shape
carat
color
clarity

Potential hope for Coronavirus treatment...

missy

Super_Ideal_Rock
Premium
Joined
Jun 8, 2008
Messages
54,123


The last time the government sought a ‘warp speed’ vaccine, it was a fiasco

It was 1976, and President Gerald Ford was racing to come up with a vaccine for a new strain of swine flu

President Gerald Ford receives a swine flu inoculation from White House physician William Lukash in 1976. (David Hume Kennerly/Gerald R. Ford Library)
President Gerald Ford receives a swine flu inoculation from White House physician William Lukash in 1976. (David Hume Kennerly/Gerald R. Ford Library)
By
Michael S. Rosenwald
May 1, 2020 at 1:20 p.m. EDT

The federal government has launched “Operation Warp Speed” to deliver a covid-19 vaccine by January, months ahead of standard vaccine timelines.
The last time the government tried that, it was a total fiasco.

Gerald Ford was president. It was 1976. Early that year, a mysterious new strain of swine flu turned up at Fort Dix in New Jersey. One Army private died. Many others became severely ill. The nation’s top infectious disease doctors were shaken.
“They were well aware of the ravages of the 1918 flu, and this virus appeared to be closely related,” political scientist Max J. Skidmore wrote in his book “Presidents, Pandemics, and Politics.” “The officials were concerned about a repetition of the tragedy, or the threat of perhaps an even more virulent pandemic.”

Ford raced to come up with a response, consulting with Jonas Salk and Albert Sabin, the scientists behind the polio vaccine, and in late March he announced an audacious plan for the federal government to produce the vaccine and organize its distribution.
“No one knows exactly how serious this threat could be,” Ford said, with Salk and Sabin by his side, a shocking sight given the two scientists had become enemies over who should get credit for the polio vaccine. “Nevertheless we cannot afford to take a chance with the health of our nation.”
Every American, Ford said, would be vaccinated.
The government had never attempted such an endeavor — both in its breadth and speed.


Almost immediately, there was chaos.
According to Skidmore, a professor at the University of Missouri at Kansas City, insurers were concerned about liability and balked at covering the costs. Manufacturers the government wanted to partner with had similar concerns, prompting Congress to pass a law waiving liability.
One manufacturer produced 2 million doses with the wrong strain. As tests progressed, more scientific problems emerged — even as there were few, if any, signs that a pandemic was materializing. In June, tests showed the vaccine was not effective in children, prompting a public squabble between Salk and Sabin over who should be vaccinated.
Jonas Salk, developer of the polio vaccine, holds a rack of test tubes in his lab in Pittsburgh in 1954. (AP)
Jonas Salk, developer of the polio vaccine, holds a rack of test tubes in his lab in Pittsburgh in 1954. (AP)
But Ford was undeterred. He directed the vaccination program to proceed, announcing plans to inoculate 1 million people per day by the fall — an unprecedented timeline the government struggled to meet.
 

missy

Super_Ideal_Rock
Premium
Joined
Jun 8, 2008
Messages
54,123
From Medscape
May18, 2020:


The first coronavirus vaccine tested on humans has yielded positive results, with a small number of people who were tested showing an immunity against the virus, drugmaker Moderna said Monday in a news release.

Moderna, a Massachusetts-based company, said the vaccine called mRNA-1273 "was generally safe and well tolerated." The company said it plans to move ahead with the next two phases, in which larger numbers of people will be tested this year.

The news release said three different dosage levels — 25, 100 and 250 micrograms — were given to 45 participants, and all of them developed detectable antibodies.

But the eight people who received doses of 25 and 100 micrograms in March responded best, developing antibodies that were just as high or higher than the antibodies found in people who'd gotten the coronavirus and then recovered, the company said.

The vaccine uses something called the messenger RNA approach. It does not require a virus to make the vaccine.

"I think the totality of science tells us that this is the right antigen and it should be protective," Tal Zaks, Moderna's chief medical officer, said Monday on a call with journalists to discuss the results, according to Business Insider.



The testing is being done in coordination with the National Institutes of Health and the National Institute of Allergy and Infectious Diseases. It has not been peer-reviewed or published in a medical journal.

There currently is no vaccine against the coronavirus. Moderna and other companies are racing to develop a vaccine against the virus, which has killed 89,000 people in the United States alone.


It's unclear how soon a vaccine might hit the market. Anthony Fauci, MD, of the White House coronavirus task force, has cited a 12- to 18-month timeline for development.


At least 90 potential COVID-19 vaccines are under study, and six of those are already being tested on humans in clinical trials to determine if they're safe. “
 

missy

Super_Ideal_Rock
Premium
Joined
Jun 8, 2008
Messages
54,123

Matata

Ideal_Rock
Premium
Joined
Sep 10, 2003
Messages
9,037
Interesting!

Thanks for posting that. I'm curious what the impact is on their research of the newly emerging symptoms (stroke, blood clots etc) in those younger vaccinated populations and in young children. Is it purely covid-19 alone that causes those issues or could it be related to the vaccinations and their impact on immune systems. So much still to learn.
 

OboeGal

Brilliant_Rock
Premium
Joined
Mar 22, 2017
Messages
917

Oh, boy, do I hope this turns out to be the case. I just had an MMR booster last July. Bear in mind, though, that this is a preprint, so it has not undergone peer review yet. Response to this hypothesis has been mixed on the medical and COVID-19 research subreddits so far. I'm holding out hope.
 

missy

Super_Ideal_Rock
Premium
Joined
Jun 8, 2008
Messages
54,123

A conversation with J&J’s vaccine hunter
Despite decades studying diseases like HIV, Ebola and tuberculosis, Dr. Paul Stoffels says the breakneck speed at which Covid-19 spread around the world was “completely unexpected.”
Stoffels, the chief scientific officer of drug giant Johnson & Johnson, says he’s now putting his long experience researching infectious diseases and developing drugs and vaccines to work for one ambitious goal:
“Putting an end to this epidemic.”
The Belgian doctor-turned-executive is leading the development of an experimental vaccine that's received a $456 million award from BARDA, the U.S. agency responsible for developing medical countermeasures to emergencies. The White House recently tapped J&J as one of a select few it will provide additional resources and aid to get a shot across the finish line. The drug giant has suggested it is closer than previously anticipated to that goal.

Paul Stoffels, chief scientific officer of Johnson & Johnson, in 2017.
Photographer: Michele Limina/Bloomberg
Stoffels, 58, began his career as a physician in Africa focusing on HIV and tropical diseases. After joining J&J in 2002, he spearheaded development of several HIV drugs and worked on inoculations for Ebola and Zika.
He spoke to Bloomberg News about the race for a Covid-19 vaccine.
What is the minimum rate of efficacy you believe should be reached for a coronavirus vaccine to be considered useful, or successful?

STOFFELS: There’s a debate which is ongoing in the medical community: Is 50% enough? Does it have to be 70%? Does it have to be 90%? If you can prevent 7 out of 10 people from getting infected or getting sick, it’s valuable to do a large vaccination, and that’s not up to us to say that, but that is what the assumption of the authorities is today that we go for a 70% efficacy. It’s a common, accepted number at the moment for a target.
J&J has signed on collaborators to build out manufacturing capacity so that it can produce one billion doses before the end of 2021. Do you have enough capacity already to reach that objective?
STOFFELS: With our current capacity, we are almost there, but we want to go further to have more capacity if need be for the world. So we are at least going do two additional collaborations with either CMOs, contract manufacturing organizations, or with partners to build additional capacity for getting up to significantly above a billion vaccines a year.
Now for vaccine manufacturing, you have two parts: You have what is called vaccine substance, which is the vaccine itself, and then you actually have to fill it. And that process from vaccine substance to filling to release is several months. That process starts later in the year, toward an October or November time-frame, when we will actually start manufacturing large scale batches of vaccines.
J&J has received significant funding from the U.S. government. Have you made any formal commitments to the country should the vaccine prove successful?
STOFFELS: There is no contract that says the U.S. will be first, but we needed to expand very significant the manufacturing capacity. There was a site available in the U.S. already funded by BARDA, in the past. We contracted that site, and that does accelerate the availability of vaccines the U.S.
J&J has committed to offer its vaccine on a not-for-profit basis amid the pandemic. What kind of at-risk investments and manufacturing costs will the company include in the ultimate price-tag, and would you agree to disclose those costs?

STOFFELS: We are working on that and at a certain point we’ll disclose and make that public. We are not yet ready for that as we are still working on our cost structure in the world, on what it will take to get it all done. But we will be public about how we do this. We commit to equitable access globally, as well as to volume to make sure people can get access on a global scale.--Riley Griffin
Tracking the U.S. Small Business Virus Impact
Small businesses, the beating heart of the U.S. economy, have been hard hit by the fallout from the coronavirus pandemic. About $349 billion in federal relief loans designed to help them survive amid shutdowns ran out in just 13 days in April, with many mom-and-pop stores being shut out.

Coming events: Can the world’s medical researchers, scientists and public policy advocates work in tandem to outwit the virus and health challenges that now threaten mankind? Join us on June 16 at 10 a.m. EDT as we discuss how to overcome these crises. See the full lineup and register here.
On June 18th, hear from senior leaders including Dame Jayne-Anne Gadhia of Snoop and Johann Butting of Slack on how they bolstered digital offerings and positioned for the pandemic amid a surging need for digital technologies. “
 

missy

Super_Ideal_Rock
Premium
Joined
Jun 8, 2008
Messages
54,123
“Pharma giant Gilead is charging more than $3,000 for their coronavirus treatment remdesivir if you have private insurance, $2,500 if you have government insurance like Medicare. This price is indefensible considering that Gilead received at least $70 million in taxpayer money to develop the drug. Why are taxpayers forced to PAY TWICE for drugs? How much do you think the treatment should cost?



SMH. Not surprised. Just pissed.
 

Dancing Fire

Super_Ideal_Rock
Premium
Joined
Apr 3, 2004
Messages
33,852
“Pharma giant Gilead is charging more than $3,000 for their coronavirus treatment remdesivir if you have private insurance, $2,500 if you have government insurance like Medicare. This price is indefensible considering that Gilead received at least $70 million in taxpayer money to develop the drug. Why are taxpayers forced to PAY TWICE for drugs? How much do you think the treatment should cost?
$100 bucks and I still wouldn't pay it.
 

missy

Super_Ideal_Rock
Premium
Joined
Jun 8, 2008
Messages
54,123
Interesting. An osteoporosis drug might help treat Covid 19.

 

Matata

Ideal_Rock
Premium
Joined
Sep 10, 2003
Messages
9,037

missy

Super_Ideal_Rock
Premium
Joined
Jun 8, 2008
Messages
54,123
@Bayek hope you don't mind if I add your post here.


I believe anything to do with Covid 19 is free on the NYTimes, if not, and you want to read this report let me know here and I'll copy and paste.



"
Coronavirus Drug and Treatment Tracker
By Jonathan Corum, Katherine J. Wu and Carl ZimmerUpdated July 17, 2020
Leer en español

The Covid-19 pandemic is one of the greatest challenges modern medicine has ever faced. Doctors and scientists are scrambling to find treatments and drugs that can save the lives of infected people and perhaps even prevent infection.
Below is an updated list of 19 of the most-talked-about treatments for the coronavirus. While some are accumulating evidence that they’re effective, most are still at early stages of research. We also included a warning about a few that are just bunk.

ratings-600.png

We are following 19 coronavirus treatments for effectiveness and safety:


There is no cure yet for Covid-19. And even the most promising treatments to date only help certain groups of patients, and await validation from further trials. The F.D.A. has not fully licensed any treatment specifically for the coronavirus, but it has granted emergency use authorization to a few.
This list provides a snapshot of the latest research on the coronavirus, but does not constitute medical endorsements. Always consult your doctor about treatments for Covid-19.
We will update and expand the list as new evidence emerges. For details on evaluating treatments, see the N.I.H. Covid-19 Treatment Guidelines. For the current status of vaccine development, see our Coronavirus Vaccine Tracker.
What the Labels Mean
WIDELY USED: These treatments have been used widely by doctors and nurses to treat patients hospitalized for diseases that affect the respiratory system, including Covid-19.
PROMISING EVIDENCE: Early evidence from studies on patients suggests effectiveness, but more research is needed. This category includes treatments that have shown improvements in morbidity, mortality and recovery in at least one randomized controlled trial, in which some people get a treatment and others get a placebo.
TENTATIVE OR MIXED EVIDENCE: Some treatments show promising results in cells or animals, which need to be confirmed in people. Others have yielded encouraging results in retrospective studies in humans, which look at existing datasets rather than starting a new trial. Some treatments have produced different results in different experiments, raising the need for larger, more rigorously designed studies to clear up the confusion.
NOT PROMISING: These treatments show mixed evidence that suggests that they do not work.
PSEUDOSCIENCE OR FRAUD: These are not treatments that researchers have ever considered using for Covid-19. Experts have warned against trying them, because they do not help against the disease and can instead be dangerous. Some people have even been arrested for their false promises of a Covid-19 cure.
Filter the list of treatments:
All treatments Widely used Promising Tentative or mixed Not promising Pseudoscience
Blocking the Virus
Antivirals can stop viruses such as H.I.V. and hepatitis C from hijacking our cells. Scientists are searching for antivirals that work against the new coronavirus.
PROMISING EVIDENCE EMERGENCY USE AUTHORIZATION
Remdesivir
Remdesivir, made by Gilead Sciences, was the first drug to get emergency authorization from the F.D.A. for use on Covid-19. It stops viruses from replicating by inserting itself into new viral genes. Remdesivir was originally tested as an antiviral against Ebola and Hepatitis C, only to deliver lackluster results. But preliminary data from trials that began this spring suggested the drug can reduce the recovery timeof people hospitalized with Covid-19 from 15 to 11 days. (The study defined recovery as “either discharge from the hospital or hospitalization for infection-control purposes only.”) These early results did not show any effect on mortality, though retrospective data released in July hints that the drug might reduce death rates among those who are very ill.
TENTATIVE OR MIXED EVIDENCE
Favipiravir
Originally designed to beat back influenza, favipiravir blocks a virus’s ability to copy its genetic material. A small study in March indicated the drug might help purge the coronavirus from the airway, but results from larger, well-designed clinical trials are still pending.
TENTATIVE OR MIXED EVIDENCE
EIDD-2801
Another antiviral originally designed to fight the flu, EIDD-2801 has had promising results against the new coronavirus in studies in cells and on animals. It is still being tested in humans.
TENTATIVE OR MIXED EVIDENCE
Recombinant ACE-2
To enter cells, the coronavirus must first unlock them — a feat it accomplishes by latching onto a human protein called ACE-2. Scientists have created artificial ACE-2 proteins which might be able to act as decoys, luring the coronavirus away from vulnerable cells. Recombinant ACE-2 proteins have shown promising resultsin experiments on cells, but not yet in animals or people.
NOT PROMISING
Lopinavir and ritonavir
Twenty years ago, the F.D.A. approved this combination of drugs to treat H.I.V. Recently, researchers tried them out on the new coronavirus and found that they stopped the virus from replicating. But clinical trials in patients proved disappointing. In early July, the World Health Organization suspended trials on patients hospitalized for Covid-19. But they didn’t rule out studies to see if the drugs could help patients not sick enough to be hospitalized, or to prevent people exposed to the new coronavirus from falling ill. The drug could also still have a role to play in certain combination treatments.
NOT PROMISING
Hydroxychloroquine and chloroquine
German chemists synthesized chloroquine in the 1930s as a drug against malaria. A less toxic version, called hydroxychloroquine, was invented in 1946, and later was approved for other diseases such as lupus and rheumatoid arthritis. At the start of the Covid-19 pandemic, researchers discovered that both drugs could stop the coronavirus from replicating in cells. Since then, they’ve had a tumultuous ride. A few small studies on patients offered some hope that hydroxychloroquine could treat Covid-19. The World Health Organization launched a randomized clinical trial in March to see if it was indeed safe and effective for Covid-19, as did Novartis and a number of universities.

Meanwhile, President Trump repeatedly promoted hydroxychloroquine at press conferences, touting it as a “game changer,” and even took it himself. The F.D.A. temporarily granted hydroxychloroquine emergency authorization for use in Covid-19 patients — which a whistleblower later claimed was the result of political pressure. In the wake of the drug’s newfound publicity, demand spiked, resulting in shortages for people who rely on hydroxychloroquine as a treatment for other diseases.

When data emerged from the randomized clinical trials, the message was clear: hydroxychloroquine didn’t help people with Covid-19 get better or prevent healthy people from contracting the coronavirus. Another randomized clinical trial found that giving hydroxychloroquine to people right after being diagnosed with Covid-19 didn’t reduce the severity of their disease. (One large-scale study that concluded the drug was harmful as well was later retracted.) The World Health Organization, the National Institutes of Health and Novartis have since halted trials investigating hydroxychloroquine as a treatment for Covid-19, and the F.D.A. revoked its emergency approval. The F.D.A. now warns that the drug can cause a host of serious side effects to the heart and other organs when used to treat Covid-19.

In July, researchers at Henry Ford hospital in Detroit published a study finding that hydroxychloroquine reduced mortality in Covid-19 patients. President Trump praised the study on Twitter, but experts raised doubts about it because it was not a randomized controlled trial. Still, the White House has initiated a push for the F.D.A. to reauthorize hydroxychloroquine as an emergency Covid-19 treatment.

Despite negative results, a number of hydroxychloroquine trials have continued. A recent analysis by STAT and Applied XL found more than 180 ongoing clinical trials testing hydroxychloroquine or chloroquine, for treating or preventing Covid-19. Although it’s clear the drugs are no panacea, it’s possible they could work in combination with other treatments, or when given in early stages of the disease.
Mimicking the Immune System
Most people who get Covid-19 successfully fight off the virus with a strong immune response. Drugs might help people who can’t mount an adequate defense.
TENTATIVE OR MIXED EVIDENCE
Convalescent plasma
A century ago, doctors filtered plasma from the blood of recovered flu patients. So-called convalescent plasma, rich with antibodies, helped people sick with flu fight their illness. Now researchers are trying out this strategy on Covid-19. Early trials with convalescent plasma have yielded promising, if preliminary, results, and the F.D.A. has authorized its use on very sick patients infected by the coronavirus.
TENTATIVE OR MIXED EVIDENCE
Monoclonal antibodies
Convalescent plasma contains a mix of different antibodies, some of which can attack the coronavirus, and some of which can’t. Researchers have been sifting through the slurry for the most potent antibodies against Covid-19. Synthetic copies of these molecules, known as monoclonal antibodies, can be manufactured in bulk and then injected into patients. Safety trials for this treatment have only just begun, with several more on the way.
TENTATIVE OR MIXED EVIDENCE
Interferons
Interferons are molecules our cells naturally produce in response to viruses, rousing the immune system to attack. Injecting synthetic interferons is now a standard treatment for a number of immune disorders. Rebif, for example, is prescribed for multiple sclerosis. Early studies, including experiments in mice and cells, hint that injecting interferons may help against Covid-19. There’s even some evidence that the molecules could help prevent healthy people from getting infected.
Putting Out Friendly Fire
The most severe symptoms of Covid-19 are the result of the immune system’s overreaction to the virus. Scientists are testing drugs that can rein in its attack.
PROMISING EVIDENCE
Dexamethasone
This cheap and widely available steroid blunts many types of immune responses. Doctors have long used it to treat allergies, asthma and inflammation. In June, it became the first drug shown to reduce Covid-19 deaths. That study of more than 6,000 people, which in July was published in the New England Journal of Medicine, found that dexamethasone reduced deaths by one-third in patients on ventilators, and by one-fifth in patients on oxygen. It may be less likely to help — and may even harm — patients who are at an earlier stage of Covid-19 infections, however. In its Covid-19 treatment guidelines, the National Institutes of Health recommends only using dexamethasone in patients with COVID-19 who are on a ventilator or are receiving supplemental oxygen.
TENTATIVE OR MIXED EVIDENCE
Cytokine Inhibitors
The body produces signaling molecules called cytokines to fight off diseases. But manufactured in excess, cytokines can trigger the immune system to wildly overreact to infections, in a process sometimes called a cytokine storm. Researchers have created a number of drugs to halt cytokine storms, and they have proven effective against arthritis and other inflammatory disorders. Some turn off the supply of molecules that launch the production of the cytokines themselves. Others block the receptors on immune cells to which cytokines would normally bind. A few block the cellular messages they send.

Against the coronavirus, several of these drugs, including tocilizumab, sarilumab and anakinra, have offered modest help in some trials, but faltered in others. The drug company Regeneron recently announced that a branded version of sarilumab, Kevzara, failed Phase 3 clinical trials.
TENTATIVE OR MIXED EVIDENCE EMERGENCY USE AUTHORIZATION
Cytosorb
Cytosorb is a cartridge that filters cytokines from the blood in an attempt to cool cytokine storms. The machine can purify a patient’s entire blood supply about 70 times in a 24-hour period. It was granted emergency use authorization by the F.D.A. for Covid-19 based on a small study in March suggesting that it had helped dozens of severely ill Covid-19 patients in Europe and China. Further trials on patients with Covid-19 are now underway.
TENTATIVE OR MIXED EVIDENCE
Stem cells
Certain kinds of stem cells can secrete anti-inflammatory molecules. Over the years, researchers have tried to use them as a treatment for cytokine storms, and now dozens of clinical trials are under way to see if they can help patients with Covid-19. But these stem cell treatments haven’t worked well in the past, and it’s not clear yet if they’ll work against the coronavirus.
Other Treatments
Doctors and nurses often administer other supportive treatments to help patients with Covid-19.
WIDELY USED
Prone positioning
The simple act of flipping Covid-19 patients onto their bellies opens up the lungs. The maneuver has become commonplace in hospitals around the world since the start of the pandemic. It might help some individuals avoid the need for ventilators entirely. The treatment’s benefits continue to be tested in a range of clinical trials.
WIDELY USED EMERGENCY USE AUTHORIZATION
Ventilators and other respiratory support devices
Devices that help people breathe are an essential tool in the fight against deadly respiratory illnesses. Some patients do well if they get an extra supply of oxygen through the nose or via a mask connected to an oxygen machine. Patients in severe respiratory distress may need to have a ventilator breathe for them until their lungs heal. Doctors are divided about how long to treat patients with noninvasive oxygen before deciding whether or not they need a ventilator. Not all Covid-19 patients who go on ventilators survive, but the devices are thought to be lifesaving in many cases.
TENTATIVE OR MIXED EVIDENCE
Anticoagulants
The coronavirus can invade cells in the lining of blood vessels, leading to tiny clots that can cause strokes and other serious harm. Anticoagulants are commonly used for other conditions, such as heart disease, to slow the formation of clots, and doctors sometimes use them on patients with Covid-19 who have clots. Many clinical trials teasing out this relationship are now underway. Some of these trials are looking at whether giving anticoagulants before any sign of clotting is beneficial.
Pseudoscience and Fraud
False claims about Covid-19 cures abound. The F.D.A. maintains a list of more than 80 fraudulent Covid-19 products, and the W.H.O. debunks many myths about the disease.

WARNING: DO NOT DO THIS
Drinking or injecting bleach and disinfectants
In April, President Trump suggested that disinfectants such as alcohol or bleach might be effective against the coronavirus if directly injected into the body. His comments were immediately refuted by health professionals and researchers around the world — as well as the makers of Lysol and Clorox. Ingesting disinfectant would not only be ineffective against the virus, but also hazardous — possibly even deadly. In July, Federal prosecutors charged four Florida men with marketing bleach as a cure for COVID-19.
WARNING: NO EVIDENCE
UV light
President Trump also speculated about hitting the body with “ultraviolet or just very powerful light.” Researchers have used UV light to sterilize surfaces, including killing viruses, in carefully managed laboratories. But UV light would not be able to purge the virus from within a sick persons’ body. This kind of radiation can also damage the skin. Most skin cancers are a result of exposure to the UV rays naturally present in sunlight.
WARNING: NO EVIDENCE
Silver
The F.D.A. has threatened legal action against a host of people claiming silver-based products are safe and effective against Covid-19 — including televangelist Jim Bakker and InfoWars host Alex Jones. Several metals do have natural antimicrobial properties. But products made from them have not been shown to prevent or treat the coronavirus.
"
 

missy

Super_Ideal_Rock
Premium
Joined
Jun 8, 2008
Messages
54,123
From Medscape:

"
Drug Treatment for COVID-19: A Quick Summary for PCPs
Laurie Scudder, DNP, NP
DISCLOSURES
July 15, 2020


Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.
Information about COVID has evolved so quickly that it can be difficult for clinicians to feel confident that they are staying current. These summaries include links to our COVID-19 FAQ, which is constantly updated to make sure you have the latest information.
While treatment for COVID-19 outside of the hospital setting is currently limited to supportive therapy, over 1000 clinical trials are underway looking at a range of drug treatments. Here is a quick summary for primary care clinicians of the current state of evidence.
Remdesivir
Much-anticipated results from the National Institute of Allergy and Infectious Diseases' clinical trial of remdesivir, published in May, confirmed preliminary results suggesting that the drug shortens the disease course for hospitalized COVID-19 patients. That earlier report resulted in the US Food and Drug Administration (FDA) issuing an emergency use authorization for the drug. Drugmaker Gilead subsequently released results from the sponsored, randomized phase 3 SIMPLE trial, which found that a 5-day course of the drug improved outcomes among patients hospitalized with COVID-19 who did not need ventilation. The National Institutes of Health said that the most benefit was in patients on oxygen who did not require ventilation.

Remdesivir should be the "standard of care," according to Dr Anthony Fauci, though Dutch investigators have cautioned that it can be associated with rare but severe liver complications.
Bottom line on remdesivir. Remdesivir is administered intravenously, limiting its use to hospitalized patients. However, phase 1 trials of an inhaled nebulized version were initiated in late June 2020 to determine whether remdesivir can be used on an outpatient basis and at earlier stages of disease. The FDA has warned against use of remdesivir in combination with hydroxychloroquine (HCQ) . Stay current on remdesivir.
Dexamethasone
A cheap and widely available steroid roared to international attention in June with the announcement by British researchers that the RECOVERY trial involving over 6000 patients had been halted early due to positive results. The investigators reported that dexamethasone reduced death rates by about a third among severely ill hospitalized COVID-19 patients. Initial reaction in the United States was mixed.


While a number of clinicians indicated that the results confirmed their own experience, others were wary of embracing the study results prior to peer review. That may change, however, with the announcement by the Infectious Diseases Society of America (IDSA) that the drug will now be incorporated into COVID-19 treatment guidelines. Dexamethasone, or an equivalent steroid such as methylprednisolone or prednisone, is recommended for hospitalized patients who require supplemental oxygen, mechanical ventilation, or extracorporeal mechanical oxygenation.

Bottom line on dexamethasone. While corticosteroids are not generally recommended for treatment of COVID-19 or any viral pneumonia, the UK RECOVERY trial changed that. IDSA guidelines include low-dose dexamethasone (6 mg orally or intravenously daily for 10 days) in patients requiring respiratory support. At present, the World Health Organization has cautioned clinicians to reserve use for severely ill patients. Stay current on dexamethasone.

Hydroxychloroquine
Initial data suggested that HCQ and chloroquine, sometimes in combination with azithromycin, had some degree of efficacy in treating COVID-19. But those studies were rapidly followed by newer data from observational trials, suggesting that the drugs were not only without benefit but also could be dangerous in some patients. After 2 months of controversy, the FDA revoked the emergency use authorization it had previously granted for use of these agents in inpatient settings.

The matter seemed to be put to bed until early July when the Henry Ford Hospital released results of a retrospective, observational trial of HCQ with azithromycin that concluded that the combination, if given within the first 2 days of hospital admission, reduced COVID-19 mortality.

Trials of HCQ as preventive therapy are ongoing, though a randomized trial published in early June found that the drug was ineffective as prevention and that side effects were common.


Bottom line on HCQ. While some continue to tout its benefit, particularly if given early in the course of infection, there is little evidence at this time to support its use at any stage of illness. Stay current on HCQ.

Other Antimicrobials
In the race to find an effective therapy, clinicians around the world have launched trials of a wide range of agents, with almost universally disappointing results.

Azithromycin. While some initial trials of azithromycin in combination with HCQ were promising, later results have not held up and major cardiology organizations now warn against the combination. There are no recommendations for use of this antimicrobial.



Antiviral agents. The UK-based RECOVERY trial examined other drugs in addition to dexamethasone, concluding that the combination of lopinavir and ritonavir had no benefit in hospitalized patients. A Japanese trial of favipiravir, marketed as Avifavir, determined that patients given the drug early in the trial showed more improvement than those who received delayed doses, but the results did not reach statistical significance. Trials of other antivirals are ongoing.

A Grab Bag of Other Drugs
Convalescent plasma. While a very small Chinese pilot study of convalescent plasma reported in April that its use in severely ill COVID-19 patients raised antibody titers, reduced viral load, and led to symptom improvement, other studies have not yet shown it to be effective. The FDA has approved its use in patients with serious or immediately life-threatening infection.

Colchicine. An open-label, randomized trial currently underway in Greece has reported that hospital course was slightly shorter and the time to clinical deterioration improved in patients treated with colchicine, although there were no significant differences between treated and untreated groups in cardiac and inflammatory biomarkers.


Nitric oxide. Inhaled nitric oxide was studied as a supportive measure for patients with SARS-CoV-1 infection in 2004. It was found to reverse pulmonary hypertension, improve severe hypoxia, and shorten the length of ventilatory support. A phase 2 study is underway in patients with COVID-19, with the goal of preventing disease progression in those with severe acute respiratory distress syndrome.


Zinc. Initial trials of HCQ often studied it in combination with azithromycin and zinc. While some studies have suggested that zinc may be somewhat effective in treatment of upper respiratory infections, some of which are caused by coronaviruses, the National Academies of Sciences, Engineering, and Medicine cautions that there is no evidence to suggest that the supplement has a role in the treatment or prevention of COVID-19.


Monoclonal antibodies. The use of human antibodies is being investigated by a number of teams around the world. Eli Lilly has reported positive interim results of its trials of monoclonal antibodies, and anticipates FDA review and possible approval by September. European trials of another antibody could begin as early as this summer. And trials of a third agent are planning to start in August in Singapore.

"
 

Tekate

Ideal_Rock
Premium
Joined
May 11, 2013
Messages
7,570
@missy I should have posted it here actually! xoxoxoxo
 

missy

Super_Ideal_Rock
Premium
Joined
Jun 8, 2008
Messages
54,123
Be a part of the community Get 3 HCA Results
Top