EMA is reviewing results from the RECOVERY study arm that involved the use of dexamethasone in the treatment of patients with COVID-19 admitted to hospital. This part of the study looked into the effects of adding dexamethasone to usual care in adults receiving invasive ventilation, those given oxygen (e.g. through a mask) or those receiving no oxygen. Invasive ventilation involves use of a machine to push air through a tube inserted into the patient’s airway.
The RECOVERY study recorded deaths during 28 days after starting dexamethasone treatment. Preliminary results indicate that, compared with usual care, dexamethasone:
- reduced mortality by about 35% in patients on invasive mechanical ventilation;
- reduced mortality by about 20% in patients receiving oxygen without invasive ventilation;
- did not reduce death in patients who were not receiving oxygen therapy.
The review aims to provide an opinion on the results of the RECOVERY study and in particular the potential use of dexamethasone for the treatment of adults with COVID-19.
EMA will communicate further when the review is complete.