Dexamethasone can be used for the treatment of certain COVID-19 patients
Dexamethasone can be used for the treatment of hospitalised COVID-19 patients requiring supplemental oxygen. This has been confirmed by the European Medicines Agency (EMA) after a review of the results from the so-called RECOVERY study on the use of dexamethasone in the treatment of COVID-19.
The anti-inflammatory medicine dexamethasone has for quite some time been used by hospitals around the world, including in Denmark, to treat COVID-19 patients receiving supplemental oxygen. And now the European Medicines Agency (EMA) has concluded, following a review of the results of a major British study called RECOVERY investigating the product’s efficacy and adverse reactions in COVID-19 patients, that there is documentation to suggest that the product can be used as a treatment option in certain COVID-19 patients.
Based on a review of the available data, the EMA concluded that dexamethasone can be used in adults and adolescents from 12 years of age and weighing at least 40 kg who require supplemental oxygen therapy.
Reduced mortality in COVID-19 patients receiving oxygen
The RECOVERY study is based on a major randomized controlled trial in which hospitalised COVID-19 patients received different treatments. The results were published this summer and showed that 29% of patients on a ventilator who received treatment with dexamethasone died within 28 days compared with 41% of patients on a ventilator who did not receive dexamethasone – a relative reduction in mortality in this patient group of 35%.
The studies also showed that 23% of COVID-19 patients on dexamethasone who received oxygen without mechanical ventilation had died within 28 days compared to 26% of patients in the same patient group who did not receive dexamethasone – a relative reduction in mortality of 20%.
The studies showed no effect of dexamethasone in patients who did not receive oxygen therapy.
These results were supported by additional data, including data from a study conducted by the WHO covering data from seven clinical studies on the treatment of patients with COVID-19.
Not yet formally authorised for treatment of COVID-19
Although the EMA has announced that there is documentation supporting the use of dexamethasone in the treatment of certain patients with COVID-19, the product is not yet formally authorised. For this to happen, a company marketing the product must apply to the Danish Medicines Agency or the EMA.
Press release from the EMA: EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation