Experimental drug that “cured” Donald Trump of COVID-19 – All you need to know

The Backstory

On October 2, US President Donald Trump revealed in a tweet that he and his wife Melania had tested positive for coronavirus and would begin their treatment immediately.

The White House press secretary said the president’s symptoms were mild and that checking into Walter Reed Military Hospital in Bethesda, Maryland was made out of an abundance of caution. After a three-night hospital stay, Trump returned to the White House. In the meantime, his physicians delivered regular briefings regarding his condition. They shared his treatment protocol, which, along with the anti-viral drug Remdesivir, currently prescribed to COVID-19 patients in the US under FDA Emergency Use Authorisation, received a steroid called dexamethasone, supplements such as zinc, vitamin D and melatonin, and an experimental antibody cocktail from Regeneron Pharmaceuticals. The antibody cocktail, known by its investigational name of REGN-COV2, has been undergoing tests since June, and on September 29 Regeneron said it decreased the viral load in non-hospitalised COVID-19 patients and alleviated their symptoms.

Why was Trump’s treatment so different from a regular one?

Being no ordinary patient, the President of the United States got exceptional treatment. At a news conference on October 3, Trump’s physician Dr Sean Conley said, “He is receiving all of the standard of care and beyond for routine, international COVID protocols.” He went on to say, “he’s the president. I didn’t want to hold anything back. If there was any possibility that it would add value to his care and expedite his return, I wanted to take it.” The decision to use an experimental antibody cocktail unapproved by the FDA was an attempt to speed up his recovery as much as possible, given there are weeks left before the election. Plus, being the oldest elected president in US history, Trump at 74 is at a higher risk of severe illness than younger people, according to the CDC. This may have tipped the scale in favour of early intervention. Various health professionals have voiced concerns about the aggressive approach to the president’s treatment since some of the therapies used lack proof of efficacy and safety, and there’s little understanding how they might work in combination.

REGN-COV2 for Trump

According to a memo from Dr Conley, President Trump received an eight-gram dose of REGN-COV2. The drug uses monoclonal antibodies - synthetic versions of the antibodies naturally emerging when recovering from the disease. The concept of treatment is similar to convalescent plasma. But, instead of being a blood-derived product, REGN-COV2 is a cocktail of two cloned antibodies – one mimicking that of a recovered COVID-19 patient, and one coming from a genetically modified mouse. The experiment is very promising, but only clinical trials will determine whether the drug works. It’s not the only antibody treatment for COVID-19 in the making: at least another one is being developed by Eli Lilly. Antibody treatments have also shown promise against other viruses, like Ebola.
In July, Regeneron received $450 million from Operation Warp Speed, the White House’s task force to expedite COVID-19 vaccine development, intent on manufacturing thousands of doses of the drug. In a short video Trump twitted on October 7 upon returning to the White House he touted the drug as “the cure”.

In his address, he said, “…it’s a cure. For me, I walked in; I didn’t feel good. A short 24 hours later, I was feeling great <…> I want everybody to be given the same treatment as your president because I feel great <…> I want to get for you what I got, and I’m going to make it free.” Immediately following the endorsement from the president, Regeneron filed an application with the US Food and Drug Administration for emergency approval for the treatment and the company stock climbed by 3.73%.

How did the president get cleared to try an experimental drug?

Very few people so far have been granted access to the medicine. In his video, Trump said “I heard about this drug, I asked for it, it was my idea,” but later Regeneron CEO Leonard Schleifer told The New York Times that President Trump’s physicians requested the company’s permission to use the drug. “All we can say is that they asked to be able to use it, and we were happy to oblige,” he said in the interview.

Although not cleared with the FDA, experimental treatments like this can sometimes be accessed through “compassionate use” protocol reserved for patients who exhausted all treatment options and the drug is their only chance. Although Trump’s condition was described as mild to moderately severe, he was granted access to REGN-COV2 nonetheless. At the same time, several sources noted that Regeneron’s Leonard Schleifer has been a long-time acquaintance and golf pal of the president at his Westchester club and that at some point Trump owned Regeneron stock.

Is it a cure?

In his letter of October 10 Dr Conley reported that President Trump had been symptom-free for over 24 hours and that his oxygen saturation level was normal. The memo also said that Trump was no longer at risk of spreading the virus. If President Trump has indeed recovered, it’s hard to tease apart which drug was instrumental in his recovery since the VIP patient was treated with a whole bunch of strong medications.

In one of his previous communications, Dr Conley said the blood test taken as early as Monday, October 5, showed Trump had coronavirus antibodies. However, some experts were quick to point out that Trump recently received a large dose of the Regeneron cocktail, which contains such antibodies. Regeneron, in its turn, said the type of blood test in question wouldn’t be able to distinguish between Trump’s antibodies and those coming from the company’s drug.

Regeneron CEO Leonard Schleifer cautioned against excessive optimism concerning the drug. “So the president’s case is a case of one, and that’s what we call a case report, and it is evidence of what’s happening, but it’s kind of the weakest evidence that you can get,” he said in his interview with CBS.

Until more comprehensive clinical trials complete with hospital stay time and mortality data are published, it’s impossible to say if the Regeneron cocktail is indeed “the cure” for COVID-19 everybody’s been waiting for. Right now, it’s important to remember that many experimental drugs prove to be dangerous or useless and end up never approved. Incidentally, this is what happened to hydroxychloroquine that Trump praised as a panacea and reportedly took himself as a preventative measure. Studies demonstrated that the drug is ineffective against COVID-19 and can be dangerous, which led to FDA revoking the emergency use authorisation it had granted for the drug.