FDA greenlights expansion of COVID-19 study to VCU Medical Center after positive data

FDA greenlights expansion of COVID-19 study to VCU Medical Center after positive data

RICHMOND, Va. (WWBT) - When it comes to fighting COVID-19, doctors say your body’s immune response can often time be worse than the symptoms of the disease itself.

“Unfortunately, this COVID-19 generates a hyper-immune response. The immune response is actually maladaptive to and that actually causes its own damage above and beyond the coronavirus itself,” said Regions Hospital medical doctor Charles Bruen.

Bruen specializes in a form of treatment known as Extra Corporal Membrane Oxygenation (ECMO) which is an advanced therapy intended for patients with severe heart problems or luing disease where the use of a ventilator is no longer a viable option for life support. Bruen says a new drug trial could prevent the need for a ventilator in the most extreme COVID-19 cases.

Recently published data showed the drug Auxora - plus standard of care - reduced ventilator use by more than 50 percent, and more than doubled the rate of recovery compared to standard of care alone.

The drug is being developed by CalciMedica. It is a potent and fast-acting inflammation-blocking drug that helps maintain oxygenation into the lungs.

“This medication that we’re studying attacks the inflammatory system,” said Bruen. “This drug is working on modulating that hyperinflammatory response in hopes of preventing people from progressing from that ill phase to that super ill phase, meaning to keep patients from needing an ICU, keep patients from needing a ventilator, keep patients from needing ECMO.”

Bruen says the results from the phase two trial of Auxora have been so promising, that the FDA has allowed researchers to push ahead to phase three, which is a randomized trial that will test the drug on 400 participants with severe COVID-19 pneumonia.

“It’s not a cure for COVID itself - the virus still has to run it’s the course through the body, but if we can prevent some of the more serious, detrimental side effects of it, maybe we can prevent some of the more serious sequellae we see in patients,” said Bruen.

VCU Medical Center will be among the nearly 40 sites across the U.S. to take part in the trial. The trial will be a blinded, placebo-controlled clinical trial enrolling patients with severe COVID-19 pneumonia to assess Auxora, plus standard of care compared to placebo plus standard of care.

The drug is being developed by CalciMedica. Researchers say another added benefit of Auxora is that it can be taken with drugs like Remdesivir, which have been shown to treat the growth of the COVID-19 virus in patients.

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