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After testing positive for the coronavirus, President Donald Trump was given a dose of Regeneron Pharmaceuticals Inc.’s experimental neutralizing antibody cocktail, considered one of the most promising candidates to fill a major hole in COVID-19 treatment plans.
Trump’s diagnosis highlighted one of the still challenging elements of the COVID-19 pandemic — that there are a limited number of treatment options for people who test positive for COVID-19, and the only available therapies are proven to be effective in people with severe forms of the disease.
“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 his wife, Melania, 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.”
A second letter shared later Friday 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 the president is “fatigued” and that his wife Melania is doing well, with symptoms including a mild cough and headache.
There are two promising experimental drugs in the U.S. that are aimed at treating people with mild to moderate forms of the disease: Regeneron’s REGN-COV2 and Eli Lilly & Co.’s LLY, +0.63% LY-CoV555, both of which are still 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.
“Regeneron’s antibody cocktail has not yet received emergency use authorization so if it’s given to Trump it may be under compassionate use,” Raymond James analysts told investors on Friday. “We don’t think enrolling Trump in a clinical trial is likely, but not impossible given the strong data.”
Most of the available treatments for COVID-19 infections target severely ill patients who have been hospitalized. This includes Gilead Sciences Inc.’s GILD, -1.81% remdesivir and convalescent plasma, which is gathered from people who have recovered from COVID-19 infections. Both treatments have received emergency use authorization from the Food and Drug Administration (FDA) based on clinical data evaluating their effectiveness in hospitalized patients with more severe forms of the disease.
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.)
For medications that have not yet received any approvals or authorizations, they can sometimes get access to a drug through the FDA’s compassionate use program, which is a type of regulatory loophole that allows people to get access to investigational treatments if there are no other approved options available in some circumstances, or a clinical trial for that particular therapy if enrolled.
Trump in May disclosed that he was taking the antimalarial hydroxychloroquine that he spent months hyping as a potential COVID-19 treatment for an undisclosed reason. 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 EUA in March; however, the regulator later revoked the authorization in June.
Health care providers around the world have tested providing zinc, vitamin C, vitamin D, and the antibiotic azithromycin to COVID-19 patients; however, none of those treatments have 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.”
