Coronavirus treatment options and the impact on public policy

Dr. Scott Gottlieb on remdesivir rollout and US coronavirus response

Why have 14,000 people volunteered to be infected with coronavirus?
They want to take part in a "human challenge trial," an ethically controversial vaccine test that infects people with a virus does not yet have a cure.

Imagine being told to inhale a nasal spray full of coronavirus. More than 14,000 people in the U.S. and elsewhere are putting their names forward to do so.

They are volunteering for what's called a "human challenge trial," an ethically controversial way to test vaccines that would deliberately infect people with a virus that has killed over 270,000 people worldwide and has no cure.


"It's not every day we give a healthy individual an exposure to a pathogen — the very same thing doctors are trying to protect people from," said Dr. Nir Eyal, director of the Center for Population-Level Bioethics at Rutgers University. "But it becomes increasingly clear [that] the only sustainable exit from the current health and societal crisis is a vaccine, and there are ways to conduct such a trial that are perfectly ethical."

A vaccine is society's ticket back to normalcy — to crowded sports stadiums, birthday parties and visits to elderly loved ones, as well to some of the over 33 million jobs lost. But a solution is likely still a year to 18 months away at best, spurring warnings of social distancing until 2022 and a worse second wave this winter.

The problem is that vaccines take time to develop and test — often, upwards of a decade. The final phase of vaccine testing usually requires tracking up to tens of thousands of people to see who becomes infected in their daily lives, sometimes over several years.

But leading epidemiologists, philosophers and vaccinologists have recently advocated human challenge studies to accelerate the process. With careful design and informed consent, Eyal and his co-authors predict it could bring a vaccine months earlier and save thousands of lives.
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https://www.nbcnews.com/nightly-new...of-its-kind-genetic-vaccine-trial-83092037727

One more story on this controversial topic
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Researchers prepare for human challenge trials of Covid-19 vaccine
Deliberately infecting volunteers could accelerate research but raises ethical questions

The US government’s medical research arm is preparing the ground for Covid-19 “human challenge trials” that would deliberately infect healthy volunteers with coronavirus, as part of efforts to accelerate work on the development of a vaccine. Francis Collins, director of National Institutes of Health, has asked the NIH vaccines working group to “write a perspective on the scientific and practical considerations for a Covid-19 human challenge model”. The group, which includes senior vaccine developers from universities and industry, will meet on May 11 to discuss the issue. Challenge trials have a long history in medicine because deliberately infecting volunteers gives results more quickly than waiting for them to be infected in the community, but they are inevitably risky. A growing number of scientists say the world needs a Covid-19 vaccine so urgently that regulators and research funders should make preparations now, enabling human infection studies to begin after potential vaccines have completed their initial safety testing.
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They have removed many safety protocols fast tracking these vaccines trials, I won't be rushing to get one.

captainmorgan said:

They have removed many safety protocols fast tracking these vaccines trials, I won't be rushing to get one.

Click to expand...

Don't feel like volunteering eh? Desperate times desperate measures.

I wouldn't trust the life of a family pet to this administration, incompetent yes men and criminals are running things, the cure may be more dangerous than the virus.

These drug companies will get blanket protection from lawsuits so it's a race to the pot of gold no matter if the shit is safe or effective.

captainmorgan said:

They have removed many safety protocols fast tracking these vaccines trials, I won't be rushing to get one.

Click to expand...

I figure its gonna come down to Dr. Fauci's question, "how many deaths are you willing to accept"? By the end of summer treatment protocols and options should whittle the mortality rate down considerably, as well as greatly diminish hospital resource requirements. So if we can knock the mortality and hospital resource rates down to flu like levels, will it increase pressure to open things back up even more? Will it allow us to open back up more quickly and more extensively? These two things will have to be in balance, how fast do you open and by how much, vs how many lives do you want to lose, with treatments hopefully the numbers of dead will be much lower than they would be otherwise.

captainmorgan said:

I wouldn't trust the life of a family pet to this administration, incompetent yes men and criminals are running things, the cure may be more dangerous than the virus.

Click to expand...

Trump corrupts everything he touches, the FDA and CDC included.

There is no shortage of volunteers for these trials, they are international and will speed up development and deployment of vaccines, hopefully they don't grow a set of horns on people! It's causing quite an ethical stink in the medical and scientific communities.

I'll pass on the UV anal probe and bleach chaser.

captainmorgan said:

I'll pass on the UV anal probe and bleach chaser.

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It appears the WH is a festering caudron of infection now, an unsafe workplace even, three top healthcare people isolating. Steven Miller and his wife are self isolating and Pence should too, but Donald forced him back to work, they need and want to wear masks, but Donald thinks it looks bad. Appearance and image are everything to him, there is a vacuum behind the facade. Washington is a virus hotspot and there was even talk of moving the government from there, move the fucking capital! MAGA

Donald wants to avoid the reality of the coronavirus, but it keeps getting in his face and hopefully in his lungs! The GOP senate is freaking out and a lot of senators are worried about november now, just wait a month or two when the death tolls from their home red states start to roll in.

Do not trust anything this administration says or does, it's all about the money with them and nothing else.

captainmorgan said:

Do not trust anything this administration says or does, it's all about the money with them and nothing else.

Inside the NIH’s controversial decision to stop its big remdesivir study

A clinical trial for remdesivir, Gilead's Covid-19 treatment, faced one of the toughest quandaries in medicine: how to balance the need to rigorously test the medicine with the imperative to get patients a treatment quickly.

www.statnews.com

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Like I said Trump or those he appoints corrupt everything. In this case there is a shortage of the drug and someone is gonna compare outcomes etc with those who get it and those who don't. It's not as good as a double blind placebo study but it does provide a control to compare with, some people are unhappy about cutting the study short, but others are not. This fight is gonna happen in the scientific arena and they are real good at filtering out bullshit, it goes with the job, for a scientist integrity is everything, they aren't politicians for the most part, not on the job anyway.

I think this was a results driven and politically driven too, you can't buy Dr Fauci's obvious enthusiasm. It's no magic bullet, but another useful tool in the fight to save lives, one that once fully deployed will have an impact on mortality rates, how much of an impact is yet to be determined.

I believe this drug works, we just don't know how well it works, when is the best time to use it is and with limited supply, on who. Politics had an impact on the decision, but so did indicated efficacy.

I posted this one on the last page of this thread, also from the Philippines and it's referenced in the story. I figured Vitamin D had big roll to play in people with severe outcomes, I take around 3,000 IUs a day along with fish oil supplements and get some shirt off sun on the back deck when I can. They need much more public education about this especially among African Americans, giving out supplements would be cheaper than hospital costs, if money was the issue. Chronic low Vitamin D levels are associated with many comorbidities like hypertension and type 2 diabetes among other things, including poor immune response and over reaction. Much more public education is required about vitamin D and covid -19 IMHO and how to avoid the worst outcomes, especially among younger folks.
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Vitamin D Supplementation Could Possibly Improve Clinical Outcomes of Patients Infected with Coronavirus-2019 (COVID-19) by Mark Alipio :: SSRN
The rapid spread of COVID-19 in many areas of the world calls for preventive health measures. Although basic guidelines on infection control are suggested, trea
papers.ssrn.com

Vitamin D Supplementation Could Possibly Improve Clinical Outcomes of Patients Infected with Coronavirus-2019 (COVID-19)

9 Pages Posted: 9 Apr 2020 Last revised: 7 May 2020

Mark Alipio
Davao Doctors College; University of Southeastern Philippines
Date Written: April 9, 2020

May 11, 2020
COVID-19 and Racial/Ethnic Disparities
The novel SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) has led to a global pandemic manifested as coronavirus disease 2019 (COVID-19), with its most severe presentation being acute respiratory distress syndrome leading to severe complications and death. Select underlying medical comorbidities, older age, diabetes, obesity, and male sex have been identified as biological vulnerabilities for more severe COVID-19 outcomes.1 Geographic locations that reported data by race/ethnicity indicate that African American individuals and, to a lesser extent, Latino individuals bear a disproportionate burden of COVID-19–related outcomes. The pandemic has shone a spotlight on health disparities and created an opportunity to address the causes underlying these inequities.2
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Chicago, cases per 100, 000 (as of May 6, 2020)
Latino, 1000
African American/black, 925
‘Other’ racial groups, 865
White, 389

Chicago, deaths per 100,000 residents
African American/black, 73
Latino, 36
White, 22

New York City, deaths per 100,000 (as of May 7, 2020)
Latino, 187
African American, 184
White, 93

Gilead strikes deal to make remdesivir coronavirus treatment in 127 countries

KEY POINTS

• Gilead Sciences has struck a licensing agreement with five generic drugmakers to make antiviral drug remdesivir in 127 countries, not including the United States.
• The deal is “royalty-free” until WHO says the Covid-19 outbreak is no longer a global health crisis or “until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent Covid-19.”

Gilead Sciences has struck a licensing agreement with five generic drugmakers to make antiviral drug remdesivir in 127 countries, not including the United States, the company announced Tuesday.

Drugmakers Mylan, Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences will manufacture remdesivir for distribution in “low-income and lower-middle-income countries, as well as several upper-middle- and high-income countries” that face health-care obstacles amid the coronavirus pandemic, the company said.

The deal is “royalty-free” until the World Health Organization says the Covid-19 outbreak is no longer a global health crisis or “until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent Covid-19, whichever is earlier,” the company said.
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WHO sees 'potentially positive data' in treating coronavirus

GENEVA (Reuters) - The World Health Organization said on Tuesday that some treatments appear to be limiting the severity or length of the COVID-19 disease and that it was focusing on learning more about four or five of the most promising ones

The Geneva-based WHO is leading a global initiative to develop safe and effective vaccines, tests and drugs to prevent, diagnose and treat COVID-19. The respiratory illness has infected 4.19 million people around the world, according to a Reuters tally.

“We do have some treatments that seem to be in very early studies limiting the severity or the length of the illness but we do not have anything that can kill or stop the virus,” spokeswoman Margaret Harris told a briefing, referring to the body’s so-called Solidarity Trial of drugs against the disease.

“We do have potentially positive data coming out but we need to see more data to be 100% confident that we can say this treatment over that one,” she added, saying more research was needed and planned.

Harris did not name the treatments. Gilead Science Inc says its antiviral drug remdesivir has helped improve outcomes for COVID-19 patients.

Click here for a graphic of the drugs, vaccines and other therapies in development around the world.

Clinical data released last month on remdesivir raised hopes it might be an effective treatment. Several studies looking at combinations of antiviral medicines have also suggested they may help patients fight off the virus.

Results of a trial in Hong Kong released this month showed a triple drug combination of antiviral medicines helped relieve symptoms in patients with mild to moderate COVID-19 infection and swiftly reduced the amount of virus in their bodies.

The trial, which involved 127 patients, compared those given the combination drug, made up of the HIV medicine lopinavir-ritonavir, the hepatitis drug ribavirin, and the multiple sclerosis treatment interferon beta, with a control group given just the HIV drug.

Many of the drugs, treatments, tests and vaccines for Covid-19 under study or development in one article. There is a lot being done to address this crises and things will likely improve over the summer, when testing and effective treatments becoming available.
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The lifeline pipeline
By Christine Soares
Published: April 13, 2020
Updated: May 12, 2020

With much of the world living in lockdown, the spread of the new coronavirus, SARS-CoV-2, that was first detected in China late last year is beginning to slow in some places. As of May 11, 4.3 million had been infected and 290,000 killed by COVID-19, the disease caused by the virus.
While a safe, effective vaccine is still more than a year away, researchers are rushing to repurpose existing drugs and non-drug therapies as well as testing promising experimental drugs that were already in clinical trials.

Even moderately effective therapies or combinations could dramatically reduce the crushing demand on hospitals and intensive care units, changing the nature of the risk the new pathogen represents to populations and healthcare systems. New drugs, together with new diagnostics, antibody tests, patient- and contact-tracing technologies, disease surveillance and other early-warning tools, mean the anticipated next 'wave' of the global pandemic does not have to be nearly as bad as the first.
Spotlight: Latest in COVID research - May 11
Click for more information
Men's blood contains more of enzyme that helps coronavirus infect cells

Adding interferon may boost effectiveness of coronavirus treatment

UK coronavirus study reassures pregnant women; Swedish study says don't downplay risks

More than 70 vaccine candidates are also in development around the world, with at least five in preliminary testing in people. Here are some of the drugs, vaccines and other therapies in development:
more...

Her family searched for coronavirus plasma while Ferndale woman was in serious condition

Plasma donated by those who survive COVID-19 might be one of the best immediate hopes for the sickest patients in the coronavirus outbreak. But a logistical logjam — donor confusion, lengthy screening, special scheduling, and extra testing for antibodies — means critically ill patients often cannot get hold of the plasma in a timely fashion.

“At nearly every step, we see barriers,” said Dr. Nigel Paneth, a Michigan State University professor who’s helping to lead efforts in the National COVID-19 Convalescent Plasma Project.

In more routine times at Ascension Providence Southfield Hospital, a doctor could order a unit or two of plasma from the hospital blood bank and have it thawed, prepared and ready for an infusion within an hour. Plasma (the clear, yellow liquid part of blood) typically is used for cancer patients, or people with liver and bone marrow transplants. Its clotting factors also can help hemophilia patients.

Dr. Nigel Paneth, a Michigan State University professor. (Photo: Michigan State University)
But during the new coronavirus outbreak, finding convalescent plasma — plasma donated by someone who recently survived COVID-19 — can be an agonizing search as doctors are forced to make calls and families turn to social media or mass emails in a desperate bid to find donors.

Across the country, just over 6,600 hospital patients have been given the experimental treatment, with demand nearly twice that number.

“It can take five days or longer,” Ascension Providence Dr. Shukri David told Bridge Magazine about the hunt for COVID-19 plasma.

“A patient on a ventilator doesn’t have five days to wait.”

Promise in small studies
Convalescent plasma is donated by people who have recovered from a COVID-19 infection and hopefully built an immune response to the virus that can be useful to others. Antibodies captured in plasma are collected mostly by donation agencies such as the American Red Cross and others in the AABB, which represents the nation’s accredited blood banks.


Plasma transfusions are hardly new as a means to fight back against attacking viruses; there is mixed evidence they have provided at least short-term immunity to diphtheria, flu, measles and other infectious diseases.

Anecdotally and in small studies at least, convalescent plasma as a treatment for COVID-19 patients seems promising, though it is too soon to know for sure. Researchers hope it might even help those with underlying medical conditions or who are most highly exposed to the virus, such as health care workers and front-line responders, to ward off infection.

More: A look back at when the coronavirus started and how it spread in Michigan

As doctors scramble to find treatments until a vaccine is developed, convalescent plasma is but one of several possibilities. The U.S. Food and Drug Administration recently approved a drug, remdesivir, to treat COVID-19. But even after its fast-track approval this month, the extent of its benefits remain unclear. Also in doubt is the effectiveness, and safety, of hydroxychloroquine, which early on had also seemed promising.

More: Ann Arbor company says its nasal antiseptic can kill coronavirus

Bottlenecks in donations
But with any large, national endeavor, it takes time to set up a system, and delays connecting plasma donors to doctors to COVID-19 recipients “are not trivial,” said Paneth, head of the national project.

One major impediment is a small pool of donors. There are several reasons for this.

Thousands of potential donors may be asymptomatic carriers of COVID-19, and don’t know they have valuable antibodies they can donate. A national shortage of tests means few people without symptoms have been eligible to be tested.

Then there are the strict eligibility requirements for blood (and plasma) donations. The restrictions are designed to ensure a person’s blood (and plasma) is safe to donate, but they can also create a backlog, said Todd Kulman, spokesman for the Michigan region of the American Red Cross.

In addition to the routine criteria for blood donations, until recently a convalescent plasma donor had to have had a prior verified diagnosis of COVID-19 and be symptom-free for a period of weeks and fully recovered.

That left plenty of people who may have had mild cases of the coronavirus but who, on medical advice, stayed home until they felt better and never got tested.

“Only a small number of those who applied are eligible,” Kuhlman said, noting that it can take “up to seven days” for staff to review an application and reconnect with potential donors.

“It's taking more time than we thought it would,” he said.

Earlier this month, the Red Cross changed its policy and began testing plasma from donors who believed they had been sick with COVID-19 but never been tested.

That should break some of the logjam, both Kuhlman and MSU’s Paneth said.

Late last month, nearly 11,500 COVID-19 patients had received transfusions across the country, according to the COVID-19 expanded access program, which allows patients to receive plasma if they follow FDA-approved protocols set out by the Mayo Clinic.

For one who received plasma, a “miracle”

Clare Carr of Ferndale received a transfusion of convalescent plasma. (Photo: Carr Family)
For Clare Carr’s family, the scramble for plasma was part of a harrowing two weeks that began with a bit of achiness and a fever April 15.

Tested curbside outside her doctor’s office, Carr, a yoga instructor, who, according to her family, had been practicing social distancing, was found positive for the virus.

Still, the 32-year-old Ferndale woman felt well enough to quarantine herself at home, playing with her dog, Luna. For several days, she suffered minor aches and grogginess, but no fever.

But then things changed fast.

On April 22, Carr was on the phone with her doctor in the middle of the night after experiencing chest pain.

She was sent to Ascension Providence Hospital and, hours later, was flown by helicopter to the University of Michigan where she was immediately connected to an EMCO machine, which does the work of a patient’s lung and heart, allowing these organs to rest as the body fights the virus. On Thursday, U-M’s Dr. Robertson Davenport, head of its blood bank, called Carol Carr, Clare’s mother, to say Clare’s serious condition made her a candidate for convalescent plasma.

The mother signed consent papers for her unconscious daughter; and Davenport ordered the plasma from the hospital's supplier, the Red Cross.

Then days passed with no plasma.

So the family turned to social media in its own search for donors.

The confusion was apparent among those who responded: Could they donate if they had been sick but hadn’t had a test? How could they get their plasma to Clare?

The uncertainty is understandable, said Paneth. Potential donors don’t know how to navigate a large network of blood banks, and online searches can be overwhelming.

Five days after her family OK’d the treatment — late Tuesday evening, Clare Carr received a transfusion of convalescent plasma. The family said it isn’t sure where it came from.

One week later, she was off the ECMO machine, off the ventilator and has been able to FaceTime with her family, though she remains too ill to speak publicly, according to her family.

“It has been only a couple of weeks, but it feels like forever,” said her mom, a retired teacher.

Whether it was the ECMO, the ventilator, the plasma, the power of prayer, the “good vibes” from social media supporters, or a combination of them all, she’s improved. “It is a miracle,” said Carol Carr.

As it stands now, COVID-19 patients may receive convalescent plasma one of three ways.

The very sickest patients may be eligible to receive plasma through a special “compassionate use” permit that is fast-tracked through FDA’s Investigational New Drug application process. A doctor submits an online form for each patient; approval can happen within hours.

Hospitals, including Michigan Medicine and scores of others in Michigan, can offer plasma through the Expanded Access program, meaning they’ve agreed to follow protocols established by the Mayo Clinic and approved by the FDA. The 21-page protocol document puts limits on which patients receive plasma (only the seriously ill in acute care facilities) and requires certain paperwork (signed consent forms by the patient or their proxy, among them).

And patients also can receive treatment if they are part of a clinical trial. The University of Michigan is finalizing paperwork that could establish a clinical trial to test whether non-critical patients treated with convalescent plasma can be prevented from getting worse. And Beaumont Health launched a program to test antibodies as a step toward understanding their effect against COVID-19.

Those large-scale clinical trials will eventually determine whether the donor plasma is effective against COVID-19 and at what stages of the infection. more...