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Uptake and comparative safety of new COVID-19 therapeutics

Title

Uptake and comparative safety of new COVID-19 therapeutics by age, sex, region, ethnicity, comorbidities, medication, deprivation, risk level and evidence of prior COVID infection

What is the aim of the study and why is it important?

COVID-19 has affected millions of people around the world and has had major consequences for peoples’ health, work and lives. This made it important to quickly develop vaccines to help protect people against COVID-19.
Several vaccines and other medicines to help prevent or treat COVID-19 have been approved for use in the UK and are now being given in the general population. All these were shown to be safe in the trials that tested them before they were approved. It is also really important to see how these treatments work when they start being used in the real-world. This is because real-world populations can be different from the populations included in vaccine trials, for example, people in trials might be younger or have less health problems. Monitoring treatments in the real-world includes looking at how safe the vaccine is, and how well it works in the wider world, for example in older patients, people with various illnesses and those from different ethnic backgrounds.
As well as safety, another important thing to monitor is whether there are patterns that show differences in who is having each treatment (i.e. uptake). It is crucial to monitor uptake, because if there are population groups who are not having the treatments, then this could create or worsen inequalities in health. Knowing about these patterns means interventions can be designed that could help increase vaccine uptake to improve this.
One important way that the new treatments can be monitored is by using the information in healthcare records about what happens when the treatment is given. This includes looking at whether the treatment is working and whether there are symptoms recorded after that treatment has been given that might suggest unexpected side effects.
General practice (GP) patient records contain the information needed to answer these questions quickly and on very large numbers of people. The QResearch database contains millions of anonymised GP records which can be used by researchers to answer these questions.
This project will assess uptake of the COVID-19 vaccination programme and monitor the safety of the new COVID-19 treatments using the QResearch database.

Chief Investigator

Professor Julia Hippisley-Cox

Sponsor

Oxford

Location of research

University of Oxford

Date on which research approved

19-Jan-2021

Project reference ID

OX107

Generic ethics approval reference

18/EM/0400

Are all data accessed are in anonymised form?

Yes

Brief summary of the dataset to be released (including any sensitive data)

GP data on demographics, risk factors for COVID-19, co-morbidities,

Hospital data including clinical outcomes which might indicate serious adverse events

Mortality data including date of death, cause of death including where the cause of death indicates one of the clinical outcomes which might indicate serious adverse events (see indicator list in protocol)

Cancer registry dates and diagnoses of cancer, chemotherapy, radiotherapy

ICNARC data, transplant data and COVID-19 test results.

ONS occupation data

National Immunisation Database

Monoclonal antibody and antiviral datasets

Funding Source

Health Data Research UK (HDR-UK); Oxford NIR BRC; NIHR Health Technology Program

Research Team

The researchers are from the Universities of Oxford, Cambridge, Nottingham, Leicester, Guys and Thomas's, NHS Blood and Transplant Service, Kings College London, the Intensive Care National Audit and Research Centr (ICNARC).

Julia Hippisley-Cox, Carol Coupland, Peter Watkinson, Kathy Rowan, David Harrison, Fergus Gleeson, Manu Shankar-Hari, Anthony Harnden, Douglas Thornburn, Tom Ranger, Winnie Mei, Pui San Tan, Martina Patone, Rommel Ravanan, Kamlesh Khunti, Francesco Zaccardi, Simon Griffin, Chris Callaghan

Approval Letters

Download Approval Letter

Download Approval Letter amendment 1

Download Approval Letter amendment 2

Publications

Press Releases

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