- President Donald Trump was treated with an experimental antibody drug from Regeneron hours after testing positive for coronavirus infection, according to a memo released by the White House physician Friday.
- The president received the drug, which Regeneron is currently studying in several clinical trials, as a "precautionary measure," the memo said. But Trump was taken to Walter Reed Military Medical Center on Friday, and subsequently received two other medicines, the antiviral Veklury and the steroid dexamethasone, shown to benefit patients with more severe cases of COVID-19.
- Regeneron's drug, which combines two antibodies designed to target the new coronavirus, is unproven as a treatment for COVID-19, although the company has advanced into late-stage testing. The dose given to the president was 8 grams, the higher of two Regeneron is now studying.
Earlier this week, Regeneron released the first clinical trial results for its drug, preliminary data that suggested the experimental antibody treatment might reduce coronavirus levels and, possibly, help people with minor COVID-19 symptoms recover faster.
Three days later, Regeneron's treatment is on the biggest possible stage, given to the president after he began experiencing mild symptoms of COVID-19 following a positive coronavirus test. The news immediately raises the profile of Regeneron's drug, and might spur more patients in similar circumstances to make such a request of the company.
Its use also raises questions about the severity of the president's illness, as doctors don't yet know how beneficial or how risky the drug might be. Little information is available from Regeneron's trials about potential side effects to its treatment, but the company noted Tuesday that both the high and low dose were "well tolerated."
"President Trump remains in good spirits, has mild symptoms, and has been working throughout the day," White House Press Secretary Kayleigh McEnany said in a statement.
The move to Walter Reed was made out of an "abundance of caution," McEnany added. In addition to Regeneron's drug, the president has been taking zinc, vitamin D, generic Pepcid and a daily aspirin, the presidential doctor, Sean Conley, confirmed.
But developments over the weekend painted a more ominous picture. Reports suggested Trump twice needed supplemental oxygen, an indicator of respiratory difficulty characteristic of a more serious case. Conley also confirmed that while hospitalized, Trump began a 5-day course of Gilead’s Veklury and received the steroid dexamethasone.
Both drugs have only been proven to benefit hospitalized patients with more advanced disease, though there is a scientific rationale to believe Gilead’s antiviral - meant to stop the coronavirus from replicating - might help earlier in the course of infection.
Conley, in two separate weekend briefings, declined to provide a detailed account of Trump’s oxygen levels or lung condition. He also revised earlier details he’d written about the timing of Trump’s positive test and when the president had been treated. Trump later posted a video saying he’s “learned a lot” about the coronavirus and then surprisingly left the hospital, waving to supporters while wearing a mask in a motorcade.
Most patients with minor cases of COVID-19 cases can recover on their own. In Regeneron's early results, for example, the company noted that treatment made little difference for people with lower virus levels or whose bodies already seemed to be fighting off infection. Only in people with high viral levels, or muted immune responses to infection, appeared to benefit from treatment.
The data Regeneron released Tuesday are only from 275 people and were meant to help design further study, rather than conclusively prove anything about the drug.
As an antibody-based medicine, Regeneron's treatment is designed to mimic the effects of a natural immune response to infection. It is one of several in development to either treat COVID-19 or prevent infections. Their potential versatility could make these drugs potentially powerful tools in addressing the pandemic, although at this point it's unclear what role, if any, they'll play.
Regeneron's drug, known as REGN-COV-2, and another treatment from Eli Lilly are furthest along in development, with both companies now enrolling thousands of people into several Phase 3 trials.
Results disclosed by the companies to date indicate the drugs may reduce viral levels, and potentially help people infected with coronavirus recover faster or even avoid hospitalization. But the data are extremely early, and don't show conclusively whether either drug works.
In a statement, Regeneron said it provided REGN-COV-2 to the president through a compassionate use request made by the president's doctors.
The company stressed, however, that its priority is maintaining its supply of drug doses for use in clinical trials, rather than for more widespread individual use, as a high-profile case like the president's could prompt.
There is "limited product available for compassionate use requests that have been approved under rare, exceptional circumstances on a case-by-case basis by a treating physician," Regeneron said.
Regeneron president and chief scientific officer George Yancopoulos said on MSNBC Monday that the company had reached out to Democratic presidential candidate Joe Biden to receive REGN-COV2. Biden and his team were possibly exposed to the virus at last week's debate.
Editor's Note: This story has been updated with new information regarding the use of Veklury and remdesivir to treat Trump's condition as well.