RECOVERY trial investigates baricitinib as potential COVID-19 treatment
The NIHR-supported RECOVERY trial has begun investigating the anti-inflammatory arthritis drug, baricitinib, as a potential treatment for hospitalised COVID-19 patients.
As an anti-inflammatory, baricitinib may block the signalling activity of cytokine molecules which contribute to the hyper-inflammatory state caused by severe COVID-19.
The researchers will investigate whether the drug reduces the risk of death for patients with COVID-19, whether the treatment reduces the length of hospital stay, and whether it can reduce the risk of hospitalised patients requiring mechanical ventilation.
The trial will randomise 2,500 participants to receive baricitinib - with results compared against a further 2,500 participants receiving standard care alone. Participants randomised to receive this treatment will take a standard oral dose (4mg) of the drug, once a day.
Professor Martin Landray, co-Chief Investigator for the RECOVERY trial from the University of Oxford, said:
“Inflammation is a fundamental feature of COVID-19 and the RECOVERY trial has already found that one anti-inflammatory drug, dexamethasone, can reduce deaths in the most severely ill patients with COVID-19. Baricitinib is widely used to treat rheumatoid arthritis. By including baricitinib in the RECOVERY trial, we will be able to generate robust evidence on whether it helps tackle the worst consequences of COVID-19.”
Professor Peter Horby, co-Chief Investigator said:
“Baricitinib will be the tenth potential COVID-19 treatment to be tested through RECOVERY and we will continue testing new drugs as fast as we possibly can.”
Baricitinib has been included as a treatment arm as part of the RECOVERY trial following a decision by the University of Oxford researchers and trial steering committee in conjunction with the Chief Medical Officer. This follows a recommendation by the UK COVID-19 Therapeutics Advisory Panel.
There is already some clinical evidence to suggest baricitinib may be effective against COVID-19. The Adaptive Covid-19 Treatment Trial (ACTT-2) study investigated baricitinib with remdesivir, against remdesivir with a placebo. A paper published in the New England Journal of Medicine concluded that baricitinib with remdesivir was superior to remdesivir alone in reducing recovery time among COVID-19 patients, particularly amongst those receiving oxygen or non-invasive ventilation.
Urgent public health research
The RECOVERY trial is the world’s largest study into potential COVID-19 treatments amongst hospitalised patients.
The trial is jointly funded by UK Research and Innovation (UKRI) and the NIHR. While as urgent public health research, delivery of the study is supported by the NIHR Clinical Research Network alongside the devolved administrations. With NIHR support, over 33,000 participants have taken part in the study so far, recruited through 177 hospital sites across the country.