Oxford patients among first enrolled in COVID-19 treatment trial

Patients with COVID-19 at the John Radcliffe Hospital are among the first to be recruited to a new clinical trial to test the effects of potential drug treatments for those with the virus.

There are currently no specific treatments for COVID-19. It is possible that some existing drugs usually used for other conditions may have some benefits – but they may not. 

The Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial, which is being led by researchers from the University of Oxford, will provide doctors and the health service with information they need to determine which treatments should be used.

The treatments initially included in the study have been recommended by an expert panel that advises the Chief Medical Officer in England. These are Lopinavir-Ritonavir, normally used to treat HIV, and the steroid dexamethasone, which is used in a wide range of conditions to reduce inflammation. The safety and side effects of both drugs are well known. In the future, the RECOVERY trial will be expanded to assess the impact of other potential treatments as they become available.

The chance to join the trial will be offered to adult inpatients who have tested positive for COVID-19 in NHS hospitals, and who have not been excluded for medical reasons. All patients will receive the usual standard of care. 

Patients joining the trial will be allocated at random by computer to receive one of the two drugs being studied or no additional medication. This will enable researchers to see whether any of the possible new treatments are more or less effective than those currently used for patients with COVID-19. 

Peter Horby, Professor of Emerging Infectious Diseases and Global Health in the Nuffield Department of Medicine, University of Oxford, and Chief Investigator for the trial, said: “There is an urgent need for reliable evidence on the best care for patients with COVID-19. Providing possible new treatments through a well-designed clinical trial is the best way to get that evidence. 

“Adults admitted to hospital with COVID-19 should be offered the opportunity to participate in this trial and contribute to improving care for everyone. All patients will receive the standard full medical care, regardless of which treatment group they are placed in.”

Watch a video of Prof Horby explaining the new trial.

Martin Landray, Professor of Medicine and Epidemiology at the Nuffield Department of Population Health, University of Oxford, and Deputy Chief Investigator, added: “The streamlined design of this clinical trial allows consenting patients to be enrolled in large numbers easily and without compromising patient safety or adding significantly to the workload of busy hospitals and their staff. In this way we can rapidly assess the value of potential treatments for COVID-19 and provide reliable information on the best ways to treat patients with this disease.”

The new trial has been classed as an Urgent Public Health Research Study. Chief Medical Officer Professor Chris Whitty and NHS England Medical Director Professor Stephen Powis have written to NHS trusts in England asking them to fully support the new trial. 

Vaccine

Oxford researchers are at the forefront of other efforts to tackle COVID-19. A team from the Oxford Vaccine Group and the University of Oxford's Jenner Institute have identified a vaccine candidate for the disease, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 

The Oxford team - led by Prof Sarah Gilbert, Prof Andrew Pollard, Prof Teresa Lambe, Dr Sandy Douglas and Prof Adrian Hill - started work designing a vaccine on 10 January, have identified a vaccine candidate and are working towards the first clinical testing phase.

The chosen vaccine is one that is regarded as being the most suitable for SARS-CoV-2 as it can generate a strong immune response from one dose and it is not a replicating virus, so cannot cause an ongoing infection in the vaccinated individual. 

This also makes it safer to give to children, the elderly and anyone with a pre-existing condition such as diabetes. 

Prof Gilbert and her team have previously developed a vaccine for another human coronavirus disease, Middle East Respiratory Syndrome (MERS), and this has shown promise in early clinical trials.

Recruitment for the COVID-19 vaccine clinical trial has not yet started. The team are very busy with vaccine development, so prospective participants should not contact the team at the moment. Please keep checking the Jenner Institute website for updates, including a link to sign up for the trial, once it is open.

At the same time as preparing for and conducting the first clinical trial, production of the vaccine is being scaled up ready for larger trials, and potentially, future deployment.

Immunity

Other researchers based at the John Radcliffe Hospital are involved in attempts to better understand the immunology of COVID-19. Prof Paul Klenerman, of the Nuffield Department of Medicine, is leading Oxford’s efforts to better understand the antibodies and other immune responses.

He said: “We are rapidly developing tests to better understand why some patients do well and others suffer severe infection and what type of immunity is protective in different age groups.” 

Others within the theme working on this include Prof Graham Ogg and the MRC Human Immunology Unit, Prof Philippa Matthews and Prof Ellie Barnes. They are all coordinating closely with experts at the university in vaccines, respiratory medicine and infection control.