Video above: How the US is faring in the COVID-19 pandemic as protests continue to rage in the countryVideo may contain images that are offensive. Viewer discretion is advised.The latest:There have been more than 1.8 million coronavirus cases in the United States, according to the Johns Hopkins University tally.The U.S. death toll has surpassed 105,000 people, according to Hopkins. Nearly 26,000 nursing home residents have died from coronavirus, according to federal data released Monday.The Food and Drug Administration is expanding the kinds of companies that can make hand sanitizer while demand continues to outpace supply.North Carolina’s governor said Tuesday that the GOP must prepare for a scaled-back Charlotte convention because of the coronavirus pandemic, with the national Republican chairwoman responding that organizers would begin visiting other potential host cities.Gov. Roy Cooper, a Democrat, said in a letter to the top convention organizer and the national GOP chairwoman that he’s happy to continue conversations over how to hold the convention safely, and is still awaiting a safety plan requested by North Carolina officials.“The people of North Carolina do not know what the status of COVID-19 will be in August, so planning for a scaled-down convention with fewer people, social distancing and face coverings is a necessity,” Cooper said in the letter.Republican National Committee Chairwoman Ronna McDaniel, one of the recipients of Cooper’s letter, released a statement saying that while the party would like to hold its event in Charlotte, “we have an obligation to our delegates and nominee to begin visiting the multiple cities and states” that have reached out to express interest in hosting. Governors of Tennessee, Florida and Georgia are among the leaders who have said they would be interested in hosting if North Carolina falls through.Wednesday was the deadline from the GOP for assurances from Cooper. Last week, Trump demanded Cooper that guarantee him a full-scale event and answer him within a week. Otherwise, he has threatened to move the event elsewhere.First human trial of potential antibody treatment beginsEli Lilly and Company said Monday it has started the first human trial of an antibody therapy designed to treat COVID-19.The first phase of the trial will test whether the therapy is safe and well-tolerated; those results are expected in late June. The first COVID-19 patients being treated with the therapy are hospitalized at New York University’s Grossman School of Medicine in New York, Cedars-Sinai in Los Angeles and Emory University in Atlanta, the company told CNN.If the trial ultimately shows the treatment is effective against COVID-19, it could be available by fall, according to the Indianapolis-based company.”Until now, scientists have been trying to repurpose medicines, drugs, that were designed for new diseases to see if they work in COVID-19, but as soon as this epidemic started, we got to work making a new medicine against this disease,” said Dr. Dan Skovronsky, Eli Lilly’s senior vice president and chief scientific officer.”Now we’re ready and testing it in patients.”The treatment was created in collaboration with AbCellera, a biotechnology company based in Canada. When someone recovers from a disease like COVID-19, their body produces millions of proteins called antibodies, which fight off the disease and help them recover. AbCellera acquired a blood sample from one of the first U.S. patients who had recovered from COVID-19, and the companies sorted through millions of this patient’s cells to find hundreds of antibodies.Scientists at AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases selected those they thought would be most potent and Lilly scientists engineered the treatment, known as a monoclonal antibody therapy. This approach has worked to treat other illnesses; there are monoclonal antibody therapies that treat HIV, asthma, lupus, Ebola and some forms of cancer.It’s not clear if such a therapy will work against COVID-19, but when this treatment was used on on cells in the lab, it blocked the ability of the virus to infect the cells, Skovronsky said. The data is not yet published, but based on those results, scientists got the green light to take the next step and prepare it to be tried in patients.They also gave it a temporary name.”We call it LY-CoV555, lucky triple 5,” Skovronsky said. Manufacturing has already begunThis will be a randomized, placebo-controlled, double-blind Phase I trial. Some patients will be receive the medicine and some will receive a placebo, and patients or their doctors won’t be informed who received it and who didn’t.If the treatment appears to be safe, the company would move to the next phase of testing in a matter of weeks. The second phase of the trial will involve a larger number of patients, including patients who are not hospitalized, and will test whether the therapy is effective.The company also plans to study the drug as prevention. The treatment could be used for vulnerable patient populations for whom vaccines might not be a great option, such as the elderly or people who have chronic disease or compromised immune systems.Eli Lilly has already begun manufacturing the antibody therapy in large quantities so it could be tested and potentially for use in patients beyond the trial. Under non-pandemic circumstances, the companies would usually wait to find out if it worked first before it started making it.”If it does work, we don’t want to waste a single day, we want to have as much medicine as possible available to help as many people quickly,” Skovronsky said.In trials over the next several months, Lilly says it will test different mixtures of a few of the other antibodies scientists think might provide protection. The optimal scenario, though, Skovronsky said, is if they only need one antibody at a relatively low dose.”The more antibodies are mixed together, higher doses, the more difficult it is to manufacture,” Skovronsky said. “But if it has to be two antibodies, higher doses, or even three antibodies mixed together at higher doses, we’ll do whatever it takes to make effective medicine for patients.”Other antibody therapies in developmentEli Lilly isn’t the only company working on antibody treatments. Several U.S. teams have cloned antibodies to COVID-19 and many are close to testing in patients. Regeneron Pharmaceuticals has said it hopes to start human trials this month and to have a treatment by the end of the summer.”This approach definitely has promise and it is something we need,” said Dr. Peter Hotez, a vaccine specialist at Baylor College of Medicine who is not involved in this research. He said the challenge with COVID-19 is that there are two phases to the disease — the initial viral infection phase and then the host response, or the inflammatory response. Generally, a treatment like this is more likely to be effective if a patient gets it early in the course of the illness, when the virus is still replicating.”That’s always the problem with treating COVID-19 with monoclonal antibodies — if you wait until things are pretty far along, like including patients that are already on the ventilator, it may not have any clinical impact,” Hotez said. If it works though, it could also be useful if, for example, a patient in a nursing home tested positive for COVID-19, and such a treatment could be given to others at the facility; for a first responder that had just been exposed to a patient with COVID-19; or for health care workers, Hotez said.One challenge Hotez noted: Monoclonal antibody therapies tend to be “pretty expensive,” he said.Typically, such treatments would take many years to develop, but COVID-19 treatments are on an accelerated schedule. Pharmaceutical companies have said that government approvals that normally take weeks have sometimes come within a day.”It’s really been a privilege to be able to operate in this kind of environment,” Lilly’s Skovronksy said. He said he and others in the pharmaceutical industry have wondered if the same collaboration and urgency could be applied to treatments for other diseases like cancer or Alzheimer’s.”For many of us, this feels a little like a moonshot or a Manhattan Project, where so many scientists are working together at breakneck speeds,” Skovronksy said. “Surely there will be other advances that come of this.”A quarter of nursing homes report at least one infection, first official tally showsNearly 26,000 nursing home residents have died from coronavirus, according to federal data released Monday.One quarter of nursing homes had at least one case, and one in five had at least one death, according to the federal Centers for Medicare and Medicaid Services. The cases were more prevalent in poorly rated facilities, which typically have weaker infection controls and fewer staffers per resident.The report marks the first nationwide government tally showing the impact of the pandemic on nursing homes, which have been hit especially hard by the outbreak since the elderly are particularly vulnerable to the virus. Deaths in these facilities account for at least 25% of the total in the U.S.More than 60,000 nursing home residents have tested positive for the virus.The data, however, is not a complete picture, said Seema Verma, the agency’s administrator. It covers only about 80% of nursing homes, and it doesn’t include assisted living facilities. Also, CMS did not issue the requirement that nursing homes provide this information to the federal government until May 1, though Verma said that most facilities likely reported cases and deaths before that date, as well.Washington, D.C. had the highest rate, with 206 cases per 1,000 nursing home residents, followed by Massachusetts and Arizona. On the other hand, Hawaii reported no cases, while Vermont and Montana had fewer than one case per 1,000 facility residents.More data will be available on the agency’s Nursing Home Compare website starting on Thursday, including information about specific facilities. Families have complained that many homes have resisted sharing how many residents and staffers have tested positive and have died.The numbers of cases, which will be updated weekly, will likely increase.”We hope this public reporting system will help identify areas that are most in need of resources to fight the battle against COVID-19,” said Mark Parkinson, CEO of the American Health Care Association and National Center for Assisted Living. “We hope state and federal public health officials can use the data to help nursing homes by sending urgently needed resources.”The agency also announced new guidelines and enforcement actions to bring low-performing nursing homes into compliance. States will be required to conduct focused infection control surveys of their facilities by the end of July or submit a corrective action plan. If states still fail to do so, their federal coronavirus relief funding earmarked for surveys for 2021 may be reduced.CMS is providing $80 million to states in funding to perform those reviews, the agency said. A little more than half of facilities have been surveyed as of May 24.The tally comes two weeks after the agency recommended that nursing homes test all residents and staff for the coronavirus — and then continue to test employees weekly — as part of its plan to relax restrictions at the facilities. Industry groups immediately said that they cannot afford such a requirement and called for additional government assistance.States can use some of the $11 billion in federal funding allocated for testing to support nursing homes, Verma said.CMS in March advised nursing homes to close their doors to visitors and volunteers, with few exceptions, as the pandemic began to spread in the U.S.W2lmcmFtZSBzcmM9Imh0dHBzOi8vZDJjbXZicTdzeHgzM2ouY2xvdWRmcm9udC5uZXQvZW1haWwvcHJvZF9jb3JvbmF2aXJ1c19pZnJhbWVfYXJ0aWNsZS5odG1sIiBoZWlnaHQ9IjQxNCIgc3R5bGU9IndpZHRoOjEwMCU7Ym9yZGVyOm5vbmU7b3ZlcmZsb3c6aGlkZGVuIiBzY3JvbGxpbmc9Im5vIiBmcmFtZWJvcmRlcj0iMCIgYWxsb3dUcmFuc3BhcmVuY3k9InRydWUiXVsvaWZyYW1lXQ==
Video above: How the US is faring in the COVID-19 pandemic as protests continue to rage in the country
Video may contain images that are offensive. Viewer discretion is advised.
The latest:
- There have been more than 1.8 million coronavirus cases in the United States, according to the Johns Hopkins University tally.
- The U.S. death toll has surpassed 105,000 people, according to Hopkins.
- Nearly 26,000 nursing home residents have died from coronavirus, according to federal data released Monday.
- The Food and Drug Administration is expanding the kinds of companies that can make hand sanitizer while demand continues to outpace supply.
North Carolina’s governor said Tuesday that the GOP must prepare for a scaled-back Charlotte convention because of the coronavirus pandemic, with the national Republican chairwoman responding that organizers would begin visiting other potential host cities.
Gov. Roy Cooper, a Democrat, said in a letter to the top convention organizer and the national GOP chairwoman that he’s happy to continue conversations over how to hold the convention safely, and is still awaiting a safety plan requested by North Carolina officials.
“The people of North Carolina do not know what the status of COVID-19 will be in August, so planning for a scaled-down convention with fewer people, social distancing and face coverings is a necessity,” Cooper said in the letter.
Republican National Committee Chairwoman Ronna McDaniel, one of the recipients of Cooper’s letter, released a statement saying that while the party would like to hold its event in Charlotte, “we have an obligation to our delegates and nominee to begin visiting the multiple cities and states” that have reached out to express interest in hosting. Governors of Tennessee, Florida and Georgia are among the leaders who have said they would be interested in hosting if North Carolina falls through.
Wednesday was the deadline from the GOP for assurances from Cooper. Last week, Trump demanded Cooper that guarantee him a full-scale event and answer him within a week. Otherwise, he has threatened to move the event elsewhere.
First human trial of potential antibody treatment begins
Eli Lilly and Company said Monday it has started the first human trial of an antibody therapy designed to treat COVID-19.
The first phase of the trial will test whether the therapy is safe and well-tolerated; those results are expected in late June. The first COVID-19 patients being treated with the therapy are hospitalized at New York University’s Grossman School of Medicine in New York, Cedars-Sinai in Los Angeles and Emory University in Atlanta, the company told CNN.
If the trial ultimately shows the treatment is effective against COVID-19, it could be available by fall, according to the Indianapolis-based company.
“Until now, scientists have been trying to repurpose medicines, drugs, that were designed for new diseases to see if they work in COVID-19, but as soon as this epidemic started, we got to work making a new medicine against this disease,” said Dr. Dan Skovronsky, Eli Lilly’s senior vice president and chief scientific officer.
“Now we’re ready and testing it in patients.”
The treatment was created in collaboration with AbCellera, a biotechnology company based in Canada. When someone recovers from a disease like COVID-19, their body produces millions of proteins called antibodies, which fight off the disease and help them recover. AbCellera acquired a blood sample from one of the first U.S. patients who had recovered from COVID-19, and the companies sorted through millions of this patient’s cells to find hundreds of antibodies.
Scientists at AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases selected those they thought would be most potent and Lilly scientists engineered the treatment, known as a monoclonal antibody therapy. This approach has worked to treat other illnesses; there are monoclonal antibody therapies that treat HIV, asthma, lupus, Ebola and some forms of cancer.
It’s not clear if such a therapy will work against COVID-19, but when this treatment was used on on cells in the lab, it blocked the ability of the virus to infect the cells, Skovronsky said. The data is not yet published, but based on those results, scientists got the green light to take the next step and prepare it to be tried in patients.
They also gave it a temporary name.
“We call it LY-CoV555, lucky triple 5,” Skovronsky said.
Manufacturing has already begun
This will be a randomized, placebo-controlled, double-blind Phase I trial. Some patients will be receive the medicine and some will receive a placebo, and patients or their doctors won’t be informed who received it and who didn’t.
If the treatment appears to be safe, the company would move to the next phase of testing in a matter of weeks. The second phase of the trial will involve a larger number of patients, including patients who are not hospitalized, and will test whether the therapy is effective.
The company also plans to study the drug as prevention. The treatment could be used for vulnerable patient populations for whom vaccines might not be a great option, such as the elderly or people who have chronic disease or compromised immune systems.
Eli Lilly has already begun manufacturing the antibody therapy in large quantities so it could be tested and potentially for use in patients beyond the trial. Under non-pandemic circumstances, the companies would usually wait to find out if it worked first before it started making it.
“If it does work, we don’t want to waste a single day, we want to have as much medicine as possible available to help as many people quickly,” Skovronsky said.
In trials over the next several months, Lilly says it will test different mixtures of a few of the other antibodies scientists think might provide protection. The optimal scenario, though, Skovronsky said, is if they only need one antibody at a relatively low dose.
“The more antibodies are mixed together, higher doses, the more difficult it is to manufacture,” Skovronsky said. “But if it has to be two antibodies, higher doses, or even three antibodies mixed together at higher doses, we’ll do whatever it takes to make effective medicine for patients.”
Other antibody therapies in development
Eli Lilly isn’t the only company working on antibody treatments. Several U.S. teams have cloned antibodies to COVID-19 and many are close to testing in patients. Regeneron Pharmaceuticals has said it hopes to start human trials this month and to have a treatment by the end of the summer.
“This approach definitely has promise and it is something we need,” said Dr. Peter Hotez, a vaccine specialist at Baylor College of Medicine who is not involved in this research. He said the challenge with COVID-19 is that there are two phases to the disease — the initial viral infection phase and then the host response, or the inflammatory response. Generally, a treatment like this is more likely to be effective if a patient gets it early in the course of the illness, when the virus is still replicating.
“That’s always the problem with treating COVID-19 with monoclonal antibodies — if you wait until things are pretty far along, like including patients that are already on the ventilator, it may not have any clinical impact,” Hotez said.
If it works though, it could also be useful if, for example, a patient in a nursing home tested positive for COVID-19, and such a treatment could be given to others at the facility; for a first responder that had just been exposed to a patient with COVID-19; or for health care workers, Hotez said.
One challenge Hotez noted: Monoclonal antibody therapies tend to be “pretty expensive,” he said.
Typically, such treatments would take many years to develop, but COVID-19 treatments are on an accelerated schedule. Pharmaceutical companies have said that government approvals that normally take weeks have sometimes come within a day.
“It’s really been a privilege to be able to operate in this kind of environment,” Lilly’s Skovronksy said. He said he and others in the pharmaceutical industry have wondered if the same collaboration and urgency could be applied to treatments for other diseases like cancer or Alzheimer’s.
“For many of us, this feels a little like a moonshot or a Manhattan Project, where so many scientists are working together at breakneck speeds,” Skovronksy said. “Surely there will be other advances that come of this.”
A quarter of nursing homes report at least one infection, first official tally shows
Nearly 26,000 nursing home residents have died from coronavirus, according to federal data released Monday.
One quarter of nursing homes had at least one case, and one in five had at least one death, according to the federal Centers for Medicare and Medicaid Services. The cases were more prevalent in poorly rated facilities, which typically have weaker infection controls and fewer staffers per resident.
The report marks the first nationwide government tally showing the impact of the pandemic on nursing homes, which have been hit especially hard by the outbreak since the elderly are particularly vulnerable to the virus. Deaths in these facilities account for at least 25% of the total in the U.S.
More than 60,000 nursing home residents have tested positive for the virus.
The data, however, is not a complete picture, said Seema Verma, the agency’s administrator. It covers only about 80% of nursing homes, and it doesn’t include assisted living facilities. Also, CMS did not issue the requirement that nursing homes provide this information to the federal government until May 1, though Verma said that most facilities likely reported cases and deaths before that date, as well.
Washington, D.C. had the highest rate, with 206 cases per 1,000 nursing home residents, followed by Massachusetts and Arizona. On the other hand, Hawaii reported no cases, while Vermont and Montana had fewer than one case per 1,000 facility residents.
More data will be available on the agency’s Nursing Home Compare website starting on Thursday, including information about specific facilities. Families have complained that many homes have resisted sharing how many residents and staffers have tested positive and have died.
The numbers of cases, which will be updated weekly, will likely increase.
“We hope this public reporting system will help identify areas that are most in need of resources to fight the battle against COVID-19,” said Mark Parkinson, CEO of the American Health Care Association and National Center for Assisted Living. “We hope state and federal public health officials can use the data to help nursing homes by sending urgently needed resources.”
The agency also announced new guidelines and enforcement actions to bring low-performing nursing homes into compliance. States will be required to conduct focused infection control surveys of their facilities by the end of July or submit a corrective action plan. If states still fail to do so, their federal coronavirus relief funding earmarked for surveys for 2021 may be reduced.
CMS is providing $80 million to states in funding to perform those reviews, the agency said. A little more than half of facilities have been surveyed as of May 24.
The tally comes two weeks after the agency recommended that nursing homes test all residents and staff for the coronavirus — and then continue to test employees weekly — as part of its plan to relax restrictions at the facilities. Industry groups immediately said that they cannot afford such a requirement and called for additional government assistance.
States can use some of the $11 billion in federal funding allocated for testing to support nursing homes, Verma said.
CMS in March advised nursing homes to close their doors to visitors and volunteers, with few exceptions, as the pandemic began to spread in the U.S.
