Serious Questions On Treatment

Please consider Science.Org's take on Antibody Treatment for COVID-19.

The article is confusing in that it discusses treatments by two different companies, Regeneron and Lily.

Here are a few snips regarding Regeneron.

James Crowe, a viroimmunologist at Vanderbilt University who is working with AstraZeneca to develop COVID-19 monoclonal antibodies, welcomed Regeneron’s detailed preliminary results. “I applaud Regeneron for releasing so much information,” Crowe says. “They’re contributing to public health by releasing this as soon as possible.” But he notes even people who did well on the monoclonal cocktail still had low levels of virus detectable after their treatment, which in theory could cause problems. “I was surprised that there was any virus at all given that these are such potent antibodies,” he says, adding that the residual virus detected in the swab tests may not be capable of copying itself.

Regeneron's trial had only 12 patients who had “COVID-19–related medically attended visits.” Although there was a trend toward more of these in the placebo group than treatment arms, only one was hospitalized.

Regeneron’s data raise difficult questions about when to use its cocktail. People who test positive for SARS-CoV-2 aren’t routinely screened for antibodies to it or for levels of the virus. “If the decision is going to be made to deploy such a therapeutic solution in the patients who might benefit the most and need it most, we’re going to have to solve the problem of using the right point-of-care diagnostic tools, either for serology or high viral load,” Yancopoulos said, noting that their partners—including Roche—are developing these types of assays.

Monoclonal antibodies are more difficult to make than many drugs and often are extremely expensive, which means that supply could outstrip demand and many countries might not be able to afford them. The U.S. government’s Operation Warp Speed has invested $450 million in Regeneron to produce up to 300,000 “doses” of its cocktail by the end of the year, which would be distributed to Americans free of charge.

Regeneron saw no difference between its low- and high-dose preparations used in the study. 

Key Details

  • Trump took a large doses even though they performed no better in tests.
  • The trial only had 12 patients who had “COVID-19–related medically attended visits.
  • Trump's Operation Warp Speed has invested $450 million in Regeneron

Statement from Regeneron

Please consider Regeneron Confirms that REGN-COV2 Antibody Cocktail Provided to  President Trump Under Compassionate Use Request.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today confirmed that, as announced  by the White House Press Secretary, Regeneron provided a single 8 gram dose of REGNCOV2, a cocktail of two monoclonal antibodies, for use by President Trump. REGN-COV2 is an investigational COVID-19 therapy, which was provided in response to an Individual Patient Investigational New Drug (IND) application (commonly known as ‘compassionate  use’ request) from the President’s physicians.

Dose Questioned

Physicians Decided to Start Remdesivir Therapy for Trump

Bloomberg reports Physicians Decided to Start Remdesivir Therapy for Trump

Medical specialists have elected to start Remdesivir therapy for President Donald Trump, according to a tweet from Press Secretary Kayleigh McEnany that cites a statement from his physician.

Remdesivir is made by Gilead.

Remdesivir and COVID-19

Finally, please consider Remdesivir and COVID-19

In the first published placebo-controlled trial of remdesivir for treating severe COVID-19, Yeming Wang and colleagues were unable to attain their primary endpoint of time to clinical improvement. Although admittedly underpowered due to early trial termination, remdesivir did not appear to affect rates of severe acute respiratory syndrome coronavirus  (SARS-CoV-2) viral RNA load decline and mortality when compared with placebo. Given these disappointing findings, we are left to wonder if a lack of clinically significant outcomes in placebo-controlled trials could have been predicted. By inhibiting early coronavirus life cycle in vitro and in animal models, remdesivir might require initiation before the peak viral replication, which is not feasible in the clinical human presentation of COVID-19.

In cell cultures exposed to murine coronavirus, early remdesivir initiation substantially decreased viral titres compared with control. However, this treatment effect was completely lost when initiation occurred just 8 h after infection. In another study, mice administered early remdesivir relative to inoculation with SARS-CoV had substantially reduced lung damage compared with untreated cohorts, an effect that was lost when initiation was delayed by 2 days after inoculation. The need for early treatment has been identified in additional animal models, as Wang and colleagues confirm, with remdesivir initiation following peak viral replication being unable to affect disease severity or mortality.

The stories indicate Trump is on at least two distinct treatments. 

There are many COVID-19 Disease Treatments in various states of testing by Regeneron Pharmaceuticals, Mateon Therapeutics, Ely Lily, Innovation Pharmaceuticals, Sorrento Therapeutics, Algernon Pharmaceuticals,  Genentech, Humanigen, Inc., Eiger BioPharmaceuticals, FSD Pharma Inc. RedHill Biopharma Ltd, Corvus Pharmaceuticals, Organicell Regenerative Medicine, and others.

If you are confused, you are not the only one.

Mish