While a proactive COVID-19 testing strategy is out-of-reach for much
of the U.S., one large town in Indiana is hoping to show the public
health benefits of screening for the disease early and often.
Last week, the city of Carmel, Indiana
— just north of Indianapolis, with about 100,000 residents — started
weekly screening all of its first responders and some city employees, as
well as staff and residents of its nursing homes.
Mayor James Brainard said he hopes to next expand the program to all
city employees and their dependents, and eventually to all city
residents.
“We’re doing this to slow the spread. Ideally, the U.S. would have been able to do this weeks ago,” Brainard told MedPage Today.
“We’ll find out who has it, quarantine them, and test their contacts,
so that our hospitals and medical personnel do not become overwhelmed.”
As of Monday afternoon, 315 workers had been tested; the city has thus far sidelined four police officers who’ve been infected.
Angela Caliendo, MD, PhD, of Brown University in Rhode Island, said
during an Infectious Diseases Society of America press briefing on
Tuesday morning, that early testing could work in certain parts of the
country.
“There are areas of the country that have not been hit yet, so we
might be able to impact the epidemiology of this infection or their
curve more effectively than we have in places like New York, Louisiana,
and Detroit,” Caliendo said during the briefing. “If we have adequate
testing, we could consider areas of the country that can implement a
strategy of more broad testing than those hit early. The testing done in
South Korea was very important in controlling their outbreak.”
Carmel entrepreneur Zak Khan, who grew up in the city and has a
history of philanthropy there, pitched Brainard the idea of proactive
testing, which was sanctioned by local medical experts, Brainard said.
Khan owns a network of surgery centers, many of which have been
temporarily closed due to elective surgery cancellations. He also owns a
laboratory, Aria Diagnostics, which purchased a COVID-19 PCR testing unit from Thermo Fisher. That lab has set up drive-through testing for the program.
Khan’s lab charges about $150 per test, covered by Carmel’s
self-insured health policy. Brainard anticipates a total cost of
$500,000 to $600,000 for the first phase of the project. Ultimately,
he’d like to test all 700 city employees, and eventually their total
network of 1,800, which includes dependents, and eventually screen the
entire city.
Khan said one challenge has been procuring test kits; none were
available from the company’s regular supply chains, so he had to
assemble his own kit and get FDA approval.
“It forces labs like us to be more entrepreneurial in putting it together,” Khan told MedPage Today.
He now buys sterile swabs and viral transport media separately. Since
the typical Amies solution that’s used isn’t available, he’s found
other types of viral transport media that can be substituted. While
Amies is better for a full pathogen panel, there’s less concern about
that since testing is now “laser-focused on COVID,” he said.
Reagents for the Thermo Fisher test have also been a challenge, one
that he says may be a bigger roadblock than test kits, though his team
is actively seeking out supply, he said.
While the machine can yield results within four hours, the volume of
testing and the need to confirm positives extends that time; Khan tells
customers to expect a result within 48 hours. He also partners with
Indiana University Health which has access to rapid testing if needed.
For instance, if a firefighter is potentially exposed, he can be told
quickly whether or not he has to quarantine. Quarantine costs the city
because it requires paying time-and-a-half to another employee to cover
that shift. If a test quickly comes back negative, Khan said, that
firefighter can continue his shift.
Khan said his lab is working with another town in Indiana, and with a
home health agency in Texas, on early testing and hopes to expand to
others as well.
“We can beat this thing back,” Khan said. “If testing starts with
first responders, then moves to healthcare providers, and then the rest
of the community, Mayor Brainard’s vision will make Carmel’s line flat.”
Beth Rupp, MD, of Indiana University Health, who isn’t involved in
the Carmel testing project, said it could help prevent spread of
disease, but cautioned that Carmel’s situation is unique.
“If they have the resources to do that, I think it’s a really
interesting idea,” she said, noting that Carmel is a wealthier city than
many in Indiana. “A lot of people don’t have the resources to be able
to carry that out.”
Rupp added that the “whole testing situation has been such a
frustration to all of us in healthcare. I would love it if more testing
were available for everyone everywhere.”
Khan expressed similar frustration that the current strategy in the
U.S. “is based on a scarcity of tests. I want to make it based on, how
do we flatten the curve? Basing it on not having availability of kits is
an awful way of practicing medicine.”
https://www.medpagetoday.com/infectiousdisease/covid19/85834
Tuesday, April 7, 2020
Walgreens to open 15 COVID-19 testing sites in 7 states
Walgreens is opening 15 COVID-19 test sites in seven states across the country, the retail pharmacy chain said April 7.
The company said it will open sites in Arizona, Florida, Illinois, Kentucky, Louisiana, Tennessee and Texas and that it chose the states based on hot spot markets with escalating COVID-19 cases.
The sites will be in Walgreens parking lots, and pharmacists will oversee self-administration of the test. The company will use Abbott’s new COVID-19 test, which delivers results in five to 13 minutes.
Walgreens said it expects to be able to test up to 3,000 people per day, and the sites are expected to be up and running this week.
The tests will be free for people who meet CDC criteria for testing.
Read the full news release here.
https://www.beckershospitalreview.com/pharmacy/walgreens-to-open-15-covid-19-testing-sites-in-7-states.html
The company said it will open sites in Arizona, Florida, Illinois, Kentucky, Louisiana, Tennessee and Texas and that it chose the states based on hot spot markets with escalating COVID-19 cases.
The sites will be in Walgreens parking lots, and pharmacists will oversee self-administration of the test. The company will use Abbott’s new COVID-19 test, which delivers results in five to 13 minutes.
Walgreens said it expects to be able to test up to 3,000 people per day, and the sites are expected to be up and running this week.
The tests will be free for people who meet CDC criteria for testing.
Read the full news release here.
https://www.beckershospitalreview.com/pharmacy/walgreens-to-open-15-covid-19-testing-sites-in-7-states.html
Mount Sinai reworks stroke platform to monitor COVID-19 patients remotely
New York City-based Mount Sinai Health System has adapted its stroke
platform to remotely monitor COVID-19 patients, according to FOX News.
The Precision Recovery Platform has been designed for COVID-19 patients with symptoms not severe enough for hospitalization. Patients simply text “Precision Recovery” to 332-213-9130. A physician will then chat with the patient via video. Patients go on to download an app where they input their symptoms.
If physician notices concerning data about a patient, they can video chat with them or send an emergency medical team to evaluate the patient.
Assistant professor of neurosurgery at the Icahn School of Medicine at Mount Sinai Christopher Kellner, MD, co-developed the platform with David Putrino, MD.
“With remote monitoring of COVID-19, we can save hospital resources for the patients who need them most, but also quickly triage patients if and when they begin to show more severe symptoms while they are being monitored at home,” said Dr. Kellner, according to FOX News.
https://www.beckershospitalreview.com/healthcare-information-technology/mount-sinai-reworks-stroke-platform-to-monitor-covid-19-patients-remotely.html
The Precision Recovery Platform has been designed for COVID-19 patients with symptoms not severe enough for hospitalization. Patients simply text “Precision Recovery” to 332-213-9130. A physician will then chat with the patient via video. Patients go on to download an app where they input their symptoms.
If physician notices concerning data about a patient, they can video chat with them or send an emergency medical team to evaluate the patient.
Assistant professor of neurosurgery at the Icahn School of Medicine at Mount Sinai Christopher Kellner, MD, co-developed the platform with David Putrino, MD.
“With remote monitoring of COVID-19, we can save hospital resources for the patients who need them most, but also quickly triage patients if and when they begin to show more severe symptoms while they are being monitored at home,” said Dr. Kellner, according to FOX News.
https://www.beckershospitalreview.com/healthcare-information-technology/mount-sinai-reworks-stroke-platform-to-monitor-covid-19-patients-remotely.html
How hospitals are responding to surge in telehealth visits
Hospitals and health systems are relying on their telehealth platforms to treat patients amid the COVID-19 pandemic.
With the federal government losening restrictions surrounding telehealth and also improving reimbursement, hospitals across the country have bolstered their virtual technology. Cleveland Clinic completed more than 60,000 telehealth visits in March, officials told Kaiser Health News.
Prior to the pandemic, Cleveland Clinic averaged 3,400 telehealth visits a month. Approximately 75 percent of the virtual visits come from patients worried they have contracted COVID-19. With the surge in visits, Cleveland Clinic has waived patient copays.
Cleveland Clinic has also transitioned more physicians to its telehealth network after canceling elective surgeries.
New York City-based NYU Langone Health has also enhanced its virtual platform as the system averages around 900 telehealth visits a day. During these visits, 80 percent of which are patients suffering from a cough and fever, physicians are recommending self-care, hydration and self-isolation.
“The goal is to create a new front line for these patients rather than have them rush into an urgent care or ER,” said Paul Testa, MD, chief medical information officer, to Kaiser Health News.
https://www.beckershospitalreview.com/telehealth/how-hospitals-are-responding-to-surge-in-telehealth-visits.html
With the federal government losening restrictions surrounding telehealth and also improving reimbursement, hospitals across the country have bolstered their virtual technology. Cleveland Clinic completed more than 60,000 telehealth visits in March, officials told Kaiser Health News.
Prior to the pandemic, Cleveland Clinic averaged 3,400 telehealth visits a month. Approximately 75 percent of the virtual visits come from patients worried they have contracted COVID-19. With the surge in visits, Cleveland Clinic has waived patient copays.
Cleveland Clinic has also transitioned more physicians to its telehealth network after canceling elective surgeries.
New York City-based NYU Langone Health has also enhanced its virtual platform as the system averages around 900 telehealth visits a day. During these visits, 80 percent of which are patients suffering from a cough and fever, physicians are recommending self-care, hydration and self-isolation.
“The goal is to create a new front line for these patients rather than have them rush into an urgent care or ER,” said Paul Testa, MD, chief medical information officer, to Kaiser Health News.
https://www.beckershospitalreview.com/telehealth/how-hospitals-are-responding-to-surge-in-telehealth-visits.html
Donor programs to collect recovered COVID-19 patient plasma in 4 states
Blood donation programs are being launched in four states to collect
the plasma from recovered COVID-19 patients, a company official told The Arizona Republic.
The blood donation company Vitalant is starting pilot programs in Arizona, Colorado, New Mexico and Pennsylvania, Ralph Vassallo, the chief medical and scientific officer, told the Republic Monday.
Vitalant, which was formerly known as United Blood Services, is seeking recovered COVID-19 patients, who officially tested positive, to donate blood to investigate a potential treatment for the virus.
Currently the virus has no proven treatments, but plasma from past
patients has anecdotally been used to treat the novel coronavirus which
causes COVID-19 and other coronaviruses in the past, according to the
Arizona newspaper.
“Unfortunately, it’s kind of the only ray of hope at present until we identify some medications that have some promise,” Vassallo said.
The body develops antibodies to fight viruses, which can stay in the blood for some time and could be helpful in fighting the infection in another person. The collected plasma, which includes the liquid part of blood after removing blood cells and platelets, could hold these antibodies, which could be transferred to another patient.
The programs are seeking people who have recovered and who have been symptom-free for at least 14 days to donate blood for the treatment. The participants must have tested positive for COVID-19 previously but negative now.
The Food and Drug Administration (FDA) designates this treatment as “investigational” and requires clinical trials to ensure its safety before the treatment can be used regularly. The FDA has permitted doctors to use the plasma treatment with an emergency investigational new drug application to the administration.
“Although promising, convalescent plasma has not yet been shown to be effective in COVID-19,” the FDA’s website said.
There is no testing currently widely available to determine if a person has already had the disease and has antibodies to fight it.
Plasma has previously been utilized to fight SARS, MERS and H1N1, the FDA reported.
https://thehill.com/policy/healthcare/public-global-health/491559-blood-donation-programs-to-accept-plasma-from
The blood donation company Vitalant is starting pilot programs in Arizona, Colorado, New Mexico and Pennsylvania, Ralph Vassallo, the chief medical and scientific officer, told the Republic Monday.
Vitalant, which was formerly known as United Blood Services, is seeking recovered COVID-19 patients, who officially tested positive, to donate blood to investigate a potential treatment for the virus.
“Unfortunately, it’s kind of the only ray of hope at present until we identify some medications that have some promise,” Vassallo said.
The body develops antibodies to fight viruses, which can stay in the blood for some time and could be helpful in fighting the infection in another person. The collected plasma, which includes the liquid part of blood after removing blood cells and platelets, could hold these antibodies, which could be transferred to another patient.
The programs are seeking people who have recovered and who have been symptom-free for at least 14 days to donate blood for the treatment. The participants must have tested positive for COVID-19 previously but negative now.
The Food and Drug Administration (FDA) designates this treatment as “investigational” and requires clinical trials to ensure its safety before the treatment can be used regularly. The FDA has permitted doctors to use the plasma treatment with an emergency investigational new drug application to the administration.
“Although promising, convalescent plasma has not yet been shown to be effective in COVID-19,” the FDA’s website said.
There is no testing currently widely available to determine if a person has already had the disease and has antibodies to fight it.
Plasma has previously been utilized to fight SARS, MERS and H1N1, the FDA reported.
https://thehill.com/policy/healthcare/public-global-health/491559-blood-donation-programs-to-accept-plasma-from
Will Coronavirus Cause Health Insurance Premiums to Soar?
In a widely cited article, the New York Times recently warned
that health “insurance premiums could spike as much as 40 percent next
year.” Such a scenario would clearly add an enormous burden to
businesses and individuals already struggling with hardship induced by
the coronavirus. But the assumed average cost of treating coronavirus
cases, on which the article was based, is highly inflated. In fact,
overall, healthcare spending will likely fall significantly over the
coming year, as the volume of other medical procedures falls
significantly.
The underlying report was written by the government agency responsible for regulating the Obamacare market in the state of California. It projected one-year nationwide costs from coronavirus to private insurance ranging from $34 billion to $251 billion – ranging from 2% to 21% of premiums. The eye-catching 40% figure came from the dubious inference that two years’ worth of insurance losses at the top end of projections would be entirely financed through one year of premium increases.
Most of this additional cost comes from the report’s $29 billion to $216 billion estimate of the total costs of treating coronavirus patients admitted to hospital – a figure which seems to be wildly inflated. It is based on the assumption that insurers will be required to pay an average of $72,000 per patient hospitalized, that 4 to 15 million would be infected, and that 10% to 20% would be hospitalized.
A recent study by the Kaiser Family Foundation found that, in 2018, privately insured patients hospitalized with pneumonia without complications were billed an average of $9,763; those with major complications and comorbidities, an average of $20,292; and those requiring ventilator support for over 96 hours (as is most often the case with coronavirus patients needing intensive care), an average of $88,114. A mid-March CDC study of COVID-19 cases in the United States found that 10% of those aged under 65 testing positive for COVID-19 were hospitalized, but that only 2% required admission to intensive care.
Taking a mid-range estimate of 1.2 million hospitalizations in the California study, which seems in line with other current projections, hospitalization costs could be expected to be around $35 billion, in addition to $8 billion estimated for outpatient services and $8 billion for testing. In total, this would add $51 billion to private insurance spending (which was $1,243 billion in 2018) – an increase of roughly 4%.
Such an increase would likely be more than offset by the effect of declining utilization of other medical services as people increasingly stay at home – reducing the number of traffic accidents, the transmission of other diseases, and the number of visits to doctors. Indeed, the decline in elective procedures undertaken has been dramatic. Bon Secours Mercy Health, which operates in seven states, estimated that it would suffer a $100 million decline in revenue. Similarly, a Kentucky hospital system, which saw a 30% decline in business, has furloughed 500 staff. The CEO of a Michigan hospital system has estimated that the crisis has caused it to cancel 80% of projected surgeries to free up capacity for COVID-19 patients and other emergency cases. He argued this would lead to a 20% to 40% drop in revenue.
At this point, therefore, it seems more likely that the coronavirus will cause health insurance premiums to fall rather than increase overall.
https://economics21.org/will-coronavirus-spike-health-insurance-premiums
The underlying report was written by the government agency responsible for regulating the Obamacare market in the state of California. It projected one-year nationwide costs from coronavirus to private insurance ranging from $34 billion to $251 billion – ranging from 2% to 21% of premiums. The eye-catching 40% figure came from the dubious inference that two years’ worth of insurance losses at the top end of projections would be entirely financed through one year of premium increases.
Most of this additional cost comes from the report’s $29 billion to $216 billion estimate of the total costs of treating coronavirus patients admitted to hospital – a figure which seems to be wildly inflated. It is based on the assumption that insurers will be required to pay an average of $72,000 per patient hospitalized, that 4 to 15 million would be infected, and that 10% to 20% would be hospitalized.
A recent study by the Kaiser Family Foundation found that, in 2018, privately insured patients hospitalized with pneumonia without complications were billed an average of $9,763; those with major complications and comorbidities, an average of $20,292; and those requiring ventilator support for over 96 hours (as is most often the case with coronavirus patients needing intensive care), an average of $88,114. A mid-March CDC study of COVID-19 cases in the United States found that 10% of those aged under 65 testing positive for COVID-19 were hospitalized, but that only 2% required admission to intensive care.
Taking a mid-range estimate of 1.2 million hospitalizations in the California study, which seems in line with other current projections, hospitalization costs could be expected to be around $35 billion, in addition to $8 billion estimated for outpatient services and $8 billion for testing. In total, this would add $51 billion to private insurance spending (which was $1,243 billion in 2018) – an increase of roughly 4%.
Such an increase would likely be more than offset by the effect of declining utilization of other medical services as people increasingly stay at home – reducing the number of traffic accidents, the transmission of other diseases, and the number of visits to doctors. Indeed, the decline in elective procedures undertaken has been dramatic. Bon Secours Mercy Health, which operates in seven states, estimated that it would suffer a $100 million decline in revenue. Similarly, a Kentucky hospital system, which saw a 30% decline in business, has furloughed 500 staff. The CEO of a Michigan hospital system has estimated that the crisis has caused it to cancel 80% of projected surgeries to free up capacity for COVID-19 patients and other emergency cases. He argued this would lead to a 20% to 40% drop in revenue.
At this point, therefore, it seems more likely that the coronavirus will cause health insurance premiums to fall rather than increase overall.
https://economics21.org/will-coronavirus-spike-health-insurance-premiums
COVID-19 Innovations in the U.S. Versus the Rest of the World
The United States leads the world in biotech innovation, but does it
also lead the world in the development of COVID-19 diagnostics, vaccines
and therapeutics?
Based upon the number of clinical trials listed with ClinicalTrials.gov, the answer, so far, is “no.” But, if the number of potential solutions in development are considered, “no” may become “yes.”
Clinical Trials by the Numbers
In sheer numbers of therapeutic trials at all stages, China has the most, with 62. Europe has 53 and the U.S. has 32, according to ClinicalTrials.gov. Other countries or regions have only a handful. Canada, for example has 12, the Middle East has six, Southeast Asia has five, Australia has four, Africa and Mexico two each and India one. For some trials, locations were not listed. A total of 230 trials were reported.
When we look at vaccine trials, Europe leads with seven, followed by China with six and the U.S. with four. A total of 23 trials were reported. Of those, only one – in Wuhan, China – was active, and nine were recruiting.
In terms of clinical trials involving diagnostics tests, ClinicalTrials.gov reports 118. Europe leads with 36, followed by China with 25, and the U.S. with 19. Canada is in fourth position, with six.
The numbers of therapeutics, vaccines and diagnostics in clinical trials don’t show the complete picture, though. Many biopharma companies and academic labs are actively engaged in the COVID-19 battle but are not yet ready for clinical trials.
United States
The FDA is working with more than 240 diagnostic test developers who have said they plan to submit emergency use authorization (EUA) requests.
As of April 2, the FDA had issued 25 EUAs, including one to Cellex to detect the presence of coronavirus antibodies. It is designed as an adjunct to laboratory results rather than as a definitive diagnostic. More than 125 labs now provide COVID-19 testing.
Currently, the FDA is allowing four developer-validated diagnostic tests to be distributed while awaiting FDA validation or issuance of an EUA. They are:
The FDA also is looking at new ways to bring efficacious products through the regulatory process faster. Initially, that meant using the emergency investigational new drug application (eIND) process. The agency also is expanding access to clinical trials to institutions, such as rural hospitals, that currently lack such access.
Europe
The EMA is working with the developers of approximately 40 therapeutics that may have potential against COVID-19. Some of the most promising candidates and their current authorized uses are:
• remdesivir (investigational)
• lopinavir/ritonavir (for HIV)
• chloroquine and hydroxychloroquine (for malaria and autoimmune diseases)
• systemic interferons and, in particular interferon beta (for multiple sclerosis)
• monoclonal antibodies with activity against components of the immune system
The EMA also is talking with developers of a dozen or so potential COVID-19 vaccines, but cautions that it may take a year or more before a vaccine is ready for approval.
As of Friday, April 3, the EMA maintained, “There are currently no authorized vaccines or treatments in the EU to prevent or treat novel coronavirus disease (COVID-19) specifically or any other coronaviruses.” Chloroquine and hydroxychloroquine, it instructed, were to be used only in clinical trials or emergency programs.
The EMA did, however, outline compassionate use recommendations for the investigational antiviral medicine remdesivir in the context of COVID-19. Laboratory studies indicate remdesivir, a viral RNA polymerase inhibitor, prevents SARS-CoV-1 and 2 (SARS and COVID-19) and MERS-CoV from replicating.
The United Kingdom
What the U.K. billed as “the world’s largest randomized clinical trial of potential coronavirus treatments,” was announced last Thursday, but actually began in mid-March. As part of the U.K.’s prioritization of COVID-19 research, some 1,000 patients from 132 hospitals were recruited in the first 15 days, and thousands more are joining the trials.
The trial tests:
This trial, called “Recovery” received £2.1 million in funding from UK Research and Innovation and the Department of Health and Social Care. It is part of a wider £20 million rapid research response investment by the government to identify ways to tackle the coronavirus outbreak. COVID-19 trials will be fast-tracked.
Additionally, the BioIndustry Association (BIA) is working with the Coalition for Epidemic Preparedness Innovations (CEPI) and the British government to coordinate manufacturing capacity and ideas to support the research, development and scale-up of life sciences sector responses to the pandemic.
China
China admits COVID-19 infections are continuing. April 3, the National Health Commission of the PRC reported, “31 new cases of confirmed infections, 12 new cases of suspected infections (all are imported cases), and 4 deaths (all in Hubei province)” based on data from China’s 31 providences and the Xinjiang Production and Construction Corps. The report cited 870 cases of “imported infections” and 60 asymptomatic cases (a new data point). It started the day with “81,620 reports of confirmed cases and 3,322 deaths.” Of those cases, 76,571 had been discharged from the hospital.
“China will overcome difficulties to give priority to restoring and raising the output of medicine and disease prevention materials, strengthen supervision over product quality, and provide more materials for the global fight against the disease,” China’s President, Xi Jinping, told Belgian King Philippe and Indonesian President Joko Widodo during an April 2 phone call.
That pledge to improve quality came after a Reuters report that Spain and Slovakia complained that results from diagnostic kits produced in China and supplied to 11 countries were inaccurate. Soon afterward, the National Medical Products Administration (NMPA) – formerly the China FDA – began requiring certification before medical products (including assays, kits, and masks) could be exported.
https://www.biospace.com/article/comparison-covid-19-innovations-in-the-u-s-versus-the-rest-of-the-world/
Based upon the number of clinical trials listed with ClinicalTrials.gov, the answer, so far, is “no.” But, if the number of potential solutions in development are considered, “no” may become “yes.”
Clinical Trials by the Numbers
In sheer numbers of therapeutic trials at all stages, China has the most, with 62. Europe has 53 and the U.S. has 32, according to ClinicalTrials.gov. Other countries or regions have only a handful. Canada, for example has 12, the Middle East has six, Southeast Asia has five, Australia has four, Africa and Mexico two each and India one. For some trials, locations were not listed. A total of 230 trials were reported.
When we look at vaccine trials, Europe leads with seven, followed by China with six and the U.S. with four. A total of 23 trials were reported. Of those, only one – in Wuhan, China – was active, and nine were recruiting.
In terms of clinical trials involving diagnostics tests, ClinicalTrials.gov reports 118. Europe leads with 36, followed by China with 25, and the U.S. with 19. Canada is in fourth position, with six.
The numbers of therapeutics, vaccines and diagnostics in clinical trials don’t show the complete picture, though. Many biopharma companies and academic labs are actively engaged in the COVID-19 battle but are not yet ready for clinical trials.
United States
The FDA is working with more than 240 diagnostic test developers who have said they plan to submit emergency use authorization (EUA) requests.
As of April 2, the FDA had issued 25 EUAs, including one to Cellex to detect the presence of coronavirus antibodies. It is designed as an adjunct to laboratory results rather than as a definitive diagnostic. More than 125 labs now provide COVID-19 testing.
Currently, the FDA is allowing four developer-validated diagnostic tests to be distributed while awaiting FDA validation or issuance of an EUA. They are:
- BD BioGx SARS-CoV-2 Reagents for BD MAX System
- BGI Genomics Co. Ltd
- Co-Diagnostics, Inc.
- OSANG Healthcare Co., Ltd, GeneFinder COVID-19 Plus RealAmp Kit
The FDA also is looking at new ways to bring efficacious products through the regulatory process faster. Initially, that meant using the emergency investigational new drug application (eIND) process. The agency also is expanding access to clinical trials to institutions, such as rural hospitals, that currently lack such access.
Europe
The EMA is working with the developers of approximately 40 therapeutics that may have potential against COVID-19. Some of the most promising candidates and their current authorized uses are:
• remdesivir (investigational)
• lopinavir/ritonavir (for HIV)
• chloroquine and hydroxychloroquine (for malaria and autoimmune diseases)
• systemic interferons and, in particular interferon beta (for multiple sclerosis)
• monoclonal antibodies with activity against components of the immune system
The EMA also is talking with developers of a dozen or so potential COVID-19 vaccines, but cautions that it may take a year or more before a vaccine is ready for approval.
As of Friday, April 3, the EMA maintained, “There are currently no authorized vaccines or treatments in the EU to prevent or treat novel coronavirus disease (COVID-19) specifically or any other coronaviruses.” Chloroquine and hydroxychloroquine, it instructed, were to be used only in clinical trials or emergency programs.
The EMA did, however, outline compassionate use recommendations for the investigational antiviral medicine remdesivir in the context of COVID-19. Laboratory studies indicate remdesivir, a viral RNA polymerase inhibitor, prevents SARS-CoV-1 and 2 (SARS and COVID-19) and MERS-CoV from replicating.
The United Kingdom
What the U.K. billed as “the world’s largest randomized clinical trial of potential coronavirus treatments,” was announced last Thursday, but actually began in mid-March. As part of the U.K.’s prioritization of COVID-19 research, some 1,000 patients from 132 hospitals were recruited in the first 15 days, and thousands more are joining the trials.
The trial tests:
- lopinavir-litonavir, an HIV treatment
- dexamethasone, a steroid to reduce inflammation
- hydroxychloroquine, a malaria treatment
This trial, called “Recovery” received £2.1 million in funding from UK Research and Innovation and the Department of Health and Social Care. It is part of a wider £20 million rapid research response investment by the government to identify ways to tackle the coronavirus outbreak. COVID-19 trials will be fast-tracked.
Additionally, the BioIndustry Association (BIA) is working with the Coalition for Epidemic Preparedness Innovations (CEPI) and the British government to coordinate manufacturing capacity and ideas to support the research, development and scale-up of life sciences sector responses to the pandemic.
China
China admits COVID-19 infections are continuing. April 3, the National Health Commission of the PRC reported, “31 new cases of confirmed infections, 12 new cases of suspected infections (all are imported cases), and 4 deaths (all in Hubei province)” based on data from China’s 31 providences and the Xinjiang Production and Construction Corps. The report cited 870 cases of “imported infections” and 60 asymptomatic cases (a new data point). It started the day with “81,620 reports of confirmed cases and 3,322 deaths.” Of those cases, 76,571 had been discharged from the hospital.
“China will overcome difficulties to give priority to restoring and raising the output of medicine and disease prevention materials, strengthen supervision over product quality, and provide more materials for the global fight against the disease,” China’s President, Xi Jinping, told Belgian King Philippe and Indonesian President Joko Widodo during an April 2 phone call.
That pledge to improve quality came after a Reuters report that Spain and Slovakia complained that results from diagnostic kits produced in China and supplied to 11 countries were inaccurate. Soon afterward, the National Medical Products Administration (NMPA) – formerly the China FDA – began requiring certification before medical products (including assays, kits, and masks) could be exported.
https://www.biospace.com/article/comparison-covid-19-innovations-in-the-u-s-versus-the-rest-of-the-world/
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