Sorrento to test COVID-9 candidates in infection cell model with live virus

Sorrento Therapeutics (SRNE -1.4%) inks an agreement with the University of Texas Medical Branch (UTMB) at Galveston for the preclinical testing of its COVID-19 therapeutic candidates using an infection cell model for SARS-CoV-2. The testing will be conducted in a Biosafety Level 4 (maximum containment) laboratory at UTMB, one of only two on a university campus in the U.S., since it will be working with a COVID-19 viral isolate.

The company says it has a range of preclinical candidates across its platforms, including natural killer (NK) cell therapies, neutralizing antibodies (NAbs) and soluble recombinant fusion protein traps (COVIDTRAP) to potentially inhibit the binding of SARS-CoV-2’s spike protein with host ACE2 receptors on the surface of cells, thereby potentially preventing the first step in the infection process.

https://seekingalpha.com/news/3556953-sorrento-to-test-covidminus-9-candidates-in-infection-cell-model-live-virus

Pneumonia, a Dangerous Coronavirus Complication

Scientists—and the rest of us—are learning more each day about COVID-19, the illness caused by the novel coronavirus that’s been spreading across the globe.
For those who come down with COVID-19, developing pneumonia is a common complication.

“Pneumonia is essentially an infection of the lungs,” says Nikita Desai, M.D., a pulmonary and critical care physician at Cleveland Clinic. Symptoms can include cough, shortness of breath, fever, malaise, chest pain, and the production of sputum, or phlegm.
Pneumonia is sometimes on the milder side—meaning that you can still go about at least some of your daily activities, even though you may feel quite sick. This is sometimes called walking pneumonia, because you can walk around, Desai says.

In many instances, however, pneumonia is severe, sending people to the hospital, requiring the use of a ventilator, or even leading to death. COVID-19 aside, pneumonia generally sends more than 250,000 people to the hospital and kills about 50,000 each year, according to the Centers for Disease Control and Prevention.
We don’t yet know what percentage of people with COVID-19 will go on to develop pneumonia, but we know that some have died as a result. We spoke with pulmonary medicine experts to find out what scientists currently understand about COVID-19-related pneumonia. Here, the answers to key questions.

What Causes Pneumonia?

Bacteria, fungal infections, and viruses such as the coronavirus can all lead to pneumonia, although the way it develops can vary. For instance, viruses can cause pneumonia directly. But in some cases, if a viral respiratory infection is severe enough, it can damage the lungs and leave them vulnerable to a secondary infection: bacterial pneumonia. This is common with flu, though scientists aren’t exactly sure how often it occurs.

How Might I Know If I Have Pneumonia?

Doctors usually diagnose pneumonia by evaluating your symptoms—and by taking an X-ray of your chest. An X-ray is critical in diagnosing pneumonia, according to Nicholas Hill, M.D., chief of the division of pulmonary critical care and sleep medicine at Tufts Medical Center in Boston and a past president of the American Thoracic Society. “We often see what we call infiltrates, abnormal shadows that indicate the presence of a pneumonia,” he says.
A doctor may also listen to your breathing for the crackling sounds of fluid in your lungs, which can occur because of inflammation from infection, he says.

How Is Pneumonia Usually Treated?

If your doctor diagnoses you with pneumonia, you’ll probably undergo additional tests to help determine whether your illness is caused by bacteria or viruses, because the treatment depends on the type. But this can be tricky, in part because you may have a viral infection and a secondary bacterial pneumonia infection at the same time.
Sometimes, viral infections can be identified. For instance, your doctor can give you a flu test, which will return a quick result. If flu is the cause, you’ll probably receive an antiviral medication such as oseltamivir (Tamiflu).
But test results for bacterial pneumonia, which is treated with antibiotics, may take a day or two, and even with testing, doctors often can’t pinpoint the cause. In these cases, it may be unwise to wait before starting antibiotics, notes Hill, for fear of the condition worsening. So antibiotics are often prescribed before tests results arrive—frequently amoxicillin is given first. Once test results return, the type of antibiotic prescribed may be adjusted to better target the underlying bacteria. (Scientists are working on developing better tests to pinpoint bacterial causes earlier, to reduce the unnecessary use of these drugs.)
Some people become ill enough with pneumonia to require hospitalization. If you have pneumonia, doctors may decide whether you need to stay in a hospital by looking at the level of oxygen in your blood, whether you have any cognitive or functional impairments, whether you show signs of sepsis (a life-threatening complication of an infection), and other factors.

Is Pneumonia Related to COVID-19 Being Diagnosed and Treated Differently?

Diagnosing pneumonia right now may be more challenging than usual, because of the logistics of taking X-rays in people suspected of having COVID-19, according to Michael Niederman, M.D., clinical director and associate chief of pulmonary and critical care at Weill Cornell Medicine. That’s because imaging equipment used for someone who may have COVID-19 requires extensive disinfecting afterward, and various people and areas of the hospital or health center may be exposed before, during, and afterward. For COVID-19, he says, “The very starting point of doing an X-ray to recognize pneumonia is not as simple as it was.”
Otherwise, a case of COVID-19 pneumonia is generally diagnosed in the same way as other types. Sometimes, chest X-rays can hint at whether a pneumonia is viral or bacterial, but even in cases of a probable viral cause, the image can’t tell doctors which virus is the culprit, Desai says. Testing for flu—and, if that test is negative, then testing for COVID-19—can help pinpoint the cause.
In terms of treatment, even though COVID-19 is a virus, people who develop severe pneumonia are likely to be given antibiotics, just in case of a secondary bacterial infection, according to the experts we spoke with.
So far it’s unclear how often people with COVID-19 develop secondary bacterial pneumonia, says Charles Dela Cruz, M.D., Ph.D., director of the Center of Pulmonary Infection Research and Treatment at Yale University. But during the H1N1 influenza pandemic in 2009, secondary bacterial infections were common.
Beyond that, however, another major difference with COVID-19 is that there are no treatments proved to effectively fight the virus. Those hospitalized for COVID-19 will receive supportive care, such as oxygen. Some people have also received antiviral drugs, but none have yet been shown to be effective against the virus in clinical trials.

Are Some People More Likely to Have Serious Effects From Pneumonia?

The people who are most at risk from a serious pneumonia are older adults and people with underlying health conditions, including diabetes, heart disease, lung disease, and anyone with a suppressed immune system. In the CDC’s most recent data, people ages 85 and older faced the greatest risk of dying from COVID-19 (though the data didn’t break down the specific causes of death).
It’s important to note that pneumonia isn’t the only potentially severe complication of COVID-19. Also possible are sepsis, organ damage, and a condition called acute respiratory distress syndrome (ARDS), which occurs when fluid collects in the lungs. People with ARDS often need the assistance of ventilators in order to breathe. All these complications are more likely in people in high-risk categories.

What Should I Do If I Suspect COVID-19 or Pneumonia?

The main symptoms of COVID-19 are fever, cough, and shortness of breath. According to the CDC, you should call a healthcare provider if you develop these symptoms to find out whether you need to seek medical attention—many people may not need to be treated in a clinic or a hospital for COVID-19 or a mild case of pneumonia.
If you don’t need to be hospitalized, stay home, get lots of rest, and stay hydrated. Try to steer clear of any other people in your home, and keep up with good hygiene practices like handwashing and covering your cough, in order to avoid infecting anyone else.
Generally speaking, having trouble breathing and consistent chest pain are signs of a possible emergency from pneumonia, flu, or COVID-19 and should prompt you to immediately seek care. Normally, that would mean visiting an emergency department. Now that COVID-19 is circulating widely, the CDC recommends calling 911 and telling the operator you might have COVID-19 so that responders can prepare appropriately.

Should I Get Vaccinated Now Against Flu and Pneumococcal Bacteria?

Along with the flu shot, vaccines are available against some of the common bacterial causes of pneumonia. Pneumococcal vaccines are recommended for adults ages 65 and older, and people with certain underlying health conditions.
We asked experts whether it’s still a good idea to get a flu shot if you haven’t had one this year, given that flu season has begun to wane.
Dela Cruz says he’s hesitant to recommend a flu vaccine right now, especially for people who are in high-risk categories, because of the possibility of exposure to coronavirus during a visit to a healthcare office or clinic. While it’s important to reduce your likelihood of flu right now, if you opt for a vaccine, Hill recommends getting it at a pharmacy rather than a doctor’s office. “You’d rather go to a place where people who might have COVID aren’t hanging around,” he says.
As for the pneumococcal vaccine, Niederman recommends consulting your doctor beforehand to make sure you’ll be getting the one that’s most appropriate for you and at the right time. (All adults should get the vaccine known as PPSV23, or Pneumovax, at age 65; some should also get PVC13, or Prevnar 13.) And if you get the vaccine, do so at a pharmacy.
https://www.consumerreports.org/coronavirus/understanding-pneumonia-a-dangerous-coronavirus-complication/

Coronavirus could travel 27 feet, stay in air for hours: MIT PhD

Social-distancing guidelines to stay 6 feet from others may be woefully inadequate, one scientist warns — saying the coronavirus can travel 27 feet and linger for hours.
MIT associate professor Lydia Bourouiba, who has researched the dynamics of coughs and sneezes for years, warns in newly published research that the current guidelines are based on outdated models from the 1930s.
Rather than the assumed safety of 6 feet, Bourouiba warns that “pathogen-bearing droplets of all sizes can travel 23 to 27 feet.”
Her research, published in the Journal of the American Medical Association, also warns that “droplets that settle along the trajectory can contaminate surfaces” — and “residues or droplet nuclei” may “stay suspended in the air for hours.”
She notes a 2020 report from China that showed that “virus particles could be found in the ventilation systems in hospital rooms of patients with COVID-19.”
Bourouiba fears that the current guidelines are “overly simplified” and “may limit the effectiveness of the proposed interventions” against the deadly pandemic.
She says it is particularly urgent for health care workers who, she argues in her report, face an “underappreciated potential exposure range” while treating the sick and dying.

“There’s an urgency in revising the guidelines currently being given by the [World Health Organization] and the [Centers for Disease Control and Prevention] on the needs for protective equipment, particularly for the frontline health care workers,” Bourouiba told USA Today.
The World Health Organization — which suggests 3 feet is enough to remain safe — told USA Today it “welcomed” studies.
“WHO carefully monitors emerging evidence about this critical topic and will update this scientific brief as more information becomes available,” WHO said in a statement to the paper.
https://nypost.com/2020/03/31/coronavirus-could-travel-27-feet-stay-in-air-for-hours-mit-researcher/

U.S. COVID-19 pandemic could peak late April – former FDA Commish Gottlieb

In an interview on CNBC’s Squawk Box, former FDA Commission Scott Gottlieb, M.D., stated that COVID-19 models indicate that the pandemic in the U.S. may peak in late April or early May, adding that the entire country is probably two or three weeks behind New York. Afterward, if the infection curve flattens then drops, authorities may consider a slow rollback of mitigation efforts.

Summer weather should be an effective backstop since coronaviruses typically don’t circulate then. April will be a tough month, May one of transition, then June onward life should (somewhat) return to normal, he says.

He also stated that health authorities will be much better prepared in the fall if the virus resurfaces than they were in January.

https://seekingalpha.com/news/3556925-u-s-covidminus-19-pandemic-peak-late-april-former-fda-commish-gottlieb

Medicare will accelerate payments to providers and suppliers: CMS

Healthcare providers and suppliers throughout the country can start receiving accelerated and advance payments from the Medicare program to offer emergency funding and address cash flow issues caused by COVID-19 disruptions.
Over the weekend, the Centers for Medicare & Medicaid Services (CMS) announced it is expanding its accelerated and advance payment program for Medicare (PDF) providers based on historical payments when there is a disruption in claims submission and/or claims processing to ensure they have the resources to fight COVID-19.
The expedited payments are typically offered in natural disasters to accelerate cash flow to the impacted healthcare providers and suppliers, officials said. But, in this situation, CMS is expanding the program for all Medicare providers throughout the country. The payments can be requested by hospitals, doctors, durable medical equipment suppliers and other Medicare Part A and Part B providers and suppliers.

The expansion comes as the industry has seen great disruption, with providers being asked to delay revenue-generating but nonessential surgeries and procedures even as healthcare staff are unable to work due to childcare demands, billing has been disrupted and expenses have risen.

“With our nation’s health care providers on the front lines in the fight against COVID-19, dollars and cents shouldn’t be adding to their worries,” said CMS Administrator Seema Verma in a statement. “Unfortunately, the major disruptions to the healthcare system caused by COVID-19 are a significant financial burden on providers. Today’s action will ensure that they have the resources they need to maintain their all-important focus on patient care during the pandemic.”
It’s among a number of areas of regulatory relief CMS has extended in recent days as providers face the growing tide of COVID-19 patients. For instance, the Trump administration extended the deadlines for quality reporting and applications for providers in value-based care programs and announced it will not use any quality data on services from Jan. 1 through June 30 in the agency’s calculations for quality reporting and value-based purchasing programs.
To qualify for accelerated or advance payments, the provider or supplier must:

• Have billed Medicare for claims within 180 days immediately prior to the date of signature on the provider’s/supplier’s request form
• Not be in bankruptcy
• Not be under active medical review or program integrity investigation
• Not have any outstanding delinquent Medicare overpayments

Most providers and suppliers will be able to request up to 100% of the Medicare payment amount for a three-month period, officials said. Inpatient acute care hospitals, children’s hospitals and certain cancer hospitals are able to request up to 100% of the Medicare payment amount for a six-month period while critical access hospitals can request up to 125% of their payment amount for a six-month period.
The majority of hospitals will have up to one year from the date the accelerated payment was made to repay the balance.
Officials said Medicare will start accepting and processing the accelerated/advance payment requests immediately and anticipate the payments will be issued within seven days of the provider’s request.
https://www.fiercehealthcare.com/payer/medicare-will-accelerate-payments-to-providers-and-suppliers-cms-announces

U.S. resumes visa processing for physicians

With the increasing need for more physicians to treat coronavirus patients, the U.S. State Department says it will resume processing visas needed by international doctors to enter the country and work here.
That is good news for U.S. teaching hospitals and physicians who are not U.S. citizens, as the State Department updated information on visas, signaling that it will resume processing of J and H visa applications for medical professionals seeking to enter the U.S.

The Department of State (DOS) advised medical professionals with an approved U.S. non-immigrant or immigrant visa petition or a certificate of eligibility in an approved exchange visitor program to review the website of their nearest embassy or consulate for procedures to request a visa appointment.
That communication followed a March 18 announcement that because of COVID-19, the U.S. was suspending routine processing of immigrant and non-immigration visas, including J and H visas, at embassies and consulates worldwide.
That left visas in doubt for 4,222 medical graduates who matched with residency programs at U.S. hospitals, at a time when they may be critically needed to combat the coronavirus pandemic. That’s according to the Educational Commission for Foreign Medical Graduates (ECFMG), which appealed to the State Department to lift the suspension.

The new residents are scheduled to start work at teaching hospitals across the U.S. on July 1, joining the physician workforce during the national healthcare crisis created by COVID-19. Medical graduates who are citizens of other countries require J-1 visas to work in the U.S.
“We are encouraged that our close relationship and communications with DOS on this issue have resulted in this positive development,” said ECFMG President and CEO William W. Pinsky, M.D., in an announcement. “There are still significant obstacles to getting these physicians here, and we can now shift our focus to addressing these other issues.”
The coronavirus, which has resulted in travel restrictions imposed by many countries, may make it difficult for those medical graduates to travel to the U.S. and they may need to be quarantined upon arrival.
The State Department also included directions for foreign medical professionals already working in the U.S. Medical residents now working here on J-1 visas were told to consult with ECFMG to extend their programs in the U.S.
https://www.fiercehealthcare.com/practices/good-news-for-u-s-teaching-hospitals-as-u-s-resumes-visa-processing-for-physicians

Biotech VC Nelsen, right on coronavirus, has thoughts on therapeutics, masks

Bob Nelsen was right.
The co-founder and managing partner of Arch Venture Partners is one of biotech’s most successful venture capitalists. He’s also deeply wary of unchecked viruses, a fear he shares regularly with friends, family, and his Twitter followers. “Flu. Get shot. Get antivirals. Don’t die,” Nelsen tweeted right before Christmas.
Most people don’t worry about viruses the way Nelsen does, so when his tweets started to take on a much darker tone in January, I paid little attention. It was just Bob being Bob.

“Very scary,” he warned on Jan. 20, linking to a report of human-to-human transmission of a novel coronavirus in China. A day later, he likened the emerging outbreak to the video game Plague and said he was shorting airline stocks.
And then on Jan. 31, there was this Nelsen tweet, which at the time seemed overly alarmist, but now reads eerily prescient:

Robert Nelsen @rtnarch

Estimates: multiple sources: 500,000+ infected:China. R0 2.5-3+ Doubling time 3 days. Unprecedented speed. Fatality rate range .1-1%+: truly unknown. 2-14 day incubation. 20% diagnosed at hospital need critical care. If sustained transmission, could infect 15-20 percent world.

1,103

11:59 AM – Jan 31, 2020

“By tomorrow, Bob will be living in a bunker,” I slacked to my STAT colleagues.
Sure enough, there was this Nelsen tweet in late February: A photo of his Costco shopping cart loaded with bottled water, Frosted Flakes cereal, a small generator, plastic bins, and six large bottles of Grey Goose vodka.

Robert Nelsen @rtnarch

Look closely

93

6:03 PM – Feb 25, 2020

I regret not listening to Nelsen sooner. I wanted to tell him that, and hear more about where he thought the pandemic was going and how we get out of it. Here is a condensed and lightly edited transcript of our conversation.
You were right, pretty much from the beginning, and I get the sense that you still believe the pandemic is being under-estimated and not taken seriously enough by some people.
Yeah, that one tweet that I sent out in January. That was, I still believe, pretty close to being right. I said that there were something like 500,000 infected people in China. And it was doubling in three to five days with a [case fatality rate] of 0.5 to 1. And 20% of people were in the hospital. I still believe that is probably about right. And I got that from a bunch of really smart people who were in places where they couldn’t say it publicly because it might be viewed as alarmist.
There’s a lot that is sad about all of this. Obviously, the human cost is sad and it’s only going to get sadder. The devastation in some countries that we haven’t even seen yet, like India or throughout Africa is going to be profound, I think.
And the failure of our public institutions. And even some, you know, large private institutions. I would say that complete and utter failure of almost any of us to learn the lessons from what was happening, even from city to city. It’s amazing, every city seems to repeat the errors of every other city, even in the U.S. In New York, you have [Mayor Bill] de Blasio telling everybody to go out and party on March 2nd, and people in Seattle are going. What … are you doing? Are you kidding me?
Early in the epidemic, you argued for total lockdowns of cities in order to stop the spread of the coronavirus. What did you see that worried you so much?
We know there are asymptomatic spreaders. You have to do asymptomatic quarantine or self-isolation. And even when we re-emerge, we’re going to have to figure out a way if we’re in close proximity to other people in the workplace to reduce the probability of asymptomatic spread, which means you have to test like crazy and you probably have to wear masks.
Are Americans ready to wear masks in public?
The first thing is we don’t have enough masks because the supply was never replenished. There’s plenty of criticism of the current administration that can be made and plenty of criticism of the last administration for not refilling the supply. Our bureaucracies are failing, everywhere.
So we don’t have any masks. Therefore, they’re not going to tell everybody that wearing a mask is the right thing to do. Right now, all the masks need to go to health care workers. But really, everyone in an enclosed space needs to have a mask.
The U.S. is still not testing enough people.
We need to go to a system of rapid testing, and that’s going to happen, especially with this new Abbott machine. And some of the other machines, there’s several other efforts that are happening. After that, we need really fast home antibody tests. Nobody wants to go out, anywhere. If you’re healthy you need to get confirmed that you had it. We need to figure out the extent of community spread. My guess is a lot more people have had it. And we need to get those people back to work. We need to have an app that says, you’re clear.
How do you feel about the efforts right now to develop both treatments and vaccines? One the biotech companies you helped start, Vir Biotechnology, is working on antibody-based treatment against Covid-19.
I mean, I’m biased, but I think antibodies are probably the highest probability to work. I hope some mRNA works. I think if you ask scientists, they’re more skeptical. But I hope it works, especially in populations that tend to have weak immune systems. When you get skepticism about mRNA, it tends to be, ‘Yeah, it might work in a young person, but how is it going to work in the populations at risk?’ My own gut feeling is that mRNAt works a little and I hope it works a lot. And even then, there’s a role for all of the systems.
If mRNA works, it bides us time to develop more potent, longer term vaccines. Antibodies will likely work and have the highest probability of working. There are multiple companies pursuing antibody therapy. So you hope that mRNA and antibiotic therapy start ramping up by the fall.

And antivirals?
I think we’re going to get lucky on some stuff. I don’t know that it’s any of the things we’ve been talking about yet, but it could be. The Chinese really believe in chloroquine. The Japanese believe in favipiravir but they’re not letting anybody have it.
Any thoughts on the Gilead Sciences antiviral remdesivir?
I have no idea, but if I had the virus, I would absolutely take it. I mean, I have chloroquine and if I get the virus, I’m going to take chloroquine and Kaletra. But the idea that chloroquine is the answer — I mean, you have to be really careful with some of the side effects of chloroquine.
But getting back to antibodies, you can use them as a therapy and as prophylaxis. You can imagine a system where you’re using mRNA and antibodies as a ring prophylaxis. Going after health care workers, nursing homes, retirement homes. So if we could insulate the weakest people with underlying health conditions and the weakest in our society with the prophylaxis, they would have a lot less of a problem for round two.
What is the development timeline for antibodies right now?
I think what Vir and Regeneron have said is that they will be in the clinic this summer and have something in the fall, if everything goes well.
How do we get through this pandemic?
Social distancing is number one; contact tracing and antibody testing are number two; and therapeutics in the fall are number three. And then vaccines. We’re going to be fine. And I know this because the Chinese are asking me all kinds of questions about business stuff that I don’t want to answer because we’re in the middle of a pandemic.
Arch has not shut down.
We expect to close deals in the next few weeks of at least $500 million. None are Covid-19 related.
How are you doing?
I’m driving my wife crazy because I’m Covid-19 24-7. I’m highly motivated. I live in an industry that gets a lot of [criticism], but working on this is their sense of purpose like I’ve never seen, ever, with anything else. We have a common purpose, which is a wonderful thing. I mean, it’s a scary thing and it’s a wonderful thing.

Biotech VC Bob Nelsen called it right on the coronavirus. Now he has thoughts on therapeutics — and masks