After testing positive for the coronavirus, President Donald Trump was given a dose of Regeneron Pharmaceuticals Inc.’s experimental neutralizing antibody cocktail, considered one among the foremost promising candidates to fill a serious hole in COVID-19 treatment plans.
Trump’s diagnosis highlighted one among the still challenging elements of the COVID-19 pandemic — that there are a limited number of treatment options for people that test positive for COVID-19, and therefore the only available therapies are proven to be effective in people with severe sorts of the disease.
“There really aren’t tons of very effective therapies we’ve at this stage of the disease,” said Dr. Steven Shapiro, chief medical and scientific officer at UPMC, a hospital system based in Pittsburgh. he’s not treating the Trumps. “The thing that we all know that’s best immediately are steroids. But that tends to figure later within 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 during 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 is also taking zinc, vitamin D, an acid reducer, melatonin and aspirin. Conley said the president is “fatigued” which his wife, Melania, is doing well, with symptoms including a light cough and headache.
There are two promising experimental drugs within the U.S. that are aimed toward treating people with mild to moderate sorts 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 among these investigational drugs would be presumably prescribed to Trump.
Like convalescent-plasma treatments, these drugs also use antibodies, and both have shown thus far that they assist reduce viral load, supported interim data shared within the past month.
“Regeneron’s antibody cocktail has not yet received emergency use authorization so if it’s given to Trump it’s going to be under compassionate use,” Raymond James analysts told investors on Friday. “We don’t think enrolling Trump during a clinical test is probably going , but not impossible given the strong data.”
Most of the available treatments for COVID-19 infections target severely ill patients who are hospitalized. This includes Gilead Sciences Inc.’s GILD, -1.81% remdesivir and convalescent plasma, which is gathered from people that have recovered from COVID-19 infections. Both treatments have received emergency use authorization from the Food and Drug Administration supported clinical data evaluating their effectiveness in hospitalized patients with more severe sorts of the disease.
The steroid dexamethasone is an alternative choice 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 within 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 aren’t approved or authorized by the FDA for a selected use. this is often called off-label prescribing, and it’s common within the U.S. health care system. (One 2006 study found that one-fifth of U.S. prescriptions are off-label.)
For medications that haven’t yet received any approvals or authorizations, they will sometimes get access to a drug through the FDA’s compassionate use program, which may be a sort of regulatory loophole that permits people to urge access to investigational treatments if there are not any other approved options available in some circumstances, or a clinical test for that specific therapy if enrolled.
Trump in May disclosed that he was taking the antimalarial hydroxychloroquine that he spent months promoting as a possible COVID-19 treatment. At that point it had been being tested in clinical trials as both a treatment and to ascertain if it could prevent infections in people that 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 round the world have tested the efficacy of providing zinc, vitamin C, vitamin D and therefore the antibiotic azithromycin to COVID-19 patients; however, none of these treatments has thus far shown a clinical benefit, consistent with Shapiro.