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Trump’s Coronavirus Drugs: Regeneron, Dexamethasone and More, explained



Donald Trump in the White House

After spending three nights at Walter Reed Medical Center, President Donald Trump returned to the White House on Monday.

Win McNamee / Getty

President Donald Trump returned to the White House on Monday after announcing Thursday that he had tested positive for coronavirus and spent three nights at Walter Reed National Military Medical Center. When he fights covid-19, Trump has received a handful of different treatments for the disease, including an experimental antibody cocktail produced by the biotechnology company Regeneron.

As a 74-year-old overweight man, Trump has an increased risk of experiencing serious complications from COVID-19, according to the CDC. Both age and obesity increase the risk of hospitalization by a factor of three. The White House has maintained a stoic optimism about his condition since diagnosis, and Trump himself has downplayed the seriousness of the new coronavirus and tweeted on Monday “do not be afraid of Covid.”

But his treatment regimen seems to be focused on dealing with a more serious case of illness. So far, the president has received:

  • Supplemental oxygen
  • An antibody cocktail developed by Regeneron (REGN-COV2)
  • Remdesivir, an antiviral manufactured by Gilead
  • Dexamethasone, a common corticosteroid

The treatments described by White House physician Dr. Sean Conley in recent days may signal concern over Trump’s forecast. It can also be too cautious due to his many risk factors and of course his VIP status. In addition, COVID-19 is a complex, multifaceted disease that affects many organs. Although doctors and researchers have dramatically improved our understanding of how it affects the human body, there is no proven method to get from disease to health. Questions remain as to the effectiveness of these treatments and clinical trials are ongoing worldwide.

Here’s what we know about the drugs Trump has taken to treat his COVID-19 infection.

Supplemental oxygen

There are two generally recognized “phases” of COVID-19. The first is during the first stage of infection, when SARS-CoV-2, the coronavirus that causes COVID-19, replicates exponentially in the lung cells. The immune system, noticing the infection, flares up, which can cause the lungs to fill with fluid and prevent adequate oxygen flow. A normal oxygen level in the blood is at least 95%, but in some COVID-19 patients it drops significantly. The guidelines for treatment from the National Institutes of Health suggest that serious illness can be defined in part by an oxygen concentration in the blood below 94%.

Trump doctor Conley would have avoided if Trump got extra oxygen but confirmed that the president received an hour of treatment on Friday. The president’s oxygen level dropped below 95% again on Saturday, but it is unclear if he received oxygen another time.

“In the President’s case, the time from the initial diagnosis to the time showing severe symptoms, such as sudden drops in blood pressure and the need to administer supplemental oxygen, is exceptionally short,” said Jeremy Nicholson, Rector of Health Sciences at Murdoch University in Perth, Australia. .

The oxygen levels give an indication of how a patient is doing early in the course of the disease and, together with scans in the lungs, can help determine any internal injuries. Lower levels in the initial phase may indicate a worse prognosis – and the oxygen levels that Trump has experienced have probably informed the experimental therapies he has received since the diagnosis. Current evidence suggests that the Regeneron antibody cocktail and remdesivir may work better early.

As the disease progresses to its second stage, these treatments do not seem to work as well. During the second phase, the virus has caused an extreme reaction from the immune system that can affect many different organ systems. Dexamethasone, for example, is just a drug that aims to trample on this response.

Regeneron’s cocktail

Regeneron’s antibody cocktail is known as REGN-COV2. On Friday, the White House released a memo that Trump had received an infusion of the experimental mix.

RAIN-COV2 is a cocktail of neutralizing antibodies, Y-shaped proteins that adhere to SARS-CoV-2, preventing it from using its viral machinery to hijack cells. The cocktail was developed in mice that had been genetically modified to have a human-like immune response and by identifying antibodies in humans that had recovered from COVID-19. The cocktail uses two neutralizing antibodies that attach to the nail protein of the coronavirus. It takes some time for the immune system to generate these antibodies naturally, so giving a cocktail like this early in the course of the disease can benefit patients.

The drug has not yet been approved for randomized clinical trials, and no data from human trials have been released in a peer-reviewed scientific journal. The cocktail development process is described in an article in the journal Science in August. Preclinical studies in primates and hamsters, published as a repression of biorXiv, showed that it reduced virus levels, providing evidence of its potential.

Regeneron released an investor note on September 29 that described a “descriptive analysis of a seamless phase 1/2/3 study” of REGN-COV2, indicating the “reduced viral load and time to relieve symptoms in non-hospital patients. ” The results are based on the first 275 patients enrolled in Regeneron’s trials, but the full published data have not been published.

“We plan to promptly submit detailed results from this analysis for publication to share insights with public health and medical communities,” said David Weinreich, head of global clinical development at Regeneron, in the press release.

The cocktail is also being studied in three more phase 3 studies to assess its usefulness in different disease phases.

Trump received a high-dose infusion of the drug after one of his doctors made a request to the FDA and Regeneron for “compassionate use.” It is not widely used for patients in the United States and would not be made available unless authorized by the FDA for emergency use.

The president has ties to Regeneron’s CEO Leonard Schleifer, according to a CNN report. On Wednesday, in a video that tweeted to his 87 million followers, the president called it “incredible” but it is unclear how successful the cocktail is. Trump said he had “authorized” it on “an emergency” that could see it soon get an emergency use permit from the FDA.

“It will be a little unknown how he will respond to this therapy,” said Elizabeth Hartland, director of the Hudson Institute of Medical Research in Melbourne, Australia.

Remdesivir

Remdesivir, a drug developed by California’s Gilead Sciences, has been in the limelight as a COVID-19 therapist since March. It was first developed to treat hepatitis C and was also used to fight Ebola.

Belt desivir is not specifically designed to destroy SARS-CoV-2. Instead, it works by knocking out a specific machine in the virus, known as “RNA polymerase,” which many viruses use to replicate. It has previously been shown to be effective in human cells and mouse models. During an information meeting at the White House on April 29, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases in the United States, announced that as something that can become a standard of care. It has been approved for emergency use by the FDA.

Trump is receiving five doses of stradesivir, according to his doctor.

Its modest benefits were reported in the New England Journal of Medicine in July. The drug reduced hospital stays from a median time of 15 days to 11, but it showed no significant benefit in reducing the odds of dying from COVID-19.

Dexamethasone

Dexamethasone is a cheap and widely available corticosteroid that has anti-inflammatory activity and can narrow the blood vessels.

“These drugs attenuate the immune system’s response to COVID,” said Greg Kyle, a professor of pharmacy at Queensland University of Technology. Corticosteroids have been evaluated in patients with respiratory distress for decades, with many clinical trials examining their usefulness, but only a handful have examined their use in COVID-19 patients.

Dexamethasone rose to prominence as a treatment for COVID-19 after researchers at the University of Oxford in the UK conducted a 6,000 patient study. The results, published in the New England Journal of Medicine in July, demonstrated Dexamethasone can reduce the number of deaths in patients on mechanical ventilation by one third. In patients who received extra oxygen, the death rate decreased by one-fifth. It did not seem to help patients who did not receive respiratory support. Another study, in the Journal of the American Medical Association in September, looked at a group of 299 patients with moderate or severe respiratory distress and suggested that it could keep patients off the ventilators – although this was not a randomized study.

However, an observational study in the Journal of Hospital Medicine in July followed the positive NEJM document, suggesting that there may be problems with administering dexamethasone early in the course of the disease.

Some doctors have pointed out the more serious side effects of dexamethasone treatment. “They work on a whole range of different body systems and they work at the core level,” says Kyle. This means that it affects almost all cells in the body – and so the side effects are quite varied. There are potential negative effects on the brain that affect aggression, anxiety and mood. Another side effect is “euphoria,” according to Nicholson, who says it “may partly explain the president’s strong sense that he is recovering quickly.”

Long-term health effects

Researchers and researchers are still agreeing on the lasting effects of SARS-CoV-2 infection. While the course of a mild illness can only last for a couple of weeks, those who have experienced severe COVID-19 may have long-term health effects. An Italian team assessed a small group of COVID-19 patients in hospitals in April and May this year, with almost 90% reporting that it was at least one symptom – usually fatigue or strained breathing.

Although Trump is back on his feet producing videos for Twitter with seemingly good health, his doctor warns Conley that he “is not out in the woods yet.”

While Trump downplayed the severity of his illness and the threat of coronavirus in White House briefings on Monday, science shows that surviving the disease is not the end of the battle. The effects of COVID-19 can last a long time. There is still so much we do not know about COVID-19 and the immune response and the factors that can dictate how well a patient responds to complications.

So far, it has been difficult to get a clear understanding of how difficult Trump’s forecast is. This makes it difficult for external experts to draw conclusions about what the president is experiencing. Kyle likens it to fighting “with one arm behind your back.”

“It will be very difficult to make an assessment based on the information that has come out,” he said. “You have to get a whole picture of the patient.”

Progression to more severe COVID-19 usually occurs about seven to ten days after a positive test is returned. It is still unclear the last time Trump was tested before returning a positive test last week. “If the COVID-19 course that the president is showing is ‘typical,’ we will not know if he will really recover for several days yet,” Nicholson said.

Updated October 7: Added Trump’s comments on Regeneron from Wednesday.




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