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The benefit of baricitinib is 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 researchers 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,” said Sir Martin Landray, a professor at Oxford Population Health, and joint chief investigator for the trial.
”The 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,” Landray said.
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The Oxford-led Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial has been testing a range of potential treatments for patients admitted to hospital for COVID-19 since March 2020.
The researchers randomly allocated 4,008 patients to usual care alone compared with 4,148 patients who were randomly allocated to usual care plus baricitinib.
The dose of baricitinib tablets was 4 milligrammes (mg) once daily for 10 days.
At randomisation, 95 per cent of patients were receiving a corticosteroid such as dexamethasone, 23 per cent were receiving tocilizumab, and 20 per cent were receiving the anti-viral drug remdesivir.
Two-thirds of patients were receiving oxygen and one quarter were receiving additional respiratory support, the researchers said.
Treatment with baricitinib significantly reduced deaths: 513 of the patients in the baricitinib group died within 28 days compared with 546 patients in the usual care group, a reduction of 13 per cent, they said.
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, according to the researchers.
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 per cent to 16 per cent, they said.
There was no evidence that the short course of baricitinib used in the trial increased the risk of other infections or of blood clotting complications.
The study considerably strengthens the evidence from earlier trials that baricitinib is beneficial in severe COVID-19, and provides new evidence of the additional benefit of baricitinib on top of other immunomodulatory treatments.
The RECOVERY trial is twice as large as the eight previous trials of baricitinib and similar drugs for the treatment of COVID-19 combined, the researchers said.
Overall the nine trials, which involved about 12,000 patients, found that the use of baricitinib reduced deaths in patients hospitalised for COVID-19 by about one-fifth, they 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,” said Sir Peter Horby, a professor at the University of Oxford, and joint chief investigator for RECOVERY.
”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,” Horby said.