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Medicine Government United States

NIH Begins Clinical Trial To Test Hydroxychloroquine To Treat COVID-19 (thehill.com) 284

The National Institutes of Health (NIH) announced Thursday that it's begun enrolling participants in a clinical trial to test the effectiveness of hydroxychloroquine in treating COVID-19. The Hill reports: The first participants have enrolled in the trial at Vanderbilt University Medical Center in Nashville, Tenn. The study will be conducted by the NIH's National Heart, Lung, and Blood Institute. According to the NIH, the blinded, placebo-controlled randomized clinical trial aims to enroll more than 500 adults who are currently hospitalized with COVID-19, the disease caused by the novel coronavirus, or who are in an emergency department with anticipated hospitalization.

Participants will be randomly assigned to receive 400 mg of hydroxychloroquine twice daily for two doses (day one), then 200 mg twice daily for the subsequent eight doses (days two through five) or a placebo twice daily for five days. Hydroxychloroquine is used to treat malaria, lupus and rheumatoid conditions such as arthritis. However, its effectiveness at treating COVID-19 has never been proven, despite its embrace by President Trump. The evidence on hydroxychloroquine is conflicting, at best. NIH scientists said urgent clinical evidence is needed. Even so, the study is not estimated to be completed until July 2021.

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NIH Begins Clinical Trial To Test Hydroxychloroquine To Treat COVID-19

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  • There's something really ridiculous when something as a clearly scientific question of whether a specific drug is useful for a specific disease has become an essentially partian issue. But this is apparently where we are. While much of this is due to Fox News trying to turn this into a culture war issue, there's also been a segment of the left concluding that it must be completely ineffective, rather than either group acknowleding that the evidence right now is complicated and unclear https://www.washington [washingtonpost.com]
    • Re: (Score:3, Insightful)

      by seebs ( 15766 )

      I wouldn't say it's definitely ineffective, but the initial research was retracted for severe flaws, and so far as I can tell there's no reasonable studies showing any benefit yet. If you remove anyone who dies or goes to the ICU from your sample, then claim your sample had better than average results, that's pretty suspicious.

      • The study wasn't about patient outcomes, it was about detection of the RNA on nasal swabs using a standard RRT-PCR test - termed "virological cure". It makes sense that you have to exclude patients who don't get tested.

        Even if you assume that all 6 of the dropouts would have had positive test results, the HCQ treated group would been under 50% (12 of 26) still testing positive. Meanwhile, essentially all of the untreated group (14 of 16) was still testing positive.

        The paper is freely available. There is

    • Re: (Score:3, Insightful)

      by sexconker ( 1179573 )

      While much of this is due to Fox News trying to turn this into a culture war issue

      WTF?

      When did Fox News do anything regarding this drug?

      All I ever saw was MSNBC, CNN, et al claiming it was the same as fish tank cleaner, Trump killed the people who drank fish tank cleaner, it doesn't work, there's no evidence of it working, it's a conspiracy so Trump can make money, etc.

      We know from Italy that it's a very promising drug. The drug is safe, widely available, and not encumbered by patents. Does more study need to be done? Yes. If I were a COVID-19 patient going from bad to worse would I de

      • All I ever saw was MSNBC, CNN, et al claiming it was the same as fish tank cleaner,

        They never claimed that. They claimed it was the same as chloroquine phosphate [aquariumstoredepot.com] which is used to treat fish ich... and... it is [cdc.gov].

        The drug just can be fatal if the wrong dose is given.

        • Re: (Score:3, Informative)

          by GetBent4Me ( 6758308 )

          All I ever saw was MSNBC, CNN, et al claiming it was the same as fish tank cleaner,

          They never claimed that. They claimed it was the same as chloroquine phosphate [aquariumstoredepot.com] which is used to treat fish ich... and... it is [cdc.gov].

          The drug just can be fatal if the wrong dose is given.

          What an asinine comment. Most drugs are fatal if the wrong dose is given... Many people commit suicide every year using this very method. To say that Chloroquine Phosphate is the same as Hydroxychloroquine is like saying that Polyethylene Glycol (Colonoscopy prep) is the same as Ethylene Glycol (Antifreeze) - It's a very disingenuous comment.

          • Re: (Score:3, Informative)

            by LiENUS ( 207736 )

            To say that Chloroquine Phosphate is the same as Hydroxychloroquine is like saying that Polyethylene Glycol (Colonoscopy prep) is the same as Ethylene Glycol (Antifreeze) - It's a very disingenuous comment.

            Boy are you going to feel stupid [cdc.gov]

            • Interesting. From the link...

              Chloroquine (also known as chloroquine phosphate) is an antimalarial medicine. It is available in the United States by prescription only. It is sold under the brand name Aralen, and it is also sold as a generic medicine.

              Overdose of antimalarial drugs, particularly chloroquine, can be fatal. Medication should be stored in childproof containers out of the reach of infants and children.

        • >"The drug just can be fatal if the wrong dose is given."

          Or when you take it in the form of aquarium cleaner that has lots of OTHER possible chemicals in it.

        • Re: (Score:3, Informative)

          by modecx ( 130548 )

          Hydroxychloroquine and chloroquine are related naturally, but they're not the same. One of the differences being that regular plain old chloroquine is about three times more toxic than the hydroxy version [wikipedia.org], and if you overdose on it, you stand a pretty good chance of dying, much more than Hydroxychloroquine. The side effects with improper dose can be much more significant as well.
          That being said, it's massively irresponsible to draw a false equivalence between a highly purified, precise dosage capsule made a

        • by sjames ( 1099 )

          The drug just can be fatal if the wrong dose is given.

          Yes, just like aspirin, tylenol, and water.

      • by Dantoo ( 176555 ) on Friday April 10, 2020 @07:17PM (#59930622)

        From The Atlantic April 6

        "Two weeks ago, French doctors published a provocative observation in a microbiology journal. In the absence of a known treatment for COVID-19, the doctors had taken to experimentation with a potent drug known as hydroxychloroquine. For decades, the drug has been used to treat malaria—which is caused by a parasite, not a virus. In six patients with COVID-19, the doctors combined hydroxychloroquine with azithromycin (known to many as “Z-Pak,” an antibiotic that kills bacteria, not viruses) and reported that after six days of this regimen, all six people tested negative for the virus.

        The report caught the eye of the celebrity doctor Mehmet Oz, who has since appeared on Fox News to talk about hydroxychloroquine 21 times. As Oz put it to Sean Hannity, “This French doctor, [Didier] Raoult, a very famous infectious-disease specialist, had done some interesting work at a pilot study showing that he could get rid of the virus in six days in 100 percent of the patients he treated.” Raoult has made news in recent years as a pan-disciplinary provocateur; he has questioned climate change and Darwinian evolution. On January 21, at the height of the coronavirus outbreak in China, Raoult said in a YouTube video, “The fact that people have died of coronavirus in China, you know, I don’t feel very concerned.” Last week, Oz, who has been advising the president on the coronavirus, described Raoult to Hannity as “very impressive.” Oz told Hannity that he had informed the White House as much.
        More Stories

        Anthony Fauci is not among the impressed. "

      • by quantaman ( 517394 ) on Friday April 10, 2020 @07:26PM (#59930664)

        While much of this is due to Fox News trying to turn this into a culture war issue

        WTF?

        When did Fox News do anything regarding this drug?

        They only promoted it 275 times between March 23rd and April 6th [mediamatters.org].

        • Re: (Score:2, Insightful)

          by Orgasmatron ( 8103 )

          LOL "promoted"

          We counted as promotion of the use of chloroquine or hydroxychloroquine any claims that encouraged the use of the drugs, including statements endorsing such treatments currently in use, mentions of personal use of such treatments, and expressions of hope or optimism that such treatments will work. We included any statements indicating that the drugs saved someone's life as promotion.

          • Before you laugh I suggest you look up the word promoted in the dictionary. - This is me promoting your continued intellectual development.

      • by timholman ( 71886 ) on Friday April 10, 2020 @08:43PM (#59930908)

        We know from Italy that it's a very promising drug. The drug is safe, widely available, and not encumbered by patents. Does more study need to be done? Yes. If I were a COVID-19 patient going from bad to worse would I demand a regimen of hydrox + azi, even if things weren't yet conclusive? Yes.

        Purely personal and anecdotal comment on my part: the 66-year-old cousin of my wife is ill with COVID-19 in Kansas. He has preexisting lung issues, his condition became critical, and he was sent to the ICU. There was no ventilator immediately available for him, so he was given hydroxychloroquine instead.

        That was 3 days ago. He is much better now (in fact, he was much better the very next morning), and it now appears he will recover.

      • by pz ( 113803 )

        Please, while the drug has many uses, one of which may well be for corona viruses like C19, it in no way is a safe drug by the common understanding of what "safe" means.

        "Safe" drugs are ones that we, meaning the non-medically-trained public, know how to take with or without physician supervision. Ones that don't kill us, and that don't have side effects that we worry about very much.

        Hydrochloroquine is NOT one of those drugs. It has a very narrow useful range before it becomes seriously toxic, with side e

      • Fake news (Score:5, Insightful)

        by Camel Pilot ( 78781 ) on Friday April 10, 2020 @08:47PM (#59930922) Homepage Journal

        All I ever saw was MSNBC, CNN, et al claiming it was the same as fish tank cleaner

        That is a lie! Can you point to one article that claimed hydroxychloroquine was the same as a fish tank cleaner?

        Here is the problem. If you lie you can't then go and complain about "fake news" because you are fake news.

        I know Trump does this. Trump is changing our culture - changing our attitudes towards ethical failures as normal and OK. The irony is that Trump is destroying the ethical norms that made us great.

      • Re: (Score:2, Informative)

        by PopeRatzo ( 965947 )

        WTF?

        When did Fox News do anything regarding this drug?

        When, indeed:

        https://www.foxnews.com/health... [foxnews.com]

        https://www.foxnews.com/media/... [foxnews.com]

        https://www.foxnews.com/health... [foxnews.com]

        If you want more examples, I'd be happy to provide them.

      • While much of this is due to Fox News trying to turn this into a culture war issue

        WTF?

        When did Fox News do anything regarding this drug?

        Well, a lot just in the last few days. Searching on foxnews.com shows these stories just in the last two days! It's almost as though someone at Fox News was trying to orchestrating propaganda, realizing that the base is so easily pliable that they wouldn't even recognize the manipulation.

        Laura Ingraham examines the left’s denial of hydroxychloroquine success against COVID-19 [foxnews.com]

        Media pundits, medical establishment in denial about hydroxychloroquine? [foxnews.com]

        Billy Saracino touts benefits of hydroxychloroquine. [foxnews.com]

        Tru [foxnews.com]

        • Maybe you could explain to us what you think Fox News gets out of it? What if it doesn't work? What if it does work? Do you think there is a downside if it does work? What makes you think that any "manipulation" on this is worthwhile?

          • Maybe you could explain to us what you think Fox News gets out of it? What if it doesn't work? What if it does work? Do you think there is a downside if it does work? What makes you think that any "manipulation" on this is worthwhile?

            Well, it's obvious that Fox News tells one side of a story and repeatedly and concertedly pounds on that one side of the story. As I did, searching on foxnews.com or watching the channel or reading the website demonstrates that easily.

            Why does Fox News pound on one side of the story? I'm not Fox News, so you'd have to ask them. The stories are there, and they're obviously heavily promoting one side of each story. That fact is easily shown. Why do they go it? I don't know. Maybe they seeking for ratin

      • "The drug is safe" I can stop you right there. The drug can have nasty side effect not limited to blindness and cardiac arrest, and the difference between toxic dose and therapeutic dose, is, shall we say, "small".
        Do i need to bother reading the rest of your argument if you are so wrong on that one alone ? Well I still checked for hydroquinone+italy and no surprise : no answer. To my knowledge there are clinical test in various countries but no result whatsoever. They take weeks at best , if not month to a
    • Re: (Score:3, Funny)

      by OrangeTide ( 124937 )

      Just like I don't know if hydroxychloroquine is effective against COVID-19, I cannot say for certain that 7-Up and mentos isn't an effective treatment. With a study we cannot say for certain, and every day that goes by without a 7-Up study means we have potentially lost human lives!

      While I haven't tried a study with 26 patients reporting from several different hospitals, my gut, as tremendous as it is, says it might maybe could be a game changer.

      • I demand a study into the effectiveness of a 14 day regimen of dandelion juice and rendered snake fat.

        Without a study, all we have is a forest of straw men burning while people die. People are so scared of the 1800s they think a salesman is going to time travel to steal their cheesy poofs just because it comes from a snake. Get over the phobia, people! Without a study, the complaints are baseless. This treatment could work!

      • by gweihir ( 88907 )

        Pretty accurate. It is a sad state of affairs that so many people have so little clue about this.

    • by Frank Burly ( 4247955 ) on Friday April 10, 2020 @06:50PM (#59930516)

      I half agree. But: on one side you have the President, his cabinet, Barr, and Fox News saying that Democrats don't like hydroxychloroquine because the President touts it; on the other side you have groups of people who think anything the President says is untrue. The partisan bias is asymmetrical on several axes.

    • Who would've thunk it? We are so galvanized, politically, that at the start of the Covid-19 pandemic, simply preparing properly for the known threat of an especially virulent virus became an issue of for/against the current administration.

      Both US parties are so close to equally responsible that it's akin to splitting hairs to issue more blame to one side over the other, but the Democrats, in a final moment of as close to sanity as they could muster, chose their most moderate, popular, flawed candidate to co

      • We are so galvanized, politically, that at the start of the Covid-19 pandemic, simply preparing properly for the known threat of an especially virulent virus became an issue of for/against the current administration.

        I think you'd acknowledge that if he had done anything like prepare properly for this threat we wouldn't have the federal government seizing PPE in April. https://www.youtube.com/watch?... [youtube.com]

        I understand that you see the divide as partisans for and against Trump, but Dems do not generally abandon policies just because Trump endorses them, while Republicans (with rare and well-publicized exceptions ) will eat three meals a day of whatever shit sandwich Trump decides to serve up.

        That is why it is farcical to sa

        • The plain truth of the partisanship matter is that it's neither unique, nor new to, the current US administration... it is merely magnified by the current administration's not so especially competent handling of the reins.

    • It is ridiculous, isn't it? It's not as though Trump dreamed up this treatment himself.
      • Americans are hoarding toilet paper and flour, Finland is hoarding hydroxychloroquine.

        The apocalypse is weirder than I expected. And slower.

    • I expressed doubts about taking this until more tests are done, but I never said it wasn't going to work. And I'm in the center. I think there are many who have a very strong political motive against any government and government regulation, and they see the FDA as slow and cumbersome and getting in their way of having unproven treatments.

      I'm not trying to give a partisan argument, I'm trying to be logical and scientific. If some people think that logic and science are political, then so be it. The FDA

    • by Dunbal ( 464142 ) *
      If it was obviously useful, there wouldn't be so much kerfuffle and so many trials. There's so much BS going on around this precisely because there's no data showing that it's clearly useful. Don't get your hopes up.
    • There's something really ridiculous when something as a clearly scientific question of whether a specific drug is useful for a specific disease has become an essentially partian issue. But this is apparently where we are. While much of this is due to Fox News trying to turn this into a culture war issue, there's also been a segment of the left concluding that it must be completely ineffective,

      No this is a false equivalence. You can also find a "segment of the left" that worships Stalin and space aliens. Meaningless drivel.

      rather than either group acknowleding that the evidence right now is complicated and unclear

      It's the process not the underlying facts that are at issue and what makes this so sad.

      Even if it were subsequently shown to be an amazingly effective wonder cure that still wouldn't absolve the Trump/Fixed news propaganda machine from peddling unproven bullshit on national television.

    • by gweihir ( 88907 )

      Well, both sides mistakenly believe they know how reality works. That is not good at all. Fortunately, some actual scientists still know how to get a good approximation of the truth. For now. If they find that the stuff is not effective, some orange moron will probably at least fire all of them. If they find the stuff works at least to some degree, the same moron will think he is the second coming. Now take into account that around half the citizens have voted for that moron and the scale of the problem bec

    • by Cylix ( 55374 )

      It is fairly simple...

      This is a known anti-inflammatory and the wuhan-flu causes inflammation.

      The street reports and fast track are in itself enough to justify the usage.

      This is just more political posturing and what is sad is they don't care how many people they kill.

  • 1918 all over again (Score:5, Interesting)

    by Art Challenor ( 2621733 ) on Friday April 10, 2020 @06:50PM (#59930518)
    It's amusing, or distressing, to watch the repeat of the snake-oil sales resulting from the 1918 influenza epidemic. Quinine was in big demand because of it's effectiveness against malaria. (It's totally useless against the flu.) We can but hope that hydroxychloroquine , or something, will be found to be effective, even if only in certain cases. I'm not convinced but, until we have some science behind it, I'm just guessing like everyone else.
  • Hydroxychloroquine might be a critical part of the treatment for COVID-19, or it might not.

    The problem is that Trump's obsession with it means that a disproportionate number of resources are being focused on this one drug. Even if it's effective they may end up overlooking treatments that were more effective because this is the one getting the big push.

    There's a reason that leaders try to coordinate the big things (like disaster relief) and leave the technical details (drug cocktails) to the experts. The US

    • The problem is that Trump's obsession with it means that a disproportionate number of resources are being focused on this one drug.

      Not really. Quinine and various related compounds have been around for a long time and are inexpensive. There are many companies making them, and in some cases they are donating large numbers of doses
      .
      Bayer Is Donating Its Malaria Drug That Could Help Coronavirus Patients In The U.S. [fool.com]

      Novartis, Mylan and Teva to supply tens of millions of chloroquine tablets to fight COVID-19 [fiercepharma.com]

      Novartis has pledged a global donation of up to 130 million hydroxychloroquine tablets, pending regulatory approvals for COVID-19. Mylan is ramping up production at its West Virginia Facility with enough supplies to make 50 million tablets. Teva is donating 16 million tablets to hospitals around the U.S. On Friday afternoon, Amneal pledged to make 20 million tablets by mid-April.

      Investigation into other drugs continues.

      I take it you will be gutted if it turns out to be helpful.

  • >"Even so, the study is not estimated to be completed until July 2021."

    It seems like in an emergency such as this, they could find 500 candidates pretty quickly, start the trial immediately, and know something in just a few weeks.

  • by Dan667 ( 564390 ) on Friday April 10, 2020 @08:37PM (#59930884)
    science will tell the truth, but I don't believe a word out of trump. Especially, since it has been reported he looks to gain from hydroxychloroquine sales
  • It's amazing how almost all of the time this drug comes up, the only thing people talk about is the politics of it. So far, the only actual scientific article in the press I've read was in the Wall Street Journal. The article describes in detail what the drug really does in this case. One of the effects is that it keeps the alveoli from absorbing too much water which is what kills you in this case. It's not a cure. It does, however give your body time to fight it off. There is evidence that people tak

  • It’s about Trump (Score:2, Insightful)

    by MikeMo ( 521697 )
    I’m willing to bet that most of the people on this board are supporting or dissing HCQ based entirely on whether or not they hate Trump.
  • Cytokine storm (Score:5, Interesting)

    by Dan East ( 318230 ) on Friday April 10, 2020 @10:15PM (#59931168) Journal

    The main aspect of COVID-19 that kills people is what is called a cytokine storm. That is basically when the immune system becomes so active in the lungs it floods the lungs with fluid, and can also destroy lung tissue. That is a response to COVID-19. Google cytokine storm and you'll find vast amounts of information. Now, look at hydroxychloroquine and why it is used to treat lupus and malaria... surprise, surprise, both of those diseases also cause cytokine storm. So this drug is not some antiviral, or lupus cure or malarial antiviral, but it helps control that overwhelming immune response which causes respiratory failure.

    So it is no small surprise that doctors, upon discovering a prominent mechanism of death from COVID-19, would immediately key on a drug like hydroxychloroquine.

    • by jimbo ( 1370 )

      Chloroquine exerts direct antiviral effects AND suppress the production/release of tumour necrosis factor alpha. So both.

      The cytokine storm is also why Adalimumab is being trialled. Adalimumab is a TNF Inhibitor specifically. Not that it'd help much even if it works, Humira is extremely expensive and in very short supply.

  • by magusxxx ( 751600 ) <magusxxx_2000 AT yahoo DOT com> on Saturday April 11, 2020 @01:17AM (#59931576)

    "In the United States the wholesale cost of a month of treatment is about US$25 as of 2020." - Source WIKI
    Wanna bet that won't be the price when all is said and done.

    Also, I have two nagging questions which may explain why Trump is pushing this drug...

    What side-effect conditions may result which can only be treated by high priced patent pending drugs? And which company owns them?

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