Kent, Surrey and Sussex supported RECOVERY Trial shows baricitinib reduces deaths in COVID-19 hospitalised patients

The NIHR-supported RECOVERY trial, has found that baricitinib, an anti-inflammatory rheumatoid arthritis drug, reduces deaths in patients hospitalised for COVID-19 by around one-fifth. 440 participants were recruited to this arm from nine acute hospital sites across Kent, Surrey and Sussex.

The benefit was in addition to those of dexamethasone and tocilizumab, two other anti-inflammatory treatments which have previously been shown to reduce the risk of death in these patients.

The University of Oxford-led trial has been testing a range of potential treatments for patients admitted to hospital for COVID-19 since March 2020. Between February and December 2021, 4,008 patients randomly allocated to usual care alone were compared with 4,148 patients who were randomly allocated to usual care plus baricitinib.

The dose of baricitinib was a 4mg tablet once daily for 10 days (or until discharge from hospital if sooner). Treatment with baricitinib significantly reduced deaths, with a reduction of 33 deaths compared to patients within the usual care group - from 546 to 513.

The benefit of baricitinib was consistent regardless of which other COVID-19 treatments the patients were also receiving, including corticosteroids, tocilizumab, or remdesivir.

Patients receiving baricitinib were also more likely to be discharged alive within 28 days. Among patients not on invasive mechanical ventilation when entered into the trial, baricitinib reduced the chance of progressing to invasive mechanical ventilation or death from 17% to 16%.

Professor Nick Lemoine, Medical Director of the NIHR Clinical Research Network, said: "The incredible contribution of all those involved in the NIHR-supported RECOVERY trial has led to the discovery of a further life-saving treatment against COVID-19.

“We're particularly grateful to the 47,000 RECOVERY participants who have taken part in the study so far - without whom these game-changing discoveries would not be possible."

Sir Martin Landray, Professor of Medicine and Epidemiology at Oxford Population Health, University of Oxford, and Joint Chief Investigator for RECOVERY, said: “It is now well established that in people admitted to hospital because of severe COVID-19, an over-active immune response is a key driver of lung damage.

“Today’s results not only show that treatment with baricitinib improves the chances of survival for patients with severe COVID- 19, but that this benefit is additional to that from other treatments that dampen down the over-active immune response, such as dexamethasone and tocilizumab. This opens up the possibility of using combinations of anti-inflammatory drugs to further drive down the risk of death for some of the sickest patients.”

Sir Peter Horby, Professor of Emerging Infectious Diseases in the Nuffield Department of Medicine, University of Oxford, and Joint Chief Investigator for RECOVERY, said: “This result confirms and extends earlier findings, providing greater certainty that baricitinib is beneficial and new data to guide the treatment of COVID-19 patients with a combination of drugs to dampen the immune response.

“As always, the next challenge is ensuring this and other COVID-19 treatments are available and affordable for everyone who can benefit, regardless of where they live.”

Baricitnib is the fourth treatment the RECOVERY trial has shown to save lives, following the steroid dexamethasone, the arthritis treatment tocilizumab, and a combination of monoclonal antibodies targeting the viral spike protein, known as Ronapreve. These discoveries have changed clinical practice worldwide and been credited with saving hundreds of thousands, if not millions, of lives.

A manuscript providing further details on these results has been submitted to medRxiv.