UVA Health joins nationwide study examining ivermectin as COVID-19 treatment



The University of Virginia Health System has joined a nationwide clinical study to evaluate ivermectin and fluvoxamine as possible treatments for mild-to-moderate COVID-19.

The study, called ACTIV-6, is funded by the National Institutes of Health and seeks to determine whether cheap, widely available, and FDA-approved drugs can be repurposed to treat the coronavirus. Researchers are testing several medications including ivermectin, an anti-parasitic drug that some claim is an effective early treatment or prophylaxis for COVID-19.

The FDA has repeatedly warned against using ivermectin as a COVID-19 therapeutic, along with the World Health Organization, the European Union's drug regulators, and the drug's manufacturer Merck. But some doctors in the U.S. and medical freedom advocates have demanded a right to try ivermectin and other unproven drugs to treat COVID-19, claiming some coronavirus patients have shown improvement after taking those off-label medications.

Patrick E. H. Jackson, MD, the principal investigator for the ACTIV-6 clinical trial at UVA Health, is hopeful that the study will provide "conclusive answers about drugs like ivermectin and fluvoxamine for the treatment of mild-moderate COVID-19."

"While the monoclonal antibodies and nirmatrelvir-ritonavir (Paxlovid) are wonderful to have, there is a clear need for more (and more broadly available) drugs to help patients around the world," Jackson told TheBlaze.

He explained that the ACTIV6 study includes participants who have mild to moderate COVID-19 symptoms and who are within seven days of the onset of symptoms. The study is a double-blind placebo controlled trial. COVID-19 Patients will be given a random drug or a placebo and researchers will collect information from them on the duration of their symptoms, as well as whether they are required to go to the hospital.

Most of the participants will be at home and will complete questionnaires to report their condition.

Previous studies examining ivermectin as a COVID-19 treatment have failed to prove it is an effective treatment. While laboratory studies show that ivermectin appears to have an anti-viral effect against COVID-19 and some early clinical trials seemed to support its use as a COVID-19 treatment, doctors and public health experts have identified serious errors in methodology in many of those studies.

An investigative report by the BBC found that more than a third of 26 major trials with ivermectin against COVID-19 had "serious errors or signs of potential fraud," and that the remaining studies did not show it was effective as a treatment for COVID.

More widely accepted studies do not support the use of ivermectin for patients with COVID-19.

Some proponents of ivermectin as a COVID-19 treatment have championed a more recent peer-reviewed study that concluded "regular use of ivermectin as a prophylactic agent was associated with significantly reduced COVID-19 infection, hospitalization, and mortality rates," based on an observational study of 159,561 residents ages 18 and over in Itajaí, Brazil.

A group called the Front Line COVID-19 Critical Care Alliance touted the study as the "world's largest study of ivermectin."

According to the study's authors, between July 7, 2020, and Dec. 2, 2020, 113,845 participants of a citywide program opted to take ivermectin while 45,716 did not. Researchers found that 3.7% of the group that took ivermectin tested positive for coronavirus while 6.6% of those that didn't take ivermectin tested positive.

The study's authors claimed that after adjusting for variables, there was a 67% reduction in COVID-19 hospitalizations and a 70% reduction in the mortality rate for ivermectin users.

Though those results appear to be good news, experts that did not participate in the study criticized its methodology.

Dr. Jackson noted that the Brazil study was a non-randomized observational study. "Such studies can really only ever be hypothesis generating - that is they can raise interesting questions to be studied further, but can't show a causal relationship between an intervention and an outcome (in that case, ivermectin and COVID infection/hospitalization/mortality)," he said.

"I'm very hopeful that trials like ACTIV6 and COVID-OUT will give us conclusive answers about drugs like ivermectin and fluvoxamine for the treatment of mild-moderate COVID-19," he added.

New study finds aspirin can significantly cut COVID risks — and even death



A new study finds that simple, over-the-counter aspirin may be able to protect COVID-19 patients from extreme risk, including the need for mechanical ventilation, the Jerusalem Post reported.

What are the details?

New research from George Washington University has determined that treating COVID patients with aspirin reduced the risk of severe illness by nearly half.

The report noted that an aspirin regimen in more than 400 COVID-19 patients in hospitals across the United States cut the need for ventilation by 44%, slashed ICU admission by 43%, and reduced overall in-hospital mortality rates by 47%.

Dr. Jonathan Chow, one of the study's researchers, said, "As we learned about the connection between blood clots and COVID-19, we knew that aspirin — used to prevent stroke and heart attack — could be important for COVID-19 patients. Our research found an association between low-dose aspirin and decreased severity of COVID-19 and death."

A low-dose aspirin regimen has long been touted as potentially lifesaving for people at risk of heart attack or stroke or who are afflicted by blood clotting issues.

Chow added, "Aspirin is low-cost, easily accessible, and millions are already using it to treat their health conditions. Finding this association is a huge win for those looking to reduce risk from some of the most devastating effects of COVID-19."

What else?

This isn't the only study professing the possible benefits of aspirin in COVID patients. Earlier in October, Medical Express reported that researchers from the University of Minnesota and Basel University in Switzerland came to the same conclusion.

The researchers' findings were published in Lancet's Open Access eClinical Medicine and revealed that patients on blood thinners before getting COVID were admitted less often to the hospital despite being older and having more chronic medical conditions than their peers. The findings also revealed that blood thinners — whether started before or after COVID-19 infection — reduced death by nearly half.

Lead author Sameh Hozayen said, "We know that COVID-19 causes blood clots that can kill patients. But, do blood thinners save lives in COVID-19? Blood thinners are medications prescribed to prevent blood clots in patients with a prior blood clot in their lungs or legs. They also prevent blood clots in the brain secondary to abnormal heart rhythms, like atrial fibrillation. Blood thinners are the standard of treatment in these diseases, which is why we looked at data to see if it impacted hospitalizations related to COVID-19."

"We already know that overwhelmed hospitals have a higher risk for death among their patients, so reducing hospitalization may have a positive impact during a COVID-19 surge," Hozayen added.

"Unfortunately, about half of patients who are being prescribed blood thinners for blood clots in their legs, lungs, abnormal heart rhythms or other reasons, do not take them," Hozayen continued. "By increasing adherence for people already prescribed blood thinners, we can potentially reduce the bad effects of COVID-19.

Horowitz: 120 doctors ask JAMA to retract misleading Colombian study downplaying efficacy of ivermectin



We knew this would happen. The health establishment didn't use fabricated data from a study authored by a science fiction writer and porn star (later retracted), as they did with hydroxychloroquine, but it was almost as bad.

No, they didn't find any harm from ivermectin, but after every study showing the amazing efficacy of ivermectin against SARS-CoV-2 at every stage of the disease, the media breathlessly promoted a Colombian study supposedly showing no statistically meaningful benefit among those COVID-19 patients who were treated with it.

Last month, a group of Colombian researchers published a study inthe Journal of the American Medical Association (JAMA) concluding that, contrary to the findings of every other study, ivermectin showed no signs of bettering outcomes in COVID-19 patients in Cali, Colombia. "Among adults with mild COVID-19, a 5-day course of ivermectin, compared with placebo, did not significantly improve the time to resolution of symptoms," concluded the authors. "The findings do not support the use of ivermectin for treatment of mild COVID-19, although larger trials may be needed to understand the effects of ivermectin on other clinically relevant outcomes."

After ignoring dozens of other studies on ivermectin for months, the New York Times got hold of this study the day it was published and penned an article titled, "Popular Drug Does Not Alleviate Mild Covid-19 Symptoms, Study Finds." I immediately thought this sounded suspicious, given all the evidence that ivermectin helps against even more severe symptoms.

It turns out that the study design was flawed from the beginning, in addition to the fact that the study's own results do not bear out the conclusion posited by the authors. In a letter signed by 120 doctors, concerned clinicians who have successfully treated patients with ivermectin note the following flaws with the design:

The study's flaws span subject population, design, execution and controls. The small sample size (n = 400) had a median age of 37 and a BMI of 26, making them extremely low risk for COVID-19 hard endpoints. Faced with this low-relevance study group, the study authors improperly changed primary endpoint midway, moving the main endpoint to full symptom resolution by day 21. This self-reported subjective endpoint, obtained through telephone survey, is not credible for avoiding nondifferential nullward bias of the results.

Anyone who has paid attention this past year knows that people in their 30s who aren't overweight rarely get severe symptoms, and most suffer quite unremarkable symptoms that are some degree less than a flu. To attempt to prove improved outcomes with a group like this never made any sense.

The letter also highlights three other flaws with the study:

The authors incorrectly administered ivermectin on an empty stomach, reducing drug bioavailability in lung tissue, the critical drug target, by a factor of roughly 2.5. Additionally, ivermectin is readily available over-the-counter in Colombia, where sales have been ubiquitous (1.6 doses per COVID-19 case) in Cali during the study period.[2] Lack of serum testing in the study prevented identification of subjects who may have used the drug at intervals longer than the study lookback.

Thus, you literally had a placebo control group where they didn't ensure they were not taking ivermectin! It would be bad enough not to control for this factor (the primary study point) in an area where ivermectin was not widely available. But it turns out that the department of health in the state of Valle del Cauca – where this study took place – began distributing ivermectin to COVID patients right when the study period began.

Also, just from June to July of last year when the study period began, over-the-counter sales of ivermectin in the Cali region quintupled — to the point that there were more doses administered than number of recorded COVID patients. Given the popularity of the drug in that region at that time, it's inconceivable that a number of those who tested positive in the placebo group did not avail themselves to this drug. In fact, so popular was ivermectin in Valle del Cauca during the study period that during the week of July 5, Google searches for "ivermectina" outpaced searches for "vacuna covid" (COVID vaccine) by a factor of 33.

Contrast that to the U.S., where ivermectin is essentially unknown outside small circles.


Thus, Cali, Colombia, was probably the worst place to study outcomes against those who weren't officially administered ivermectin but were not prevented from taking it on their own preventively, as many people in the region were doing.

The doctors protesting this study originally sent this letter to JAMA to be published, but after JAMA declined, the authors posted it as an open letter on their own landing page.

There are also ethical questions about the Colombian study, because TrialSite News forced the authors to admit that they did not tell the study participants they were receiving ivermectin. Instead, they referred to the drug as "D11AX22 Molecule." While this point does not have bearings on the results of the study, it does show they violated participant consent rules, which raises questions about the broad ethics and agenda of the authors.

The Front Line COVID-19 Critical Care Alliance (FLCCC), which is the lead group in the United States promoting ivermectin as the staple of COVID early therapeutic treatment, wrote a paper calling into question the protocols of the study, noting that a labeling error substituted 38 ivermectin doses as part of the placebo group. They also accuse the authors of a conflict of interest for receiving grants from "Sanofi Pasteur, a vaccine manufacturer; Janssen, a J&J vaccine partner; and GlaxoSmithKline, Merck, and Gilead, which manufacture COVID-19 drugs."

Those relationships were properly disclosed on the study's conflict of interest disclosure.

Gilead is the maker of Remdesivir, the super expensive drug that is being used in nearly every hospital with zero evidence of efficacy. Despite its price tag, and the fact that the WHO found remdesivir use in 11,000 patients across 400 hospitals in the world had "little or no effect on hospitalized patients with Covid-19," it is still being used as the only major treatment.

So why is there such an agenda to discredit other cheap, repurposed drugs but then use expensive, ineffective drugs or questionable vaccines without applying a fraction of the same scrutiny? Follow the money.

Sadly, lives are being lost in the process. As German immunologist Dr. Peter Schleicher recently said, "It is completely incomprehensible that there is no approval for this [ivermectin] in Germany. We would have thousands fewer deaths to complain about" (translated from German via Google translate).

Horowitz: Court orders NY hospital to administer ivermectin to COVID patient who began breathing on his own after one dose



Americans woke up to the shocking news today that the CDC is recommending a pause on the Johnson & Johnson vaccine due to blood clotting issues, a decision that will undoubtedly make the public nervous about the other two experimental vaccines in use. Now is the time for the government to tell the public the truth that there is a safe and effective treatment for this virus from a cheap drug that has been safely used for years. No experimentation needed.

The same international and national health agencies that continue to panic about COVID-19 are refusing to allow early and preventive treatment of ivermectin or even further study of its efficacy. The more studies and real-world experience show that it works marvelously against the virus, the more they stall, censor, or obfuscate information. At this point, almost nobody should be dying from COVID if everyone were given ivermectin among other proven early treatments. Why is there no effort to promote these early treatments — to the point that desperate patients are forced to go to court to access treatment?

John Swanson, 81, of Genesee County, New York, like so many elderly Americans, was given no legitimate preventive or early treatment options for this now very predictable inflammatory response to COVID-19. He wound up on a ventilator at the United Memorial Medical Center in Batavia and, according to the court affidavit, was "on death's doorstep." The Buffalo News reports that, according to attorney Ralph C. Lorigo, Swanson was given one dose of ivermectin and began breathing on his own, was then taken off the ventilator, and began to show great progress. However, the hospital, with no other legitimate treatment options to offer, refused to give him follow-up doses.

On April 2, state Supreme Court Justice Frederick J. Marshall ordered the hospital to administer the follow-up doses at the request of Swanson's wife.

As of late Friday afternoon, his attorneys described Swanson as "stable."

"I definitely think the Ivermectin is helping him," Sandra Swanson told The Buffalo News, but she said she is upset and frustrated that hospital officials would not allow her to visit with her husband.

"They held the phone to his ear, and I read him a long list of people who are praying for him every day, about 20 people," she said. "But I need to see him."

There have been at least two other instances where New York judges had to force local hospitals to administer lifesaving treatment to those who appeared on their way to death.

It is shocking how 13 months into this pandemic, the medical profession has nothing to offer but a ventilator, keeping loved ones away from seeing the patient, and blocking the only known lifesaving treatments.

What is even more bewildering is the fact that the World Health Organization's own data show that early-use ivermectin is even more effective, reducing mortality by 81%. Were every vulnerable person to use it preventively, one can only speculate that the results would be even better, because the key to fighting the inflammatory response is to pre-empt it from getting off the ground.

Despite 50 studies, 26 of them randomized controlled trials, showing the amazing efficacy of this cheap and safe drug, the NIH refuses to recommend its use. As late as January, health officials continued to say that "there are insufficient data to recommend either for or against the use of ivermectin for the treatment of COVID-19." But three months later, why have they not aggressively studied ivermectin to at least confirm or refute the wealth of existing studies they evidently don't want to rely upon?

On Feb. 15, Dr. Maria Van Kerkhove, the head of the World Health Organization's technical response team to COVID-19, promised that within the "next six weeks or so" they would be coming out with guidance on use of ivermectin for COVID. She hinted at the fact that they felt some of the positive studies had too small a sample size and were looking to pool and synthesize the data. At the same forum, Dr. Sylvie Briand, director of the Pandemic and Epidemic Diseases Department at the World Health Organization, admitted that ivermectin induced "broad spectrum activity" against viruses and looked promising and that studies were ongoing.

Two months later, with panic abounding about variants despite all the vaccines, why is there still radio silence? Why was there such a rush to make experimental gene therapy approved as a vaccine under emergency use for hundreds of millions of people at the same time they drag their feet on a drug that has been proven safe for years?

Dr. Fauci is telling people that it's still not OK for vaccinated Americans to eat and drink indoors. He and his colleagues in the various health agencies keep spreading fear about variants of the virus escaping the utility of the vaccine. According to a recent YouGov poll, 54% of those vaccinated in America say they still fear getting the virus. Why wouldn't we tell everyone the good news that there is a safe, non-invasive drug they can take at the first sign of COVID (and even preemptively) that will almost certainly ward off serious or even mild illness without any unknown long-term effects like the vaccines?

"The bottom line is that ivermectin works. I've seen that in my patients as well as treating my own family in Italy," Yale University professor and renowned cancer researcher Dr. Alessandro Santin said in an interview with TrialSite News last month. "We must find a way to administer it on a large scale to a lot of people."

Aside from ivermectin's ability to treat COVID and its inflammatory response in the immune system at all stages of the virus, Dr. Santin notes that it seems to work effectively to quell long-term symptoms in those who take a while to recover.

Even if one is not sold on hydroxychloroquine or ivermectin, just think of any hypothetical cheap and safe de facto cure to the virus. With the political class and their corporate allies obtaining so much money, power, and social transformation from keeping people fearful and controlled, would they really allow any such cure to come to become ubiquitous in public health?

The lie told by public health officials about the lack of early treatments is perhaps the most dastardly and revealing of all the COVID lies, manipulation, censorship, and panic-mongering. It demonstrates that they don't really want to cure — with the least risk — a disease that, according to their own sentiments, is the greatest threat to mankind.

As George Orwell wrote in "1984," "The war is not meant to be won, it is meant to be continuous."

Chris Christie released from hospital following COVID-19 diagnosis, treatment with remdesivir



Former New Jersey Gov. Chris Christie (R) has been released from a New Jersey hospital after testing positive for COVID-19 diagnosis of last week.

Christie was admitted to the hospital last week, just hours after releasing the news of his diagnosis.

Christie, who is 58 years old, is overweight and has asthma, putting him at more serious risk than those without contributing factors who end up infected with the virus.

What are the details?

On Saturday morning, the former New Jersey governor shared the news on Twitter, writing, "I am happy to let you know that this morning I was released from Morristown Medical Center. I want to thank the extraordinary doctors & nurses who cared for me the last week. Thanks to my family & friends for their prayers. I will have more to say about all of this next week."

I am happy to let you know that this morning I was released from Morristown Medical Center. I want to thank the ext… https://t.co/vHixaAeBmp
— Governor Christie (@Governor Christie)1602335671.0

This is Christie's first tweet following the announcement that he'd be checking into the hospital for treatment following news of the positive coronavirus diagnosis.

Last Saturday, he wrote, "In consultation with my doctors, I checked myself into Morristown Medical Center this afternoon. While I am feeling good and only have mild symptoms, due to my history of asthma we decided this is an important precautionary measure."

In consultation with my doctors, I checked myself into Morristown Medical Center this afternoon. While I am feeling… https://t.co/KTlTraEUOI
— Governor Christie (@Governor Christie)1601761979.0

According to CNN, doctors prescribed the anti-viral drug remdesivir to assist in Christie's treatment.

Christie's positive diagnosis announcement came a day after that of President Donald Trump, who last week announced that he and his wife, Melania Trump, tested positive for the virus.

Trump spent the entirety of last weekend at Walter Reed National Military Medical Center for treatment. He was released on Monday.

Last week, the New Jersey Republican told ABC News that he had spent some time "off and on" at the White House and with Trump himself in order to help prep for the president's debate against Democratic presidential nominee Joe Biden.

Christie isn't the only Trump cohort who has tested positive for the virus after the president's positive diagnosis: White House Press Secretary Kayleigh McEnany tested positive for COVID-19 last week, as did Trump aides Kellyanne Conway, Hope Hicks, Stephen Miller, and more.

President Trump touts convalescent plasma as 'major therapeutic breakthrough' for COVID-19



President Donald Trump announced a "major therapeutic breakthrough" regarding COVID-19 on Sunday. The president heralded the emergency authorization for convalescent plasma therapy as a coronavirus treatment that is "very effective."

"Today I am pleased to make a truly historic announcement in our battle against the China virus that will save countless lives," Trump said at a White House press briefing. "Today's action will dramatically increase access to this treatment."

"Based on the science and the data, the FDA has made the independent determination that the treatment is safe and very effective," Trump said.

The U.S. Food and Drug Administration issued an emergency use authorization for the use of convalescent plasma as a COVID-19 treatment. Convalescent plasma therapy was greenlit by the FDA based on preliminary data, but is still undergoing testing.

FDA Commissioner Stephen Hahn said convalescent plasma reduced the COVID-19 morality rate by 35% in early findings.

"I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives," Hahn said. "We're encouraged by the early promising data that we've seen about convalescent plasma."

"The FDA's emergency authorization for convalescent plasma is a milestone achievement in President Trump's efforts to save lives from COVID-19," Health and Human Services Secretary Alex Azar said. "The Trump Administration recognized the potential of convalescent plasma early on."

"We dream in drug development of something like a 35% mortality reduction," Azar said. "This is a major advance in the treatment of patients."

The FDA said convalescent plasma "may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product."

Over 70,000 U.S. patients have been given convalescent plasma as part of an expanded access program from the FDA and the Mayo Clinic, officials told the Washington Post.

Mayo Clinic researchers and collaborators found convalescent plasma "to be safe following transfusion in a diverse group of 20,000 patients."

JUST IN: President Trump announces FDA's authorization of COVID-19 plasma treatment https://t.co/unOyNteLA5 https://t.co/hfqNH4pRnV
— The Hill (@The Hill)1598218829.0

Convalescent plasma is blood plasma extracted from a human patient who has recovered from a disease and given to a patient who is battling the same disease.

Convalescent plasma provides passive immunity, which means that the body doesn't create its own antibodies. Instead, the body borrows the antibodies from the plasma of the patient who fought off the disease. Convalescent plasma is different than a vaccine, which is active immunity, because the borrowed antibodies don't last a lifetime, but can be a lifesaving treatment.

"Convalescent plasma has been used throughout history when confronting an infectious disease where you have people who recover and there's no other therapy available," according to Warner Greene, director of the Center for HIV Cure Research at the Gladstone Institutes. "There must be something in their plasma—i.e. an antibody—that helped them recover."

Convalescent plasma has been used for over a century, and cut the fatality rate in half during the Spanish flu, also known as the 1918 influenza pandemic. It was also effective against polio before there was a vaccine. However, it was not successful against Ebola.

There are nearly 5.7 million confirmed cases of COVID-19 in the United States.

The potential of convalescent plasma therapy for COVID-19 patients www.youtube.com