Coronavirus treatment options and the impact on public policy

Some people may have an immunological 'head start' against the new coronavirus, even if they've never been exposed, new research finds

• A recent study showed that some people who were never exposed to the coronavirus still have a type of T cell that can identify and react to it.
• The scientists think this "head start" could be because of previous exposures to other coronaviruses, like those that cause the common cold.
• The research also offers evidence that even patients with mild cases develop antibodies and virus-specific T cells that can protect them from future infections.

Some people's immune systems may have a head start in fighting the coronavirus, recent research suggested.

A study published last month in the journal Cell showed that some people who have never been exposed to the coronavirus have helper T cells that are capable of recognizing and responding to it.

The likeliest explanation for the surprising finding, according to the researchers, is a phenomenon called cross-reactivity: when helper T cells developed in response to another virus react to a similar but previously unknown pathogen.

In this case, those T cells may be left over from people's previous exposure to a different coronavirus — likely one of the four that cause common colds.

"You're starting with a little bit of an advantage — a head start in the arms race between the virus that wants to reproduce and the immune system wanting to eliminate it," Alessandro Sette, one of the study's coauthors, told Business Insider.

He added that cross-reactive helper T cells could "help generate a faster, stronger immune response."
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Study: Hydroxychloroquine had no benefit for hospitalized Covid-19 patients, possibly closing door to use of drug

A major clinical trial showed the malaria drug hydroxychloroquine had no benefit for patients hospitalized with Covid-19, likely closing the door to the use of the highly publicized medicine in the sickest patients — a use for which it was widely prescribed as the pandemic hit the U.S.

The results come from a study called RECOVERY, funded by the U.K. government, that sought to randomly assign large numbers of patients to multiple potential treatments in the country’s National Health Service. The goal was to rapidly get answers as to what worked and what didn’t.

“Today’s preliminary results from the RECOVERY trial are quite clear – hydroxychloroquine does not reduce the risk of death among hospitalized patients with this new disease,” University of Oxford epidemiologist Martin Landray, one of the study’s leaders, said in a statement. “This result should change medical practice worldwide and demonstrates the importance of large, randomized trials to inform decisions about both the efficacy and the safety of treatments.”

A total of 1,542 received hydroxychloroquine, and 3,132 received usual care. After 28 days of treatment, 25.7% of those on hydroxychloroquine and 23.5% of those received usual care had died, meaning those on hydroxychloroquine were 11% more likely to die. That difference was not statistically significant.

There was “no beneficial effect” on how long patients stayed in the hospital, or on other outcomes.

The results were shared via a press release, which the study’s lead authors shared on Twitter. They have not been peer-reviewed or published in a medical journal. The researchers said that full results would be shared as soon as possible.

Still, experts said even the top-line results showed they were meaningful.

“This is a hugely important finding that will likely end use of the drug in hospitalized Covid patients, given the other existing data as well,” said Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. Gellad said that he is curious to see the results of other ongoing studies, and that it is still an open question whether the medicine might work earlier in the disease. “We need real answers there as well,” he said.

Robert Califf, the former Food and Drug Administration commissioner and Alphabet employee, tweeted that the study “essentially rules out benefit of [hydroxychloroquine] in critically ill hospitalized patients.” He wrote that the results showed “no benefit; no major risk.”
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captainmorgan said:

Satellite data suggests coronavirus may have hit China earlier: Researchers

After analyzing satellite imagery, researchers say surge in cars at hospitals in Wuhan, China may indicate outbreak in the fall.

abcnews.go.com

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This could be confirmed by genetic mapping, but original samples from China are suspect, they claim to have traced the etiology of the virus from the market and tracked it's genetic changes. Much of this could be local officials not reporting things properly or recognisinging an emerging problem, another problem and motivation is one we have seen elsewhere is the economic problems it would cause, this can make people go into denial. Xi might have heard about this late and delayed himself (like other leaders). When he realised the magnitude of the problem and received expert advice and council, he dealt with it in a most decisive, dramatic and effective way. He mitigated the damage with bullshit stories and a brilliant PR campaign of free (samples to promote sales too) aid once it hit other countries and prepared for a major demand in PPE and other supplies by the world. They defeated the virus or beat it back and turned the situation from a disaster to one of economic and political advantage. China has been in overdrive producing PPE since January, they knew this would go global after they knocked it down at home, Chinese business people are not stupid, they prepared months ahead of time before it hit America in a big way.

Know thy enemy (oppoinate is more correct) Captain and give him his due, it's the only way we stand a chance, also by uniting together in a common front, many have issues with China. Even thought Xi has more authority, the POTUS, if competent and can lead, could have mustered the national will, determination and resources to knock this thing down. Bare competence would have never seen this happen in the first place, only an idiot would have disbanded the pandemic response team and defunded the CDC.

I'll bet Donald has thousands of doses stashed for friends, family and other elites he wants to impress or influence. This is no different than anything else, Donald will pig out for himself, its a source of power and Donald always abuses that and people too.
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We’re running out of the only coronavirus drug that works

June 8th, 2020 at 10:52 AM

• The only effective coronavirus treatment approved for standard care so far will run out at the end of this month, the US government said.
• Our supply of remdesivir is expected to be depleted by June 29th, and Gilead likely won’t be able to deliver more until this summer, as manufacturing efforts increase.
• Gilead plans to have more than 500,000 treatment courses by October, and more than 1 million by December.

The race to develop vaccines and new drugs for the novel coronavirus is promising, but it’ll be months before they could be ready. Once they’re approved, there will be a limited supply at first and it might take a few more months for the drugs to be widely available. Separately, doctors have obtained good results at repurposing some of the existing drugs to treat COVID-19 patients, with several clinical trials aimed at offering new treatment protocols for the disease. But only one of them was officially confirmed to be effective in certain types of COVID-19 cases. That’s remdesivir, the drug that Gilead Sciences developed for Ebola. However, the available supply will run out at the end of the month in the US, and more doses are not expected to be available until later this year.

Does Vitamin D Protect Against COVID-19?

By Jessica McDonald
Posted on June 8, 2020

Q: Does vitamin D help protect against COVID-19?

A: Some scientists have hypothesized vitamin D might be helpful, but there is no direct evidence that vitamin D can prevent COVID-19 or lessen disease severity. Nevertheless, it should be part of a healthy lifestyle.

FULL QUESTION
Could vitamin D help decrease the chance of covid 19?

FULL ANSWER
As the coronavirus has spread around the globe, some scientists have proposed that vitamin D could help with COVID-19, the disease caused by the virus.

Former Centers for Disease Control and Prevention Director Dr. Tom Frieden, for example, published a March 23 column on Fox News’ website suggesting that vitamin D could reduce a person’s COVID-19 risk.

“There are many crackpot claims about miracle cures floating around,” he wrote, “but the science supports the possibility – although not the proof – that Vitamin D may strengthen the immune system, particularly of people whose Vitamin D levels are low.”

The idea stems in part from experiments that have found that the vitamin, which is synthesized in the skin after sun exposure and is found in select foods, is used by the immune system. Some research also suggests vitamin D supplements might protect against respiratory infections, especially if someone is deficient in the vitamin. And many of the people most affected by the coronavirus, such as the elderly and minority populations, tend to have lower vitamin D levels.

But experts caution against overinterpreting preliminary correlations or hypothetical mechanisms. As Pennsylvania State University nutrition researcher A. Catharine Ross told us, associations are not the same as cause and effect, and the evidence either for or against vitamin D and COVID-19 is “extremely weak.”

A rapid review from Oxford University’s Centre for Evidence-Based Medicine found “no clinical evidence” that vitamin D could prevent or treat COVID-19, and another review on the topic published by nearly two dozen nutrition experts in BMJ Nutrition, Prevention & Health recommended avoiding vitamin D deficiency, but warned against taking high doses of the vitamin.

“As a key micronutrient,” the authors wrote, “vitamin D should be given particular focus—not as a ‘magic bullet’ to beat COVID-19, as the scientific evidence base is severely lacking at this time—but rather as part of a healthy lifestyle strategy to ensure that populations are nutritionally in the best possible place.”

Thus, while it’s a good idea to get enough vitamin D — pandemic or not — it’s too early to say that a lack of vitamin D makes COVID-19 worse, or that supplementing with vitamin D provides any protection against the disease.

Vitamin D Basics
Although called a vitamin, vitamin D acts as a hormone in the body, and is best known for building strong bones, which is done in large part by promoting absorption of calcium and phosphorus in the intestine.

“It’s actually a prohormone, and of all the nutrients that we have, it’s the only nutrient where the main source is not diet,” said Susan Lanham-New, a vitamin D researcher at the University of Surrey in the U.K.

Instead, she told us, most of a person’s vitamin D is made in the skin upon exposure to sunlight, which is why darker-skinned people are more likely to have lower levels of the vitamin, and why people who go outside less frequently, including those who are older or less healthy, are susceptible to deficiencies.

For vitamin D to be used by the body, it must be converted into an active form, typically by the liver and kidney, according to a National Institutes of Health fact sheet. The nutrient is found naturally in only a few foods, such as eggs and oily fish, but is more widely available in the U.S. in food that has been fortified, including milk and cereals.

While there is a debate about exactly how much vitamin D a person needs, and what constitutes a deficiency, Lanham-New said a commonly used metric for deficiency is a blood level below 25-30 nanomoles per liter. Too little vitamin D can lead to rickets in children or osteomalacia in adults — conditions in which bones become soft and deformed.

More is not always better, however, since vitamin D is fat-soluble, and is stored in the body. “You can get what we call hypercalcemia if you take too much vitamin D,” Lanham-New said, referring to elevated levels of calcium in the blood that can be especially dangerous for those with kidney diseases.

Vitamin D and Immunity
Beyond its role in bone health, vitamin D is also known to function in the immune system, which is a key reason why some think it’s plausible the nutrient might impact COVID-19.

Lanham-New, for example, said that vitamin D receptors are present on immune cells, and some immune cells make enzymes that help convert the nutrient into an active form.
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US human trials begin for first antibody cocktail that might treat and prevent Covid-19

(CNN)A medicine that may treat and prevent Covid-19 is now being tested in patients in multiple sites around the United States, according to an announcement Thursday from Regeneron Pharmaceuticals Inc.

It is the first trial of a Covid-19 antibody cocktail in the United States. If successful, Regeneron hopes it could be available by the fall.
The clinical trial started Wednesday. Regeneron said its antibody cocktail will be tested in four separate study populations: people who are hospitalized with Covid-19; people who have symptoms for the disease, but are not hospitalized; people who are healthy but are at a high risk for getting sick; and healthy people who have come into close contact with a person who is sick.

They prepared for years for a pandemic. Now the pressure is on to create a therapy that could help control it

"We have created a unique anti-viral antibody cocktail with the potential both to prevent and treat infection, and also to preempt viral 'escape,' a critical precaution in the midst of an ongoing global pandemic," Dr. George Yancopoulos, co-founder, president and chief scientific officer at Regeneron, said in a press release. "Ultimately, the world needs multiple solutions, and the innovative biopharma industry is collectively working hard to help as many people as possible with a variety of complementary approaches."

Antibodies are proteins the body naturally makes to protect the body from a threat like Covid-19. To make what's called monoclonal antibodies for an antibody cocktail, scientists comb through thousands of antibodies to figure out which ones fight the novel coronavirus most effectively.
In this case, Regeneron's scientists picked two antibodies, scaled them up and put them into a medicine that it hopes can be used to treat symptoms or and as protection for vulnerable communities such as the elderly or health care workers.

The first part of the trial will check to see if the antibody therapy is safe to be used in humans. Scientists will also want to if it works.
An antibody treatment is not a vaccine and does not provide permanent protection. But this kind of passive immunization works right away, and could potentially be available before a Covid-19 vaccine.

More antibody treatments in trials


First human trial of potential antibody treatment for Covid-19 begins

Regeneron is not the first company to get a Covid-19 antibody therapy into human trials. Eli Lilly and AbCellera started testing their antibody treatment in humans June 1. That trial uses a single antibody in its therapy. Eli Lilly has also started a second clinical trial in China of another single antibody treatment it created with Chinese company Junshi Biosciences. Eli Lilly said that they will test combinations of antibodies in the future. There are a handful of other companies working on additional antibody therapies.

Tarrytown, New York-based Regeneron has successfully created other US Food and Drug Administration-approved antibody therapies that fight eye problems, rheumatoid arthritis, cancer and cardiovascular disease.

Regeneron's Ebola treatment worked so well, its clinical trial was stopped early in August 2019. Data showed it was better at saving lives than some of the other therapies being tested. The FDA accepted REGN-EB3 for priority review in April. The agency is expected to make a decision about whether to OK the Ebola therapy by October.

Regeneron scientists said they had spent years preparing for a pandemic like Covid-19.
"Most scientist have said for years there's potential for pandemics like this novel coronavirus to emerge," Regenron scientist Kristin Pascal previously told CNN. "So we thought, let's be prepared."

To get ready, Pascal and her team ran speed challenges to see exactly how fast they could create a treatment for an emerging threat. They did it for MERS and Ebola and they hope all that practice will pay off against Covid-19.

The company, which some financial backing from the US Biomedical Advance Research and Development Authority to develop the Covid-19 therapy, said it set a company speed record by creating REGN-COV2 in months.

Apparently another treatment option, this one cheap and readily available, everything that works helps and this should help quite a bit.
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Coronavirus: Dexamethasone proves first life-saving drug

A cheap and widely available drug can help save the lives of patients seriously ill with coronavirus.

The low-dose steroid treatment dexamethasone is a major breakthrough in the fight against the deadly virus, UK experts say.

The drug is part of the world's biggest trial testing existing treatments to see if they also work for coronavirus.

It cut the risk of death by a third for patients on ventilators. For those on oxygen, it cut deaths by a fifth.

Had the drug had been used to treat patients in the UK from the start of the pandemic, up to 5,000 lives could have been saved, researchers say.

And it could be of huge benefit in poorer countries with high numbers of Covid-19 patients.

The UK government has 200,000 courses of the drug in its stockpile and says the NHS will make dexamethasone available to patients.

Prime Minister Boris Johnson said there was a genuine case to celebrate "a remarkable British scientific achievement", adding: "We have taken steps to ensure we have enough supplies, even in the event of a second peak."

Chief Medical Officer for England Prof Chris Whitty said it would save lives around the world.

About 19 out of 20 patients with coronavirus recover without being admitted to hospital.

Of those who are admitted, most also recover but some may need oxygen or mechanical ventilation.

And these are the high-risk patients dexamethasone appears to help.

The drug is already used to reduce inflammation in a range of other conditions, including arthritis, asthma and some skin conditions.

And it appears to help stop some of the damage that can happen when the body's immune system goes into overdrive as it tries to fight off coronavirus.

This over-reaction, a cytokine storm, can be deadly.


In the trial, led by a team from Oxford University, about 2,000 hospital patients were given dexamethasone and compared with more than 4,000 who were not.

For patients on ventilators, it cut the risk of death from 40% to 28%.

For patients needing oxygen, it cut the risk of death from 25% to 20%.

Chief investigator Prof Peter Horby said: "This is the only drug so far that has been shown to reduce mortality - and it reduces it significantly. It's a major breakthrough."

Lead researcher Prof Martin Landray said the findings suggested one life could be saved for:

• every eight patients on a ventilator
• every 20-25 treated with oxygen

"There is a clear, clear benefit," he said.

"The treatment is up to 10 days of dexamethasone and it costs about £5 per patient.

"So essentially it costs £35 to save a life.

"This is a drug that is globally available."

When appropriate, hospital patients should now be given it without delay, Prof Landray said.

But people should not go out and buy it to take at home.

Dexamethasone does not appear to help people with milder symptoms of coronavirus who do not need help with their breathing.
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Another take on the story above, we should be hearing more about this in the news, I wonder if Donald will climb on board and fuck this up too. This appears to work as a supportive anti inflammatory and not an antiviral treatment. This will not prevent covid and has no effect on the virus itself, it may only help you to survive if you become very ill in the hospital and have breathing difficulties.
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Study shows first evidence that a drug can improve survival from COVID-19
Steroid dexamethasone found to reduce deaths among patients with severe cases
Researchers in England say they have the first evidence that a drug can improve COVID-19 survival: a steroid called dexamethasone reduced deaths by up to one-third in severely ill hospitalized patients.

Results were announced Tuesday and researchers said they would publish them soon. The study is a large, strict test that randomly assigned 2,104 patients to get the drug and compared them with 4,321 patients getting only usual care.

The drug was given either orally or through an IV. It reduced deaths by 35 per cent in patients who needed treatment with breathing machines and by 20 per cent in those only needing supplemental oxygen. It did not appear to help less ill patients.

"This is an extremely welcome result," said one study leader, Peter Horby of the University of Oxford, in a statement.

"The survival benefit is clear and large in those patients who are sick enough to require oxygen treatment, so dexamethasone should now become standard of care in these patients. Dexamethasone is inexpensive, on the shelf, and can be used immediately to save lives worldwide."

Even though the drug only helps in severe cases, "countless lives will be saved globally," said Nick Cammack of Wellcome, a British charity that supports science research.

"Dexamethasone must now be rolled out and accessed by thousands of critically ill patients around the world," said Cammack, who had no role in the study. "It is highly affordable, easy to make, can be scaled up quickly and only needs a small dosage."

Matt Hancock
@MattHancock

https://twitter.com/i/web/status/1272863009493389313

WATCH: Delighted to announce the first successful clinical trial for a life-saving #coronavirus treatment- reducing mortality by up to a third & further protecting our NHS

This global first exemplifies the power of science- huge thanks to the team, @oxforduni & Jonathan Van-Tam

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9:06 AM - Jun 16, 2020
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Steroid drugs reduce inflammation, which sometimes develops in COVID-19 patients as the immune system overreacts to fight the infection. This overreaction can prove fatal, so doctors have been testing steroids and other anti-inflammatory drugs in such patients.

There are currently no approved treatments or vaccines for COVID-19, the disease caused by the novel coronavirus that has killed more than 431,000 people globally.

The World Health Organization advises against using steroids earlier in the course of illness, because they can slow the time until patients clear the virus.

David Juurlink
@DavidJuurlink

https://twitter.com/i/web/status/1272881062230835202

Needs to be said:

Do not take dexamethasone to prevent COVID-19.
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Researchers estimated that the drug would prevent one death for every eight patients treated while on breathing machines and one for every 25 patients on extra oxygen alone.

Huge effect in hospital
Having eight people on ventilators and one not dying is a huge effect size that's not seen very often in medicine, says Dr. David Juurlink, head of clinical pharmacology at the University of Toronto.

"Since this press release has come out I think it's going to grab the attention of every hospital-based physician who looks after patients with COVID and I think we're going to start using it right away," said Juurlink, who treats patients with COVID-19 in hospital.
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Mayo Clinic says convalescent plasma safe, looks promising for treating COVID-19

Researchers at Mayo Clinic gave an update Thursday on the experimental plasma program being used to treat patients with severe cases of COVID-19.

Dr. Michael Joyner, the principal investigator, said new data shows plasma transfusions are safe and the outcomes "continue to look promising."

Mayo Clinic is the lead institution in the Expanded Access Program for COVID-19, sponsored by the U.S. government, collecting and distributing convalescent plasma to patients in need across the country.

"When we started in early April, we thought this would be of interest to people but it's really taken off like wildfire," Dr. Joyner said.

Mayo Clinic said more than 33,000 people who have recovered from COVID-19 have donated plasma containing antibodies that may help sick patients fight the virus. Nearly 24,000 patients have received plasma transfusions so far.

A new safety report released Thursday looked at data from 20,000 hospitalized patients transfused with convalescent plasma from April 3 through June 11 at health care facilities across the country.

Mayo Clinic said it was a diverse population of patients. About 20% were African American, nearly 35% Hispanic and 5% Asian.

The data shows less than 1% of patients who received plasma had serious adverse side effects.

"That's really excellent news because that means even the sickest patients can get the plasma without too much worry, or really much worry at all, related to problems stemming from plasma transfusion," Dr. Joyner said.

The report also shows seven-day mortality rates have been declining since early April among patients who received plasma to the current level of 8.6%.

"What does that mean? Well, it could mean a couple things," Dr. Joyner explained. "Maybe we're giving it to less sick patients, and that's probably true, but we're also probably using it in a smarter way. I think the main thing is you want to give it early. It seems to work better before people have prolonged, extreme life-threatening illness."

Dr. Joyner said the mortality rate for patients who received plasma also appears to be "very low" compared to those who did not receive plasma.

He is careful to say the effectiveness of plasma in treating COVID-19 patients is still being studied.

"The physician part of me always wants to be in a position to give people the most hopeful possible message, and I certainly believe I can do that here," said Dr. Joyner. "The scientist part requires me to say, 'All the information is not there yet. It's emerging, we're working on it and we're attempting to answer these very questions as speak. The efficacy continues to look promising and we may be inching toward being able to make more definitive statements."

Dr. Joyner said they are seeing "interesting case studies" of "nice recoveries" in patients who have received plasma, making it a reasonable treatment for people with very limited options.

"We continue to think about what the next step is and how plasma might be able to help us sort of 'hold the line' until vaccines or newer and better drugs are available, hopefully, sooner rather than later," Dr. Joyner said. "This is what we have right now so we have to try to use it in the most intelligent possible way."

Dr. Joyner said, so far, supply appears to be keeping up with demand but he encourages anyone who has recovered from COVID-19 to consider donating plasma.

Not much talk about this because it's a old cheap drug and they won't be able to make mountains of money off it.

captainmorgan said:

Not much talk about this because it's a old cheap drug and they won't be able to make mountains of money off it.

Effect of Dexamethasone in Hospitalized Patients with COVID-19 – Preliminary Report

Background Coronavirus disease 2019 (COVID-19) is associated with diffuse lung damage. Corticosteroids may modulate immune-mediated lung injury and reducing progression to respiratory failure and death. Methods The Randomised Evaluation of COVID-19 therapy (RECOVERY) trial is a randomized...

www.medrxiv.org

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They will use it in hospitals and already are as a supportive therapy, something that addresses to major a issue that is killing and injuring people who have covid. This steroid is cutting the mortality rate significantly among those more seriously ill or likely to become that way.

We should be hearing more about convalescent plasma therapy soon and if the clinical trials are positive, I would expect a big ramp up in transfusion programs, preparations are being made. Also artificial antibody therapy is expected to be rolled out later this summer. Unless they find a drug that can be repurposed, there will be logistical problems producing many of the antivirals.

captainmorgan said:

Chinese study: Antibodies in COVID-19 patients fade quickly

www.cidrap.umn.edu

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Here's my take on it, just conjecture mind you. It appears that this problem is most prevalent among those who were asymptomatic or had mild cases. This seems to indicate that their innate immune systems dealt with it more effectively and the acquired immune system didn't "learn" enough, if you had a more severe case, your acquired immune system has a chance to mount a full blown antibody defense, taylor made for the bug.

Anyway that's my take on the deeply flawed study, but it will be replicated and we will get better data. This time when they do convalescent plasma therapy they will immunoassay the donations for consistent results.

Problem is a bit of a catch 22, if you need a severe case to produce enough antibodies for more than short term protection it affects convalescent plasma treatment. If the vast majority are mild cases and they don't produce enough antibodies for protection their plasma is of little use there by making useful plasma a rarer commodity. That would explain the early reports I'm seeing about how convalescent plasma is not as helpful as many had hoped.