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A PROMISING COVID-19 TREATMENT GETS FAST-TRACKED

sglowrider

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Arturo Casadevall and collaborators at Johns Hopkins and beyond have worked around the clock to develop a convalescent serum therapy to treat COVID-19 using blood plasma from recovered patients. If early promising studies on the therapy done in China are confirmed by U.S. trials, thousands of survivors might soon line up to donate their antibody-rich plasma. "I absolutely think this could be the best treatment we have for the next few months," Hopkins pathologist Aaron Tobian says.
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https://hub.jhu.edu/2020/04/08/arturo-casadevall-blood-sera-profile/


Under the leadership of immunologist Arturo Casadevall, Johns Hopkins has spearheaded the use of a convalescent serum therapy, a potential COVID-19 treatment—with an old pedigree. On March 24, the U.S. Food and Drug Administration began allowing researchers to request emergency authorization for its use. Within three days hospitals in Houston and New York City started treatments, and now under a FDA "expanded access program" soon "a very large number" of U.S. hospitals will follow suit, according to Tobian.

On Friday, the FDA approved a clinical trial specifically for Johns Hopkins that will allow its researchers to further test the therapy as a means of preventing otherwise healthy people, notably front-line medical staff, from getting sick. FDA approval is pending for a second Hopkins clinical trial on patients who are slightly or moderately ill to see if the serum will keep them out of ICUs and help bring them back to health.

In recent weeks, Casadevall has led a team of physicians and scientists from around the United States to establish a network of at least 40 hospitals and blood banks in 20 states that can begin collecting, isolating, and processing blood plasma from COVID-19 survivors. People who recover from an infection develop antibodies that circulate in the blood and can neutralize the pathogen. Researchers hope to use the technique to treat critically ill COVID-19 patients and boost the immune systems of health care providers and first responders. Currently, there are no proven drug therapies or effective vaccines for treating the novel coronavirus.

"At the end of January, I knew this disease was going to get out of China, and I knew there was a huge history of the use of plasma and serum in the 20th century," says Casadevall, a Bloomberg Distinguished Professor of molecular microbiology and immunology and infectious diseases at the Johns Hopkins Bloomberg School of Public Health and School of Medicine. "This [medical effort] has become a juggernaut… We're racing to deploy this."

Thousands of survivors might soon line up to donate their antibody-rich plasma, according to physicians. But that's only if early promising studies on the therapy done in China are confirmed by U.S. trials that show "dramatic effects and improvements" in patients, according to Tobian. He is optimistic the therapy will do just that. "I absolutely think this could be the best treatment we have for the next few months."


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This passive-antibody therapy has been used since the 1890s to combat diseases as wide-ranging as measles, SARS, Ebola, H1N1 flu, and polio—and holds the promise of keeping the virus at bay until a vaccine can be developed. (Current estimates are that a vaccine for emergency use could be available by early 2021.) During the SARS outbreak in 2002–2003, an 80-person trial of convalescent serum in Hong Kong found that people treated with it within two weeks of showing symptoms had a higher chance of being discharged from hospital than did those who weren't treated.

The beauty of the therapy, says Casadevall, is that it involves the well-established—and safe—method of blood donation. Except in this case, survivors' plasma (or serum), which contains the antibody to COVID-19, is separated from red blood cells and transfused into the three categories of recipients: the critically ill as a last-stop "compassionate care" measure; patients who are slightly or moderately ill to keep them out of ICUs and off scarce ventilators, and front-line medical workers to prevent them from getting sick. Nearly a cup of the serum (200 milliliters, or one unit) would be administered to each recipient, according to Tobian, with each donor providing enough serum for up to four patients. (Each donor, depending on body size, can provide two to four units.)

Casadevall had the vision for this treatment. He also had the wisdom not to micromanage his team of doctors, whom he set free to create their own fast-flowing mini-teams. Together, they united with peers around the world in a marathon of selfless, round-the-clock work toward an urgent common goal—to overwhelm and crush the COVID-19 virus. "Looking forward to another day of working with an incredible set of colleagues," tweeted Casadevall in late March. "Day began at 4 a.m. and will go to near midnight." In this process, doctors, researchers, and regulators from as far away as Israel and Ethiopia banded with Hopkins doctors to create treatment protocols, open labs, win regulatory and institutional approvals, identify donors, compile data, and organize and share vital information. The research effort received a welcome boost in late March with a gift of $3 million from Bloomberg Philanthropies and $1 million in funding from the state of Maryland.

"We usually spend a year preparing for the next flu season," says Andy Pekosz, vice chair of the Department of Molecular Microbiology and Immunology at the Bloomberg School of Public Health. "What we do for flu in a year, we're trying to do in a month for COVID-19. Our window of acting is a small one." The fast-spreading coronavirus has already killed at least 70,000 people around the world, with nearly 1,300,000 total confirmed cases. Numbers that continue to grow.

From the beginning, Casadevall knew he faced more than a medical problem. Plasma therapy's history was unknown to most people, so he needed to draw public attention to his cause. Realizing a medical journal commentary would reach a limited audience, Casadevall shopped around an editorial that urged the use of convalescent serum. The essay, published in the Feb. 27 edition of The Wall Street Journal, told the story of an ingenious Pottstown, Pennsylvania, doctor who in 1934 arrested a measles outbreak at a boys boarding school by using serum therapy. "A remarkable victory against a highly contagious disease," Casadevall wrote.
 
It looks like the second wave is hitting you guys harder:



For those eager to open up quickly both recent and past history can provide a good lesson in opening too soon. And yes, we all understand the economic impact:

Why the Second Wave of the 1918 Spanish Flu Was So Deadly
The first strain of the Spanish flu wasn’t particularly deadly. Then it came back in the fall with a vengeance.

https://www.history.com/news/spanish-flu-second-wave-resurgence


Four lessons the Spanish flu can teach us about coronavirus

https://www.theguardian.com/world/2...he-spanish-flu-can-teach-us-about-coronavirus
 
It looks like the second wave is hitting you guys harder:



For those eager to open up quickly both recent and past history can provide a good lesson in opening too soon. And yes, we all understand the economic impact:

Why the Second Wave of the 1918 Spanish Flu Was So Deadly
The first strain of the Spanish flu wasn’t particularly deadly. Then it came back in the fall with a vengeance.

https://www.history.com/news/spanish-flu-second-wave-resurgence


Four lessons the Spanish flu can teach us about coronavirus

https://www.theguardian.com/world/2...he-spanish-flu-can-teach-us-about-coronavirus

Yeap. We were on 70-90 cases for like 2 months. Then suddenly the world caught up and started offering us 'imports'. That was our sudden surge to now 1000+ and raising :eek:
Damn you... you Asymptos!!
 
It looks like the second wave is hitting you guys harder:



For those eager to open up quickly both recent and past history can provide a good lesson in opening too soon. And yes, we all understand the economic impact:

Why the Second Wave of the 1918 Spanish Flu Was So Deadly
The first strain of the Spanish flu wasn’t particularly deadly. Then it came back in the fall with a vengeance.

https://www.history.com/news/spanish-flu-second-wave-resurgence


Four lessons the Spanish flu can teach us about coronavirus

https://www.theguardian.com/world/2...he-spanish-flu-can-teach-us-about-coronavirus

There is something that is implied in the Spanish Flu comparison that may not be true. The Spanish Flu came back more deadly in the fall. Corona does not have to do that, it *could* come back less deadly. Not that it will, just that we do not know.
 
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Once the scientists wrap this up, it'll be up to the capitalists to get it into the bloodstreams of the rich ASAP, then start developing an marketing campaign to sell it to the unwashed masses.

Ask your doctor if Coplasmavid is right for you.
 
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Always the easy solution, hard to draw water from a dry well.

We’re pulling hundreds of billions from that dry well to bail out the hotel and casino industry. I guess that'll be funded with a tax cut.
 
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We’re pulling hundreds of billions from that dry well to bail out the hotel and casino industry. I guess that'll be funded with a tax cut.
Sounds to me we are pulling hundreds of billions to "bail out" many industries, I believe the hope is that this infusion of capital will keep businesses afloat allowing individuals to come back to work and resume business as usual.
 
Sounds to me we are pulling hundreds of billions to "bail out" many industries, I believe the hope is that this infusion of capital will keep businesses afloat allowing individuals to come back to work and resume business as usual.
Gosh. Thanks. I had no idea what that was all about!

So the idea here is to draw from the already-dry well to spare the investors, but let the customers and employees die because it's impossible to draw from a dry well. Is that about right?
 
Gosh. Thanks. I had no idea what that was all about!

So the idea here is to draw from the already-dry well to spare the investors, but let the customers and employees die because it's impossible to draw from a dry well. Is that about right?
A one time fix as opposed to an ongoing issue, but then again you already knew that as well!!!!!
 
You want the government so stand up and operate a pharmaceutical plant. For this.

We don’t even do that for our navy nuclear program. Private industry can and does it better and always will. This isn’t news.
This isn't a drug we're talking about. It's a course of treatment, and probably very expensive. Under our current system,
You want the government so stand up and operate a pharmaceutical plant. For this.

We don’t even do that for our navy nuclear program. Private industry can and does it better and always will. This isn’t news.

I was being fascetious. This isn't a drug, it's a course of treatment, so no factory will be necessary. However, it's probably a very expensive treatment, which it may or may not be covered by health insurance....meaning that only the rich can be assured of getting it.

If it WAS a drug, why would the government build a factory. You've no doubt heard of the "Defense Production Act", which has been all over the news lately. It give the government of the American people a means to tell a business (drug company in this example) "F#*K your schedule. F#*K your profits. You're gonna make the thing the American people need, NOW!"

BTW....Apparently the Defense Production Act is routinely by the government. https://www.nytimes.com/2020/03/31/us/politics/coronavirus-defense-production-act.html
 
This isn't a drug we're talking about. It's a course of treatment, and probably very expensive. Under our current system,


I was being fascetious. This isn't a drug, it's a course of treatment, so no factory will be necessary. However, it's probably a very expensive treatment, which it may or may not be covered by health insurance....meaning that only the rich can be assured of getting it.

If it WAS a drug, why would the government build a factory. You've no doubt heard of the "Defense Production Act", which has been all over the news lately. It give the government of the American people a means to tell a business (drug company in this example) "F#*K your schedule. F#*K your profits. You're gonna make the thing the American people need, NOW!"

BTW....Apparently the Defense Production Act is routinely by the government. https://www.nytimes.com/2020/03/31/us/politics/coronavirus-defense-production-act.html
Why would this not require a large scale manufacturing sterile or aseptic facility?

edit: by the way, all of the big bad pharma companies are donating products left and right to support COVID-19 treatment and studies. So go ahead and tell me how invoking the DPA would do more?
 
You didn't get one a couple years ago? You must be one of the losers then.
Consider me one of the losers.
You still haven't addressed the issue. Are we to spare businesses and let people die?
Who are the investors you speak of? So how long do you stop the economy, businesses even the large can only sustain for so long. I know many are still at work, hell I go everyday, my hope is we gradually integrate the rest of America back into the fold and get back to business as usual. By your posts you expect this virus to have a enormous impact well into the latter part of the year? Possibly next year? If so we will have Major issues beyond Covid 19 to deal with.
 
Why would this not require a large scale manufacturing sterile or aseptic facility?

edit: by the way, all of the big bad pharma companies are donating products left and right to support COVID-19 treatment and studies. So go ahead and tell me how invoking the DPA would do more?
The DPA would not do any more, many large manufacturers as well as pharma companies are stepping up. I believe that is what Trump would hope would happen, those in America stepping up to help one another without using the word "forced".
 
The DPA would not do any more, many large manufacturers as well as pharma companies are stepping up. I believe that is what Trump would hope would happen, those in America stepping up to help one another without using the word "forced".
One can read your post in multiple ways. If the way of reading it as “Trump is responsible for pharma doing this thing” is what you meant then you are very wrong.
 
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After Rejecting A Coronavirus Lockdown, Sweden Sees Rise In Deaths

After taking a laid back approach to the pandemic that has involved no lockdowns like the rest of Europe, Sweden’s daily coronavirus death rate has spiked over two days and has put more pressure on officials to enact tougher restrictions on movement to hinder the virus’ spread.
  • Unlike other European countries with widespread shelter-in-place orders, Sweden has not enforced a nationwide lockdown and instead aims to isolate and treat confirmed coronavirus cases—with many businesses, gyms, restaurants, bars and schools remaining open.
  • Experts say the Swedish government approach may be a contributing factor in why Sweden has experienced high death rates compared to other countries, with nearly 8% of Swedes infected with coronavirus dying from it, compared to less than 2% and 4% for neighbors Norway and Denmark, respectively.
  • On Thursday, there were nearly 10,000 cases nationwide, with 719 Swedes in intensive care. More than 100 Swedes have died per day for two days in a row, according to the Swedish Public Health Agency, bringing the total death count to 782.
  • Statistics show Swedes appear to be practicing social distancing on their own, resulting in drops in public transport ridership and half of Stockholm residents reportedly working from home—but it may not have been enough to slow the virus’ spread.
  • Sweden’s chief epidemiologist Anders Tegnell has continuously advocated for laid back measures, saying on Swedish TV Sunday that the pandemic could be defeated by herd immunity, or the indirect protection from a large portion of a population being immune to an infection, or a combination of “immunity and vaccination.”
  • However, critics have argued that with a coronavirus vaccine could be more than a year away, and insufficient evidence that coronavirus patients that recover are immune from becoming infected again, the strategy of relying on herd immunity and vaccinations ineffective.

source.gif
 
The COVID-19 vaccine development landscape

As of 8 April 2020, the global COVID-19 vaccine R&D landscape includes 115 vaccine candidates, of which 78 are confirmed as active and 37 are unconfirmed (development status cannot be determined from publicly available or proprietary information sources).

Of the 78 confirmed active projects, 73 are currently at exploratory or preclinical stages. The most advanced candidates have recently moved into clinical development, including mRNA-1273 from Moderna, Ad5-nCoV from CanSino Biologicals, INO-4800 from Inovio, LV-SMENP-DC and pathogen-specific aAPC from Shenzhen Geno-Immune Medical Institute (Table 1). Numerous other vaccine developers have indicated plans to initiate human testing in 2020.


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Diversity of technology platforms.
A striking feature of the vaccine development landscape for COVID-19 is the range of technology platforms being evaluated, including nucleic acid (DNA and RNA), virus-like particle, peptide, viral vector (replicating and non-replicating), recombinant protein, live attenuated virus and inactivated virus approaches (Fig. 1). Many of these platforms are not currently the basis for licensed vaccines, but experience in fields such as oncology is encouraging developers to exploit the opportunities that next-generation approaches offer for increased speed of development and manufacture. It is conceivable that some vaccine platforms may be better suited to specific population subtypes (such as the elderly, children, pregnant women or immunocompromised patients).

Outlook
The global vaccine R&D effort in response to the COVID-19 pandemic is unprecedented in terms of scale and speed. Given the imperative for speed, there is an indication that vaccine could be available under emergency use or similar protocols by early 2021.

This would represent a fundamental step-change from the traditional vaccine development pathway, which takes on average over 10 years, even compared with the accelerated 5-year timescale for the development of the first Ebola vaccine, and will necessitate novel vaccine development paradigms involving parallel and adaptive development phases, innovative regulatory processes and scaling manufacturing capacity.
 
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