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FDA says a coronavirus vaccine would have to be at least 50% effective to be approved

The FDA has issued emergency approval for a vaccine only once, for an experimental anthrax vaccine in 2005. The FDA had originally declined to issue an emergency use authorization, but the Department of Defense pushed for one due to concerns over possible anthrax attacks against U.S. military forces. 

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Vaccine-associated enhanced respiratory disease

A clear concern in the FDA’s guidance for the coronavirus vaccine is whether vaccine candidates might cause enhanced respiratory disease —not only failing to decrease the severity of COVID-19, but causing it to get worse. 

While rare, data from animal studies in some vaccine candidates for other coronaviruses, such as SARS-CoV and MERS-CoV, has raised concerns regarding COVID-19, the FDA said.

Infecting healthy people to test a vaccine

The FDA also said challenge trials could be considered to test COVID-19 vaccines. In those trials, healthy people are intentionally infected to see if the vaccine keeps them from getting COVID-19.

That might be necessary if there were so little SARS-CoV-2 virus circulating that it was no longer possible to study whether a vaccine was effective.  If there’s no chance people who’ve gotten test injections could get infected, it wouldn’t be possible to test whether the vaccine works.

US coronavirus map: Tracking the outbreak

The agency made clear in its document that challenge trials are not ideal. “Many issues, including logistical, human subject protection, ethical, and scientific issues, would need to be satisfactorily addressed,” it said. 

Side effects, public trust could undermine vaccine

There are several possible downsides to issuing a vaccine prematurely.

Side effects and bad outcomes may be rare enough that they appear only when many people receive the vaccine, or after enough time has passed for them to appear. That could give fuel to anti-vaccine groups that claim without evidence that vaccines are harmful.

Some people could be scared away from the vaccine if they don’t believe it has been properly and thoroughly tested. If people won’t take the vaccine, it doesn’t matter how soon it’s available.

Paul Offit, a vaccine expert at the University of Pennsylvania, has spoken of the possibility that a vaccine could be unveiled as an “October surprise” and the harm that could cause. The FDA’s guidance made him less concerned, he said.

“I think this is all very reassuring,” he said. “Now all they have to do is follow their own guidelines.

Source: https://www.usatoday.com/story/news/2020/06/30/fda-coronavirus-vaccine-would-have-least-50-effective/5349964002/

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This coronavirus mutation has taken over the world. Scientists are trying to understand why.

When the first coronavirus cases in Chicago appeared in January, they bore the same genetic signatures as a germ that emerged in China weeks before. But as Egon Ozer, an infectious-disease specialist at the Northwestern University Feinberg School of Medicine, examined the genetic structure of virus samples from local patients, he noticed something different.

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A change in the virus was appearing again and again. This mutation, associated with outbreaks in Europe and New York, eventually took over the city. By May, it was found in 95 percent of all the genomes Ozer sequenced. 

At a glance, the mutation seemed trivial. About 1,300 amino acids serve as building blocks for a protein on the surface of the virus. In the mutant virus, the genetic instructions for just one of those amino acids — number 614 — switched in the new variant from a “D” (shorthand for aspartic acid) to a “G” (short for glycine).

But the location was significant, because the switch occurred in the part of the genome that codes for the all-important “spike protein” — the protruding structure that gives the coronavirus its crownlike profile and allows it to enter human cells the way a burglar picks a lock.

And its ubiquity is undeniable. Of the approximately 50,000 genomes of the new virus that researchers worldwide have uploaded to a shared database, about 70 percent carry the mutation, officially designated D614G but known more familiarly to scientists as “G.”

“G” hasn’t just dominated the outbreak in Chicago — it has taken over the world. Now scientists are racing to figure out what it means.

At least four laboratory experiments suggest that the mutation makes the virus more infectious, although none of that work has been peer-reviewed. Another unpublished study led by scientists at Los Alamos National Laboratory asserts that patients with the G variant actually have more virus in their bodies, making them more likely to spread it to others.

The mutation doesn’t appear to make people sicker, but a growing number of scientists worry that it has made the virus more contagious.

“The epidemiological study and our data together really explain why the [G variant’s] spread in Europe and the U.S. was really fast,” said Hyeryun Choe, a virologist at Scripps Research and a lead author of an unpublished study on the G variant’s enhanced infectiousness in laboratory cell cultures. “This is not just accidental.”

But there may be other explanations for the G variant’s dominance: biases in where genetic data are being collected, quirks of timing that gave the mutated virus an early foothold in susceptible populations.

“The bottom line is, we haven’t seen anything definitive yet,” said Jeremy Luban, a virologist at the University of Massachusetts Medical School.

The scramble to unravel this mutation mystery embodies the challenges of science during the coronavirus pandemic. With millions of people infected and thousands dying every day around the world, researchers must strike a high-stakes balance between getting information out quickly and making sure that it’s right.

A better lock pick

SARS-CoV-2, the novel coronavirus that causes the disease covid-19, can be thought of as an extremely destructive burglar. Unable to live or reproduce on its own, it breaks into human cells and co-opts their biological machinery to make thousands of copies of itself. That leaves a trail of damaged tissue and triggers an immune system response that for some people can be disastrous.

This replication process is messy. Even though it has a “proofreading” mechanism for copying its genome, the coronavirus frequently makes mistakes, or mutations. The vast majority of mutations have no effect on the behavior of the virus.

But since the virus’s genome was first sequenced in January, scientists have been on the lookout for changes that are meaningful. And few genetic mutations could be more significant than ones that affect the spike protein — the virus’s most powerful tool.

This protein attaches to a receptor on respiratory cells called ACE2, which opens the cell and lets the virus slip inside. The more effective the spike protein, the more easily the virus can break into the bodies of its hosts. Even when the original variant of the virus emerged in Wuhan, China, it was obvious that the spike protein on SARS-CoV-2 was already quite effective.

But it could have been even better, said Choe, who has studied spike proteins and the way they bind to the ACE2 receptor since the severe acute respiratory syndrome outbreak in 2003.

The spike protein for SARS-CoV-2 has two parts that don’t always hold together well. In the version of the virus that arose in China, Choe said, the outer part — which the virus needs to attach to a human receptor — frequently broke off. Equipped with this faulty lock pick, the virus had a harder time invading host cells.

“I think this mutation happened to compensate,” Choe said.

Studying both versions of the gene using a proxy virus in a petri dish of human cells, Choe and her colleagues found that viruses with the G variant had more spike proteins, and the outer parts of those proteins were less likely to break off. This made the virus approximately 10 times more infectious in the lab experiment.

The mutation does not seem to lead to worse outcomes in patients. Nor did it alter the virus’s response to antibodies from patients who had the D variant, Choe said, suggesting that vaccines being developed based on the original version of the virus will be effective against the new strain.

Choe has uploaded a manuscript describing this study to the website BioRxiv, where scientists can post “preprint” research that has not yet been peer reviewed. She has also submitted the paper to an academic journal, which has not yet published it.

The distinctive infectiousness of the G strain is so strong that scientists have been drawn to the mutation even when they weren’t looking for it.

Neville Sanjana, a geneticist at the New York Genome Center and New York University, was trying to figure out which genes enable SARS-CoV-2 to infiltrate human cells. But in experiments based on a gene sequence taken from an early case of the virus in Wuhan, he struggled to get that form of the virus to infect cells. Then the team switched to a model virus based on the G variant.

“We were shocked,” Sanjana said. “Voilà! It was just this huge increase in viral transduction.” They repeated the experiment in many types of cells, and every time the variant was many times more infectious.

Their findings, published as a preprint on BioRxiv, generally matched what Choe and other laboratory scientists were seeing.

But the New York team offers a different explanation as to why the variant is so infectious. Whereas Choe’s study proposes that the mutation made the spike protein more stable, Sanjana said experiments in the past two weeks, not yet made public, suggest that the improvement is actually in the infection process. He hypothesized that the G variant is more efficient at beginning the process of invading the human cell and taking over its reproductive machinery.

Luban, who has also been experimenting with the D614G mutation, has been drawn to a third possibility: His experiments suggest that the mutation allows the spike protein to change shape as it attaches to the ACE2 receptor, improving its ability to fuse to the host cell.

Different approaches to making their model virus might explain these discrepancies, Luban said. “But it’s quite clear that something is going on.”

Unanswered questions

Although these experiments are compelling, they’re not conclusive, said Kristian Andersen, a Scripps virologist not involved in any of the studies. The scientists need to figure out why they’ve identified different mechanisms for the same effect. All the studies still have to pass peer review, and they have to be reproduced using the real version of the virus.

Even then, Andersen said, it will be too soon to say that the G variant transmits faster among people.

Cell culture experiments have been wrong before, noted Anderson Brito, a computational biologist at Yale University. Early experiments with hydroxychloroquine, a malaria drug, hinted that it was effective at fighting the coronavirus in a petri dish. The drug was touted by President Trump, and the Food and Drug Administration authorized it for emergency use in hospitalized covid-19 patients. But that authorization was withdrawn this month after evidence showed that the drug was “unlikely to be effective” against the virus and posed potential safety risks.

So far, the biggest study of transmission has come from Bette Korber, a computational biologist at Los Alamos National Laboratory who built one of the world’s biggest viral genome databases for tracking HIV. In late April, she and colleagues at Duke University and the University of Sheffield in Britain released a draft of their work arguing that the mutation boosts transmission of the virus.

Analyzing sequences from more than two dozen regions across the world, they found that most places where the original virus was dominant before March were eventually taken over by the mutated version. This switch was especially apparent in the United States: Ninety-six percent of early sequences here belonged to the D variant, but by the end of March, almost 70 percent of sequences carried the G amino acid instead.

The British researchers also found evidence that people with the G variant had more viral particles in their bodies. Although this higher viral load didn’t seem to make people sicker, it might explain the G variant’s rapid spread, the scientists wrote. People with more virus to shed are more likely to infect others.

The Los Alamos draft drew intense scrutiny when it was released in the spring, and many researchers remain skeptical of its conclusions.

“There are so many biases in the data set here that you can’t control for and you might not know exist,” Andersen said. In a time when as many as 90 percent of U.S. infections are still undetected and countries with limited public health infrastructure are struggling to keep up with surging cases, a shortage of data means “we can’t answer all the questions we want to answer.”

Pardis Sabeti, a computational biologist at Harvard University and the Broad Institute, noted that the vast majority of sequenced genomes come from Europe, where the G variant first emerged, and the United States, where infections thought to have been introduced by travelers from Europe spread undetected for weeks before the country shut down. This could at least partly explain why it appears so dominant.

The mutation’s success might also be a “founder effect,” she said. Arriving in a place like Northern Italy — where the vast majority of sequenced infections are caused by the G variant — it found easy purchase in an older and largely unprepared population, which then unwittingly spread it far and wide.

Scientists may be able to rule out these alternative explanations with more rigorous statistical analyses or a controlled experiment in an animal population. And as studies on the D614G mutation accumulate, researchers are starting to be convinced of its significance.

“I think that slowly we’re beginning to come to a consensus,” said Judd Hultquist, a virologist at Northwestern University.

Solving the mystery of the D614G mutation won’t make much of a difference in the short term, Andersen said. “We were unable to deal with D,” he said. “If G transmits even better, we’re going to be unable to deal with that one.”

But it’s still essential to understand how the genome influences the behavior of the virus, scientists say. Identifying emerging mutations allows researchers to track their spread. Knowing what genes affect how the virus transmits enables public health officials to tailor their efforts to contain it. Once therapeutics and vaccines are distributed on a large scale, having a baseline understanding of the genome will help pinpoint when drug resistance starts to evolve.

“Understanding how transmissions are happening won’t be a magic bullet, but it will help us respond better,” Sabeti said. “This is a race against time.”

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Scientists just beginning to understand the many health problems caused by COVID-19

CHICAGO – Scientists are only starting to grasp the vast array of health problems caused by the novel coronavirus, some of which may have lingering effects on patients and health systems for years to come, according to doctors and infectious disease experts.

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Besides the respiratory issues that leave patients gasping for breath, the virus that causes COVID-19 attacks many organ systems, in some cases causing catastrophic damage.

“We thought this was only a respiratory virus. Turns out, it goes after the pancreas. It goes after the heart. It goes after the liver, the brain, the kidney and other organs. We didn’t appreciate that in the beginning,” said Dr. Eric Topol, a cardiologist and director of the Scripps Research Translational Institute in La Jolla, California.

In addition to respiratory distress, patients with COVID-19 can experience blood clotting disorders that can lead to strokes, and extreme inflammation that attacks multiple organ systems. The virus can also cause neurological complications that range from headache, dizziness and loss of taste or smell to seizures and confusion.

And recovery can be slow, incomplete and costly, with a huge impact on quality of life.

The broad and diverse manifestations of COVID-19 are somewhat unique, said Dr. Sadiya Khan, a cardiologist at Northwestern Medicine in Chicago.

With influenza, people with underlying heart conditions are also at higher risk of complications, Khan said. What is surprising about this virus is the extent of the complications occurring outside the lungs.

Khan believes there will be a huge healthcare expenditure and burden for individuals who have survived COVID-19.

LENGTHY REHAB FOR MANY

Patients who were in the intensive care unit or on a ventilator for weeks will need to spend extensive time in rehab to regain mobility and strength.

“It can take up to seven days for every one day that you’re hospitalized to recover that type of strength,” Khan said. “It’s harder the older you are, and you may never get back to the same level of function.”

While much of the focus has been on the minority of patients who experience severe disease, doctors increasingly are looking to the needs of patients who were not sick enough to require hospitalization, but are still suffering months after first becoming infected.

Studies are just getting underway to understand the long-term effects of infection, Jay Butler, deputy director of infectious diseases at the U.S. Centers for Disease Control and Prevention, told reporters in a telephone briefing on Thursday.

“We hear anecdotal reports of people who have persistent fatigue, shortness of breath,” Butler said. “How long that will last is hard to say.”

While coronavirus symptoms typically resolve in two or three weeks, an estimated 1 in 10 experience prolonged symptoms, Dr. Helen Salisbury of the University of Oxford wrote in the British Medical Journal on Tuesday.

Salisbury said many of her patients have normal chest X-rays and no sign of inflammation, but they are still not back to normal.

“If you previously ran 5k three times a week and now feel breathless after a single flight of stairs, or if you cough incessantly and are too exhausted to return to work, then the fear that you may never regain your previous health is very real,” she wrote.

Dr. Igor Koralnik, chief of neuro-infectious diseases at Northwestern Medicine, reviewed current scientific literature and found about half of patients hospitalized with COVID-19 had neurological complications, such as dizziness, decreased alertness, difficulty concentrating, disorders of smell and taste, seizures, strokes, weakness and muscle pain.

Koralnik, whose findings were published in the Annals of Neurology, has started an outpatient clinic for COVID-19 patients to study whether these neurological problems are temporary or permanent.

Khan sees parallels with HIV, the virus that causes AIDS. Much of the early focus was on deaths.

“In recent years, we’ve been very focused on the cardiovascular complications of HIV survivorship,” Khan said.

HOW D’OXYVA CAN HELP?

D’OXYVA is the only fully noninvasive, completely painless over-the-skin microcirculatory and nerve stimulant solution that has been validated to significantly improve microcirculation.

The improvement of microcirculation, i.e., blood flow to the smallest blood vessels, benefits one’s health, immune system and overall sense of well-being in a variety of ways.

Reduce unwanted doctor visits, recommended and ranked top by experts!

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Circularity Healthcare Joins Springer Publishing Company, Daily Nurse, and Minority Nurse In Recognizing Nurses and Giving Back

In these uncertain times, we must recognize and promote our nurses on the frontlines of the COVID-19 pandemic. Circularity Healthcare is finding ways to share in recognizing those who deserve recognition.

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“We’ve been on the lookout for publishers we can partner with who have the same goal as ours; that is, to help our front liners. In our participation with Springer Publishing’s Nurses’ Week 2020, we want to spread the message that D’OXYVA is readily available for them to keep them protected by boosting their immune system and by providing armor against infection,” said Jennifer Boadilla-Pelaez, Circularity Healthcare’s Senior Sales and Marketing Manager and Creative Director.

Last May, Springer Publishing Company launched its Nurses’ Week 2020 issue to help support and recognize nurses who are leading via change. In this special issue presented by Springer Publishing Company, Daily Nurse, and Minority Nurse, we’ll hear from frontline nurses, nurse researchers, and nurse educators to learn how they lead during the COVID-19 pandemic.

Circularity showed their support by securing a 2-page advertorial for this issue and showcased how to help front liners stay healthy during these uncertain times via its latest article discussing a new clinical trial involving Circularity’s already FDA-approved drug and IDE device D’OXYVA®, which could significantly increase the recovery rate for COVID-19 patients with underlying health conditions and save lives! Circularity has also been calling out all doctors and nurses that Circularity is accepting D’OXYVA donation requests.

(Read the full issue here: https://dailynurse.com/nurses-week-2020-special-issue/)

20% of all proceeds will be donated to the GLO GOOD Foundation, who have joined with the Society of Nurse Scientists Innovators Entrepreneurs and Leaders (SONSIEL) to launch an urgent call-to-action to move personal protective equipment (PPE) supplies, including vital respirator masks, to frontline health-care providers for COVID-19 patients.

About Springer Publishing

Springer Publishing is an award-winning publisher of health-care and behavioral sciences content, featuring books, apps, journals, and digital products. With an acute understanding of how educators teach, how practitioners work, and how students learn, we design our digital and print products for optimal outcomes for learners, patients, and clients. We’ve been proudly educating people in the health-care and helping professions for over 70 years.

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Why COVID-19 kills some people and spares others. Here’s what scientists are finding

The novel coronavirus causing COVID-19 seems to hit some people harder than others, with some people experiencing only mild symptoms and others being hospitalized and requiring ventilation. Though scientists at first thought age was the dominant factor, with young people avoiding the worst outcomes, new research has revealed a suite of features impacting disease severity. These influences could explain why some perfectly healthy 20-year-old with the disease is in dire straits, while an older 70-year-old dodges the need for critical interventions.

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Underlying health conditions are thought to be an important factor influencing disease severity. Indeed, a study of more than 1.3 million COVID-19 cases in the United States, published June 15 in the journal Morbidity and Mortality Weekly Report, found that rates of hospitalizations were six times higher and rates of death were 12 times higher among COVID-19 patients with underlying conditions, compared with patients without underlying conditions. The most commonly reported underlying conditions were heart disease, diabetes and chronic lung disease.

In general, risk factors for more severe COVID-19 outcomes include:

About 8 out of 10 deaths associated with COVID-19 in the U.S. have occurred in adults ages 65 and older, according to the U.S. Centers for Disease Control and Prevention (CDC). The risk of dying from the infection, and the likelihood of requiring hospitalization or intensive medical care, increases significantly with age. For instance, adults ages 65-84 make up an estimated 4-11% of COVID-19 deaths in the U.S, while adults ages 85 and above make up 10-27%.

The trend may be due, in part, to the fact that many elderly people have chronic medical conditions, such as heart disease and diabetes, that can exacerbate the symptoms of COVID-19, according to the CDC. The ability of the immune system to fight off pathogens also declines with age, leaving elderly people vulnerable to severe viral infections, Stat News reported.

Diabetes mellitus — a group of diseases that result in harmful high blood sugar levels — also seems to be linked to risk of more severe COVID-19 infections.

The most common form in the U.S. is type 2 diabetes, which occurs when the body’s cells don’t respond to the hormone insulin. As a result, the sugar that would otherwise move from the bloodstream into cells to be used as energy just builds up in the bloodstream. (When the pancreas makes little to no insulin in the first place, the condition is called type 1 diabetes.)

In a review of 13 relevant studies, scientists found that people with diabetes were nearly 3.7 times more likely to have a critical case of COVID-19 or to die from the disease compared with COVID-19 patients without any underlying health conditions (including diabetes, hypertension, heart disease or respiratory disease), they reported online April 23 in the Journal of Infection.

Even so, scientists don’t know whether diabetes is directly increasing severity or whether other health conditions that seem to tag along with diabetes, including cardiovascular and kidney conditions, are to blame.

That fits with what researchers have seen with other infections and diabetes. For instance, flu and pneumonia are more common and more serious in older individuals with type 2 diabetes, scientists reported online April 9 in the journal Diabetes Research and Clinical Practice. In a literature search of relevant studies looking at the link between COVID-19 and diabetes, the authors of that paper found a few possible mechanisms to explain why a person with diabetes might fare worse when infected with COVID-19. These mechanisms include: “Chronic inflammation, increased coagulation activity, immune response impairment and potential direct pancreatic damage by SARS-CoV-2.”

Related: 13 coronavirus myths busted by science

Mounting research has shown the progression of type 2 diabetes is tied to changes in the body’s immune system. This link could also play a role in poorer outcomes in a person with diabetes exposed to SARS-CoV-2, the virus that causes COVID-19.

No research has looked at this particular virus and immune response in patients with diabetes; however, in a study published in 2018 in the Journal of Diabetes Research, scientists found through a review of past research that patients with obesity or diabetes showed immune systems that were out of whack, with an impairment of white blood cells called Natural Killer (NK) cells and B cells, both of which help the body fight off infections. The research also showed that these patients had an increase in the production of inflammatory molecules called cytokines. When the immune system secretes too many cytokines,a so-called “cytokine storm” can erupt and damage the body’s organs. Some research has suggested that cytokine storms may be responsible for causing serious complications in people with COVID-19, Live Science previously reported. Overall, type 2 diabetes has been linked with impairment of the very system in the body that helps to fight off infections like COVID-19 and could explain why a person with diabetes is at high risk for a severe infection.

Not all people with type 2 diabetes are at the same risk, though: A study published May 1 in the journal Cell Metabolism found that people with diabetes who keep their blood sugar levels in a tighter range were much less likely to have a severe disease course than those with more fluctuations in their blood sugar levels.

People with type 1 diabetes (T1D) are also at elevated risk of adverse outcomes, a small study published in Diabetes Care suggests. The study, coordinated by T1D Exchange — a nonprofit research organization focused on therapies for those with type 1 diabetes — found that of 64 people with either COVID-19 or COVID-19-like symptoms, two died. Nearly 4 in 10 people had to be treated in a hospital. And nearly a third experienced diabetic ketoacidosis — a potentially deadly condition in which the body experiences a shortage of insulin and blood sugar levels rise dangerously high. The average patient was about 21 years old, suggesting that risks could be potentially higher for older age groups.

People with conditions that affect the cardiovascular system, such as heart disease and hypertension, generally suffer worse complications from COVID-19 than those with no preexisting conditions, according to the American Heart Association. That said, historically healthy people can also suffer heart damage from the viral infection.

The first reported coronavirus death in the U.S., for instance, occurred when the virus somehow damaged a woman’s heart muscle, eventually causing it to burst, Live Science reported. The 57-year-old maintained good health and exercised regularly before becoming infected, and she reportedly had a healthy heart of “normal size and weight.” A study of COVID-19 patients in Wuhan, China, found that more than 1 in 5 patients developed heart damage — some of the sampled patients had existing heart conditions, and some did not.

In seeing these patterns emerge, scientists developed several theories as to why COVID-19 might hurt both damaged hearts and healthy ones, according to a Live Science report.

In one scenario, by attacking the lungs directly, the virus might deplete the body’s supply of oxygen to the point that the heart must work harder to pump oxygenated blood through the body. The virus might also attack the heart directly, as cardiac tissue contains angiotensin-converting enzyme 2 (ACE2) — a molecule that the virus plugs into to infect cells. In some individuals, COVID-19 can also kickstart an overblown immune response known as a cytokine storm, wherein the body becomes severely inflamed and the heart could suffer damage as a result.

People who smoke cigarettes may be prone to severe COVID-19 infections, meaning they face a heightened risk of developing pneumonia, suffering organ damage and requiring breathing support. A study of more than 1,000 patients in China, published in the New England Journal of Medicine, illustrates this trend: 12.3% of current smokers included in the study were admitted to an ICU, were placed on a ventilator or died, as compared with 4.7% of nonsmokers. Cigarette smoke might render the body vulnerable to the coronavirus in several ways, according to a recent Live Science report. At baseline, smokers may be vulnerable to catching viral infections because smoke exposure dampens the immune system over time, damages tissues of the respiratory tract and triggers chronic inflammation. Smoking is also associated with a multitude of medical conditions, such as emphysema and atherosclerosis, which could exacerbate the symptoms of COVID-19. A recent study, posted March 31 to the preprint database bioRxiv, proposed a more speculative explanation as to why COVID-19 hits smokers harder. The preliminary research has not yet been peer-reviewed, but early interpretations of the data suggest that smoke exposure increases the number of ACE2 receptors in the lungs — the receptor that SARS-CoV-2 plugs into to infect cells. Many of the receptors appear on so-called goblet and club cells, which secrete a mucus-like fluid to protect respiratory tissues from pathogens, debris and toxins. It’s well-established that these cells grow in number the longer a person smokes, but scientists don’t know whether the subsequent boost in ACE2 receptors directly translates to worse COVID-19 symptoms. What’s more, it’s unknown whether high ACE2 levels are relatively unique to smokers, or common among people with chronic lung conditions.
Several early studies have suggested a link between obesity and more severe COVID-19 disease in people. One study, which analyzed a group of COVID-19 patients who were younger than the age of 60 in New York City, found that those who were obese were twice as likely as non-obese individuals to be hospitalized and were 1.8 times as likely to be admitted into critical care. “This has important and practical implications” in a country like the U.S. where nearly 40% of adults are obese, the authors wrote in the study, which was accepted into the journal Clinical Infectious Diseases but not yet peer-reviewed or published. Similarly, another preliminary study that hasn’t yet been peer-reviewed found that the two biggest risk factors for being hospitalized from the coronavirus are age and obesity. This study, published in medRxiv looked at data from thousands of COVID-19 patients in New York City, but studies from other cities around the world found similar results, as reported by The New York Times. A preliminary study from Shenzhen, China, which also hasn’t been peer-reviewed, found that obese COVID-19 patients were more than twice as likely to develop severe pneumonia as compared with patients who were normal weight, according to the report published as a preprint online in the journal The Lancet Infectious Diseases. Those who were overweight, but not obese, had an 86% higher risk of developing severe pneumonia than did people of “normal” weight, the authors reported. Another study, accepted into the journal Obesity and peer-reviewed, found that nearly half of 124 COVID-19 patients admitted to an intensive care unit in Lille, France, were obese. It’s not clear why obesity is linked to more hospitalizations and more severe COVID-19 disease, but there are several possibilities, the authors wrote in the study. Obesity is generally thought of as a risk factor for severe infection. For example, those who are obese had longer and more severe disease during the swine flu epidemic, the authors wrote. Obese patients might also have reduced lung capacity or increased inflammation in the body. A greater number of inflammatory molecules circulating in the body might cause harmful immune responses and lead to severe disease.

Blood type seems to be a predictor of how susceptible a person is to contracting SARS-CoV-2, though scientists haven’t found a link between blood type per se and severity of disease.

Jiao Zhao, of The Southern University of Science and Technology, Shenzhen, and colleagues looked at blood types of 2,173 patients with COVID-19 in three hospitals in Wuhan, China, as well as blood types of more than 23,000 non-COVID-19 individuals in Wuhan and Shenzhen. They found that individuals with blood types in the A group (A-positive, A-negative and AB-positive, AB-negative) were at a higher risk of contracting the disease compared with non-A-group types. People with O blood types (O-negative and O-positive) had a lower risk of getting the infection compared with non-O blood types, the scientists wrote in the preprint database medRxiv on March 27; the study has yet to be reviewed by peers in the field.

In a more recent study of blood type and COVID-19, published online April 11 to medRxiv, scientists looked at 1,559 people tested for SARS-CoV-2 at New York Presbyterian hospital; of those, 682 tested positive. Individuals with A blood types (A-positive and A-negative) were 33% more likely to test positive than other blood types and both O-negative and O-positive blood types were less likely to test positive than other blood groups. (There’s a 95% chance that the increase in risk ranges from 7% to 67% more likely.) Though only 68 individuals with an AB blood type were included, the results showed this group was also less likely than others to test positive for COVID-19.
The researchers considered associations between blood type and risk factors for COVID-19, including age, sex, whether a person was overweight, other underlying health conditions such as diabetes mellitus, hypertension, pulmonary diseases and cardiovascular diseases. Some of these factors are linked to blood type, they found, with a link between diabetes and B and A-negative blood types, between overweight status and O-positive blood groups, for instance, among others. When they accounted for these links, the researchers still found an association between blood type and COVID-19 susceptibility. When the researchers pooled their data with the research by Zhao and colleagues out of China, they found similar results as well as a significant drop in positive COVID-19 cases among blood type B individuals.

Why blood type might increase or decrease a person’s risk of getting SARS-CoV-2 is not known. A person’s blood type indicates what kind of certain antigens cover the surfaces of their blood cells; These antigens produce certain antibodies to help fight off a pathogen. Past research has suggested that at least in the SARS coronavirus (SARS-CoV), anti-A antibodies helped to inhibit the virus; that could be the same mechanism with SARS-CoV-2, helping blood group O individuals to keep out the virus, according to Zhao’s team.

Many medical conditions can worsen the symptoms of COVID-19, but why do historically healthy people sometimes fall dangerously ill or die from the virus? Scientists suspect that certain genetic factors may leave some people especially susceptible to the disease, and many research groups aim to pinpoint exactly where those vulnerabilities lie in our genetic code.

In one scenario, the genes that instruct cells to build ACE2 receptors may differ between people who contract severe infections and those who hardly develop any symptoms at all, Science magazine reported. Alternatively, differences may lie in genes that help rally the immune system against invasive pathogens, according to a recent Live Science report.

For instance, a study published April 17 in the Journal of Virology suggests that specific combinations of human leukocyte antigen (HLA) genes, which train immune cells to recognize germs, may be protective against SARS-CoV-2, while other combinations leave the body open to attack. HLAs represent just one cog in our immune system machinery, though, so their relative influence over COVID-19 infection remains unclear. Additionally, the Journal of Virology study only used computer models to simulate HLA activity against the coronavirus; clinical and genetic data from COVID-19 patients would be needed to flesh out the role of HLAs in real-life immune responses.

HOW D’OXYVA CAN HELP?

D’OXYVA is the only fully noninvasive, completely painless over-the-skin microcirculatory and nerve stimulant solution that has been validated to significantly improve microcirculation.

The improvement of microcirculation, i.e., blood flow to the smallest blood vessels, benefits one’s health, immune system and overall sense of well-being in a variety of ways.

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Sally Pipes: Coronavirus lockdown — How many harmed by disruption to routine medical care?

With states in the initial stages of reopening their economies, early research seems to indicate that the stay-at-home orders may not have had as much impact on the spread of COVID-19 as the conventional wisdom held.

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We may be on the cusp of a different “mass casualty incident,” a group of over 600 doctors recently argued in an open letter to President Trump. The doctors assert that 150,000 patients have had cancer go undetected during the lockdown. Even more have foregone treatment for conditions that could lead to heart disease or stroke.

Sadly, these physicians may be right.

Suspensions of routine medical care and elective surgeries have harmed patients across the country. In the end, the lockdowns may result in more sickness and death from other causes than the pandemic itself.

Nearly half of Americans say the outbreak has forced them or someone in their household to delay care, according to a new Kaiser Family Foundation poll. Over 10 percent of those reporting delays said their or their family member’s condition worsened because of the delay.

In a few short months, stay-at-home orders have caused Americans to shun essential care. From February to March, the insurance company Cigna reported a 35 percent drop in claims for atrial fibrillation, an irregular heartbeat that can lead to blood clots, heart failure and stroke. The insurer also noted a 28 percent decrease in claims for epilepsy and seizure and a 13 percent decrease in claims for appendicitis.

In a recent study published in The New England Journal of Medicine, Kaiser Permanente reported a nearly 50 percent drop in heart attack admissions at its Northern California hospitals since March.

Of course, disease hasn’t taken a holiday while patients stay away from hospitals. In late May, Dr. Michael Apostolakos, chief medical officer of the University of Rochester Medical Center, told The New York Times that patients who do seek help often arrive in the late, painful stages of heart attacks and strokes. The hospital’s emergency room has reported a 50 percent drop in admissions.

Delaying trips to the hospital for urgent conditions can cost patients their lives. In Newark, N.J., the number of deaths declared on the scene by the city’s emergency medical services in April quadrupled compared to the previous year. Fewer than half of those pronouncements were directly attributable to COVID-19. That suggests that some Newark residents are waiting until they’re on death’s door to call for help.

Even patients receiving treatment for serious diseases have seen their care interrupted. Four in five cancer patients currently undergoing treatment report delays in health care, according to a recent survey from the American Cancer Society. Seventeen percent of patients reported delays in cancer therapies like chemotherapy and radiation.

Some states have been slow to lift restrictions on routine care. Michigan Gov. Gretchen Whitmer did not green-light the resumption of elective surgeries until May 29. In late May, the University of Michigan Health System had a backlog of about 12,000 such surgeries. New York Gov. Andrew Cuomo’s administration only gave the green light to all hospitals in Erie County – home to Buffalo – to resume elective surgeries last week.

Of course, simply permitting surgeries once again may not bring patients back. Nationwide, hospital visits through the first half of May were down 40 percent, compared to 2019. Even though most states’ stay-at-home orders had expired by then, states have still been discouraging people from venturing out.

Such discouragement can have deadly consequences. Even as they relax their stay-at-home orders, states must make sure that they don’t further obstruct patients from seeking the medical care they’ve postponed and need.

HOW D’OXYVA CAN HELP?

D’OXYVA is the only fully noninvasive, completely painless over-the-skin microcirculatory and nerve stimulant solution that has been validated to significantly improve microcirculation at the comforts of your home.

The improvement of microcirculation, i.e., blood flow to the smallest blood vessels, benefits one’s health, immune system and overall sense of well-being in a variety of ways.

Reduce unwanted doctor visits, recommended and ranked top by experts!

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An interview with Dr. Geoffrey Watson: Diabetic patients and Covid-19

About Dr. Geoffrey Watson

Watson Wellness Center in Oakland, CA

A native and resident of Oakland, California, Geoffrey Watson obtained a Bachelor of Science in Health Care Administration from the University of California at Davis and a medical degree from Vanderbilt University in Nashville, Tennessee. Dr. Watson completed two years of his medical residency at the Vanderbilt Medical Center with his final year of medical residency completed at the University of California Medical Center in San Francisco. In 1985, Dr. Watson started his medical career in Oakland as a specialist in the art of Internal Medicine working as a staff physician at the Arlington Medical Center alongside his father, Dr. James A. Watson.

Dr. Watson has a special interest in education and has earned the position of Director of Continuing Medical Education at Fairmont Hospital in San Leandro and Alameda County Medical Center of the East Bay. In 1992, as a Board Certified Internist, his love for teaching and medical education has earned him a position as Assistant Clinical Professor of Medicine at the U.C.S.F. Medical Center. Also in 1992, as the Co-Medical Director of the Arlington Medical Center, Dr. Watson became a key player in the Oakland community as a leader in managed care and positioned himself as a Founding Member of the Alta Bates Medical Associates. He developed medical groups, leading the way in managed care, and helped to organize a merger of prominent physicians resulting in a powerful African American Primary Care Group geared towards serving the needs of African Americans in the East Bay, including the development of preventive care programs focused in the areas of hypertension, asthma, diabetes, heart disease, substance abuse and weight control.

Dr. Watson has served as the Secretary for the Sinkler Miller Medical and the Golden State Medical Associations during 1994. In May, 1997, he was inaugurated into office as President of the Golden State Medical Association and served through 1998. From 1996 through 1997 he has been honored with serving as the President of the Sinkler Miller Medical Association of the East Bay. On March 1, 1997, Dr. Watson established a new medical facility, The James A. Watson Wellness Center, a legacy of his father, moving his practice to Pill Hill and continuing to provide high quality and sensitive care to patients by treating the physical, socioeconomic, spiritual and psychological ailments and employing medical and practical solutions with hopes of resulting in complete wellness.

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1. What should patients with diabetes know about COVID-19 and how it may affect them?

Those people who are at the highest risks of contracting covid-19, are those over the age 65, have heart disease, liver disorders, diabetes and other underlying health issues. Because it effects the immune system and compromises the bodies natural defenses fight off infections, it is critical for a person with diabetes to have good blood flow circulation, reducing the chance of infection, ulcers and at worse case amputations.

2. How does Circularity’s  over-the-counter (OTC) transdermal device helps patients with foot issues, potentially including COVID?

D’OXYVA®  (deoxyhemoglobin vasodilator) is validated to significantly improve macro- and micro-circulation of blood flow and certain nerve activities in the body, which together are widely reported to form an effective non-invasive, pain-free solution option for many conditions. It provides accelerated and comprehensive wound care — plus infection protection — in a painless, affordable non-prescription solution available in a clinical setting, or in the comfort and privacy of your own home.

D’OXYVA has shown significant promise for severe cases of diabetic foot ulcers. Its therapeutic effects have circulatory and neurological benefits as well.

3. Tell us about CO2, microcirculation, and its effects on the body.

D’OXYVA uses ultra-purified carbon dioxide, which has been shown to produce higher oxygen unloading by hemoglobin, thereby increasing oxygen-rich blood flow in the local microcirculatory system. This improved dermal microcirculation leads, in turn, to enhanced wound healing.

Good blood circulation has many important health benefits. Among the most prominent is the optimal oxygenation of bodily tissues and organs, which allows for efficient functioning of the heart, lungs and muscles. Active blood circulation also improves the immune response against disease by allowing the better transportation of white blood cells throughout the body. Furthermore, proper blood circulation improves cellular detoxification, while waste removal becomes more efficient. Among its other health benefits, D’OXYVA® has been also validated as a successful means of improving the autonomic nervous system.

4. What have clinical trials shown about how this device helps patients, especially diabetics with foot problems?

Studies with D’OXYVA have shown increased oxygen concentration and lower carbon dioxide concentration in the blood just 30 minutes after treatment that can last upto 60 minutes. Over two dozen studies demonstrated convincing results at clinics and at home with no adverse events.

Many treatments make bold online claims to help cure various conditions and restore you to health — pills, shots, creams, procedures, and devices. But only science-backed, one-of-a-kind D’OXYVA stands alone, delivering the remarkable physical, mental, and emotionally rejuvenating results.

5. As a Internist ­focused on prevention, what do you want diabetics to know about making their foot health a priority?

The heart is the engine that makes the body function. The foot though a far distance from the heart requires consistent blood flow. It requires open pathways. If those pathways are constricted, which is fairly normal occurrence with diabetic patients, those areas have a tendency to die off, because of the poor blood circulation. That is why it is key to some type of vasodilation to promote microcirculatory blood flow to supply adequate oxygenation the the feet. There by likely helping to prevent infections, ulcers and wounds.

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How a New OTC Medical Device Backed by Nobel Prize-winning Science Can Protect You by Targeting Underlying Conditions

treat underlying condition in covid patients

Patients dealing with underlying health issues, including diabetes and chronic heart conditions, as well as COVID-19, may find fast and painless relief from an over the counter (OTC) device.

An easy-to-use , commercially-available device, D’OXYVA (deoxyhemoglobin vasodilator) by Circularity Healthcare, LLC, delivers transdermal ultra-purified medical gas directly to the blood stream and body tissues that are low in oxygen-rich blood flow.

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The handheld, lightweight device – which promotes  the rest and digest functions of the autonomic nervous system  and the circulation of the blood in the smallest blood vessels, known as microcirculation – has demonstrated over years of studies and user feedback great efficacy in treating a number of health issues, including treating and closing so-called non-healing diabetic wounds. 

D’OXYVA has shown significant promise for severe cases of diabetic foot ulcers,” says Dr. Michael McGlamry, a podiatrist in Georgia.

He says the device helps increase oxygen-rich blood flow in the local microcirculatory system, leading to better blood perfusion and tissue oxygenation.  

“Improved microcirculation leads to better tissue oxygenation and better heart function, as the heart does not need to exert extra force to bring the blood to all the organs of the body,” says Dr. McGlamry.

Wound healing

Foot wounds are a significant concern for diabetics: 15% will develop a foot ulcer, and 14-24% of individuals with a foot ulcer, will need amputation.  

Dr. Felix Sigal, a Los Angeles podiatrist, says this device is a game changer.

“Transdermal delivery of carbon dioxide has therapeutic effects on both the microcirculation and tissue oxygenation,” he says. “By improving tissue oxygenation and microcirculation, studies have shown greater progress in wound healing with respect to wound size and area of injury.”

The device was evaluated over eight years and three dozen human studies where zero adverse effects were reported. The CO₂ is approved by the FDA for anesthesia and oxygen therapy as a non-toxic, simple molecule under the Medical Gas Safety Act of 2012. It’s in the final phase of getting a combination device-drug approval. 

“D’OXYVA has recorded significant results, delivering major outcomes for well over 90% of users,” says Dr. McGlamry. 

Applications for COVID-19 patients

The device may help improved blood flow and tissue oxygenation for people with COVID-19 . Patients most at risk for the novel coronavirus include those over 65 who have heart disease, liver disorders, diabetes or other underlying health issues.

“Because it affects the immune system and compromises the body’s natural defenses fight off infections, it is critical for a person with diabetes to have good blood flow circulation, reducing the chance of infection, ulcers and at worst case amputations,” says Dr. Geoffrey Watson, who specializes in chronic care management in Oakland, California.

He says while the heart is a far distance from the foot, the foot relies on the heart for consistent blood flow, requiring open pathways. Often those pathways are constricted in diabetics, resulting in poor blood circulation

Dr. Watson says vasodilation is essential, “to promote microcirculatory blood flow to supply adequate oxygenation the feet, thereby likely helping to prevent infections, ulcers and wounds.” 

Clinical Trial

Circularity Healthcare’s Phase 3 clinical trial — which involves the use of an FDA-approved drug in addition to IDE device D’OXYVA® (deoxyhemoglobin vasodilator), a non-toxic, non-invasive  transdermal drug delivery device — is poised to help the most at-risk coronavirus patients experiencing complications due to diabetes, poor circulation, hypertension, high blood pressure, and cardiovascular disease. 

“Further studies are needed but this device has the potential to prevent symmetrical peripheral gangrene, a limb threatening complication of COVID-19,” says Dr. Sigal, who is helping conduct the D’OXYVA Phase 3 diabetic foot ulcer clinical trials.

This clinical trial represents the first biotech solution to improve a patient’s overall oxygen-rich blood flow. 

For more information: https://doxyva.com/covid-19/

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An interview with Dr. Michael McGlamry: Diabetic patients and Covid-19

Michael Mcglamry

About Dr. Michael McGlamry

Forsyth Foot and Ankle Associates, Cumming, GA

Dr. McGlamry was born and raised in Atlanta.  He graduated from Tucker High School in 1982, and earned a Bachelor of Science in Engineering with honors from The University of Florida. In 1991, he earned a Doctorate of Podiatric Medicine from The Penn. College of Podiatric Medicine/Temple University.

In 1991, he began his residency training in reconstructive surgery of the foot and leg at Northlake Regional Medical Center in Tucker. After completion, he started a practice in Gainesville, Fl where he practiced for 11 years.

Currently, he teaches at DeKalb Medical Center, with the residency program. He also teach on the post graduate level with the Podiatry Institute, and AO North America; both of which are renowned for their dedication to physicians’ education, and for the improvement of quality patient care.

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1. What should patients with diabetes know about COVID-19 and how it may affect them?

In the middle of a global pandemic, like the one we’re living, it is very important to be able to assess risks and try to diminish their effects. Cardiovascular disease is one of the most relevant and impactful; that is why improving blood flow and tissue oxygenation is so important for improving the health outcomes of a COVID-19 infection.

People with diabetes, especially those over 65 years of age, have been shown to be affected more often and with greater severity by coronavirus infection. Diabetic patients, particularly those with more longstanding and poorly controlled disease, suffer from diminished oxygen-rich blood in their microcirculation, which may be a major risk factor for why COVID is so deadly for them. Reports from Chinese authorities and from top American institutions, such as Harvard Medical School, show that underlying cardiovascular disease is associated with an increased risk of in-hospital death for patients hospitalized with COVID-19.

2. How does Circularity’s  over-the-counter (OTC) transdermal device helps patients with foot issues, potentially including COVID?

D’OXYVA® (deoxyhemoglobin vasodilator) is a groundbreaking noninvasive, painless transdermal delivery system based on widely established, groundbreaking, Nobel Prize-winning science and is shown to increase oxygen-rich blood flow in the local microcirculatory system, which in turn leads to better blood perfusion and tissue oxygenation. The increased peripheral perfusion plays a significant role in enhancing the wound healing process, which may lead to a reduction in the influence of preexisting conditions in cases of a coronavirus infection.

D’OXYVA has shown significant promise for severe cases of diabetic foot ulcers. Its therapeutic effects have circulatory and neurological benefits as well.

3. Tell us about CO2, microcirculation, and its effects on the body.

D’OXYVA uses ultra-purified carbon dioxide (CO2), a naturally occurring nontoxic substance, which is delivered via the D’OXYVA noninvasive skin delivery system. The CO2 acts as a signaling agent for the body to help stimulate delivery of red blood cells loaded with fresh oxygen to the peripheral tissue. D’OXYVA’s over-the-skin route of administration has demonstrated a safer, more effective alternative route to inhalation — a routine CO2 delivery method in hospitals. Purified carbon dioxide is a nontoxic molecule and can be sold by Circularity over the counter (OTC) and online without the need for a prescription. Circularity’s products are manufactured in compliance with the highest standards.

Improved microcirculation leads to better tissue oxygenation and better heart function, as the heart does not need to exert extra force to propel the blood to all the organs of the body.

4. What have clinical trials shown about how this device helps patients, especially diabetics with foot problems?

Over two dozen studies have demonstrated convincing results at clinics and in homes with no adverse events. D’OXYVA has recorded significant results, delivering major outcomes for well over 90% of users. Studies of D’OXYVA have shown unmatched results in noninvasive wound care — particularly when all other approaches have failed. D’OXYVA provides an adjunct to accelerate comprehensive wound care programs and infection protection in a painless, affordable nonprescription solution that is available in a clinical setting or in the comfort and privacy of your own home.

In an ongoing multiyear, multicountry, multicenter randomized clinical trial on patients with diabetic foot ulcers, D’OXYVA demonstrated hastened wound improvement and eventual wound closure in an average of 5 weeks**.

In addition, D’OXYVA eliminated pain and improved quality of life such as in regard to sleep, appetite, and mood in just a week in 100% of subjects.

No adverse events of any kind were reported during and for years after the studies.

5. As a Internist ­focused on prevention, what do you want diabetics to know about making their foot health a priority?

Microcirculation is often disregarded by diabetic patients, and I’d like to emphasize to them that microcirculation is important, especially in wound healing. In other words, microcirculation is the bridge between blood and single cells that supply oxygen and nutrients to human tissues, especially where it is needed the most. Without proper blood flow, their body will be prone to more complications, including the development of foot ulcers that could lead to amputation. Remember that having improved microcirculation and oxygenation promotes faster wound healing, promotes better performance, and enhances the renewal and replacement of damaged tissues.

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An interview with Dr. Felix Sigal: Diabetic patients and Covid-19

Felix Sigal

About Dr. Felix Sigal

Foot and Ankle Clinic, Los Angeles Podiatrist

Dr. Felix Sigal, DPM is a podiatry specialist in Los Angeles, CA. He graduated from California College of Podiatric Medicine and specializes in podiatry. He is the principal doctor at our clinic, graduated from California State University of Northridge and pursued his training at the California College of Podiatric Medicine, completing his residency at USC General Hospital. Throughout his training, Dr. Sigal expanded his interests in diabetic limb salvage and became one of the most distinguished specialists in the field. Dr. Sigal currently is on staff at both the St. Vincent Medical Center and the California Hospital Medical Center, where he focuses on wound care, diabetic limb salvage, as well as pursues his interest in clinical research to enable better treatment options for his patients. Dr. Sigal serves as a Principal Investigator on numerous clinical research studies in the field of diabetic complications, wound care and has contributed his expertise to the field of clinical research always searching for better treatment options to improve the lives of patients. Dr. Sigal is seeing patients in the Los Angeles and Lancaster offices.

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1. What should patients with diabetes know about COVID-19 and how it may affect them?

COVID-19 can infect people of all ages. However, two groups are at higher risk of developing severe complications secondary to COVID-19. These are older adults (over 60 years old) and individuals with underlying medical conditions such as obesity, cancer, diabetes, cardiovascular disease, and chronic respiratory disease. Because diabetic patients often have multiple comorbidities, such as obesity and cardiovascular disease, new data suggests that the death rate and hospitalization duration are four times higher for this subset of the population.

2. How does Circularity’s  over-the-counter (OTC) transdermal device helps patients with foot issues, potentially including COVID?

Disseminated intravascular coagulation (DIC) is one of the severe complications related to COVID-19. This is a serious disorder in which the proteins that control blood clotting become overactive, which can result in symmetrical peripheral gangrene. The Circularity OTC device is a novel transdermal delivery system that can deliver carbon dioxide directly to body tissues low in oxygen. Further studies are needed, but this device has the potential to prevent symmetrical peripheral gangrene, a limb-threatening complication of COVID-19.

3. Tell us about CO2, microcirculation, and its effects on the body.

Inadequate wound healing in chronic wounds is secondary to poor blood perfusion at the level of the wound and surrounding tissues, defined as local hypoxia. Transdermal delivery of carbon dioxide has therapeutic effects on both the microcirculation and tissue oxygenation. By improving tissue oxygenation and microcirculation, studies have shown greater progress in wound healing with respect to wound size and area of injury.

4. What have clinical trials shown about how this device helps patients, especially diabetics with foot problems?

Among patients with diabetes, 15% develop a foot ulcer, and 12-24% of individuals with a foot ulcer require amputation. The average cost of treatment ranges from $16,500 for patients without severely impaired circulation to about $63,000 for patients undergoing an amputation. Capillary microcirculation to foot skin has shown signs of significant impairment in diabetic patients when metabolic control is poor, resulting in poor healing rates for ulcers and worsening of diabetic peripheral neuropathy. The preliminary studies of the Circularity OTC medical device have shown increased oxygenation to tissue, resulting in improved wound healing.

5. As a Internist ­focused on prevention, what do you want diabetics to know about making their foot health a priority?

During the COVID-19 pandemic, it has become even more imperative for diabetic patients to avoid hospitalization from foot complications. To prevent foot complications, diabetic patients must continue to control their diabetes, look at their feet on a daily basis, and become comfortable with using telemedicine to communicate their medical needs to their physicians. During their daily exam, diabetics should look for blisters, minor injuries, sores, and any other abnormal changes to their feet. By following these simple steps, they can reduce the risk of foot complications and amputations.

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