca COVID-19 vaccine in England. The study is using linkage of the English national databases on COVID-19 vaccination, testing, medical records, hospitalization, and death.
The United Kingdom (UK) is one of the first countries that introduced a mass vaccination campaign for COVID-19 and vaccination of the adult population first focused on the oldest age groups, their carers and health care workers (JCVI, 2020). Three COVID-19 vaccines were licensed and are being used including the Moderna, the BioNTech/Pfizer, and the Oxford/AstraZeneca vaccines. Vaccination with the BioNTech/Pfizer vaccine started in December 2020 and the Oxford/AstraZeneca vaccine started in early January 2021. This study is to primarily assess the effectiveness of the Oxford/AstraZeneca COVID-19 vaccine. Given the known high efficacy of the mRNA vaccines in randomized controlled trials (RCTs) and real-world evidence studies, the study aims also to evaluate the vaccine effectiveness (VE) of other COVID-19 vaccines as a validation of the study's methods. On 16 September 2021 it was announced that Booster doses would be introduced in the UK to address vaccine waning and for groups with a suboptimal response. Little is known about health care resource utilisation (HCRU) and health care costs for those who have had COVID-19 or by individual clinical risk group. The RAVEN study is a retrospective cohort study to assess the real-world effectiveness of the Oxford/AstraZeneca COVID-19 vaccine in England. The study is using linkage of the English national databases on COVID-19 vaccination, testing, medical records, hospitalization, and death. Analyses will examine the effectiveness of one and two doses, and booster or other additional doses if applicable. This study's extension (October 2021) adds a more detailed exploration of VE in risk groups and an evaluation of the HCRU by people with COVID-19 compared with those who are vaccinated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concurrent Controls | |||
| Vaccinated Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of COVID-19 related hospitalizations, COVID-19 related ICU admissions and COVID-19 related deaths | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of all-cause hospitalisations, all-cause ICU admissions and all-cause deaths | up to 12 months | |
| Incidence of positive SARS-CoV-2 test | up to 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
• People with a history of COVID-19 infection (confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) or not) prior index date
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12 years old or older population in England who met inclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Leeds | United Kingdom |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Incidence of medically attended COVID-19 |
| up to 12 months |
| Incidence of COVID-19 related emergency department visit | up to 12 months |
| COVID-19 related healthcare resource utilisation | Number of primary care consultations, prescriptions, medical tests and investigations, hospital outpatient attendances and procedures, hospital emergency department attendances without admission, hospital admissions | up to 12 months |
| Costs for COVID-19 related healthcare | Costs for primary care consultations, prescriptions, medical tests and investigations, hospital outpatient attendances and procedures, hospital emergency department attendances without admission, hospital admissions | up to 12 months |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |