U.S. drugmaker Eli Lilly & Co. said on Monday it is beginning a late-stage trial to study whether one of its experimental COVID-19 antibody treatments can prevent the virus' spread in residents and staff in U.S. nursing homes.
The phase 3 trial will test LY-CoV555, a treatment developed in partnership with Canadian biotech AbCellera, is expected to enroll up to 2,400 participants who live or work at a facility that have had a recently diagnosed case of COVID-19.
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"COVID-19 has had a devastating impact on nursing home residents," Lilly's chief scientific officer Daniel Skovronsky said in a statement. "Were working as fast as we can to create medicines that might stop the spread of the virus to these vulnerable individuals."
Lilly is already testing the drug in hospitals to study whether it can work as a treatment in patients who have the disease. This trial will test whether it works prophylactically.
It is launching the phase 3 trial in partnership with several long-term care facility networks across the country as well as the U.S. National Institute of Allergy and Infectious Diseases (NIAID).
Lilly said in order to speed the study it has created mobile research units including retrofitted recreational vehicles that can be deployed in response to outbreaks of the virus at nursing homes across the U.S.
LY-CoV555 belongs to a class of treatments known as monoclonal antibodies that are among the most widely used biotechnology medicines. Regeneron Pharmaceuticals Inc., and other drugmakers are testing similar treatments against COVID-19.
Last week Lilly told investors that LY-CoV555 had moved into mid-stage trials as a treatment and would start late stage-trials in the coming weeks. It expects efficacy data from the mid-stage trial in the fourth quarter.
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A Grand Traverse County woman is speaking out about her own exposure to COVID-19. 9&10s Bill Froehlich sat down with her one-on-one, to talk about how she caught the virus, what her symptoms were, and what she wants others to know.
A month ago, nurse Hannah Borsvold was focused on planning for the birth of her sisters baby. But she was exposed to the Coronavirus at work, so she got tested simply for peace of mind. She waited six days for test results. I kind of figured that my risk was pretty low, but with my sisters baby coming I wanted to be sure that Id test negative and be safe around the baby.
DAY ONE: Ill come right out and say it be brutally honest. I have COVID-19.
Hannah says she was surprised by the diagnosis. I was pretty positive I was going to have a negative screen based on the limited time I was around this person. Were all wearing a mask at work, were washing hands, were sanitizing. I got tested for peace of mind for myself and also for my sister and her husband.
Hannah started a daily video journal and shared it to Facebook. She says she wanted to document the experience. I myself am curious about how this virus progression is going to go. Id be lying if I said I wasnt nervous or scared.
DAY TWO: Hannah says she had a sore throat, headache, congestion, muscle aches, and loss of taste and smell. My throat hurts a little more today. All of the symptoms I had yesterday are progressing I still cant taste or smell anything. But she never had a fever, and her symptoms didnt last.
DAY THREE: I feel good today. Whatever Im doing is working, at least I hope. Im hoping this isnt a calm before the storm type of thing.
DAY FOUR: My grocery delivery was awesome. Im eating a lot of food. I have no problems with food intake, its just a big bummer that I cant taste anything.
DAY FIVE: Today I woke up feeling pretty darn good. I can feel every day a difference.
DAY SIX: And then the best day of isolation- meeting her niece through the window. Oh, hi! Hi baby!
DAY SEVEN: Halfway through quarantine she says symptoms disappeared and she was feeling good. Its day seven of COVID Chronicles which means Im halfway done with isolation.
The emotional and mental toll, she says, was the toughest. The 14 days of quarantine, the hardest part is life being put on pause, I think. You see and hear about everybody continuing on or not being able to hug people or theyre just within reach. Especially when you have big family moments that are passing you by. And the time is just ticking until you can be there and be a part of that. That got really tough.
Hannah kept up with the videos, as friends were concerned when she wouldnt check in with updates. I had good days and then really tough days. But the whole world is passing you by and theres nothing you can do about it because you have to protect everyone else around you.
And there was the fear which she tried to hide. I was pretty scared with how this virus was going to progress for me. I didnt tell people that I did pack a hospital bag and I was prepared if it got to that point for me. I think that was the scariest thing that I wasnt quite ready to share and scare people, because I wasnt sure how scared I needed to be.Ultimately, Hannah says her symptoms improved fairly quickly, and she spent most of isolation symptom-free. Im very thankful that my symptoms were so mild and I do try to remind people that its not like that for everybody.
Meeting her niece was Hannahs biggest priority but after two weeks stuck at home shes venturing out into the world slowly. Im just trying to get back to normal. Obviously I visited my sister. I went to a gas station to fill up my gas station, and I went to a beach.
Hannah says shes still being safe, and believes strongly in wearing a mask. I still feel the responsibility to be really cautious. Now, isolation is over and Hannah is free. Shes even hugged her brand new niece, and also added another item to her to-do list. Ive applied to be a plasma donor. Recovered COVID patients can donate their plasma, they assume my plasma has antibodies that can fight off the disease for really sick patients.
The two sides will further investigated the possible animal source, intermediate host and transmission route of the coronavirus.
BEIJING, China China and the World Health Organization are discussing plans to trace the origin of the coronavirus outbreak following a visit to the country by two experts from the U.N. agency, the foreign ministry said Tuesday.
Ministry spokesperson Wang Wenbin told reporters the experts conducted preparatory consultations on scientific research cooperation on virus tracing during their two-week stay, which ended Sunday.
Their talks touched on research in the areas of population, environment, molecules, animal traceability and transmission routes of the coronavirus, as well as plans for further scientific research, Wang said.
The two sides also further investigated the possible animal source, intermediate host and transmission route of the coronavirus to more effectively prevent and control the epidemic, Wang said.
Wang said the two sides worked on formulating a plan for Chinas contribution to the global tracing effort under a resolution passed by the World Health Assembly under WHO. No word was given on when that effort will begin in earnest.
The virus was first detected in the central Chinese city of Wuhan late last year and has been linked to a wholesale food market where wild animals were sold. Scientists think it likely jumped from a wild animal such as a bat to humans via an intermediary species, possibly the anteater-like pangolin.
However, China says a full investigation may have to wait until the pandemic is under control and has rejected accusations that it delayed releasing information to WHO at the start of the outbreak.
For most people, the new coronaviruscauses mild or moderate symptoms. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia and death.
The United States has more than 4.7 million confirmed cases of COVID-19, according to statistics from Johns Hopkins University.
Just after 7 a.m. EDT Tuesday, the U.S. more than 155,000 deaths from the virus. Worldwide, there are more than 18 million confirmed cases with nearly 700,000 deaths.
George Washington University is among the test sites for leading coronavirus vaccine candidate Washington Business Journal
More than 63 percent of U.S. residents are waiting longer than one to two days to get their coronavirus test resultsdelays that undermine the contact tracing that could identify individuals who are contagious but show no symptoms, according to results of a new survey by researchers from Northeastern, Harvard, Northwestern, and Rutgers universities.
Overall, the average wait was four days, but in some cases grew to as long as ten days or more for about 10 percent of respondents in a study. The discovery is significant in that health authorities consider rapid turnarounds essential to containing the COVID-19 pandemic, which has so far resulted in the deaths of more than 150,000 in the United States.
David Lazer is university distinguished professor of political science and computer and information sciences with joint appointments in the College of Social Sciences and Humanities and the Khoury College of Computer Sciences at Northeastern. Photo by Adam Glanzman/Northeastern University
Even more worrisome is that wait times do not seem to be diminishing across the country.
Given the timing of how quickly and how long someone is infectious, speed in producing reliable enough results is of the essence for COVID-19, researchers wrote.
A delay of even a day is critical given that the peak of contagiousness lasts about one week. In that time, scores more could be infected with SARS-CoV-2, the coronavirus that causes COVID-19, if they come in contact with someone who may seem healthy, making a positive test virtually useless.
This is definitely a case of closing the barn doors after the horses have escaped, says David Lazer, university distinguished professor of political science and computer and information sciences at Northeastern, and one of the researchers who conducted the study.
Its too slow for contact tracing and isolation to be effective.
The study of 19,058 people across all 50 states and the District of Columbia was conducted between July 10 and July 26, 2020. It asked residents if they had been tested for COVID-19 and how long they waited to get the results back.
It found that 37 percent of those who had been tested by nasal swab received results within two days, with 31 percent taking more than 4 days. For individuals who responded that their last test had been in April, they had waited on average 4.2 days to get results; for those who were tested in July, it was 4.1 days.
Transmission by people who are infected but have no symptoms (either because they will never develop significant symptoms or are presymptomatic) is a key driver behind the spread of COVID-19 because such people are more likely to go about their lives without adopting measures such as quarantining to stem transmission to others.
If individuals with COVID-19 simply manifested with a purple nose before they were contagious, the disease would be easier to contain and would quickly disappear, the researchers wrote. Testing is the functional equivalent of that purple nose.
Reasons for delays in getting test results out faster invariably point to a bottleneck in national testing labs, says Lazer. They are simply overwhelmed.
One solution to the challenge could be at-home tests, which have yet to be approved by the Food and Drug Administration. They have greater false negative rates but appear to perform better for individuals who are shedding more virus, says the study.
In terms of demographics, researchers found that Black and Hispanic people are waiting five days for their test results compared to four days for white respondents, a difference that could be explained by resources and local conditions in their communities, according to Lazer.
In separate, COVID-19-related studies, the universities researchers reported that the pandemic is resulting in higher support for voting by mail among likely voters.
The July study found 64 percent are in favor of making it easier to cast ballots by mail, and an even larger number (66 percent) say they would support giving every American the universal right to vote by mail in November, an effort opposed by President Donald Trump because of the potential for fraud.
Approval of the presidents handling of the pandemic is down 10 points since April, the latest findings show. Some Republican governors of states that reopened earlyand that have faced surges in COVID-19 infectionscontinue to see declining approval numbers, mirroring the presidents pandemic-related approval in those states.
For media inquiries, please contact media@northeastern.edu.
A patient of mine has worked for the same company for seven years and has three children under 5. After the birth of each, her employer offered 12 weeks of paid maternity leave. She returned to work each time feeling conflicted and depressed over leaving her babies; in one instance, she needed antidepressants. She couldnt quit because she was the familys main breadwinner, and her employer turned down her requests to work from home part-time on grounds that she wouldnt be productive and it would set a precedent for other employees.
Because...
There were 922confirmed cases of COVID-19 and one coronavirus-related death statewide, health officials reported Sunday.
The positive cases make up9.6% of the 9,643 tests processed since Saturday, according to the Wisconsin Department of Health Services.
As of Sunday,337people were in hospitals with known cases of the virus. Of those, 110were in intensive care, according to the Wisconsin Hospital Association.
Over 54,920people have tested positive for the virus; 9,994of reported cases remain active, while 80.1% of people have recovered from COVID-19.
The Department of Health's weekly ratings of county COVID-19 activity were reportedWednesday.Note that ratings are based on a combination of total new cases per 100,000 people over the past two weeks and the percent change in new cases between the past seven days and the seven days before that. Parentheses reflect a change in the activity level from the previous week's rating.
Global cases have surpassed 17.8million, and deaths neared 680,800as of mid-Sunday, according to Johns Hopkins University.More than 4.6million of those cases and 154,750 deaths were in the United States.
Contact Benita Mathew at (920) 309-3428 or bmathew@gannett.com. Follow her on Twitter at @benita_mathew.
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ROME When the coronavirus erupted in the West, Italy was the nightmarish epicenter, a place to avoid at all costs and a shorthand in the United States and much of Europe for uncontrolled contagion.
You look at whats going on with Italy, President Trump told reporters on March 17. We dont want to be in a position like that. Joseph R. Biden Jr., the presumptive Democratic nominee, used Italys overwhelmed hospitals as evidence for his opposition to Medicare for All at a presidential debate. It is not working in Italy right now, he said.
Fast forward a few months, and the United States has suffered tens of thousands more deaths than any country in the world. European states that once looked smugly at Italy are facing new flare-ups. Some are imposing fresh restrictions and weighing whether to lock down again.
Prime Minister Boris Johnson of Britain on Friday announced a delay to a planned easing of measures in England as the infection rate there rose. Even Germany, lauded for its efficient response and rigorous contact tracing, has warned that lax behavior is prompting a surge in cases.
And Italy? Its hospitals are basically empty of Covid-19 patients. Daily deaths attributed to the virus in Lombardy, the northern region that bore the brunt of the pandemic, hover around zero. The number of new daily cases has plummeted to one of the lowest in Europe and the world, said Giovanni Rezza, director of the infective illness department at the National Institute of Health. We have been very prudent.
And lucky. Today, despite a tiny uptick in cases this week, Italians are cautiously optimistic that they have the virus in check even as Italys leading health experts warn that complacency remains the jet fuel of the pandemic. They are aware that the picture can change at any moment.
How Italy has gone from being a global pariah to a model however imperfect of viral containment holds fresh lessons for the rest of the world, including the United States, where the virus, never under control, now rages across the country.
After a stumbling start, Italy has consolidated, or at least maintained, the rewards of a tough nationwide lockdown through a mix of vigilance and painfully gained medical expertise.
Its government has been guided by scientific and technical committees. Local doctors, hospitals and health officials collect more than 20 indicators on the virus daily and send them to regional authorities, who then forward them to the National Institute of Health.
The result is a weekly X-ray of the countrys health upon which policy decisions are based. That is a long way from the state of panic, and near collapse, that hit Italy in March.
This week, Parliament voted to extend the governments emergency powers through Oct. 15 after Prime Minister Giuseppe Conte argued the nation could not let its guard down because the virus is still circulating.
Those powers allow the government to keep restrictions in place and respond quickly including with lockdowns to any new clusters. The government has already imposed travel restrictions on more than a dozen countries to Italy, as the importation of the virus from countries is now the governments greatest fear.
There are a lot of situations in France, Spain, the Balkans, which means that the virus is not off at all, said Ranieri Guerra, assistant director general for strategic initiatives at the World Health Organization and an Italian doctor. It can come back at any time.
There is no doubt that the privations of the lockdown were economically costly. For three months, businesses and restaurants were ordered closed, movement was highly restricted even between regions, towns and streets and tourism ground to a halt. Italy is expected to lose about 10 percent of its gross domestic product this year.
But at a certain point, as the virus threatened to spread uncontrollably, Italian officials decided to put lives ahead of the economy. The health of the Italian people comes and will always come first, Mr. Conte said at the time.
Italian officials now hope that the worst of the cure came in one large dose the painful lockdown and that the country is now safe to resume normal life, albeit with limits. They argue that the only way to start up the economy is to keep tamping down the virus, even now.
The strategy of closing down completely invited criticism that the governments excessive caution was paralyzing the economy. But it may prove to be more advantageous than trying to reopen the economy while the virus still rages, as is happening in countries like the United States, Brazil and Mexico.
That does not mean that calls for continued vigilance, as elsewhere in the world, have been immune to mockery, resistance and exasperation. In that, Italy is no different.
Masks often are missing or lowered in trains or buses, where they are mandatory. Young people are going out and doing the things young people do and risk in that way spreading the virus to more susceptible parts of the population. Adults started gathering at the beach and for birthday barbecues. There is still no clear plan for a return to school in September.
There is also a burgeoning, and politically motivated, anti-mask contingent led by nationalist Matteo Salvini, who on July 27 declared that replacing handshakes and hugs with elbow bumps was the end of the human species.
At his rallies, Mr. Salvini, the leader of the populist League party, still shakes hands and wears his mask like a chin guard. In July, during a news conference, he accused the Italian government of importing infected immigrants to create new clusters and extend the state of emergency.
This week, Mr. Salvini joined other mask skeptics nicknamed the negationists by critics for a protest in the Senate library, along with special guests such as the Italian crooner Andrea Bocelli, who said he did not believe the pandemic was so serious because I know a lot of people and I dont know anyone who ended up in an I.C.U.
But the countrys leading health experts say that the lack of severe cases is indicative of a decrease in the volume of infections, as only a small percentage of the infected get very sick. And so far, Italys malcontents have not been numerous or powerful enough to undermine what has been a hard-won trajectory of success in confronting the virus after a calamitous start.
Italys initial isolation by European neighbors at the outset of the crisis, when masks and ventilators were hardly pouring in from across the borders, may actually have helped, Mr. Guerra, the W.H.O. expert, said.
Updated July 27, 2020
There was competition initially, there was no collaboration, Mr. Guerra said. And everyone acknowledged Italy was left alone at that time. As a result, he said, what they had to do at that time because we were left alone turned out to be more effective than other countries.
Italy first quarantined towns and then the Lombardy region in the north and then the entire peninsula and its islands, despite the near absence of the virus in much of central and southern Italy. That not only prevented workers in the industrial north from returning home in the much more vulnerable south, but it also fostered and forced a unified national response.
During the lockdown, movement was strictly limited, between regions and towns and even city blocks, and people had to fill in auto-certification forms to prove that they needed to go outside for work, health or other necessities. Masks and social distancing regulations were enforced by some regional authorities with steep fines. Generally, if grudgingly, the rules were followed.
As searing scenes of human suffering, empty streets and the heavy toll on an elderly generation of northern Italians spread, the transmission rate of the virus quickly decreased, and the curve flattened, as opposed to other European countries, such as Sweden, which pursued an alternative to locking down.
That the initial outbreak was localized in the overwhelmed hospitals created enormous stress, but it also enabled doctors and nurses to expedite contact tracing.
Then the country reopened, gradually, expanding liberties at two-week intervals to respond to the viruss incubation period.
The lockdown eventually had a secondary effect of decreasing the volume of virus circulating in society, and thus reducing the probability of coming in contact with someone who had it. At the end of the lockdown, the virus circulation had steeply fallen off and in some central and southern regions, there were hardly any chains of transmission at all.
Its always a matter of probability with these pathogens, said Mr. Guerra, adding that new early alarm systems such as the monitoring of wastewater for traces of virus had lowered the probability of infection even more.
Some Italian doctors say they believe that the virus is now behaving differently in Italy. Matteo Bassetti, an infectious-disease doctor in the northwestern city of Genoa, said that during the height of the crisis, his hospital was inundated with 500 Covid-19 cases at one time. Now, he said, his intensive care unit, with 50 beds, has no coronavirus patients, and the 60-bed Covid-19 unit built specially for the crisis is empty.
He said he thought that the virus had weakened an unproven view, he acknowledged, that has nonetheless found an eager audience in Mr. Salvini and other politicians opposed to extending the state of emergency.
Most health experts said that the virus still loomed, and as the government considers a new decree to reopen night clubs, festivals and cruise ship travel, many of them have implored the country not to let down its guard.
Even if the situation is better than in other countries, we should continue to be very prudent, said Dr. Rezza of the National Institute of Health, adding that he thought the question of what Italy had done right was better posed at the end of the epidemic.
We cannot exclude that we will have outbreaks in Italy in the next few days, he said. Maybe its just a matter of time.
Emma Bubola contributed reporting from Milan.
The Northeast, once the viruss biggest hot spot, has improved considerably since its peak in April, when the region suffered more than any other region of the country. Yet cases are now increasing slightly in New Jersey, Rhode Island and Massachusetts, as residents move around more freely and gather more frequently in groups.
Across the country, deaths from the coronavirus continue to rise. The country was averaging about 500 per day at the start of July. Over the last week, it has averaged more than 1,000 daily, with many of those concentrated in Sun Belt states. On Wednesday, California, Florida and Texas reported a combined 724 deaths, about half the national total.
Houston, the fourth-largest city in the country, has been adjusting to a new normal where the only thing certain is that nothing is certain. After cases and hospitalizations seemed to level off and even decrease in recent days, Harris County on Friday broke a single-day record with 2,100 new cases.
I think to a certain extent, we saw a spike because people were fatigued over it, said Alan Rosen, who leads the Harris County Precinct One constables office. They were fatigued over hearing about it every day. They were fatigued about being cooped up in their house and being away from people.
People there have been coping with the lulls and peaks of a physical, emotional, fiscal and logistical crisis from an invisible foe nearly three years after surviving Hurricane Harvey, one of the worst disasters in American history.
It is a roller coaster, said Mr. Rosen, who recovered after getting infected with the virus in May. Its not like a hurricane thats coming through and we know what to do. We know we got to clean up and rebuild and everybody is accustomed to the time frame. But with this, there are just so many unknowns.
Julie Bosman reported from Chicago, Manny Fernandez from Houston and Thomas Fuller from Alturas, Calif. Mitch Smith contributed reporting from Chicago.
One or two confirmed cases in a single classroom would require those classes to close for 14 days, with all students and staff members ordered to quarantine. The rest of the school would continue to operate, but if two or more people in different classrooms in the same school tested positive, the entire building would close for an investigation, and might not reopen for two weeks depending on the results.
In California, where schools in two-thirds of the state have been barred from reopening in person for now, state guidelines call for a school to close for at least 14 days if more than 5 percent of its students, faculty and staff test positive over a two-week period.
Updated July 27, 2020
Chicago, the nations third-largest school district, has proposed a hybrid system for reopening that would put students into 15-member pods that can be quarantined if one member tests positive. School buildings should close if the city averages more than 400 new cases a week or 200 cases a day, the plan states, with other worrying factors like low hospital capacity or a sudden spike in cases taken into account.
In Indiana, where the middle school student tested positive on Thursday in Greenfield, an Indianapolis suburb of 23,000 people, the virus began to spike in mid-June, and the caseload has remained relatively high. This week, Indianapolis opted to start the school year online.
The Greenfield-Central Community School Corporation, with eight schools and 4,400 students, gave families the option of in-person or remote learning. At Greenfield Central Junior High School, which the student with the positive test attends, about 15 percent of the 700 enrolled students opted for remote learning, said Mr. Olin, the superintendent.
It was overwhelming that our families wanted us to return, he said, adding that families needed to be responsible and not send students to school if they were displaying symptoms or awaiting test results. Students are also required to wear masks except when they are eating or for physical education outside, he said and as far as he knew, the student who tested positive was doing so.
