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Health
Omaha medical researcher says he's excited about results of COVID-19 drug trial

The leader of the Omaha-based arm of a clinical trial of the first drug to prove effective against the novel coronavirus said Wednesday that the results are something to get excited about.

In a major international study that enrolled its first patient at the Nebraska Medical Center, the experimental drug, called remdesivir, shortened the time it takes for patients to recover by four days on average, U.S. government and company officials announced Wednesday.

Gilead Sciences’ drug is the first treatment to pass such a stringent test against the virus, which has killed more than 218,000 people since it emerged late last year in China.

The drug also showed a trend toward fewer deaths in patients who were ill enough to have lung involvement.

“When I find a positive result in a study with that kind of strict methodology, it brings me not only hope but joy that we are bringing a treatment that did not exist until today,” said Dr. Andre Kalil, a UNMC professor and infectious diseases physician with Nebraska Medicine, the health system that includes the Nebraska Medical Center.

Andre Kalil

“This is the only thing that’s saved lives,” Kalil said. “Now we can have supportive (hospital) care plus remdesivir. … If we can shorten the recovery by a third and improve their survival, this is news to definitely get excited about.”

Having a treatment could have a profound effect on the global pandemic, especially because health officials say any vaccine is most likely a year or more away.

The study, run by the National Institutes of Health, tested remdesivir versus usual care in 1,063 hospitalized coronavirus patients around the world.

The clinical trial of the drug began in Omaha in February.

The first participant in the trial was an American who was repatriated after being evacuated from the Diamond Princess cruise ship, which had docked off the coast of Japan.

A total of 15 people were brought to Omaha for quarantine or isolation and treatment, either in the National Quarantine Unit or the Nebraska Biocontainment Unit. Both are on the UNMC campus.

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Kalil said he could not specify how many patients UNMC signed up for the trial. But he said the university and clinical partner Nebraska Medicine were one of the top enrollers.

A total of 68 sites ultimately joined the study, 47 in the United States and 21 in countries in Europe and Asia.

“We were very active in offering it to our patients and we were very successful in enrolling patients in Omaha,” he said.

The NIH study quickly enrolled its original goal of 440 patients and then was expanded to give more answers on questions such as which subgroups may or may not benefit and other factors that may affect success, such as how early in the course of illness the drug was given.

The study’s main goal also was altered. Originally, the goal was to determine the percentage of patients having various outcomes such as needing a breathing machine, fully recovering or dying 15 days after starting treatment. The new main goal is to measure the time to recovery, such as no longer needing oxygen or hospitalization.

At the White House, NIH’s Dr. Anthony Fauci said the drug reduced the time it takes patients to recover by 31% — 11 days on average versus 15 days for those just given usual care. Full results will soon be published in a medical journal.

“What it has proven is that a drug can block this virus,” Fauci said. “This will be the standard of care.”

Fauci, the head of National Institute of Allergy and Infectious Diseases, said early results of the clinical trial of remdesivir offered “quite good news.”

The mortality rate also was lower among patients who received remdesivir, 8% versus 11.6% for those who received a placebo. While those results weren’t statistically significant, Kalil said, the trend was clear that patients who received remdesivir had better survival rates.

“The combination of faster recovery with lower mortality is really a combination that is very meaningful to our patients and everyone infected with this,” he said.

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A statement from the Food and Drug Administration says that the agency has been talking with California-based Gilead “regarding making remdesivir available to patients as quickly as possible, as appropriate.”

Remdesivir is among many treatments being tested against the coronavirus but was the farthest along in study.

The drug is given through an IV and is designed to interfere with the virus’s ability to copy its genetic material. In animal tests against SARS and MERS, diseases caused by similar coronaviruses, the drug helped prevent infection and reduced the severity of symptoms when given early enough in the course of illness. But it is not yet approved anywhere in the world for any use.

Kalil said researchers still have a lot of data to analyze. They also will begin a second part of the trial in the next few days in which all participants get remdesivir. They also will test another drug, an anti-inflammatory called baricitinib. The intent will be to see if it reduces the inflammatory response to the infection.

Some studies suggest that runaway immune responses pose additional risks for patients.

A less encouraging picture came from partial results of a separate study testing remdesivir in severely ill patients in China. A report published Wednesday in the British medical journal Lancet says the treatment did not speed recovery in that study, which was stopped after only 237 of a planned 453 patients were enrolled. Researchers gave 158 people the drug and 79 others got usual care.

Separately on Wednesday, Gilead announced partial results from its own ongoing study of the drug in severely ill, hospitalized COVID-19 patients. The company said patients treated for five days “achieved similar improvement” in health as others treated for 10 days. However, that result is hard to interpret because there is no comparison group of people getting usual care, so it’s impossible to know how much patients would have improved on their own.

The company also said that no new safety problems emerged in its study and that it would publish results in a medical journal soon.

Gilead also is testing remdesivir in a separate study of moderately ill coronavirus patients. No results have yet been announced from that study, which does have a comparison group getting usual care.

Besides these studies, Gilead also has given remdesivir to more than 1,700 patients on a case-by-case emergency basis.

This report includes material from the Associated Press.

April photos: Nebraska faces coronavirus

Education
OPS superintendent proposes buying laptops or iPads for all 54,000 students

Omaha Public Schools Superintendent Cheryl Logan says the district will buy laptops or iPads that have Internet connectivity built into them for all 54,000 OPS students.

The multimillion-dollar purchase, which would have to be approved by the school board, would make OPS a one-to-one device district. In doing so, OPS would join other metro area school districts such as the Millard Public Schools and Westside Community Schools.

One-to-one means putting a single, district-owned computer or iPad in the hands of each student rather than having students share classroom computers or visit computer labs.

Logan made the announcement during a Nebraska Department of Education video call last week. Superintendents from all across the state have been holding the calls regularly while all schools in the state are closed because of the coronavirus outbreak.

Jeremy Maskel, an OPS spokesman, said the district still is in the planning stages. A proposal to purchase the devices will go before the school board at or before the May 13 school board meeting.

Maskel said the district will get money from the federal coronavirus relief bill known as the CARES Act. He said the district is expecting that the cost of the devices to exceed what the CARES Act will cover and that the district will supplement the federal money.

The goal, he said, is to support distance learning.

The devices also could be used in the classroom if distance learning is not needed.

Some OPS students have struggled to participate in distance learning because of Wi-Fi connectivity problems. Other students don’t have the necessary devices to do the work and don’t have access to Wi-Fi.

Logan said the decision to buy the devices was made after looking at how much money the district will get for the next academic year.

Devices also would be purchased for paraprofessionals so they can continue to work one on one with students, Logan said.

“We decided that if we’re going to give out devices, we must give out Internet,” Logan said during the video chat. “We have to put that into our costs. We also have to think about staff.”

Earlier this month, the school board approved the purchase of 2,000 iPads with cellular data capabilities for $1.3 million for use in summer school.

Some OPS schools, but not all, had one-to-one computer arrangements before schools were closed. According to Maskel, some form of one-to-one computer use was in place at six middle schools as well as Burke, North and Northwest High Schools — at Northwest, 12th graders had it.

One-to-one practices varied at the schools, he said. At some schools, he said, students checked out the same computer during homeroom for the entire school day, then checked it back in at the end of the day. At others, students took devices home.

But those devices did not necessarily have the capability to be used without Wi-Fi, Maskel said.

Logan said that when the pandemic started, the district decided to give middle and high school students the technology OPS already had, knowing that some students would have access to the Internet and others would not.

District officials, she said, knew some students would be able to use phones as connectivity hot spots or get discounted Wi-Fi from Cox Communications.

For elementary students, the district passed out paper packets.

“We knew it was going to be piecemeal and that we were not going to be able to solve it between when the pandemic started and the end of the academic year because we would have to train everybody on new devices,” she said.

Logan said the district would have had to hand out 54,000 new devices, which could have put staff at risk. She also didn’t want to buy old machines that vendors couldn’t otherwise sell.


Omaha-area high schools ranked by 2019 ACT scores

Omaha-area high schools ranked by 2019 ACT scores

State_and_regional
More masks, more pay, more protections needed for meatpackers, Nebraska groups say

Meatpacking workers increasingly falling ill with the coronavirus shouldn’t be asked to risk their health without stronger safety measures in place, Nebraska advocacy groups said Wednesday.

They called on Nebraska Gov. Pete Ricketts and food giants like Tyson and Smithfield to work with them to institute more aggressive measures to stop the spread of COVID-19, which has infiltrated meat and food production plants across the country and in Nebraska, sending coronavirus rates soaring in communities like Grand Island, Lexington, Madison and Crete, and in Dakota County.

Ten new deaths were reported in the Grand Island area Wednesday, bringing the total number who have died from the coronavirus there to 35. And Wednesday night, Tyson Fresh Meats announced that it would temporarily close its Dakota City beef plant over the weekend to sanitize and deep clean, making it the first major meat producer to idle a facility in Nebraska.

“The spread of COVID-19 in meatpacking communities is happening because meat and poultry plants have responded insufficiently to this public health crisis,” said Becky Gould, executive director of Nebraska Appleseed, which organized a conference call with journalists. “We do not have to choose between food production and workers’ safety.”

The actions requested by representatives from groups like Nebraska Appleseed, Heartland Workers Center and the Center for Rural Affairs include spacing out workers on the production line, even if it slows productivity; providing more masks, gloves and other protective equipment; instituting paid sick leave so workers don’t have to choose between staying home and a paycheck; and more third-party inspections of facilities.

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Ricketts has refused to blame meatpacking plants for the outbreaks, saying “community issues” also must be addressed, including whether people are following social distancing recommendations outside of work and whether families live in multigenerational homes where it’s more difficult to quarantine.

“They’re probably more likely to pick up an infection outside of the workplace, where they spend two-thirds of their time,” the governor said at his daily coronavirus briefing Wednesday.

Tuesday, President Donald Trump signed an executive order requiring meatpacking and food production plants to stay open to prevent disruption to America’s meat and food supply “to the maximum extent possible.” The order relies on the Defense Production Act to classify meat processing as critical infrastructure.

But even as Trump and Ricketts stress the importance of keeping plants operational, community organizers relayed the stories and fears of workers, many of whom are immigrants and refugees.

A woman who leads a group called “Children of Smithfield” — the sons and daughters of pork plant workers in Crete — said that at first, workers were provided hair nets to cover their faces. The next day, that decision was overturned, and workers were told to bring in their own masks.

Guidelines seem to be ever-changing, she said, and don’t always square neatly with the precautionary measures that corporate executives say their plants have implemented.

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She spoke anonymously, because her father still works at the plant and has tested positive for COVID-19, one of at least 48 workers there with the virus. Asked about the use of hair nets and masks, a Smithfield spokesman sent a link to the company’s COVID-19 response website, which says the company has increased the amount of personal protective equipment provided to workers, among other safety steps.

Plant operators say they have been deep-cleaning plants, installing plastic dividers on the production line and in common areas like cafeterias and urging workers to stay home at the slightest sign of illness.

Wednesday, Tyson announced that it was offering additional bonuses to workers and truckers — $500 in May, and another $500 in July. The company will also expand short-term disability coverage to 90% of pay through the end of June and provide surgical-style masks that workers must wear.

The U.S. Centers for Disease Control and Prevention and the Occupational Safety and Health Administration released interim guidelines last weekend for meat and poultry processing facilities.

The suggestions, which are not enforceable, recommend that plants reconfigure production lines to keep workers 6 feet apart, if possible, check on HVAC and ventilation systems that could be spreading airborne virus particles, encourage workers not to carpool, a common practice, and install more hand-washing or hand-sanitizer stations.

“Workers involved in meat and poultry processing are not exposed to (the coronavirus) through the meat products they handle,” the guidance reads. “However, their work environments — processing lines and other areas in busy plants where they have close contact with co-workers and supervisors — may contribute substantially to their potential exposures.”

Ricketts said Wednesday that the state has given guidance to meatpackers via a “playbook” developed by University of Nebraska Medical Center officials, who are visiting the plants. Some recommendations, he said, go beyond what the CDC and Trump have advised.

He said he has talked to the head of the meatpackers union to gain the input of workers. He also said he has considered a personal visit to meatpacking plants but has tried to “live what I tell everybody else” to do, which is to stay at home and limit trips.

Gould said the plants seem to be the problem, not “community issues.”

“It’s pretty clear, when you look at the map of where outbreaks are happening around the country, that it’s happening where we have meat and poultry processing,” she said. “Other industries have large numbers of immigrant workers and you’re not seeing these outbreaks.”

Coronavirus clusters have emerged at other Nebraska workplaces, particularly nursing homes and other long-term care facilities.

Amanda Kohler, the executive director of the Refugee Empowerment Center in Omaha, said her organization isn’t placing any refugees in meatpacking jobs unless the organization knows the plants’ COVID-19 prevention protocols and is assured that employees are able to stay 6 feet apart.

Roughly 50 workers at the Crete facility briefly walked off the job Tuesday after Smithfield officials decided that the plant would stay open after all, on a reduced schedule, after announcing on Monday that it would temporarily shut down.

The daughter of the Smithfield worker said that despite the grueling nature of the work — slaughtering animals and cutting and packaging meat — the plant has provided steady employment for many workers and allowed them to send their children to college. Smithfield has given out scholarships.

“Many of our parents have given 10, 15, 20 and 25 years of service to the company, proving their loyalty and their continued desire to provide for their families,” she said. “What we ask for in return is responsibility, transparency and protection for our workers and our community.”

CHRIS MACHIAN/THE WORLD-HERALD 

The Nestle Purina plant in Crete, Nebraska.

Just how many meat processing workers in Nebraska have contracted the coronavirus is unknown. Workers said they often don’t know how many people have tested positive in their plant — a co-worker may be there one day, gone the next.

While some local health departments are releasing data on outbreaks at specific plants, suggesting that at least several hundred workers have tested positive, not all do. The Nebraska Department of Health and Human Services is not tracking those numbers, and several companies have declined to say how many workers are sick at specific plants, citing medical privacy.

Sergio Sosa, executive director of the Heartland Workers Center, said that anecdotally he’s heard that coronavirus cases in South Omaha meatpacking plants are ticking upward.

But “that data is not released or we don’t know,” he said. “The owners of those meatpacking plants should stand up. They should release the data.”

World-Herald staff writer Paul Hammel contributed to this report, which also includes material from the Associated Press.

April photos: Nebraska faces coronavirus

State_and_regional
special report
Fonner Park, in the heart of Nebraska, is now the center of the horse racing world

Remember the fairy tale about The Little Engine That Could?

Fonner Park is proving to be the little racetrack that could.

The Grand Island facility has continued horse racing despite an empty grandstand when many other larger tracks have been forced to shut down because of coronavirus concerns. Management has had to think outside the box to generate revenue, including sending its simulcast signal as far away as Australia. With only six tracks in America still racing, the spotlight on Fonner has gotten significantly brighter as fans from around the world watch and wager on races at a place they probably know little about.

“We figured we’d get more attention, but I’m not sure anyone thought it was going to be like this,” Fonner CEO Chris Kotulak said. “We’re doing everything we can to keep racing and raise purse money for our horsemen.”

Fonner’s 67th season has certainly proved to be the most unusual. COVID-19 has changed everything for Kotulak, an Omaha native who took over as the track’s CEO last July.

The meet started normally enough on Feb. 21, but big changes were ahead. By March 16, the facility had been shut down because of the coronavirus.

Kotulak met with Grand Island Mayor Roger Steele and discussed the possibility of continuing racing without spectators. An agreement was reached with Fonner’s assurance that all coronavirus precautions would be met.

So the track was allowed to keep racing, which it has done the past six weeks.

KENNETH FERRIERA/THE WORLD-HERALD 

Television screens show horse races inside the Fonner Park ticket office in Grand Island. Horse racing is one of the few sports that has not been canceled due to COVID-19.

Fonner’s simulcast signal is being sent all across America and to such faraway places as France, Australia, England, Ireland and Chile.

“We got a call from Scotland, and the guy had a bet with his friend about where we were located,” Kotulak said. “One guy saw ‘NE’ on the map and thought that stood for New England.”

It also has led to Fonner achieving a sort of cult status with the fans. The five-eighths mile track — smaller than the more prestigious 1-mile tracks in America that are not racing — brings its own level of Midwestern charm.

Many of those fans are taking advantage of off-track wagering through the Television Games Network, or TVG. The online horse racing business makes it easy for betting-starved fans — many of whom are already staying at home these days — to watch and wager on the races.

TVG account holders are able to wager online or by mobile phone. The service is legal in 31 states, but not Nebraska.

John Hindman, executive vice president and general counsel for TVG, knows all about Fonner. He graduated from Grand Island High in 1991 and is familiar with Nebraska racing.

“I’ve always felt like Fonner has been an unsung hero,” he said. “I have great memories of the track being a wonderful place.”

Hindman added that before this year, many race fans probably were unaware of Fonner or rarely wagered on the races there.

“There are people in our own company who didn’t know about it,” he said. “But that’s changed in recent weeks because it’s gotten national exposure.”

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That exposure has produced some eye-popping simulcast numbers, higher than Fonner management even imagined. The track’s previous single-day mutuel handle record was $1.2 million, but Fonner has easily blown past that mark and is averaging $2.8 million per day.

On-track betting numbers are considerably smaller, usually around $30,000. Fans have limited access to the facility and must stay in their cars, which are parked between the racetrack and the grandstand.

They wager via their MBet mobile accounts, which can only be activated when a fan is within the confines of the track.

Fonner gets only a small percentage of those giant simulcast pools. But it’s still been enough to generate money for live races while allowing horsemen to ply their trade.

“It’s an example of strange times calling for strange actions,” Nebraska Racing Commissioner Dennis Lee said. “Their season started the way it always has, but then they got a curveball and had to deal with it.”

Lee added that it’s taken a concerted effort by everyone at Fonner — management, trainers, jockeys, owners, breeders and others — to make it work.

“Rarely do you see so many people on such common ground,” he said. “But the desire to keep racing under really tough circumstances has brought them all together.”

Jockey Jake Olesiak said everyone is indeed on the same page.

“We’re all extremely happy that we’ve been able to keep racing,” he said. “We feel like we’re lucky to keep our livelihoods.”

The rider added that it is unusual to race in front of that empty grandstand.

“It’s definitely different,” he said. “It’s really quiet and in some ways it’s depressing, but at least we’re still racing.”

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Olesiak, who is second in the jockey standings with 41 wins, said it’s been fun to hear from relatives who are watching those Fonner races from afar.

“I’m getting calls from family all over the place,” he said. “I know a lot more people are watching our simulcasts this year, but I don’t feel any added pressure.”

Kotulak and his team made a shrewd move in late March by shifting race days from the traditional weekends to Mondays through Wednesdays. Only one other North American track — Will Rogers Downs in Oklahoma — is racing on those days.

Fonner also moved its first post time back to later in the afternoon, making it even more attractive for West Coast simulcast fans.

“They’ve made some good decisions that enhanced their racing,” Hindman said. “Moving their dates and their times helped generate even more interest.”

Adding to the track’s betting interest is a Pick 5 wager, in which fans need to correctly select the winners of five straight races. Those pots have grown enormous, including one that exceeded $4.1 million — an unheard-of amount for the small track.

The betting frenzy that day led to some controversy when the post time favorite won the first Pick 5 race but was disqualified because of jockey interference. Disgruntled fans lit up the track on Twitter, and Kotulak responded by defending the unanimous decision of his track’s stewards in a national interview.

“All of the eyes of the world seemed to be on us, so I explained it the best I could,” he said. “Was it unfortunate? Yes. Was it horse racing? Yes. Was it the crime of the century? No.”

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Kotulak said he received a lot of positive feedback after his forthright explanation.

Fonner, the first stop on the Nebraska racing circuit, has done well enough that the track was granted an extra 12 days of racing next month by the state racing commission. Many of those dates were going to be run at Omaha’s Horsemen’s Park, but its live meet recently was canceled because of stricter COVID-19 guidelines in Douglas County.

Fonner also recently received approval from the racing commission to send its simulcast signal to 15 additional outlets, including something called the Latin American Racing Channel.

“I really commend Chris and his team,” Lee said. “They’ve taken a negative situation and turned it into a positive.”

Lee added that if fans didn’t know about the racetrack before, they certainly do now.

“I’d love to see the number of Google searches for ‘Fonner Park’ before their season started and since,” he said. “Fans all over the world are getting to know about a small track located in the middle of Nebraska.”

Kotulak, who fields regular requests for Fonner memorabilia, remains a busy guy. He’s done several interviews about the track, including one with the New York Times.

But he also realizes that any racing day could be Fonner’s last, if the county deems it’s unsafe because of the coronavirus.

“I’m hopeful that if something good comes out of all this, it’s to prove that horse racing can still be a strong industry here,” Kotulak said. “We’re doing our best to prove that it can be.”

Photos: Nebraska's coronavirus helpers