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UNMC to start third phase of federal COVID-19 drug trial
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UNMC to start third phase of federal COVID-19 drug trial

Meridian Clinical Research, an Omaha firm, is enrolling patients at eight sites for the phase three clinical trial launched Monday for an experimental vaccine for COVID-19.

The Omaha-based arm of a new phase of an international drug trial testing medications for people hospitalized with COVID-19 is expected to begin this week, a University of Nebraska Medical Center researcher said.

The third phase of the trial, which launched in February, will pair the antiviral drug remdesivir with a type of interferon used to treat multiple sclerosis and some kinds of hepatitis, said Dr. Andre Kalil, a UNMC professor and infectious diseases physician with Nebraska Medicine.

Andre-Kalil-Infectious-Disease

Andre Kalil

In the first phase of the trial, remdesivir was shown to shorten, by an average of four days, the time it takes for patients to recover from the illness caused by the coronavirus.

The trial, sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, enrolled its first patient at the Nebraska Medical Center.

Researchers then paired remdesivir with an anti-inflammatory drug, Kalil said. That portion of the trial closed a month ago, and researchers hope to have the results by the end of the month.

In the meantime, they’re adding interferon beta-1a, which is based on a naturally occurring version of the protein produced by white blood cells as part of the body’s immune system response.

Kalil said researchers chose the drug because studies indicate that people who progress to more severe COVID-19 disease have lower levels of the protein in their blood and in their lungs.

“The hypothesis we have is that because of this very tough fight between the virus and our immune system, we end up getting depleted of this very important molecule that has direct antiviral properties,” he said.

By replenishing the protein and adding remdesivir, which takes aim at the virus’s ability to replicate, they hope to create a synergistic effect, Kalil said.

Interferon, he said, has been used as a treatment for many years, so researchers have a good understanding of how it works and of its safety.

The researchers plan to enroll about 1,000 patients with pneumonia related to COVID-19 at nearly 100 hospitals around the world. All patients will get remdesivir, but half will get the new drug and half will get a placebo. Neither the researchers nor the participants will know who is getting which combination. The drug, according to the NIH, is marketed under the brand name Rebif by EMD Serono, a North American arm of German drugmaker Merck.

The researchers will evaluate whether the combination shortens patients’ recovery time — defined as being well enough to leave the hospital — compared with that for remdesivir alone.

“The goal is just to keep going and find as many treatments as we can,” Kalil said of the trial. “We want to make sure we can provide as (many) as possible while we’re looking for a vaccine.”


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Julie Anderson is a medical reporter for The World-Herald. She covers health care and health care trends and developments, including hospitals, research and treatments. Follow her on Twitter @JulieAnderson41. Phone: 402-444-1066.

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