Double-blind study shows ivermectin reduces disease’s duration and infectiousness • FDA and WHO caution against its use
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.”