President Donald Trump’s physician is treating the president with an experimental antibody cocktail being developed by the drug maker Regeneron, as well as zinc, vitamin D, and the generic version of the heartburn treatment Pepcid.

There are no approved treatments for Covid-19, but the Regeneron treatment is one of the most promising candidates, along with another antibody treatment developed by Eli Lilly. Both are being tested in patients around the country. Initial results have suggested that they can reduce the level of the virus in the body and possibly shorten hospital stays — when they are given early in the course of infection.

Although Regeneron’s product has not been authorized for emergency use by the Food and Drug Administration, companies can grant access to their experimental treatments through compassionate use, for example, if all other options have failed and a patient might die without trying the drug.

In an interview Friday afternoon, Regeneron’s chief executive, Dr. Leonard S. Schleifer, said Mr. Trump’s medical staff reached out to the company for permission to use the drug, and that it was cleared with the Food and Drug Administration.

I have highlighted both Vitamin D and zinc in prior posts, in reference to potential coronavirus preventatives and treatments. The generic Pepcid was an interesting addition and appears that it may be related to the reduction of inflammation.

  • Patients taking Pepcid were 45 percent less likely to die in the hospital and less likely to have combined adverse outcomes leading to death. The patients were also 48 percent less likely to need help breathing from a ventilator.
  • Pepcid use led to lower levels of certain blood tests associated with poorer outcomes from COVID-19.

The reason for the beneficial reaction, Dr. McKay said, is still largely theoretical. Researchers have ruled out theories that Pepcid has a direct antiviral effect or hinders protein binding and, therefore, interferes with reproduction of the virus.

“Current thoughts are that it may lessen the hyperimmune inflammatory response by blocking the effects of pathological histamine release from mast cells by binding to the histamine H2 receptor,” he said.

Regeneron’s Covid-19 antibody treatment has been show to help non-hospitalized patients recover faster in early studies.

A high dose of the company’s antibody cocktail, REGN-COV2, led levels of the virus to decrease more quickly in infected, non-hospitalized patients, potentially indicating the treatment may help them get better, Regeneron reported Tuesday via press release…
In a notable finding, the data seem to show that the antibody had a bigger effect in patients who tested positive for SARS-CoV-2 but had not created high levels of their own antibodies against the virus. In this group, even a lower dose of the Regeneron antibodies seemed to result in patients getting better faster.

The data add to the early results from Eli Lilly, which showed a reduction in virus levels for patients at some doses and a tantalizing hint that the treatment might help keep patients out of the hospital.

Monoclonal antibodies are synthetic versions of one of the immune system’s own weapons against invaders. From the start of the pandemic, some experts have been most hopeful about this technology to create new medicines to fight SARS-CoV-2, the virus that causes Covid-19. But that potential could be limited by the ability to manufacture large quantities of the treatments. Regeneron has reached an agreement with Roche, the Swiss drug giant, to increase its production capacity.

Based on prior experience reviewing media reports on coronavirus treatments, I expect the unapproved aspect will be heavily featured in news coverage.

 

 
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