President Donald J Trump has maintained a regular schedule of election rallies, which may have exposed him to SARS-CoV-2
This afternoon, the White House announced that President Donald Trump had received experimental antibody treatment after a test found he was infected with SARS-CoV-2 He is said to have mild symptoms of COVID-19, including fever and congestion, and he was transferred to Walter Reed National Military Medical Center The president’s medical team later confirmed he had started a course of remdesivir, an antiviral drug that has been shown to modestly help hospital patients with COVID-19
It is a combination of two antibodies directed against a key protein of the virus that causes COVID-19, SARS-CoV-2 They bind to a region of the main surface protein, the peak, which helps the virus to bind to a receptor on human cells called ACE2 The targeted region is called the receptor binding domain An antibody is from a human who had recovered from infection with SARS-CoV-2; a B cell which produces the antibody was taken from the person’s blood and the genes for the immune protein were isolated and copied The other antibody is from a mouse, which was designed to have a human immune system, into which the spike protein was injected
Experiments on golden hamsters and rhesus macaque monkeys that were intentionally infected with SARS-CoV-2 showed that the cocktail could reduce viral levels and disease pathology
Regeneron, the maker of the cocktail, earlier this week presented preliminary data from its ongoing clinical trial in people who tested positive for SARS-CoV-2 but were asymptomatic or, in cases of more extreme, had moderate illness – a group that would appear to reflect President Trump’s current situation No serious safety concerns emerged and treatment reduced viral load and shortened symptomatic illness in patients who did not of anti-SARS-CoV-2 antibodies at the start of the trial It is not known whether the treatment can prevent serious illness, but there were indications that it could: participants who received a placebo had more visits medical
A separate trial assesses the impact of treatment on COVID-19 hospital patients, but Regeneron has yet to report results from this study
Not exactly The president received an 8 gram infusion of the treatment Regeneron data showed that a 2 The 4 gram infusion worked as well as the highest dose to reduce SARS-CoV-2 levels in humans This has been widely regarded as good news as monoclonal drugs are difficult and expensive to produce, and a lower dose means more people can ultimately receive it.
Probably out of « a lot of caution » on the part of the president’s medical team, says George Yancopoulos, co-founder and scientific director of Regeneron Yancopoulos doesn’t directly know why the president’s doctors chose to use 8 grams, but says company data indicates there is « a very, very limited risk » of antibodies causing damage at either dose The higher dose could last longer, he said, and at times in the company’s study, Regeneron saw « trends » suggesting that the higher dose is repelling the virus more powerfully – the company used the amount of viral genetic material found with nose swabs as an indicator of SARS-CoV-2 levels throughout the body
“If I had to treat a patient I would give them the high dose”, says Yancopoulos “From a societal point of view and the need to treat as many people as possible, I would give the lowest dose”
The Regeneron study found that the treatment only worked in people who did not have anti-SARS-CoV-2 antibodies at the start of the study It also worked better in people who had higher levels. high viruses Whether the president had these antibodies and a high viral load has not been made public « I couldn’t speculate as it has to do with an individual patient, » says Yancopoulos
The president’s physician memorandum stated that Trump was receiving « Regeneron’s cocktail of polyclonal antibodies » Are these antibodies « polyclonal »?
No Treatment consisted of two monoclonal antibodies, meaning that each was produced by making identical copies, or clones, of an antibody gene in a single B cell Polyclonal antibody cocktails refer to antibodies made by mixtures of B cells
What was the regulatory mechanism that allowed the president to receive the Regeneron experimental antibodies?
Antibodies are generally only available to people who participate in clinical trials Trump could theoretically have enrolled in the ongoing treatment study that reported preliminary data this week, but this trial randomly attributes the half of the participants to receive the antibodies; the other half serve as a control group and are given infusions of an inactive placebo A US Food and Drug Administration (FDA) regulation called “expanded access” – technically known as 21 CFR 312310 – allows doctors to request a ‘compassionate use’ of experimental treatments through an ‘investigational new drug’ route used for individual patients or for emergencies’ These are designed to be used in these rare and special circumstances, ‘says Yancopoulos’ This is not the first time that we have used these monoclonal antibodies with compassion. It is not a widespread diffusion mechanism «
Could Regeneron’s monoclonal antibody therapy become more widely available through the FDA’s Emergency Use Clearance (EUA) process?
Yes Regeneron and Lilly, who also reported encouraging preliminary clinical trial data last month on a single monoclonal antibody against SARS-CoV-2, discuss the possibility of an EUA with the FDA Lilly has reported signs that her antibody reduces the need for hospitalization, but as with Regeneron, too few participants are so far critically ill to come to a convincing conclusion on this critical issue.
Remdesivir is an antiviral drug developed by Gilead Sciences, originally to treat hepatitis C virus It did not work well against this pathogen, but was tried against Ebola and other viruses, after have shown some activity in cells and animal models The drug inhibits a viral enzyme used for pathogen replication Earlier this year, it showed modest clinical benefit in a trial with hospitalized COVID-19 patients, which led the FDA to grant Gilead an authorization for use emergency medication This EUA has since been extended for use in patients with mild illness, although its benefit in them is unclear.The drug has become widely used for patients with COVID-19 despite continued skepticism about its major clinical benefit
The statement released today by the president’s doctor said that in addition to antibodies, Trump was « taking zinc, vitamin D, famotidine, melatonin and an aspirin dailyThis wording does not tell if he was taking these substances before his diagnosis of infection Notably, the statement does not indicate whether Trump was taking or is taking hydroxychloroquine, the antimalarial he has controversial as a COVID treatment. 19
Famotidine has been suggested to be a treatment for COVID-19, but it is also a popular remedy for heartburn, widely sold as Pepcid Clinical trial testing it in hospital patients COVID-19 in New York City has not been able to recruit enough patients to properly assess its impact The Feinstein Medical Research Institutes, which initiated this trial, today released a statement citing evidence that it was useful for COVID-19, but also saying, « We have yet to prove the effectiveness [of famotidine] » Institute says it « looks forward to » FDA approval of trial who will assess whether famotidine can help people who are not hospitalized
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