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Regeneron to launch Phase 3 trials of antibody ‘cocktail’ for COVID-19



July 6 (UPI) — Drugmaker Regeneron announced plans Monday to begin Phase 3 clinical trials of a “double antibody cocktail” for use as a possible treatment for COVID-19.

The Phase 3 trial, the last stage of evaluation in the drug approval process, will assess the ability of the cocktail, called REGN-COV2, to prevent infection among uninfected people who have had “close exposure” to someone with COVID-19, company officials said.

COVID-19 is the disease caused by the new coronavirus, SARS-CoV-2.

“We are running simultaneous adaptive trials in order to move as quickly as possible to provide a potential solution to prevent and treat COVID-19 infections, even in the midst of an ongoing global pandemic,” Dr. George D. Yancopoulos, Regeneron’s co-founder, president and chief scientific officer, said in a statement.

The Phase 3 trial will be run by Regeneron and the National Institute of Allergy and Infectious Diseases. The cocktail, which is administered as a single IV infusion, is simultaneously undergoing Phase 2 and 3 trials designed to test its ability to treat hospitalized and non-hospitalized patients who have COVID-19, the company said.

The antibody cocktail is the result of research by company scientists in which thousands of fully human antibodies produced by Regeneron’s proprietary VelocImmune mice were evaluated along with antibodies collected from people who have recovered from COVID-19, according to Yancopoulos.

The VelocImmune mice have been genetically modified to have a human immune system, he said.

Scientists selected the two most potent antibodies against the new coronavirus to create REGN-COV2, which contains two antibodies that bind to the virus’s spike protein, diminishing the ability of mutant viruses to escape treatment and protecting against spike variants that have arisen in the human population, according to the company.

Researchers described the potential role for REGN-COV2 in an analysis published last month by the journal Science.

“We are pleased to collaborate with NIAID to study REGN-COV2 in our quest to further prevent the spread of the virus with an anti-viral antibody cocktail that could be available much sooner than a vaccine,” Yancopoulos said.

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Leg fat linked to lower risk for high blood pressure



People with fatter legs appear less likely to have high blood pressure, new research suggests.

The researchers suspect that measuring leg fat could help guide blood pressure prevention efforts. Those with bigger legs may not need to worry as much about high blood pressure — a contributor to heart attack and stroke.

“Distribution of fat matters. Even though we think that fat is bad in all cases, it might be that leg fat is not as bad as we think,” said the study’s lead author, Aayush Visaria. He’s a fourth year medical student at Rutgers New Jersey Medical School.

Previous research has found that excess weight around the middle can increase the risk of heart disease and diabetes. “Middle fat is really important because that’s where all the organs are — liver, pancreas, intestines — and they’re all affected by fat. Too much fat messes up the function of those organs,” Visaria said.

But that doesn’t mean folks who gain more weight in their lower limbs don’t need to maintain a healthy weight, too. “Regardless of where the fat is, a lot of fat isn’t good. Having muscle is better than having fat. Our study says, if you have fat, more fat in legs is better than having it in the abdomen,” Visaria said.

Dr. Vivek Bhalla is director of the Hypertension Center at Stanford University in California. “This study should not be interpreted to say that if a patient has higher leg fat that they will not develop high blood pressure. It is an important study to motivate further research into the factors as to why blood pressure would be lower,” he explained.

Bhalla said it’s not yet clear how fat distribution might affect your high blood pressure risk. He said it’s possible that fat stored in different areas of the body may act in different ways.

Visaria suggested that the difference may have something to do with triglyceride (a type of blood fat) levels. People in the study with more leg fat had decreased triglyceride levels, he noted.

The new study included almost 6,000 adults participating in national health surveys between 2011 and 2016. Their average age was 37. About half were female. Nearly one-quarter of the group had high blood pressure — defined in this study as blood pressure above 130/80 mm Hg.

The researchers used special X-ray imaging to measure fat in the legs. These measurements were compared to overall body fat measurements. Men who had 34% fat in their legs were defined as having high leg fat. For women, the cutoff was 39%.

Those with higher leg fat were 61% less likely to have high blood pressure than their slim-legged counterparts. The findings held even after the researchers adjusted for factors such as age, sex, race/ethnicity, smoking, alcohol use, cholesterol levels and levels of waist fat.

The researchers noted that this study wasn’t designed to prove a cause-and-effect relationship. It could only show an association between higher leg fat and lower blood pressure. Visaria said more research is necessary, particularly in older people. He said the people in this study were between 20 and 59, so these findings may not be generalizable to people over 60.

Bhalla pointed out that “obesity is a major epidemic in the United States and around the world, and like many things in medicine, it’s not black or white, but rather there are shades of gray.”

In addition, Bhalla advised, “As we learn more about different types of fat, the distribution of fat, what factors are secreted by different types of fat and how that affects risk of common conditions — [including] high blood pressure, heart disease and diabetes — we need to keep in mind that we have to treat patients as individuals, measure their individual risk, and counsel patients appropriately.”

He also said it’s important to remember the things people can do right now to lower their blood pressure, including:

  • Cut down on salt (sodium)
  • Exercise regularly
  • Get enough sleep
  • Reduce stress
  • Drink less alcohol

The findings were scheduled for presentation Thursday at a virtual meeting of the American Heart Association. Findings presented at meetings should be viewed as preliminary until they’ve been published in a peer-reviewed journal.

More information

Learn more about how body shape affects health risks at Penn Medicine.

Copyright 2020 HealthDay. All rights reserved.

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COVID-19 tests getting more reliable, experts say



You’re feeling pretty darned sick — headache, fever, fatigue, a cough — but your COVID-19 test came back negative.

What do you do now?

Well, chances are good that you don’t have COVID-19 if that’s what the test says, according to experts.

Labs that are testing for COVID-19 rely on what’s called a PCR test, a slow and complex molecular scan that looks for the genetic material of coronavirus in samples that boasts very high accuracy.

A negative result on this test shows there’s probably something other than COVID-19 wrong with you, said Dr. Bobbi Pritt, chair of clinical microbiology with the Mayo Clinic in Rochester, Minn.

“I know I have several work members and family members who had an influenza-like illness earlier in the year, and it probably was just the common flu or it could have been the common cold,” Pritt said.

Sick folks who test negative for COVID-19 should make sure their doctors also run tests for other infectious diseases, said Dr. Amesh Adalja, a senior scholar with the Johns Hopkins Center for Health Security, in Baltimore.

Tests becoming more accurate

“In general, the tests available are sensitive enough to diagnose those with symptoms accurately, but there are also other infections with similar symptoms that might merit testing for as well,” Adalja said.

PCR tests have improved dramatically during the pandemic, and have also gotten easier to perform.

For example, labs can now get fairly accurate results from gentle nasal swabs or saliva samples, and no longer have to use a long swab to hook a sample from deep within your nasal cavity, Pritt said.

“We can accept nasal swab specimens and even saliva and perform testing on those specimens, and if they are collected correctly the results can be just as good as those that are collected using that gold standard nasopharyngeal swab,” Pritt said.

Labs also are getting results back to doctors more quickly, although they are still struggling to maintain supplies of the chemical reagents they need to perform PCR tests, said Dr. Emily Volk, senior vice president of clinical services at University of Texas Health in San Antonio.

“Turnaround times are improving as more local laboratories and hospitals have been able to bring up the testing,” Volk said. “The more reagents we have available at the local level, the more we’re going to be able to provide turnarounds within 24 hours or less on even the most accurate PCR testing.”

However, there is a chance that you might have gotten a false negative, experts added. The exact accuracy of PCR tests has been tough to pin down. According to Dr. Robert Schmerling reporting in Harvard Health Publishing, “the reported rate of false negatives is as low as 2% and as high as 37%. The reported rate of false positives — that is, a test that says you have the virus when you actually do not — is 5% or lower.”

The timing of when the sample is collected, the type of sample collected and the quality of the sample can all influence the accuracy of the COVID-19 results, said Matthew Binnicker, director of the Clinical Virology Laboratory at the Mayo Clinic in Rochester, Minn.

Test again if needed

“The virus is thought to be present at the highest levels approximately five days, on average, after being exposed, or around the time a person develops symptoms,” Binnicker said. “If a high-quality nasopharyngeal swab is collected within 24 hours of symptom onset, is tested by an approved PCR method and the result is negative, the likelihood of the person having COVID-19 is low,” he explained.

“However, if a less preferred sample — for example, throat swab — is collected after three to five days of symptoms and tested by PCR, a negative result would be less reliable to rule out COVID-19,” Binnicker continued.

If you’re still sick a week after your negative COVID-19 test and you continue to have no idea what’s wrong with you, experts say you should reach out to your doctor for a follow-up coronavirus test.

“If a COVID-19 test is negative, then specific testing for influenza will also need to be performed,” Binnicker said. “If the results are negative for these viruses and the patient continues to be ill, a repeat COVID-19 test can be appropriate. As patients enter into the second week of illness, a lower respiratory sample — like sputum — is preferred over an upper respiratory swab to increase the likelihood of detecting SARS-CoV-2 during the later stages of disease.”

Keep in mind that if you’re sick right now, you probably won’t be given an antigen test, the other form of viral testing for COVID-19 infection.

Antigen tests are cheap and fast, looking for specific structural proteins of the coronavirus that form during infection. The Trump administration made headlines last month by buying out the entire 2020 supply of the just-approved $5 BinaxNOW COVID-19 Ag Card produced by Abbott Laboratories, which the company says will return relatively accurate results within 15 minutes.

Because antigen tests are quick but generally less accurate than PCR tests, they probably will be reserved for screening folks who don’t have any symptoms of possible COVID-19 infection, Pritt said.

“If we are screening large numbers of individuals and we plan on doing that on a regular basis, let’s say college students on a weekly basis, then using an antigen test is probably going to be the best strategy forward because it’s going to be relatively inexpensive and easy to do, and it’s going to be done on a relatively lower risk population,” Pritt said.

More information

The U.S. Centers for Disease Control and Prevention has more about testing for COVID-19.

Copyright 2020 HealthDay. All rights reserved.

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TikTok ‘Benadryl Challenge’ has killed at least one teen



A new Internet dare, broadcast widely on teen-friendly TikTok, urges kids to overdose on the over-the-counter antihistamine Benadryl.

But the “Benadryl Challenge” has already killed one teen and sent others to the ER, experts warn.

According to News4 in Oklahoma City, one 15-year-old girl suffered a fatal overdose while reportedly trying the challenge late last month. Other cases of kids being rushed to the hospital after similar incidents are popping up nationwide.

The Benadryl Challenge is circulating on social media and encourages users to overdose on the drug to achieve a hallucinatory state.

But as with any drug, taking too much Benadryl can quickly prove hazardous and even deadly, according to emergency medicine physician Dr. Robert Glatter.

“Diphenhydramine (Benadryl) causes toxicity in a dose-dependent fashion — meaning that escalating doses can be deadly,” explained Glatter, who works at Lenox Hill Hospital in New York City.

As listed on Benadryl’s website, kids between the ages of 6 and 12 should only take one tablet of the drug every four to six hours, while those older than 12 should only take up to two tablets over the same period of time. No one, no matter their age, should take more than six doses within 24 hours, the drug’s homepage states.

But there are media reports of some children involved in the Benadryl Challenge being encouraged to take up to 12 tablets at once. According to Glatter, that’s a potentially lethal amount.

“Simply put, as you approach the dose that leads to hallucinations that the ‘challenge’ calls for, the risk for seizures and deadly cardiac arrhythmias significantly increases,” he said.

“Increasing doses of Benadryl typically lead to sleepiness, confusion, vomiting, agitation, elevated heart rate, which can precipitate a cardiac arrhythmia as well as a seizure. People may also require intubation [mechanical breathing assistance] to secure their airway in the setting of a significant overdose,” Glatter added.

In fact, most of the teens who’ve harmed themselves during the Benadryl Challenge have experienced heart issues, according to a report on the phenomenon by Good Housekeeping.

Dr. Kenneth Perry, assistant medical director at Charleston, S.C.-based Trident Medical Center, provided the magazine with a list of Benadryl overdose symptoms that parents should look out for:

  • Excessive body heat and flushing of the skin, since too much of the drug can trigger overheating
  • A decrease in sweating and urination — the latter symptoms can bring on serious issues
  • Changes in vision, such as an inability to focus on your surroundings and restrictions in pupil size
  • Delirium, which may include a feeling of “spinning” or hyper-awareness, as well as long periods of anxiety.

When these symptoms appear, medical help may be necessary.

“The bottom line is that engaging in such a challenge is inherently dangerous and can be fatal,” Glatter said. “In light of these and other risky social media challenges, it’s vital that parents monitor their teens’ social media activity.”

More information

Here’s a link for advice and poison control hotlines at the National Capital Poison Center.

Copyright 2020 HealthDay. All rights reserved.

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