2020-06-20| COVID-19

Dexamethasone Renews Hopes for a Life Saving COVID-19 Treatment

by Pavel Ryzhov
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By Pavel Ryzhov, Ph.D.

The investigators of the RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial which is supported by a grant to the University of Oxford, announced that the steroid drug reduces deaths by one-third in ventilated patients.

Since the beginning of 2020, COVID-19 has caused a huge global burden taking innumerable lives. With no vaccines ready yet, the world continues to feel its wrath. Although the pandemic has severely tested healthcare systems, it has also fuelled the resilience and fight of scientists and healthcare providers. Multiple clinical trials have been initiated to repurpose various drugs and test their efficacy in helping patients to recover as well as to decrease the death rate. It has been determined that the underlying inflammatory response of the human body is one of the contributing factors to increased incidences of mortality, and several drugs that are known to decrease the cytokine storm in other disease indications are being tested.

Gilead announced the results of several clinical trials where antiviral drug Remdesivir, which was previously developed to combat the Ebola outbreak in 2014, was tested against the novel coronavirus. In 3 separate clinical trials, it was demonstrated that the recovery of moderate and severely ill COVID-19 patients had been shortened when the drug has been administered. This was considered a significant breakthrough, and Remdesivir, which can block the replication of the virus by acting on the RNA-dependent RNA polymerase (an enzyme exclusive to the virus), has been given an Emergency Use Authorization by FDA. However, one of the principal outcomes that the researchers, physicians, and most of all, patients were hoping for, the reduced mortality, was not among clinically validated outcomes at the time of the disclosure of the results. The critically ill patients often require mechanical ventilation and oxygen support and are considered among the highest risk groups for the lethal outcome.

This is about to change based on the results of the randomized controlled clinical trial RECOVERY, conducted in the UK since the beginning of March. According to the press release, the administration of the inexpensive and common corticosteroid hormone drug, dexamethasone, showed a 30% reduction in deaths of people who were on ventilators, i.e., the patients that are most likely to die. The drug is commonly used to treat arthritis, allergic reactions, and other adverse immune responses. The authors also disclosed that the patients receiving oxygen therapy saw improvement, whose risk of dying reduced by 20%. Dexamethasone showed no effect on people with mild COVID-19 cases. Among the initial concerns that were expressed by the scientific community in regards to the use of steroids was the suppression of the immune system by the drug and allowing the viral infection to continue unchecked. However, the dosing of dexamethasone (6 milligrams per day for 10 days) was considered low-to-moderate and showed the most benefit to patients who experienced an acute inflammatory response to the virus.

Another positive outcome of the clinical trial is the implications for the availability of the treatment options. Remdesivir’s supplier, Gilead, has faced supply shortages and needs to be administered as an intravenous injection, while dexamethasone is much more common and formulated as a pill. While the results of the clinical trial have been announced, it remains to be seen how soon dexamethasone will be approved for treatment, either as an emergency use or as a new standard of care, either as a standalone drug or in combination with Remdesivir going forward.

Editor: Rajaneesh K. Gopinath, Ph.D.

Related Article: FDA Revokes Emergency Authorization of Malarial Drugs for Treating COVID-19



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