President Donald Trump, who recently tested positive for the coronavirus, has been given a dose of Gilead Sciences Inc.’s remdesivir in addition to Regeneron Pharmaceuticals Inc.’s experimental neutralizing antibody cocktail.
Both treatments have received emergency use authorization from the Food and Drug Administration based on clinical data evaluating their effectiveness in hospitalized patients with more severe forms of the disease.
Trump’s diagnosis highlights one of the still challenging elements of the COVID-19 pandemic, that there are few treatment options available for patients with COVID-19.
For people with severe forms of the disease, treatment can include convalescent plasma, the steroid dexamethasone, and/or remdesivir. For people with mild to moderate forms of the disease, there are no authorized or approved drugs, though two drug makers recently shared promising results for a pair of still-investigational antibody-based treatments.
“There really aren’t a lot of very effective therapies we have at this stage of the disease,” said Dr. Steven Shapiro, chief medical and scientific officer at UPMC, a hospital system based in Pittsburgh. He is not treating the Trumps. “The thing that we know that is most effective right now are steroids. But that tends to work later in the disease when someone develops the pneumonia.”
Trump on Friday tweeted that he and First Lady Melania Trump had tested positive for the coronavirus. Both are experiencing mild symptoms. Dr. Sean Conley, Trump’s physician, wrote in a letter shared by White House officials that he expects the president to continue his duties “while recovering.” People familiar with the matter told The New York Times reported that he has a fever, congestion, and a cough, and is expected to be hospitalized for several days.
A letter shared Friday evening disclosed that Trump had received an infusion of Regeneron’s REGN, -0.58% REGN-COV2. Trump also is taking zinc, vitamin D, an acid reducer, melatonin and aspirin. Conley said Friday afternoon that the president is “fatigued” and that Melania is doing well, with symptoms including a mild cough and headache. Another letter, shared early Saturday morning, disclosed that Trump has been given Gilead’s GILD, -1.81% remdesivir and does not require supplemental oxygen.
The first drug, Regeneron’s REGN-COV2, that Trump received is being studied as a treatment for people with mild to moderate forms of the disease. A somewhat similar drug, Eli Lilly & Co.’s LLY, +0.63% LY-CoV555, is also being tested in clinical trials. Raymond James analysts predicted Friday morning that one of these investigational drugs would be most likely prescribed to Trump.
Like convalescent-plasma treatments, these drugs also use antibodies, and both have shown so far that they help reduce viral load, based on interim data shared in the past month.
Most of the available treatments for COVID-19 infections target severely ill patients who have been hospitalized. This includes Gilead’s remdesivir and convalescent plasma, which is gathered from people who have recovered from COVID-19 infections.
The steroid dexamethasone is another option for hospitalized patients who are in need of oxygen support. The steroid, which is approved by the FDA for other indications, demonstrated in clinical trials in the U.K. that it can reduce mortality in some severely ill COVID-19 patients.
That said, physicians have the discretion to prescribe medications that are not approved or authorized by the FDA for a specific use. This is called off-label prescribing, and it’s common in the U.S. health care system. (One 2006 study found that one-fifth of U.S. prescriptions are off-label.)
Trump in May disclosed that he was taking the antimalarial hydroxychloroquine that he spent months promoting as a potential COVID-19 treatment. At that time it was being tested in clinical trials as both a treatment and to see if it could prevent infections in people who had been exposed to the virus. The FDA had granted the drug an emergency-use authorization in March but revoked that authorization in June.
Health-care providers around the world have tested the efficacy of providing zinc, vitamin C, vitamin D and the antibiotic azithromycin to COVID-19 patients; however, none of those treatments has so far shown a clinical benefit, according to Shapiro.
“It’s watching, waiting … just supportive care, in general. Isolate,” he said. “Masks are really important. That is our vaccine right now. It’s really good at preventing the spread. And if not entirely, it certainly will lower the dosage and make the disease less severe. So that’s one lesson I think that everyone should learn from this.”
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