Double-blind study shows ivermectin reduces disease’s duration and infectiousness • FDA and WHO caution against its use
By MAAYAN JAFFE-HOFFMAN, JPOST AUGUST 2, 2021 21:01
Ivermectin, a drug used to fight parasites in third-world countries, could help reduce the length of infection for people who contract coronavirus for less than a $1 a day, according to recent research by Sheba Medical Center in Tel Hashomer.
Prof. Eli Schwartz, founder of the Center for Travel Medicine and Tropical Disease at Sheba, conducted a randomized, controlled, double-blinded trial from May 15, 2020, through the end of January 2021 to evaluate the effectiveness of ivermectin in reducing viral shedding among nonhospitalized patients with mild to moderate COVID-19.
Ivermectin has been approved by the US Food and Drug Administration since 1987. The drug’s discoverers were awarded the 2015 Nobel Prize in medicine for its treatment of onchocerciasis, a disease caused by infection with a parasitic roundworm.
Over the years, it has been used for other indications, including scabies and head lice. Moreover, in the last decade, several clinical studies have started to show its antiviral activity against viruses ranging from HIV and the flu to Zika and West Nile.
The drug is also extremely economical. A study published in the peer-reviewed American Journal of Therapeutics showed that the cost of ivermectin for other treatments in Bangladesh is around $0.60 to $1.80 for a five-day course. It costs up to $10 a day in Israel, Schwartz said.
In Schwartz’s study, some 89 eligible volunteers over the age of 18 who were diagnosed with coronavirus and staying in state-run COVID-19 hotels were divided into two groups: 50% received ivermectin, and 50% received a placebo, according to their weight. They were given the pills for three days in a row, an hour before a meal.
The volunteers were tested using a standard nasopharyngeal swab PCR test with the goal of evaluating whether there was a reduction in viral load by the sixth day – the third day after termination of the treatment. They were swabbed every two days.
Nearly 72% of volunteers treated with ivermectin tested negative for the virus by day six. In contrast, only 50% of those who received the placebo tested negative.
IN ADDITION, the study looked at culture viability, meaning how infectious the patients were, and found that only 13% of ivermectin patients were infectious after six days, compared with 50% of the placebo group – almost four times as many.
“Our study shows first and foremost that ivermectin has antiviral activity,” Schwartz said. “It also shows that there is almost a 100% chance that a person will be noninfectious in four to six days, which could lead to shortening isolation time for these people. This could have a huge economic and social impact.”
The study appeared on the MedRxiv health-research sharing site. It has not yet been peer reviewed.
Schwartz said other similar studies – though not all of them conducted to the same double-blind and placebo standards as his – also showed a favorable impact of ivermectin treatment.
His study did not prove ivermectin was effective as a prophylactic, meaning that it could prevent disease, he cautioned, nor did it show that it reduces the chances of hospitalization. However, other studies have shown such evidence, he added.
For example, the study published earlier this year in the American Journal of Therapeutics highlighted that “a review by the Front Line COVID-19 Critical Care Alliance summarized findings from 27 studies on the effects of ivermectin for the prevention and treatment of COVID-19 infection, concluding that ivermectin ‘demonstrates a strong signal of therapeutic efficacy’ against COVID-19.”
“Another recent review found that ivermectin reduced deaths by 75%,” the report said.
BUT IVERMECTIN is not without controversy, and hence, despite the high levels of coronavirus worldwide, neither the FDA nor the World Health Organization have been willing to approve it for use in the fight against the virus.
Prof. Ya’acov Nahmias, a Hebrew University of Jerusalem researcher, has questioned the safety of the drug.
“Ivermectin is a chemical therapeutic agent, and it has significant risks associated with it,” he said in a previous interview. “We should be very cautious about using this type of medication to treat a viral disease that the vast majority of the public is going to recover from even without this treatment.”
During Schwartz’s study, there was not any signal of significant side effects among ivermectin users.
Only five patients were referred to hospitals, with four of them being in the placebo arm. One ivermectin patient went to the hospital complaining of shortness of breath on the day of recruitment. He continued with the ivermectin treatment and was sent back to the hotel a day later in good condition.
The FDA said on its website it “received multiple reports of patients who have required medical support and been hospitalized after self-medicating with ivermectin.”
The “FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans,” it said. “Ivermectin tablets are approved at very specific doses for some parasitic worms, and there are topical (on the skin) formulations for head lice and skin conditions like rosacea. Ivermectin is not an antiviral (a drug for treating viruses). Taking large doses of this drug is dangerous and can cause serious harm.”
The World Health Organization has also recommended against using the drug except in clinical trials.
IN CONTRAST, Schwartz said he was very disappointed that the WHO did not support any trial to determine whether the drug could be viable.
Last month, Oxford University announced a large trial on ivermectin effectiveness.
Schwartz said he became interested in exploring ivermectin about a year ago, “when everyone was looking for a new drug” to treat COVID-19, and a lot of effort was being put into evaluating hydroxychloroquine, so he decided to join the effort.
“Since ivermectin was on my shelf, since we are using it for tropical diseases, and there were hints it might work, I decided to go for it,” he said.
Researchers in other places worldwide began looking into the drug at around the same time. But when they started to see positive results, no one wanted to publish them, Schwartz said.
“There is a lot of opposition,” he said. “We tried to publish it, and it was kicked away by three journals. No one even wanted to hear about it. You have to ask how come when the world is suffering.”
“This drug will not bring any big economic profits,” and so Big Pharma doesn’t want to deal with it, he said.
SOME OF the loudest opposition to ivermectin has come from Merck Co., which manufactured the drug in the 1980s. In a public statement about ivermectin on its website in February, it said: “Company scientists continue to carefully examine the findings of all available and emerging studies of ivermectin for the treatment of COVID-19 for evidence of efficacy and safety. It is important to note that, to date, our analysis has identified no scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies; no meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease, and a concerning lack of safety data in the majority of studies.”
But Merck has not launched any studies of its own on ivermectin.
“You would think Merck would be happy to hear that ivermectin might be helpful to corona patients and try to study it, but they are most loudly declaring the drug should not be used,” Schwartz said. “A billion people took it. They gave it to them. It’s a real shame.”
And not moving forward with ivermectin could potentially extend the time it takes for the world to be able to live alongside the virus, he said.
“Developing new medications can take years; therefore, identifying existing drugs that can be re-purposed against COVID-19 [and] that already have an established safety profile through decades of use could play a critical role in suppressing or even ending the SARS-CoV-2 pandemic,” wrote the researchers in the American Journal of Therapeutics. “Using re-purposed medications may be especially important because it could take months, possibly years, for much of the world’s population to get vaccinated, particularly among low- to middle-income populations.”
@Adam
Very interesting findings. There is an enzyme in snake venom that causes massive tissue damage. This is why after a snake bite, it is important that the bite wound be prevented from circulating through the body and resulting in massive organ damage, especially the heart. It should be noted that this enzyme is also commonly noted in cases of sepsis, and shock but in much lower levels than found in this study. The enzyme breaks down cell membranes and is related to the fat cycle in patients. As noted about a month ago, they found that severe patients had high levels of LDL cholesterol and triglycerides in the blood. This may or not be related to the presence or elevation of this enzyme. Normally this enzyme is only released to fight off a severe infection.
In this retrospective study, they looked at blood samples that had been collected from dead patients and stored over a period of about 9months. Retrospective studies are not designed studies. They provide good findings of common features over many cases, but such findings have built in flaws. They aren’t testing a theory, they are looking for evidence that was collected, incidentally that might support one. This means the data collected across the many cases are inconsistent in terms of the details and technique by which the data was collected and stored. There are also likely numerable other confounding factors, such as the medical standards of care each patient received, the time between the onset of severe illness and the sample collection, among other such technical factors. Any of these factors could falsify the conclusions of this study. Regardless, it was a very intelligent approach to look for support of this enzyme in these collected samples of severe Covid cases.
The levels that were found in this look back over some patients who had severe Covid, found the levels of this enzyme were unbelievably high – I mean, really, the levels seem not believable as they are that elevated. The number of cases that they inspected was about 160, which is not very big but it is larger than many of the supporting studies that the CDC has championed to support the vax program. So they now have a working hypothesis that the enzyme may be related to the severe disease. They can test that in a prospective study where they can specifically design a study to measure the levels of this enzyme in severe cases to see if it is statistically significant. If there really is a correlation, they can use drugs to block this enzyme to see if it improves the patient’s outcomes. But it gives them something to test and try to improve treatments, at least for those doctors who will risk treating patients – this used to be the model of a clinical approach in medicine before treating sick patients was prohibited.
They have also conjectured that this enzyme might be related to the long Covid syndrome, but that is just a guess, and no results were collected to indicate that one way or the other. I find that to be unlikely as this enzyme is really really damaging, but it’s worth looking at. So that would be another set of studies they can pursue, that is, if they can find funding for any of these projects. Recall there is not a lot of Federal funding for Covid treatments and Pharma is dedicated towards their own projects. Still it is good to see some inquisitive minds are still hard at work and I suspect this study will likely have a significant finding.
https://www.jpost.com/science/does-this-enzyme-raise-the-chance-of-covid-related-death-678710. Peloni, could you read this article in today’s Jerusalem Post, and give us your take on what it means? Some medical researchers at the University of Arizona claim that cv-2 releases an enzyme genetically related to snake venom that is found in people who die of Covid and/or suffer “long Covid” symptoms. I wonder if the vaccines might also release this enzyme into people as well. What do you think?
There is an absolute mental disconnect here. They are now planning a fourth round of the vax. They have no data to support this return to the vaccine trough as effective. Worse than this, they are not collecting data on any equitable basis in which any harms can be rigorously monitored or examined. If you believe in the vax efficacy, and you formed a recurring issue, inflammatory reaction, blood clots, severe migraine, or the more lethal issues, wouldn’t you think it should be warranted that these details should be closely recorded – especially as no one else is following such “treatments”. It is an experiment, by any definition you would like to apply to that term, and the lack of respect for the subjects and their safety is appalling and criminal. The very data that would spell out the true consequence of this treatment of experimental vaccines as innocuous sugar cane is alarming. Collect the data at least. You can assume they are safe or that they are not, but if they will not collect the data, the propaganda is all we have to gauge these matters.
And yes, the striking highlight of the first paragraph should not be lost on anyone. They note that of 46pregnant women 50%are vaccinated, when the alarming note should be that 50% of them are vaccinated and infected.
I believe I saw something like this several months ago, I think the estimate then was “under $3 a day”.. It was not long before that article came out about the new Israel, laser beam that would cost $1 a shot. Ot maybe the ivermectin was a dollar and the laser 3…??
It should be no surprise, as we’ve been hearing of this well used drug and HCQ for well over a year. The beginning I think was Zelenko Protocol with HCQ not very long after the virus began to proliferate..
I wonder how he is, poor man, the last I read was that his cancer had returned.
I posted this entire article in Israpundit as a comment immediately after it was published a month ago.
Interesting that this was printed 1 month ago in JPOST, while the actual study was printed 4 months ago in May and the data was collected and shared 3-4 months earlier in Jan-Feb. So, as this devastating pandemic has continued it has taken 7-8 months for this to make its way from the lab settings to the cover of a major media source, and yet there it is still as if the govts are prevented from any notice of the vital news this portrays. In truth, this is just further confirmation of every thing that has been shown with IVM. “Doesn’t matter what you add to it, or what you subtract from it because it reduces deaths by alot” as Dr. Lawrie note(I spoke of her review on IVM here: https://www.israpundit.org/as-vaccines-continue-to-not-work-as-promised-ivermectin-continues-to-work/#comment-63356000241032 ).