In the mad scramble to find safe and effective drugs to treat patients suffering from COVID-19, the winners and losers amongst the litany of candidates are starting to emerge, with a previously-strong contender—hydroxychloroquine—
The U.S. Food and Drug Administration has revoked the emergency use authorization (EUA) for the otherwise well-established malaria drugs chloroquine and hydroxychloroquine, due to the conclusion made by the Biomedical Advanced Research and Development Authority (BARDA) that the drug “may not be effective to treat COVID-19 [Coronavirus Disease 2019] and that the drug’s potential benefits for such use do not outweigh its known and potential risks,” according to the FDA’s chief scientist, RADM Denise M. Hinton.
Heavily politicized due to its endorsement by President Donald Trump, hydroxychloroquine has seen mixed results from its use as a treatment for COVID-19 patients following the drug’s emergency use authorization status granted by the FDA, allowing health-care workers to administer it as a treatment for those with severe symptoms caused by the coronavirus. But with no appreciable benefit available for COVID-19 patients from the drugs, their use could prove to be dangerous for those suffering from the disease, as chloroquine and hydroxychloroquine are known to cause abnormal heart rhythms, such as a prolonged QT interval, a side effect that could exacerbate the cardiac damage that the SARS-CoV-2 virus is known to cause.
To date, COVID-19 has infected more than 8.1 million people and killed at least 440,000 worldwide. In the U.S. alone, over 2.1 million have tested positive for the virus, with over 116,800—more than the total number of American casualties in World War I—dying from the illness.
“We will continue to examine all of the emergency use authorizations the FDA has issued and make changes, as appropriate, based on emerging evidence,” the FDA’s Anand Shah said in a statement.
But despite this setback, a commonly-used corticosteroid called dexamethasone has been shown to dramatically reduce the chances of death for COVID-19 patients. The subject of an Oxford University-led randomized trial called RECOVERY, dexamethasone has been shown to reduce the chances for critically ill patients on ventilators from dying by roughly one-third. Cases that were less severe but still required oxygen masks saw a 20 percent better chance of recovery, although there was no effect for those with only mild symptoms. First approved for use in 1961, dexamethasone is an inexpensive drug used to treat a wide variety of conditions.
“Finding effective treatments like this will transform the impact of the COVID-19 pandemic on lives and economies across the world,” according to Nick Cammack, head of the COVID-19 Therapeutics Accelerator at Wellcome, a UK biomedical research charity in London. “While this study suggests dexamethasone only benefits severe cases, countless lives will be saved globally.”