On Monday, the FDA pulled its emergency use authorization for hydroxychloroquine as a treatment for COVID-19. Despite Donald Trump claiming that he is taking the malaria medication to prevent coming down with COVID-19, there remains no evidence that the drug is effective for that purpose. In fact, the FDA concluded that the dangers of taking the drug outweigh any possible benefit. Later in the day, the FDA also put out a warning of a potential interaction between hydroxychloroquine and antiviral drug remdesivir, the only drug which had proven to provide positive benefits for some patients. Despite months of Trump bragging on the drug and calling it a “game changer,” hydroxychloroquine turns out to be a dangerous dud.
But on Tuesday, researchers in the UK announced the results of a new study that may indicate there’s a second drug in the arsenal for treating those with a serious case of COVID-19. Results from the massive, worldwide trial known as Recovery indicate that a widely available steroid used in treating inflammation could save thousands of lives.
Recovery (Randomised Evaluation of COVID-19 Therapy) is a series of connected clinical trials split across facilities around the world. The trials are testing antivirals, like the Lopinavir-Ritonavir pair used against HIV, antibiotics like azithromycin, and several anti-inflammatory agents. They were also testing hydroxychloroquin, but after finding no positive results, those tests are now closed to new patients and existing tests are winding down.
Among the test being conducted is low doses of corticosteroid dexamethasone. And that’s the first of the Recovery tests that seems to have turned up encouraging results.
Dexamethasone is a commonly used, widely available medication. It’s used for treating allergies, asthma, rheumatoid arthritis, and just about any situation when inflammation is an issue. It’s even used to treat brain swelling following a trauma. It’s often used along with chemotherapy.
The drug is not without side effects. It can cause bruising and muscle weakness and (somewhat perversely in a drug being considered as a disease treatment) can suppress the immune system leading to opportunistic infections. But it’s been around since the 1960s, is widely used, and its effects on the body are well-understood.
Which makes the results of a randomized trial of over 6,000 patients suffering from serious cases of COVID-19 rather exciting. As the BBC reports, around 2,000 of the patients were given dexamethasone. When their outcomes were compared with those who didn’t get the drug, the rate of death decreased by 20%. Among patients who were on ventilators, a dose of dexamethasone cut the chance of death by a third.
Dropping death rates by a third is a long way from “a cure” for COVID-19. But it does show that this is a simple, low-cost treatment which is already widely available and which could save thousands of lives. Which is definitely worth celebrating.
This outcome might also suggest further trials, using different dosages and periods of administration, other closely related corticosteroids, and other anti-inflammatory agents. Because dexamethasone is such a well-understood drug, these results may also be useful in understanding the mechanism by which COVID-19 causes serious illness, helping to lead to additional treatments.
Meanwhile, that FDA warning on hydroxychloroquine indicates that it is “not recommended as it may result in reduced antiviral activity of remdesivir.” Remdesivir is also being administered under an Emergency Use Authorization, but unlike hydroxychloroquine the antiviral has demonstrated positive—if limited—results.
As StatNews reports, remdesivir was most effective for those who were hospitalized but not on a ventilator, where it reduced the median length of hospital stays from 15 days to 11 days. There was also a small decrease in mortality, but considering the size of the study, it’s not clear if this was statistically significant. However, those on ventilators seemed to fair no better with the drug than without.
Considering that both drugs seemed to have a positive benefit for patients with serious, but not critical, illness, a combination of dexamethasone and remdesivir could become standard care (assuming there is no negative interaction). And for those in the worst condition, dexamethasone provides both a ray of hope for now and a signpost toward other possibilities.