Since the beginning of the year the whole world has been battling with the Corona virus and scientists are testing different drugs to control the pandemic. In a much welcome development, dexamethasone an easily obtainable, low-cost, common prescription drug, has come to the rescue. Dexamethasone, a corticosteroid that has been used to treat autoimmune problems like rheumatoid arthritis and inflammatory conditions since the 1960s, was approved by the UK government as the world’s first coronavirus treatment proven to reduce mortality risk in severely ill patients.
This news comes after hope was lost in the highly endorsed drugs chloroquine phosphate (CQ) and hydroxychloroquine sulphate (HCQ), the clinical data leading them to being revoked from emergency authorization by the U.S. FDA. The action was taken on the basis of clinical trial data which failed to indicate replicable results, thus not being able to support the claims of it possessing antiviral effect against COVID-19. This also resulted in the termination of trial arm studying HCQ & CQ in SOLIDARITY, an international clinical trial aimed at finding effective treatment for COVID-19, launched by WHO and with more than 100 countries evaluating the potential candidates. While even Remdesivir by Gilead Sciences hasn’t yet proven that it can help patients survive the illness but merely demonstrated a shorter time for recovery, dexamethasone has proved to be effective in saving lives of severely ill COVID-19 patients in respiratory distress.
UK’s RECOVERY (Randomized Evaluation of COVid-19 thERapY) trail has emerged as a well-designed and rigorous data generation effort guiding clinical decisions worldwide. This is especially relevant at a time when clinical data that is reliable and is powered by much needed statistical rigor has been one of the scarcest resources during this pandemic. The RECOVERY trail was conducted by registered clinical trials unit of Nuffield Department of Population Health in partnership with the Nuffield Department of Medicine which is supported by a grant to University of Oxford from various organisations including UK research and innovation, Wellcome Trust, the Bill and Melinda Gates Foundation amongst others. The UK government funded £2.1 million for the trial.
The RECOVERY trial enrolled 11,500 patients across 175 NHS hospitals, of which 2,104 patients received orally or via injection 6 mg of dexamethasone for ten days. Results disclosed in the preprint stated a 35% reduced risk of mortality in patients requiring ventilator support and a 20% reduced risk of mortality in patients receiving oxygen, post administration of the drug. No benefit was found on those patients that did not require any form of respiratory support. Overall, the drug reduced the 28-day mortality by 17% when compared to usual care. Being an anti-inflammatory drug, it is effective in patients that require large amounts of oxygen indicating a high inflammatory response, decreasing the chances of death by reducing inflammation.
The results of the trial have widely been appreciated and welcomed by various stakeholders. The U.K. government had authorised the state-funded National Health Service(NHS) to use the corticosteroid to treat all UK hospitalized COVID-19 patients in need of respiratory support. The authorisation given by UK government made dexamethasone, the third therapeutic to have been approved for treatment of COVID-19, others being favipiravir and remdesivir in various countries individually. However, it is deservingly being hailed as the first treatment method which can reduce the risk of death amongst critical patients. The UK government has been stockpiling dexamethasone even before the results and hence will now be able quickly mobilise treatment for 200,000 patients. It was also added to the parallel export list by the government preventing companies from buying the drug meant for UK patients and selling it at a higher price in other countries.
The research environment to find a treatment method for COVID-19 has proven to be highly dynamic in the current circumstances. Dexamethasone has been chosen as a frontline candidate amongst the various other potential therapeutic candidates under investigation around the globe. Dexamethasone can potentially benefit developing countries who have harshly been affected by the pandemic socio-economically, reducing the economic burden caused by other expensive treatment options. As the UK approval provides hope to the world, we look forward to emergence of more therapeutic and prophylactic solutions that are backed by sound scientific data demonstrated with statistical rigor.