On the morning of October 2, Donald Trump and his wife, Melania Trump, announced that they both had tested positive for COVID-19. That same day, the president made his way to the Walter Reed National Military Medical Center out of an “abundance of caution.” Over the course of his hospital stay, Trump was said to have “mild” COVID symptoms, including coughing and a fever, which led to him being treated by supplemental oxygen, vitamin D, zinc, melatonin, a daily aspirin, and famotidine, and biotechnology company Regeneron’s “polyclonal antibody cocktail.”
The cocktail, also known as REGN-COV2, is still in the experimental stage and has not been approved by the U.S. Food and Drug Administration. It has allegedly “rapidly reduced viral load and associated symptoms in infected COVID-19 patients,” George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, said in a press release. They base this statement on an analysis of 275 COVID-19 patients which, according to Regeneron’s website, were randomized to receive a one-time infusion of 8 grams of REGN-COV2 (high dose), 2.4 grams of REGN-COV2 (low dose) or a placebo. The trial found that the use of the antibody cocktail reduced viral levels and improved symptoms in non-hospitalized COVID-19 patients.
REGN-COV2 is made up of two monoclonal antibodies that are designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19, Regeneron says — but it’s important to note that there are currently no approved treatments for COVID-19. Meaning that what Trump was given is not widely available, although it does show promise.
Leonard S. Schleifer, MD, PhD, Regeneron’s chief executive, told The New York Times that Trump’s team reached out to the company asking for use of the drug on the president. “All we can say is that they asked to be able to use it, and we were happy to oblige,” he said. He also pointed out that Trump was not the first patient to use the treatment in a “compassionate case use”, something that the U.S. Food and Drug Administration (FDA) regulation also calls “expanded access,” when patients are allowed to use an experimental treatment outside of a clinical trial.
Trump has described this treatment as a “cure,” although there’s currently no scientific evidence that Regeneron’s cocktail is what made Trump allegedly feel better or that it’s a cure at all. The company has requested that the FDA grant them emergency use approval on Wednesday, just a few days after Trump was administered the drug. Peter Chin-Hong, MD, an infectious disease specialist at UCSF Health in San Francisco, told The New York Times that in his opinion, there was “one million percent no” chance that the Regeneron treatment could have cured Trump in 24 hours, as the he had claimed.
The drug is currently being studied in late-phase trials, according to Regeneron, but no word yet from the FDA regarding their emergency use application.
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