UNMC clinical trial still on despite suspended access to drug

UNMC clinical trial still on despite suspended access to drug

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The company supplying an experimental drug for treating patients with COVID-19 said it is putting restrictions on "compassionate-use" requests to the antiviral drug.

The new limits won't affect the ongoing clinical trial of remdesivir at the University of Nebraska Medical Center.

Requests to Gilead Science by those infected with the coronavirus in the U.S. and Europe to try remdesivir saw "an exponential increase" after President Donald Trump touted the drug and two others as potential cures for the disease.

The antiviral therapy has proved effective against SARS and MERS — other respiratory diseases caused by varying strains of the virus — as well as against the Ebola virus.

"In recent weeks, there has been an exponential increase in compassionate-use requests for emergency access to remdesivir," the California-based company said Sunday in a news release.

"This has flooded an emergency treatment-access system that was set up for very limited access to investigational medicines and never intended for use in response to a pandemic," Gilead said.

The drug developer said it would grant exceptions to requests made by pregnant women or children under the age of 18, and was working on a new expanded release.

UNMC is one of six hospitals across the U.S. that has enrolled 80 patients in a clinical study of remdesivir sponsored by the National Institutes of Health.

At the announcement of the clinical trial in late February, Dr. Andre Kalil, an infectious disease expert at UNMC, said the trial would enroll as many as 400 patients from 50 sites around the world.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a member of the U.S. Coronavirus Task Force, said while the clinical trial was set up quicker than most, that its methods reflect "the gold standard for determining if an experimental treatment can benefit patients."

Also this week, the Food and Drug Administration announced remdesivir would be tagged with the agency's "orphan drug" designation, typically reserved for rare illnesses affecting fewer than a quarter-million people in the U.S.

The designation gives Gilead seven years of market exclusivity on the product, as well as tax incentives and other benefits.

Latest updates on coronavirus in Lincoln and nearby

See the latest news as more coronavirus cases are identified in Nebraska.

The Nebraska Department of Health and Human Services reported late Thursday night that an 11th Nebraska resident has apparently contracted the coronavirus. HHS is waiting for confirmation from the Centers for Disease Control and Prevention.

Legislature

Hy-Vee at the Capitol had a contract to supply lunch meals and sandwiches weekdays until the end of the legislative session, but because of COVID-19 concerns it has decided to shut down its operation early.

The Zoo Bar, Duffy’s Tavern, Bourbon Theatre, 1867 Bar and Bodega’s Alley — the downtown live-music venues — have all closed and canceled shows for at least two weeks in an effort to battle the spread of the coronavirus.

“At this point, everyone should just take a deep breath and wait till we announce procedurally how we will address these things,” said Matt Larson, associate superintendent of instruction.

As bad as the losses from major event cancellations are, economists say the economic damage they cause is likely to pale compared to the effects of the widespread closings of restaurants, retail stores and other businesses.

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The mall announced in a news release that it would suspend its hours, starting at 7 p.m. Monday, with plans to reopen April 6.

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Many companies have pledged to pay employees for at least the next two weeks, ranging from large retailers such as Kohl's and The Buckle to small local businesses such as Sandy's. But plenty of people are finding themselves out of work with no pay.

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Marcus Hotels & Resorts on Tuesday announced it will close a number of hotels it owns temporarily, including the Marriott Cornhusker Hotel in Lincoln.

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Topping the list is more than 5,800 sets of gloves, with 2,500 of those coming from Iron Brush Tattoo, which decided earlier this month to shut down and donate all of its supplies to health care workers.

Reach the writer at 402-473-7120 or cdunker@journalstar.com.

On Twitter @ChrisDunkerLJS

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