Covid-19: Eli Lilly Says Its Antibody Treatment Does Not Work on Hospitalized Virus Patients – The New York Times

The drug maker Eli Lilly said on Monday that its antibody treatment was ineffective on patients hospitalized with advanced Covid-19 and that a government-sponsored trial would not administer the drug to new participants.

The company said that other trials of the treatment, in people who are not as sick or who have been exposed to the virus, would continue, and that it remained optimistic that the treatment could work if given early in the course of the disease.

Earlier this month, Chris Christie, the former governor of New Jersey, said he had received the experimental treatment shortly after he was diagnosed with Covid-19. President Trump received a similar therapy, made by Regeneron, soon after he was infected. Both companies have applied to the Food and Drug Administration for emergency use of the treatment in outpatients.

Eli Lilly’s trial of hospitalized patients was being run by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and was paused two weeks ago after an outside safety panel flagged a “potential safety concern.”

Government officials said at the time that an independent board of scientific experts had found that after five days of treatment, the group of patients who had received the antibodies showed a different “clinical status” than the group who had received a saline placebo — a difference that crossed a predetermined threshold for safety.

On Monday, Eli Lilly said the recommendation to discontinue use of the antibody treatment, called bamlanivimab, “was based on trial data suggesting that bamlanivimab is unlikely to help hospitalized Covid-19 patients recover from this advanced stage of their disease.” The company also said “differences in safety outcomes between the groups were not significant.”

Dr. Eric Topol, a clinical trial expert at the Scripps Research Institute who has been following the treatment’s development, said the news “tells us they stopped the trial due to futility, as suspected,” and that it “suggests that the timing of monoclonal antibody administration — early — will be important.”

Other trials of the antibody treatment have shown early promise in people who were newly infected with the virus, showing that it can lower viral levels in patients and reduce visits to the emergency room and hospital.

The virus surge in the El Paso metropolitan area has gotten so bad so fast that local officials are taking drastic action, imposing a two-week stay-at-home order and a 10 p.m. to 5 a.m. curfew that took effect Sunday night.

The number of people hospitalized with coronavirus in this region along the Mexico border is soaring, and officials are scrambling to make space for them by setting up overflow beds in a convention center and under tents in parking lots and by flying patients out to medical centers outside the area.

As a third surge has taken hold in the country, the El Paso metro area now ranks 11th in the nation in coronavirus cases relative to its population, according to a New York Times database. The only cities that rank higher in this fall wave are in hard-hit Idaho, North Dakota and Wisconsin.

The swell of cases comes as case numbers in the United States has reached alarming records in recent days as outbreaks continue to grow across the country. While daily numbers of deaths are still lower than they were in the spring, at least 339 new coronavirus deaths and 59,691 new cases were reported in the United States on Oct. 25.

Texas has overtaken California as the state that has recorded the most cases, with over 900,000 since the pandemic began and a per capita case rate that ranks 17th in the nation. Its seven-day average of new cases is approaching 6,000, far below its July peak of over 10,000 but climbing sharply.

In El Paso, the number of people hospitalized with Covid-19 has more than tripled over the past three weeks, officials said. As of Monday morning, the total was 853, according to the University Medical Center of El Paso, where the coronavirus patient count has doubled in four days.

As of Sunday, one-third of all the patients in the region’s hospitals had Covid-19, according the county’s curfew order. The top elected executive in El Paso, County Judge Ricardo A. Samaniego, wrote in the order that hospital intensive-care units were completely full.

Violations to the order would be a misdemeanor punishable by a fine of up to $500.

Mr. Samaniego also “strongly encouraged” the suspension of all extracurricular activities in schools.

Gov. Greg Abbott of Texas announced on Sunday that the state would provide a 50-bed temporary hospital at a convention center in the area. He has also asked the federal government to make the military hospital at Fort Bliss available for civilian patients. And the state is sending three or four mobile hospital units, which will be set up in parking lots.

At least 44 new coronavirus deaths and 3,935 new cases were reported in Texas on Sunday. Over the past week, there have been an average of 5,864 new cases a day statewide, an increase of 37 percent from the daily average two weeks earlier, according to a New York Times database.

An earlier version of this item referred incorrectly to virus outbreaks at construction sites, landscaping companies, a fire station and an eye-care clinic. Those were reported in El Paso County, Colo., not El Paso County, Texas.

The United States and much of Europe barreled into the new week scrambling to confront surges in new cases that threaten to overwhelm hospitals, with just eight days until the American presidential election.

Stock and oil prices dropped Monday in response to a continued stalemate in the United States over additional virus aid and new restrictions to halt a third surge in cases.

The United States hit a record number of daily new cases on Friday, while the death toll surpassed 225,000. Over the past week, the U.S. has averaged a record of nearly 70,000 new cases each day, an increase of over 30 percent from the average two weeks earlier.

More than 41,000 people are hospitalized with the coronavirus in the United States, a 40 percent rise in the past month. And though daily death tolls have not risen so sharply, they are inching upward.

At least five members of Vice President Mike Pence’s staff have tested positive for the coronavirus, but that’s not keeping him from the campaign trail: Mr. Pence traveled to Minnesota for a rally on Monday afternoon. But the vice president did not preside over the Senate vote for Amy Coney Barrett or attend the White House swearing-in ceremony Monday night for the new Supreme Court justice.

Mr. Pence and his wife, Karen, tested negative for the virus on Monday morning, his office said. His chief of staff, Marc Short, was among the aides who have tested positive for the virus in recent days.

A spokesman would not say whether the vice president was receiving some of the drugs Mr. Trump was given, including an experimental cocktail of antibodies by the pharmaceutical company Regeneron, as a preventive measure.

In an interview with Yahoo Finance, Dr. Anthony S. Fauci, the nation’s top infectious disease expert, pushed back on the idea that the increasing numbers of coronavirus cases are indicative of a “third wave” of infections, referring to the rise instead as a continuation of the original wave of infections from earlier this year.

“We never really cleared and got down to a very low baseline, which I would consider to be less than 10,000 per day,” Dr. Fauci said.

“We’ve never really had waves in the sense of up and then down to a good baseline,” he continued. “It’s been up and wavering up and down until now, we’re at the highest baseline we’ve ever been, which is really quite precarious.”

Stocks on Wall Street extended last week’s decline on Monday, following European shares lower as more restrictions, including curfews and business closures in Spain and Italy, were introduced to try to combat a second wave of the pandemic. The S&P 500 closed down about 1.86 percent. The Stoxx Europe 600 index closed down 1.8 percent.

Oil prices also fell, with rising cases expected to reduce demand. Futures for West Texas Intermediate, the U.S. crude benchmark, fell 2.6 percent to below $39 a barrel.

The news from Europe continued to be grim: Britain, which had the greatest surge of excess deaths during the pandemic’s first peak in Europe and still holds the most reported deaths in the region, has recorded 151,391 new cases in the past seven days, according to a Times database. And in Liege, Belgium, where about 25 percent of medical workers are sick with Covid-19 and unable to work, doctors who have tested positive for the coronavirus but are asymptomatic are being asked to stay on the job, the BBC reports.

France has added nearly a quarter of a million cases — 241,473 — in the past seven days. On Sunday alone, the country reported 52,010 new cases, and the head of the scientific council that advises the government on the pandemic said that the real number could be over 100,000 cases per day. Officials have warned repeatedly that intensive care beds were quickly filling with Covid-19 patients.

Among health care workers, nurses in particular have been at significant risk of contracting Covid-19, according to a new analysis of hospitalized patients by the Centers for Disease Control and Prevention.

The findings were released Monday as a surge of new hospitalizations sweeps the country, with several states hitting record levels of cases.

About 6 percent of adults hospitalized from March through May were health care workers, according to the researchers, with more than a third either nurses or nursing assistants. Twenty-seven percent of those hospitalized workers were admitted to the intensive care unit, and 4 percent died during their hospital stay.

The study looked at 6,760 hospitalizations across 13 states, including California, New York, Ohio and Tennessee.

Health care workers “can have severe Covid-19-associated illness, highlighting the need for continued infection prevention and control in health care settings as well community mitigation efforts to reduce transmission,” the researchers said.

From the beginning of the pandemic in the United States, front-line medical personnel have complained of shortages of personal protective equipment. Some of the shortages abated for a while, but supplies have become strained in certain areas of the country amid the new outbreaks.

“We need more testing,” said Michelle Mahon, the assistant director of nursing practice at National Nurses United, a union whose members have been vocal from the beginning of the pandemic about the dangers they faced without adequate supplies and protection.

Calling the findings no surprise, Ms. Mahon criticized federal officials for not having more robust guidelines in place. Her organization, which issued a report on workers’ deaths last month, says about 2,000 health care workers have died from the virus.

Facing a sharp rise in infections that has strained hospitals across Idaho, Gov. Brad Little on Monday reimplemented some statewide restrictions to limit the spread of the virus.

In recent months, Mr. Little has deferred to local agencies to set restrictions. But he said Idaho had reached a tipping point that required statewide action for rules that would limit gatherings and enforce masks at long-term care facilities. The governor continued to resist a statewide mask mandate, saying he wanted mask-wearing rules to be determined by local officials, and he called for people to take personal responsibility.

“I ask each of you to recommit yourselves to fighting this ugly disease — to protecting your loved ones and neighbors,” Mr. Little said.

Idaho has averaged almost 900 new coronavirus cases per day over the past week, more than triple the numbers seen in early September. Hospitals have seen case numbers surge and have been warning that the continued trajectory could leave them in a dire situation.

Dr. Andrew Wilper, the chief of staff at the Boise VA Medical Center, said the state is seeing unchecked spread of the virus, including an outbreak at the Idaho State Veterans Home. He said the outbreak was threatening the medical center’s ability to maintain hospital operations.

Since the early days of the pandemic, Idaho has faced backlash from residents who view coronavirus restrictions as an infringement on personal rights. Dr. Wilper pleaded with people to consider the risks faced by veterans and wear a mask.

“They need you to do the thing that may be an inconvenient burden for your life — but to not mistake an inconvenience for oppression,” he said.

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New Jersey Governor Addresses Newark’s Coronavirus Mandates

At his Monday news conference, Gov. Philip D. Murphy of New Jersey said the state is working with Newark to enforce new coronavirus mandates as cases surge.

I don’t anticipate more guidance. But I do anticipate continued high level of communication and cooperation. We’ve been on, back and forth, either me personally or our teams, on with Newark throughout the weekend. You know, on our side, the particular commitments are around what we could do to plus-up enforcement to augment what Newark is doing themselves. I think Pat was on with the director of law enforcement earlier today, Director Ambrose; tracing, testing, including mobile testing, amplifying the bullhorn and making sure it’s effective in cross languages. And that is — those are the areas that we’ve been focused on. And again, our lines of communication are wide open. And I can’t say enough good things about Mayor Baraka. And you’re right, it isn’t the only hot spot. It is our largest city, however, and so Newark’s number is — just as it relates to raw numbers, absolute numbers — is, you know, our large.

Newark, New Jersey’s largest city, on Monday announced an 8 p.m. daily closing time for all nonessential businesses citywide, beginning Tuesday. Sports practices and games are being canceled in a section of the city where a recent seven-day average rate of positive coronavirus tests had reached 25.3 percent.

Hair and nail salons — and City Hall — will be open by appointment only, and no one may wait indoors, Mayor Ras Baraka said. Health clubs and gyms must close for 30 minutes every hour for thorough cleaning.

Newark’s public schools had not yet reopened for in-person instruction, but all sports practices and games in the city’s East Ward, where the recent positivity rate spiked to levels not seen since May, have been suspended.

“This is not the first time Covid-19 has threatened our city and its residents at this magnitude and once again, we will meet this challenge with determination and guided by data,” Mr. Baraka said in a statement.

Gov. Philip D. Murphy said at a news conference on Monday afternoon that the state was ramping up testing and contact tracing in Newark, and helping the city enforce public health regulations.

“Mayor Baraka is a great mayor and a great leader,” Mr. Murphy said. “This isn’t the first time Newark has gone through this.”

Newark is the largest municipality in Essex County, which has had more virus-related deaths since March than any other county in New Jersey.

As of Sunday, the deaths of 672 Newark residents had been linked to Covid-19. The three-day average citywide positivity rate was 11.2 percent, more than double the statewide rate for the same period, the city said Monday.

Newark is the first municipality in New Jersey to adopt new, targeted shutdown measures, and comes as the number of virus cases is increasing across the state. As of Sunday, New Jersey has had an average of 1,208 new cases every day for the last week, an increase of 56 percent from the average two weeks earlier, according to a database compiled by The New York Times.

The governor said that recent daily case totals were particularly high in Bergen, Essex, Middlesex, Passaic and Union counties. He said the statewide daily rate of positive test results on Oct. 22, the most recent data available, was 4.48 percent.

Mr. Murphy said he and his wife, Tammy Murphy, both tested negative on Monday morning. Mr. Murphy said it was his fourth negative test since last Monday, after he had been exposed to a member of his senior staff who tested positive.

A few weeks ago, Gov. Andrew M. Cuomo of New York imposed targeted lockdowns in certain hot spots across the state in response to localized spikes in the positivity rate. Though some restrictions were eased last week, many remain in New York City, an acknowledgment that targeted rules were still key to suppress isolated outbreaks. The governor also said last week that the state would exclude nearby New Jersey, Connecticut and Pennsylvania from New York’s quarantine list, saying that there was “no practical way” to enforce the requirement.

At a news conference on Monday, Mr. Cuomo again stressed the importance of limiting travel as much as possible between the areas, and said that the state planned to make more testing available at train and bus terminals. In response to a question about the announcement in Newark, Mr. Cuomo said that he was concerned about numbers in New Jersey and that he had been in contact with Mr. Murphy.

u.s. roundup

A new study by economists at the University of Kansas has found that counties in the state where residents are obliged to wear masks in public have seen about half as many new coronavirus infections as counties that do not have a mask mandate in force.

The study by the university’s Institute for Policy & Social Research is part of a countrywide trend, experts said. Localities that impose mask mandates often see fewer cases, fewer hospitalizations, fewer deaths or lower test-positivity rates than nearby localities that do not.

The same trend has been seen in Alabama, Kansas, Oklahoma, South Carolina and Texas, according to a report from Prevent Pandemics, a nonprofit group advocating pandemic-fighting measures.

“Mask mandates, if they are done well, can increase mask use — and increased mask use is part of an effective response,” said Dr. Thomas R. Frieden, a former director of the Centers for Disease Control and Prevention who now runs Resolve to Save Lives, of which Prevent Pandemics is a part.

The Kansas study began after Gov. Laura Kelly issued a statewide mask order on July 2, but allowed counties to opt out of it. She was obliged to give counties that freedom under a law passed in June limiting her emergency management powers. All but 24 of the state’s 105 counties formally opted out of her mask order, and only 20 counties enforced it.

“Economists love natural experiments, and Kansas was running a natural experiment,” said Donna K. Ginther, director of the university’s Institute for Policy & Social Research, which conducted the study.

Differences in the spread of the virus between the masked and unmasked counties began to appear about two weeks later, she said, “and in mid-August, cases really began to take off.”

In the mask-wearing counties, new-case rates stayed roughly steady at about 7 per 100,000 residents through mid-October, her figures show, while they doubled in counties without mandates, to about 14 per 100,000.

Cellphone-tracking data from the University of Maryland showed no differences in how often people left home in the counties with or without mask mandates, she said, so it seemed likely that the masks made the difference.

The study data has been presented to state officials, but has not yet been submitted to an academic journal for review, Dr. Ginther said.

On Monday, Dr. Scott Gottlieb, a former commissioner of the Food and Drug Administration, published an editorial in The Wall Street Journal recommending a limited and temporary nationwide mandate for wearing masks as the best way to stop the spread of the coronavirus as winter approaches. Dr. Anthony S. Fauci, the nation’s top infectious disease expert, said on Friday that the country should consider taking such actions.

In other developments around the nation:

• A member of Miami Beach’s city commission, David Richardson, announced that he had tested positive for the virus, after weeks of helping to run a food drive. The news prompted candidates for other offices who had attended events with him to pause their campaigns and get tested.

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De Blasio Says In-Person Class Attendance Is a ‘Work in Progress’

Mayor Bill de Blasio of New York announced on Monday that due to coronavirus restrictions, just over a quarter of the city’s public school students have attended any in-person classes since schools reopened last month.

We knew that this would be a very, very tough year. We knew back in March when we had to close our schools instantly and go to all remote, and we knew in the months leading up to the opening of schools that this would be extremely difficult to do something that few school systems in America have even attempted to reopen in a safe, healthy manner, in a way that really would give kids both the advantage of in-person education and the health and safety they need and all the adults in the building need. Well, right now we have evidence, and it’s overwhelming and it’s outstanding evidence, that through the amazing work of our colleagues at the Department Education, and all the folks in our school buildings and our school communities, our schools are safe. It has been proven over and over again. The latest information we have from our random testing program and hundreds and hundreds of schools, is the positivity rate based on that testing program is 0.15 percent. Here’s a crucial number, and this number is one that I think needs to be understood as a work in progress. So far, we’ve had 280,000 kids who have attended school in person. Now there’s a lot more who could, and we want to address that situation. That 280,000 of course, that’s a huge number unto itself. And many, many more kids than attending in person than many parts of the country. But a lot more kids could be attending in person, and we want to make sure that their families know. And they know that school is safe.

Just over a quarter of New York City’s public school students have attended any in-person classes since the city’s school system reopened last month, Mayor Bill de Blasio announced on Monday, a low figure that undermined the mayor’s main justification for returning students to classrooms.

Mr. de Blasio has said that he pushed for in-person classes because a vast majority of city parents wanted him to do so. Yet despite his efforts, more than 500,000 of the 1.1 million children in the system, the nation’s largest, elected to start the year last month with online classes only.

Now it is clear that even more families than expected have opted out of in-person instruction, with new data showing that about 283,000 children have shown up.

“This is a number that needs to be understood as a work in progress,” Mr. de Blasio said during a news conference. “A lot more kids could be attending in person,” he added, “and we want to make sure that their families know and they know that school is safe.”

The city is facing a major test: convincing families that it is safe, and educationally sound, to send children into classrooms during the coronavirus pandemic. Those who started the year remote-only have until Nov. 15 to opt back in to classroom learning, with those children resuming in-person classes on Nov. 30.

If children do not return in significant numbers later this fall, it would severely undercut the mayor’s push to reopen, an ambitious yet fraught effort that faced strong political headwinds from union leaders, rank-and-file educators and some parents.

The mayor said he expected many more students to opt back in, in part because random testing in city schools had resulted in a remarkably low positivity rate of .15 percent as of last week. He also said Monday that the seven-day average rate of positive test results citywide was 1.73 percent.

The city had initially said that families could opt back in once a quarter, but the schools chancellor, Richard A. Carranza said on Monday that was no longer an option.

New York City is one of a few large districts nationally that have welcomed children back into classrooms this fall, and there are still more students attending classes in person than in nearly any other city in the country.

The city has roughly 1,800 schools, making the herculean task of reopening the most closely watched in America. Cities in particular have struggled with the question, with some tentatively reopening for younger students and others opting to remain all remote.

Global Roundup

China’s top leader, Xi Jinping, is expected to declare victory in the next two months in a campaign to eliminate extreme poverty in the country. The Chinese economy is once again gaining strength, and the Communist Party’s achievements in reducing poverty are expected to feature prominently this week at a conclave of party leaders in Beijing.

Four decades of fast economic growth lifted most people in China out of poverty. Mr. Xi’s antipoverty drive is focused on about five million people who earn less than 92 cents a day, down from nearly 56 million five years ago.

Vowing to “leave no one behind,” Mr. Xi has traveled to hard-hit areas like Wangjiaba to reiterate his commitment.

But the pandemic has exposed the party’s shortcomings in providing its most vulnerable citizens with more than the barest of social safeguards, especially in rural areas. And some experts warn that the government’s response to the crisis — favoring infrastructure spending and tax breaks for companies instead of direct aid for families — may widen China’s gap between rich and poor.

China has for decades treated rural people as second-class citizens, limiting their access to high-quality health care, education and other benefits under the strict Mao-era household registration system by keeping them from moving to the cities.

China’s early efforts to fight the spread of the virus, including lengthy lockdowns, left rural residents stranded hundreds of miles from the factories where they work. Many were unemployed for months. Their children also fell behind, lacking the internet connections or hardware to take part in online classes.

A recent study by Stanford University’s Rural Education Action Program found that incomes fell severely among rural workers during the peak of China’s outbreak in February and March.

The central government has done little to address the pressures facing rural workers during the pandemic, the Stanford study found. The government has directed much of its aid to businesses in urban areas.

In other developments around the world:

• Melbourne, Australia, will end a strict lockdown of more than three months, officials announced on Monday, after the city recorded no new coronavirus cases for the first time since June. Starting Wednesday, restaurants, cafes and bars will be able to reopen, with some social-distancing restrictions, for the first time since July 9, and all retail will be able to reopen for the first time since August. Asked whether the easing of restrictions meant residents “can finally get back on the beers,” the premier of Victoria State, Daniel Andrews, said: “I might go a little higher up the shelf.”

• In Canada, the House of Commons will undertake a parliamentary investigation of the government’s handling of the pandemic. The probe will examine, among other things, the government’s purchase of protective equipment, medical devices and pharmaceuticals. The parliamentary committee conducting the investigation will be empowered to interview cabinet ministers, and to gain access to emails and documents related to government contracts. The virus has been resurgent in Ontario and Quebec.