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Monday, 6 September 2021

Ivermectin still not proven as COVID drug - NHK World

The rush to find a treatment for COVID-19 has cast a spotlight on the anti-parasitic drug ivermectin, but global health experts have warned that clinical trials were still needed to establish its efficacy.




Tuesday, Aug. 24, 12:47


The oral drug is based on a compound discovered by Omura Satoshi, a Distinguished Emeritus Professor at Kitasato University. He was awarded a Nobel Prize for the discovery.

Ivermectin is widely used to treat parasite-borne infectious diseases, mainly in Africa, while it is also approved in Japan to treat scabies.

A report published last year said cell-based lab experiments have shown that ivermectin can suppress multiplication of the coronavirus.

Some Latin American countries have approved the drug to treat COVID-19 patients. But studies are still ongoing around the world, as its efficacy and safety remain unproven.

In Japan, the Kitasato Institute has been conducting a clinical trial since last September, targeting coronavirus patients with mild to moderate symptoms, with blood oxygen levels of 95 percent of more.

In the US, the National Institutes of Health warned in February that ivermectin is not approved for the treatment of any viral infection.

It said it was impossible to draw definitive conclusions on the clinical efficacy of the drug for COVID-19 treatment. The reasons it cited included the limited sample size of studies, the lack of clarity on the severity of COVID-19 in study participants, and other incomplete information.

Ivermectin's US manufacturer Merck also said in February that there was "no scientific basis" for the drug's potential therapeutic effect against COVID-19.

In March, the World Health Organization advised that ivermectin should only be used to treat patients within clinical trials.

It said data from 16 trials involving 2,407 subjects showed that evidence on whether the drug reduces mortality or quickens improvement was of "very low certainty."

Japan's health ministry's COVID-19 treatment guidelines revised in July places ivermectin in a category of drugs whose efficacy and safety have not been established.

The guidelines refer to reports that the drug does not improve mortality, shorten hospitalization or hasten the reduction of viral loads in patients with mild symptoms.

Liver disorders are among the drug's possible side effects. The manufacturer also said it was unclear whether the product could be safely used among elderly people or pregnant women.

Ivermectin is also given in high doses to animals to treat parasitic diseases. The US Food and Drug Administration said in March that it has received multiple reports of patients who have been hospitalized after self-medicating with ivermectin intended for horses.

The FDA said, "You may have heard it's okay to take large doses of ivermectin. That is wrong." It added that overdosing could cause nausea, diarrhea, seizures or even death.

The FDA ramped up its warning via Twitter in August, saying, "You are not a horse. You are not a cow. Seriously y'all. Stop it."


https://www3.nhk.or.jp/nhkworld/en/news/20210



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News Navigator: What is ivermectin, and is it effective in treating COVID-19?

 (Mainichi Japan)


This electron microscope photo provided by the National Institute of Infectious Diseases shows the coronavirus isolated at the facility. (Photo Courtesy of the National Institute of Infectious Diseases)

The Mainichi Shimbun answers some common questions readers may have about ivermectin, which is drawing attention as a possible cure for COVID-19.

    Question: What kind of a medicine is ivermectin in the first place?

    Answer: It has saved the lives of many people in Asia and Africa as a treatment for onchocerciasis, a parasitic disease that causes blindness, and lymphatic filariasis, which can lead to hardened and enlarged skin.

    It is known that Japanese biochemist Satoshi Omura, a distinguished emeritus professor of Kitasato University who received the Nobel Prize in physiology or medicine in 2015, contributed to the medicine's development. In the 1970s, he discovered an antibiotic that is effective against parasites from the chemical substances produced by a new type of fungus in the soil around a golf course. Ivermectin was developed by changing a part of the structure of the substance.

    Q: Why would a medicine for parasites be used to treat COVID-19?

    A: Ivermectin attracted attention after experiments using cells confirmed that it was effective in suppressing the increase of the coronavirus. It is thought that the medicine prevents the coronavirus from interfering with the function of innate immunity that is inherent in humans. Ivermectin also seems to have the effect of decreasing inflammation that occurs in the body due to an excessive immune reaction.

    Q: Is it being used to treat coronavirus patients?

    A: Ivermectin is being used to treat COVID-19 patients in Brazil and Peru, among other places, but it has not yet been approved in Japan. In March, the World Health Organization recommended that it be used only in clinical trials as the evidence on its effects is "of very low certainty."

    The U.S. Food and Drug Administration is concerned about side effects, and said it received "multiple reports of patients who have required medical support and been hospitalized after self-medicating with ivermectin intended for horses."

    Large-scale clinical trials are being conducted in the U.K., and pharmaceutical companies in Japan are also planning to engage in clinical trials. We are hoping for an early judgment as to whether ivermectin is effective in treating the coronavirus.

    (Japanese original by Yuki Ogawa, Lifestyle and Medical News Department)


    https://mainichi.jp/english/articles/20210803/p2a/00m/0op/013000c



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    Another false hope in battle against Covid-19...What is Ivermectin?


    Scientists from the UK, Italy, Spain and Japan claim a significant reduction in mortality, time to recovery and viral clearance in COVID-19 patients treated with Ivermectin but WHO has recommended against its general use

    BusinessToday.In

    • May 11, 2021

    Goa has also announced that all over the age of 18 years will be allowed to use Ivermectin drug irrespective of their coronavirus status to bring down mortality

    The World Health Organisation (WHO) has recommended against the general use of Ivermectin for  Covid-19 treatment. The drug is typically used for treatment of parasitic roundworm infections. However, some health experts believe it has shown benefits against Covid-19 too. Scientists from the UK, Italy, Spain and Japan claim a significant reduction in mortality, time to recovery and viral clearance in COVID-19 patients treated with Ivermectin. A scientific research paper has also claimed that global Ivermectin use can break the coronavirus chain and reduce the risk of contracting the deadly virus. Meanwhile, German healthcare giant Merck, echoing WHO, has said no scientific basis has been found on Ivermectin's potential therapeutic effect against COVID-19.

    What is Ivermectin?

    Ivermectin has been approved by the US Food and Drug Administration (FDA) as a prescription medicine against parasitic roundworm infections. Mostly, it's administered to patients with intestinal strongyloidiasis and onchocerciasis. The common antiparasitic Ivermectin is being hailed as a possible cure for Covid-19 by doctors and other care experts across the world. A peer-reviewed research paper, written by three US government senior scientists, published in the American Journal of Therapeutics (AJT), claimed that Ivermectin is effective prophylaxis and treatment for Covid-19.


    Also read: Oxford University mulls trials of coronavirus 'wonder drug'


    Ivertin effect on Covid-19 patients

    Scientists claim the regular use of Ivermectin can cut the risk of contracting coronavirus. The AJT research paper, which is the most comprehensive review of the data available on Ivermectin so far, also suggests the regular use of Ivermectin can reduce the risk of contracting Covid-19 . The research paper analysed three RCTs (randomised controlled trials) and five observational controlled trials, including 2,500 patients. Scientists also claim Ivermectin can lead to a significant reduction in mortality, recovery time and viral clearance.

    How safe is Ivermectin?

    Though approval for the drug as a possible cure against coronavirus is still at the research level. The FDA is yet to review the data related to Covid-19 patients given Ivermectin. Also, the FDA has warned against the consumption of Ivermectin in large quantities.


    Also read: Govt issues new guidelines for home isolation of mild, asymptomatic COVID-19 cases


    WHO warning against use of Ivermectin

    Dr Soumya Swaminathan, WHO chief scientist, said safety and efficacy are important when using any drug for a new indication, which is why it recommends against using Ivermectin. "Safety and efficacy are important when using any drug for a new indication. WHO recommends against use of 'ivermectin' for COVID-19 except within clinical trials," she tweeted.

    German healthcare and life sciences giant Merck also issued similar warning, saying scientists are still examining the findings of all available and emerging studies of Ivermectin against Covid-19. "...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 efficacy in patients with COVID-19 disease, and; a concerning lack of safety data in the majority of studies," it said.

    Goa to offer Ivermectin to all adults

    All over the age of 18 years in Goa will be allowed to use Ivermectin drug irrespective of their coronavirus status to bring down mortality, state health minister Vishwajit Rane has said. The minister said this treatment would not prevent COVID-19 infection but it can help reduce the severity. "The Ivermectin 12 mg tablet will be made available in all the district, sub-district, PHCs, CHCs, sub-health centres, rural dispensaries for people to collect and start treatment immediately, irrespective of any symptoms or anything," Rane said. Goa on Monday recorded 2,804 new cases of coronavirus, taking its tally to 1,21,650, while 50 more fatalities pushed the toll to 1,729.

    Edited by Manoj Sharma with PTI inputs

    Also read: Remdesivir for COVID-19 patients: No evidence of anti-viral drug's effectiveness, says WHO


    https://www.businesstoday.in/coronavirus/story/another-false-hope-in-battle-against-covid-19what-is-ivermectin-295555-2021-05-11


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