Local scientists involved in clinical trials for experimental COVID-19 drug given to Trump

Updated: Oct. 5, 2020 at 7:17 PM CDT
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NEW ORLEANS, La. (WVUE) - One of the drugs President Donald Trump received after testing positive for COVID-19 is an experimental antibody cocktail and it turns out that Tulane University scientists are investigating the drug.

Dr. Dahlene Fusco, assistant professor of medicine at the Tulane School of Medicine is the principal investigator for the work being done at Tulane.

“In this particular case for the cocktail, Regeneron therapy it’s two monoclonal antibodies. They screened about a thousand starting back in December, January when they heard about the first cases,” said Fusco. “Yes, so the president received a compassionate use dose of this and we’re administrating it in the form of trials.”

She said more people from Louisiana are needed to be a part of the investigation.

“So, we really want the public to be aware, you know, they’re hearing about this drug the president got, what I can say is the trials for these medications are active, ongoing and have a lot of spots for recruitment in Louisiana,” said Fusco.

Dr. Lucio Miele is Chairman of the Department of Genetics and assistant dean for Translational Research at LSU Health New Orleans School of Medicine. He worked at the FDA and helped to write guidelines for how to develop monoclonal antibodies and was in charge of reviewing such products.

“These are monoclonal antibodies which means that they are artificial, built in a laboratory,” said Miele.

Miele is also familiar with Regeneron Pharmaceuticals COVID-19 antibody cocktail.

“These in particular, the cocktail that Regeneron is developing and it’s not the only one, there are several other monoclonal antibodies to COVID-19 agents, SARS-CoV-2 in development, these were developed by copying the genes that drive the production of antibodies either in patients who had recovered or in mice with human immune systems, these are specially genetically-engineered mice,” said Miele.

Work being done related to the antibody-drug is happening in other locations, as well.

“It’s an international, multi-continental study, so it’s competitive recruitment, so whichever sites recruit the fastest get the most patients, there isn’t a cap in New Orleans, per se, so anyone who’s within those 72 hours of getting hospitalized we’re recruiting actively at Tulane and for the outpatients, we have an established a site where people can come an enroll in these studies even when they’re sick,” Fusco said.

The antibody combo looks promising at the current stage of trials.

“What we can specifically say for Regeneron so far is they’ve made publicly available, the little bit of preliminary data we have so far and it’s promising; it’s a clinical trial, it needs the data to be fully analyzed before we can draw any conclusions,” Fusco said.

Miele sounded a similar tone.

“In terms of establishing effectiveness, we’re moving very, very quickly. This is a Phase 1/2/3 trial. All we’ve seen so far are the Phase 1 data, so it looks the combination is safe. There may be efficacy signals there, but this is a very small amount of data compared to what is usually done to approve a monoclonal antibody,” he said.

Fusco was asked whether it is too soon for average citizens with COVID-19 to get excited about the drug given to the president and request it.

“I would say that it’s too soon for anyone to be sure with anything with COVID and I would say we definitely don’t want to judge anything by the president yet and it’s also very early in course,” said Fusco. “In terms of whether this is available for patients, we have this as a clinical trial.”

And she said it is important to have information on how people in the local population react to it.

“Well, it’s important because in some cases if you do a clinical trial in a population that has certain characteristics, for instance, if they’re all 85-year-old men and then you have an outbreak among 20-year-old women, maybe the drug works differently in men and women and maybe you have unexpected benefits and unexpected risks, so you really need to study drugs in a population to know that it works in that population,” said Fusco.

She said locals interested in more information on how to participate in the trial should call (504) 988-0200.

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