Remdesivir for COVID-19 approved but still unproven, experts say

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In light of the novel coronavirus (COVID-19) a new commentary published in the journal Contemporary Clinical Trials Communications, researchers from Florida Atlantic University's Schmidt College of Medicine reviewed available evidence from randomized trials to detect the plausible small-to-moderate effects of remdesivir. They concluded that the current totality of evidence justifies compassionate use of remdesivir for severely ill patients with COVID-19.

The United States has become the epicenter of the world in pandemic, the authors said. While public health prevention strategies of social distancing, crowd avoidance, masking, and frequent handwashing are of proven benefit, effective drug therapies for treatment are sparse.

Remdesivir has attracted worldwide attention, the authors said, first receiving an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and especially with President Donald Trump taking the drug for COVID-19 last month. The World Health Organization (WHO) also recently published the largest randomized trial showing no benefit on reducing hospital stays or mortality. Nonetheless, remdesivir has received approval from the FDA for standard of care use for patients who are hospitalized.

According to the researchers, Dexamethasone is the only other drug having received FDA approval based on a large randomized trial showing a mortality benefit among those who were receiving either invasive mechanical ventilation or oxygen alone at randomization but not among those receiving no respiratory support. This drug also was used by President Trump.

"The U.S. accounts for less than 5 percent of the world's population but more than 20 percent of the global cases and deaths,” said Charles Hennekens, MD, DrPH, senior author of the study from the Florida Atlantic University's Schmidt College of Medicine, in a statement. “We need far wider utilization of the preventive strategies of proven benefit of social distancing, crowd avoidance, masking, and frequent hand washing. While vaccine development and further research on other drug therapies to treat and prevent COVID 19 are a necessity, don't let the 'perfect be the enemy of the possible.'"

The authors said they also believe that in the U.S., cases and deaths in the fall and winter will far exceed those of last spring without effective implementation of nationally coordinated efforts at preventive strategies to mitigate and contain COVID-19 and which are well known to public health professionals.

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