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Medicine United States

FDA Testing Coronavirus Treatments, Including Chloroquine, Plasma From Recovered COVID-19 Patients (techcrunch.com) 135

Posted by msmash from the where-we-are dept.
U.S. Food and Drug Administration Commissioner Stephen Hahn addressed the ongoing work of the agency in terms of its work on potential treatments and vaccines for the COVID-19 coronavirus currently spreading globally. From a report: Despite a claim early in Thursday's White House briefing on the pandemic by President Donald Trump that one proposed treatment, anti-malarial chloroquine, had already been approved by the FDA for COVID-19 treatment, Hahn said that in fact the agency is currently looking at widespread clinical trials of the drug, but it is not yet approved for that use. "In the short term, we're looking at drugs that are already approved for other indications," Dr. Hahn said.

"Many Americans have read studies and heard media reports about this drug chloroquine, which is an anti-malarial drug. It's already approved, as the president said, for the treatment of malaria [Trump had not said this, but had instead said it was now approved for COVID-19] as well as an arthritis condition. That's a drug that the president has directed us to take a closer look at, as to whether an expanded use approach to that could be done to actually see if that benefits patients. And again, we want to do that in the setting of a clinical trial, a large pragmatic clinical trial to actually gather that information and answer the question that needs to be answered." Another potential treatment which has shown signs of possible positive effect, remdesivir, was also cited by Trump as being very "near" approval for use by the FDA. Hahn clarified that in fact, while remdesivir is currently undergoing clinical trials, it's following the normal FDA process for approval for clinical medical therapeutic use in the U.S.
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FDA Testing Coronavirus Treatments, Including Chloroquine, Plasma From Recovered COVID-19 Patients More

FDA Testing Coronavirus Treatments, Including Chloroquine, Plasma From Recovered COVID-19 Patients

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  • Why not chloroquine? Maybe we can also stave off Malaria while we are at it.

    --
    A Scout is never taken by surprise; he knows exactly what to do when anything unexpected happens. - Robert Baden-Powell

    • Re: (Score:3, Funny)

      by olsmeister ( 1488789 )
      I'm going to go ahead and jump to the conclusion that gin and tonics are effective against COVID-19, and start my preventative regimen tonight.

      • Tonic has quinine so you might be right. Off to the liquor store I go!

        • "Tonic has quinine so you might be right. Off to the liquor store I go!"

          Indeed. I'm also on my way, albeit I have 4 six-packs of tonic at home but don't have any Gin.

    • Re: (Score:2)

      by ceoyoyo ( 59147 )

      I was joking, while drinking a gin and tonic, that I was fighting coronavirus. It turns out there's a grain of truth in that.

      Just a grain though.

    • Chloroquine is a treatment, not a vaccine. So staving off Malaria would not work ...

      • You're only kind of right, if we're talking malaria (vs. COVID-19) treatment... chloroquine is both a prophylactic and a treatment, however most strains of malaria in the world are now chloroquine-resistant, which is why it's most commonly used to knock down symptoms in people who have been infected, vs. for prophylaxis. Also, all the quinine-related drugs are a bit harsh on the liver in the quantities needed to actually eradicate malaria, and so in countries where it's endemic, people don't actually take

    • Chloroquine does have applications beyond malaria. For example, it is used to treat people who have lupus, which is a medical condition that affects the immune system. I have a family member who has lupus and why it helps is not entirely clear--it just does. I'm not a biologist or a chemist, but it seems reasonable that chloroquine may affect the performance of the immune system.

      I know snark is popular on slashdot, but it does get real old.

  • I think the sheer magnitude of this pandemic is going to force health and regulatory authorities to really fast track the testing and approval of new (or existing non-label use) therapies. Years is just no longer an appropriate time frame in this circumstance. Given the choice between certain death or being human guinea pigs I think a large number of people will willingly choose the latter. The legal system needs to be modified as necessary to allow that.

    • Fast track has some serious risks though. You don't want the cure to be worse than the illness. The sole reason we have the FDA is because we had a long period in the US with dangerous quack medicine, dangerous health products, and even dangerous beauty and hair products. Also remember the problem with Thalidomide in the late 1950s, which led to a tightening of regulations.

      Covid-19 is not certain-death. I can understand patients with late stage cancer wanting to try out goofy treatments overseas, but th

      • Re:As with Ebola (Score:4, Insightful)

        by jythie ( 914043 ) on Thursday March 19, 2020 @01:39PM (#59849922)
        People tend to love the idea of fast tracking things, till the question of liability and who ends up shouldering the cost of things going wrong comes up. For something like covid-19, people are really hoping for some kind of preventative treatment, which means large scale application to people who may or may not be infected... which means lots of opportunity for non-fatal but potentially life altering side effects.

        • Re: (Score:2)

          by MrL0G1C ( 867445 )

          Well it shouldn't be hard to fast track for COVID-19 when it typically either kills people or they recover in about 18-20 days.

          And we should already know if the anti-malaria drug has side-effects since of course it is already available for malaria and very cheap too judging by the price I just saw on Lloyds pharmacy (prescription only 0.13GBP)

      • Re: (Score:2)

        by hey! ( 33014 )

        Every medicine is like a deal -- you get therapeutic effects at the cost of unwanted side effects. The time it takes to approve a medicine is largely taken up with understanding the nature of the proposition.

        Shortening the approval time means risking paying a price that hasn't been named yet.

        If we succeed in flattening the curve so peak cases are within the system's capability, we're looking at a significantly less than 1% fatality rate. So if that's what's going to happen, we don't want to rush too much.

      • Re: (Score:2)

        by sjames ( 1099 )

        OTOH, chloroquine is not thalidomide. It is already approved for other indications by the FDA and it has a decades long track record. The only open question is efficacy for COVID-19.

      • Covid-19 is not certain-death

        If you need a respirator and there are none it is pretty close.

        Biggest problem I can see is asking such ill people for consent.

      • Fast track has some serious risks though. You don't want the cure to be worse than the illness.

        Indeed you don't. Fortunately this is already a tested regulated drug produced and consumed all over the world for another illness.

        • Which was why I mentioned the Thalidomide case; it had been used for some purposes, then along the way it started being prescribed for morning sickness. True, it's an odd case since regulations were so very loose back then and the drug was still relatively new.

    • Given the choice between certain death or being human guinea pigs I think a large number of people will willingly choose the latter.

      And as soon as the immediate problem is over, the human guinea pigs will start suing the socks off the people that allowed them to be so treated....

      • And as soon as the immediate problem is over, the human guinea pigs will start suing the socks off the people that allowed them to be so treated....

        That is why the legal system needs to be modified allow for releases from indemnity in these cases.

        Hell, we do it for zip lining, bungee jumping, and many purely recreational things.

    • Re: (Score:2)

      by sjames ( 1099 )

      Since chloroquine is already approved for some conditions, doctors are free to prescribe it off-label for COVID-19. Given that it's approved for human use, well understood and generic, I don't see why it isn't being tried informally in patients now.

  • That would be incredible. Chloroquine is cheap and produced all over the world; in Papua New Guinea, I saw it in quart-sized paint cans. Literally, just a white-painted can with "CHLOROQUINE" in black lettering, as generic as you could possibly get, filled with Chloroquine tablets.

    Since most of the tropical world uses it to knock down bouts of Malaria when they occur, it's an odd twist of fate that many poor countries could be better protected against COVID-19 than the more northern industrialized countri

  • And to think we sent all the telephone handset sanitizers ahead to the new planet.

    There is rich irony in all of this. Douglas Adams was way ahead on this.

    But seriously, Don't Panic

  • There are tons of smart people working hard and long hours in this problem. So stop sniveling and complaining from your Moms basement. YOU WILL SURVIVE and will be back to your life programming websites or fixing computers or whatever the fuck you guys do.

  • The use of this malaria medicine for treating COVID-19 was discovered way back in Feb. / Jan [bjnews.com.cn] by China [huanqiu.com] [links in Chinese], not a recent discovery by French scientists. Don't plagiarize. Respect the invention!

    • Re: (Score:2)

      by djinn6 ( 1868030 )

      The Chinese are trying everything, even folk medicine. And some of those seem to have an effect.

      Apparently when you have a complete disregard for individual rights, you can just give people random drugs to see if they work, damn the consequences. It's nice to be able to learn from that, even if we can't (and shouldn't) do it here.

      • Re: (Score:2)

        by ceoyoyo ( 59147 )

        Chloroquine has been known to have antiviral effects, including against coronaviruses, for decades. It's not a random shot in the dark.

        • Re: (Score:2)

          by djinn6 ( 1868030 )

          I didn't say it was. But a lot of the other stuff they're trying might be. See paper [ijbs.com].

          • Re: (Score:2)

            by ceoyoyo ( 59147 )

            Sure. People eat up that stuff. I know a reiki practitioner who's doing a booming video consultation business. If you go down to your local drugstore you'll probably find a homeopathy section that the pharmacist tries hard to pretend isn't there.

  • "Despite a claim early in Thursday's White House briefing [that Chloroquine is approved] it is not yet approved for that use"

    Why the fuck is it not approved if it was already successfully used in China, France, and Italy? Someone needs to get their ass fired. This is sabotage.

    • Because...it isn't confirmed effective yet?

      • Also, remember, you now have "the right to try" experimental treatments outside the FDA's approvals. Given the drugs being discussed are decades old and generic, already have a long history of safe use so all that remains is to establish the effectiveness, therapeutic dose and parameters under which it should be used. I suspect that if this is shown even marginally effective in a small number of cases, then the FDA will easily agree to this and the only thing that may slow it down is if we have to manufact

    • "Despite a claim early in Thursday's White House briefing [that Chloroquine is approved] it is not yet approved for that use"

      Why the fuck is it not approved if it was already successfully used in China, France, and Italy? Someone needs to get their ass fired. This is sabotage.

      Have you heard of "right to try?" Yea, you have? Trump championed that...

      So, off label use of a drug is open to those who are critically ill, and you can bet folks will be clamoring for using a drug which is generic, has been used for decades and is widely stocked for various purposes. Until the FDA approves this use, the "right to try" will be effective, so don't worry.

  • Before you write this off as snake oil (Score:5, Interesting)

    by Solandri ( 704621 ) on Thursday March 19, 2020 @02:14PM (#59850078)
    Chloroquine is an immunosuppressive [nih.gov]. It works by suppressing the body's immune response, and thus has also been researched as a treatment for autoimune disorders. I suspect that the operating theory here is that, like the 1918 flu [wikipedia.org], in the most serious cases COVID-19 may be triggering a cytokine storm [wikipedia.org]. The body's immune system overreacts to the virus, and it's actually this immune response which kills the person. An immunosuppressive drug like chloroquine would seem to be a rather obvious way to help counter that.

    The one piece of data which doesn't fit is that the 1918 flu hit young adults the hardest because they had the strongest immune system (and thus the strongest immune response). COVID-19 is killing mostly the elderly - people normally associated with weakened immune systems. But it's possible that there are other factors at play here. e.g. Maybe the deaths are concentrated among elderly who still have strong immune systems, but whose bodies are physically too frail to survive a less-severe cytokine storm. Or maybe the 1918 flu wiped out the genes for an overly strong immune response in young adults from our gene pool, and a similar response now only occurs when we're elderly and our genes are starting to malfunction.

    • Italy says 99% of people dying from this also have some other disease or illness, so that's probably the sum total of why it's hitting old people hardest. The Diamond Princess data showed that even in the 80+ age bracket only half of those infected showed symptoms.

    • Re: (Score:2)

      by hey! ( 33014 )

      It's also possible that older people may have had partial immunity from a related flu strain.

    • Re:Before you write this off as snake oil (Score:5, Informative)

      by twocows ( 1216842 ) on Thursday March 19, 2020 @03:28PM (#59850402)
      https://en.wikipedia.org/wiki/... [wikipedia.org]

      For coronaviruses, chloroquine works by increasing endosomal pH and interfering with terminal glycosylation of the cellular receptor.[42][43]

      42: pubmeddev; MJ, Vincent; Al., Et (18 March 2020). "Chloroquine is a potent inhibitor of SARS coronavirus infection and spread. - PubMed" [nih.gov]. NCBI. Retrieved 18 March 2020.
      43: "Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro - Cell Research". Nature. Retrieved 18 March 2020. [nature.com]

    • Re:Before you write this off as snake oil (Score:4, Interesting)

      by hackingbear ( 988354 ) on Thursday March 19, 2020 @03:37PM (#59850438)

      It works by suppressing the body's immune response

      Your hypothesis is probably not true or at best partial (*).

      Researchers in Wuhan already discovered the coronavirus inhibitive effects of chloroquine in vitro [nature.com], i.e. not inside an animal body.

      * Doctors in China do use other immunosuppression to manage the cytokine storm. As they learned from the SARS treatment, while excessive application of immunosuppression would save the patient, it caused life-long severe side effects; so this time they try to minimize it usages.

    • There is also some speculation that older people may have had some residual immunity from a strain that was endemic in the mid to late 1800s and which younger people would not have been exposed to.

    • Re:Before you write this off as snake oil (Score:5, Informative)

      by slack_justyb ( 862874 ) on Thursday March 19, 2020 @06:41PM (#59851148)

      Chloroquine is an immunosuppressive. It works by suppressing the body's immune response

      No. At least not in the traditional sense of that word. In the antiviral, the pH of the endosome becomes too acidic for a virus to effectively bind to receptors. COVID-19 acts by inhibiting dendritic regulation of macrophages expression and binds to T cell activation continually causing it to send kill messages to cells that don't need it. In this case, the pH levels of the blood would deteriorate that mechanism and, yeah, in a round about way prevent over expression of the immune system, but via cytokine isn't even the pathway of action for COVID-19 nor what this medication is looking to suppress. That's like saying the thing that makes it hard to navigate a trashed piece of land is all the people there to clean it up, no it's the trash first and foremost, but yeah if a fire breaks out, you'd ideally want the people to GTFO of your way.

      and thus has also been researched as a treatment for autoimune disorders

      No that's via an entirely different set of pathways and in those cases it's not suppressing it's just blocking the pathway for damage. The immune system is still haywire just it can't find a good place to take it's rage out on.

      I suspect that the operating theory here is that, like the 1918 flu, in the most serious cases COVID-19 may be triggering a cytokine storm.

      No. The problem is dendritic regulation and T cell activation. I mean that with the assumption we're also ignoring the potential for secondary infection completely here. Add that into the mix and yeah, now, you're on to something. But the body reacts pretty standard protocol on initial infection, no storm needed. Just that killer T cells and macrophages just start eating your lining. So if we're going to get specific on culprits, those are the big ones, not cytokine.

      The body's immune system overreacts to the virus, and it's actually this immune response which kills the person

      No, it's the eating away your lining that eventually causes you to stop breathing that kills you.

      An immunosuppressive drug like chloroquine would seem to be a rather obvious way to help counter that.

      It's not an immunosuprressive drug. But ignoring that, there's some problems with it's use that I'll outline.

      COVID-19 is killing mostly the elderly - people normally associated with weakened immune systems

      It's not the immune system that's killing them. It's literally the inability to breathe. Lack of oxygen.

      So here's the deal about Chloroquine. Put it in a 70+ year old and you'll kill them. Either COVID-19 will finish it's job or their liver, kidneys, or spleen burn in a bath of acid. The metabolism of a 70+ can't regulate the ionic concentration like younger people can. You might be able to follow up on zinc ions to mitigate that, but you have to test for that. Which is why when you do give this stuff to an older person it's usually in a hospital setting. There's not a machine that monitors that, so it's blood draws and lab tests that have to happen to regulate properly. Which means that's a lot of staff resources to toss at a treatment. The 60+ group can take it but they'll need faster acting dosing rather than you're run of the mill tablet form. So they need to be monitored too. Problems from this group are mostly along the lines of small blood vessel ruptures. So blindness, hearing loss, seizures, renal failure, and that family of fun things are in there for poorly monitored patients. But that's the key here, "poorly monitored". Regular labs should keep a patient fairly in good shape with a few decreased functions, maybe you get just a wee bit blurry vision but with time will get somewhat better. Again, that's ignoring tab forms of the medication, but those are long term slower acting formulations which that kind of defeats t

      • Thank you so much info! But no sourcing. Could you give some source?

      • Repeating leehwtsohg's request for sourcing. As a nearly 70-year old (but in good health), and one who took prophylactic Aralen (= chloroquine phosphate) back in the 70s and 80s (when I was living in a malaria region), I'm interested. So I checked this:
        http://www.accessdata.fda.gov/... [fda.gov]
        (dated 2015). It does not have anything like your dire warnings that "put it in a 70+ year old and you'll kill them"; here is the most relevant part of what it says:
        -----------
        Clinical studies of ARALE

  • The drug doesn't work by itself, its not going to cure Covid-19. What it does is open certain parts of the cell to let in another drug (Zinc) that has been shown to break down the RNA virus strand from replicating.
    It wont prevent you from getting it, only if you have it, then it might help. There needs to be larger scale clinical trials still.
    You can also get this drug in Apples. So eat apples and Zinc.

  • See here, discussion on Chloroquine starts about 1:20 in: https://www.youtube.com/watch?... [youtube.com]

    Possibly works as Zinc ionophore.

    Updated here: https://www.youtube.com/watch?... [youtube.com]

    And more recently (yesterday) here: https://www.youtube.com/watch?... [youtube.com]

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