President Donald Trump’s physician confirmed Friday night he is being treated for COVID-19 with experimental Ebola drug remdesivir.
For patients hospitalized with COVID-19, the FDA has given emergency-use of the intravenous antiviral drug sold by Gilead Sciences Inc, which has been shown to shorten hospital stays.
The National Institutes of Health (NIH) found that patients being given the drug improved after 11 days, four days faster than those who didn’t receive the medication.
It works to prevent the virus from copying itself within a patient’s body so it can’t spread further but scientists have not yet discovered how.
Before he was hospitalized, the president was also treated with an experimental antibody drug from Regeneron.
Donald Trump is being treated with experimental Ebola drug remdesivir
The FDA issued an emergency use authorization for remdesivir on May 1, in response to the preliminary results the NIH study that was released at the end of April.
The results that found the medication helped patients recover 31 percent faster.
According to Hackensack Meridian Health, initially only severely ill hospitalized COVID-19 patients were eligible to be treated with remdesivir.
On August 28, however, the FDA extended its authorization to all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.
‘The FDA continues to make safe and potentially helpful treatments for COVID-19 available as quickly as possible in order to help patients. The data to support today’s action are encouraging. The data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus,’ said FDA Commissioner Stephen M. Hahn, M.D in August.
‘We are working with drug developers to conduct randomized clinical trials to further study the safety and effectiveness of a number of potential therapies for COVID-19.’
Yet the same month, a report from the drug’s California-based maker Gilead found that the effects of the medication may only be seen in those with severe infections.
Researchers found a group of patients given the drug for five days saw their conditions improved but a similar group who received the drug for an average of six days had no significant benefit.
The team looked at 584 patients with moderate cases of COVID-19.
One-third of the patients received a five-day course, one-third received a 10-day course and the remaining were given standard care.
The patients were at 105 hospitals in the US, Europe, and Asia, and were followed for a little less than two weeks.
The median length of treatment was five days for patients in the five-day remdesivir group and six days for patients in the 10-day remdesivir group.
Those treated with remdesivir for five days were much better by day 11 than the standard care group, but the authors said this ‘was of uncertain clinical importance.’
However, the group that received the drug for an average of six days did not differ from standard care group
What’s more, death rates didn’t vary between the 10-day group and those who didn’t get the treatment with two percent in each group dying.
Remdesvir is approved in the US for emergency use in patients hospitalized with COVID-19. Pictured: A vial of remdesivir at the University Hospital Eppendorf in Hamburg, Germany
Researchers say that patient receiving remdesivir did have fewer severe symptoms of the virus, they had more moderate symptoms and side effects such as headache and nausea.
The team says its not sure why there was such a difference but plant to evaluate these discrepancies in further trials.
Remdesivir produced encouraging results earlier this year when it showed promise for both preventing and treating MERS – another coronavirus – in macaque monkeys.
It was developed to treat Ebola, the deadly fever that emerged in West Africa in 2014.
While it was unsuccessful in treating Ebola, the drug appears to interfere with the ability of the coronavirus to copy its genetic material.
It’s not entirely clear how the drug accomplishes this feat, but it seems to stop the genetic material of the virus, RNA, from being able to copy itself.
That, in turn, stops the virus from being able to proliferate further inside the patient’s body.
Gilead announced in September that is looking to expand the ways that remdesivir might be used.
Its CEO Daniel O’Day on Monday told CNBC’s Squawk Box that the company has launched trials to use the drug in IV form outside of hospitals.
White House physician Sean Conley said Friday night that the president was ‘doing very well’
President Trump tweeted Friday night that he believed his treatment was ‘going well’
Many major hospitals in the US are reserving the use of remdesivir for the sickest patients and have cut their orders by a third.
At $3,120 per treatment course, remdesivir is expensive, and hospitals are reticent to buy or the drug on hand when it may go unused as hospitalizations for COVID-19 continue to decline in many states.
O’Day said his company is ‘not done with remdesivir yet’ and is also trialing an inhaled form of the antiviral.
In August, researchers want to see if adding another drug could improve the effects of remdesivir and shorten recovery time even further, reported The New York Times.
Beta interferon, currently approved to treat multiple sclerosis, also has anti-inflammatory properties and helps tame the immune system response, which may help tame a deadly overreaction the immune system has to the virus
The trial is the third phase of the Adaptive COVID-19 Treatment Trial (ACTT), being run by the NIH’s National institute of Allergy and Infectious Diseases.
The first phase of the study was the phase that helped remdesivir receive emergency use authorization as a treatment for severe coronavirus patients.
The second phase tested remdesivir and a placebo in comparison with remdesivir and baricitinib, an arthritis drug that helps suppress inflammation, according to The Times.
Researchers are still evaluating the results, but it appears baricitinib did not quell cytokine storms, which occur when the body doesn’t just fight off the virus but also attacks its own cells and tissues.
After Trump’s hospitalization, White House physician Sean Conley said in a letter to Press Secretary McEnancy that Trump began taking the drug Friday night.
‘This afternoon, in consultation with specialists from Walter Reed and Johns Hopkins University, I recommended movement of the President up to Walter Reed Military Medical Center for further monitoring,’ Conley wrote.
WHAT IS REGENERON’S ANTIBODY COCKTAIL?
Regeneron’s drug ‘cocktail,’ REGN-COV2, contains an antibody made by the company from mice and another isolated from a recovered COVID-19 patient, each of which may help to neutralize coronavirus.
The firm’s latest data from the ongoing trials, show the drug drove down the viral loads of patients who were not hospitalized and cut their recovery times by nearly half.
But it’s very much an experimental treatment, and the data announced earlier this week are the first published from the trial.
Two patients treated with the antibody cocktail had ‘adverse events’ – undesirable side effects. One of those was a ‘serious’ adverse event, but Regeneron did not reveal details of what happened to the patient, who received a low dose of the drug.
REGN-COV2 is comprised of a duo of therapeutics in a class of drugs known as monoclonal antibodies (hence REGN-COV2’s distinction as a ‘polyclonal antibody’), which are clones of antibody that attacks a specific antigen.
‘This evening I am happy to report that the President is doing very well. He is not requiring any supplemental oxygen, but in consultation with specialists we have elected to initiate remdesivir therapy. He has completed his first dose and is resting comfortably.’
Trump also tweeted that he believed his treatment was ‘going well’ on Friday night.
Earlier on Friday, the president had been treated with an experimental antibody drug that has been called one of the most promising approaches to preventing serious illness from a Covid-19 infection.
Its maker, Regeneron Pharmaceuticals, said the company agreed to supply a single dose, given intravenously, for Trump at the request of his physician under ‘compassionate use’ provisions.
The new drug is in late-stage testing and its safety and effectiveness are not yet known, and no treatment has yet proven able to prevent serious illness after a coronavirus infection.
Trump was given the experimental drug at the White House on Friday before he was taken to Walter Reed National Military Medical Centre.
Several doctors who treat Covid-19, including Dr David Boulware at the University of Minnesota, had speculated that doctors might use the antibody drug, given that this approach has worked against other diseases in the past.
‘They’re not going to just sit around and watch to see if he gets sick,’ he said.
Antibodies are proteins the body makes when an infection occurs and vaccines trick the body into thinking there is an infection so it makes these antibodies.
But it can take weeks for them to form after natural infection or a vaccine.
The drugs aim to give that protection immediately, by supplying concentrated versions of one or two antibodies that worked best against the coronavirus in laboratory and animal tests.
A scientist works in Regeneron Pharmaceuticals’ Infectious Disease Lab in New York state, for efforts on an experimental coronavirus antibody drug. Antibodies are proteins the body makes when an infection occurs; they attach to a virus and help the immune system eliminate it
Regeneron’s drug contains two antibodies to enhance chances that it will work and the company previously developed a successful Ebola treatment from an antibody combination.
Earlier this week, Regeneron said partial results from about 275 Covid-19 patients who were not sick enough to need hospital treatment suggested it might be cutting how long symptoms last.
However, the study has not been completed, the results were only announced in a company news release and have not been published or reviewed by other scientists.
On Friday, Conley said Trump also was taking zinc, vitamin D, an antacid called famotidine, melatonin and aspirin. None of those have been proven to be effective against COVID-19.
Trump apparently is not receiving hydroxychloroquine, a drug he widely promoted that has been shown in many studies to be ineffective for preventing or treating COVID-19.
The president announced he and the First Lady Melania Trump tested positive for coronavirus in the early hours of Friday morning.
The White House he will be spending a ‘few days’ in hospital but will continue to work.