Trial for potential coronavirus treatment is underway at Montefiore and Einstein

Experimental therapy might help people with serious COVID-19 complications

Albert Einstein College of Medicine

Barry Zingman, M.D., of Montefiore Health System and Albert Einstein College of Medicine, is leading a clinical trial at the institution to evaluate the experimental drug remdesivir to treat people who are hospitalized with severe COVID-19 infection. Credit Albert Einstein College of Medicine

Barry Zingman, M.D., of Montefiore Health System and Albert Einstein College of Medicine, is leading a clinical trial at the institution to evaluate the experimental drug remdesivir to treat people who are hospitalized with severe COVID-19 infection. Credit Albert Einstein College of Medicine

April 3, 2020–(BRONX, NY)– Montefiore Health System and Albert Einstein College of Medicine has joined a clinical trial to evaluate the experimental drug remdesivir to treat people who are hospitalized with severe COVID-19 infection. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring the trial. This treatment has the potential to help people who have serious lung complications as a result of COVID-19. Recruitment for the trial began in March and is still underway.

Montefiore-Einstein is one of 46 testing sites nationwide and is the first site in New York State to open. NIAID launched the multi-center international effort to determine if remdesivir, a broad-spectrum antiviral drug, acts against COVID-19 viral infection. Remdesivir has shown promise in animal models of severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), both caused by human coronaviruses.

The randomized, double-blind, placebo-controlled trial is being led by principal investigator Barry Zingman, M.D., professor of medicine at Einstein and clinical director, infectious diseases, in the Moses division of Montefiore Health System. The trial is “adaptive,” meaning it can be modified to include other investigational treatments. “This flexibility allows us to add additional therapies to the trial step-by-step to improve treatment as the pandemic continues,” said Dr. Zingman.

Trial participants are hospitalized patients with a laboratory-confirmed coronavirus infection and lung complications, including rattling sounds when breathing, a need for supplemental oxygen, abnormal chest X-rays showing pneumonia, or the need for a mechanical ventilator.

People in the treatment group will receive 200 mg of remdesivir intravenously on the first day of their enrollment in the study and will receive another 100 mg each day for the duration of hospitalization, for up to 10 days total. The placebo group will receive an equal volume of a solution that resembles remdesivir but contains inactive ingredients.

Montefiore and Einstein’s robust clinical trial infrastructure contributed to its selection and rapid approval for participation. No therapies have yet been approved by the U.S. Food and Drug Administration for treating COVID-19.

Remdesivir, an investigational antiviral therapy, was developed by Gilead Sciences, Inc.

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About Montefiore Health System

Montefiore Health System is one of New York’s premier academic health systems and is a recognized leader in providing exceptional quality and personalized, accountable care to approximately three million people in communities across the Bronx, Westchester and the Hudson Valley. It is comprised of 11 hospitals, including the Children’s Hospital at Montefiore, Burke Rehabilitation Hospital and more than 200 outpatient ambulatory care sites. The advanced clinical and translational research at its medical school, Albert Einstein College of Medicine, directly informs patient care and improves outcomes. From the Montefiore-Einstein Centers of Excellence in cancer, cardiology and vascular care, pediatrics, and transplantation, to its preeminent school-based health program, Montefiore is a fully integrated healthcare delivery system providing coordinated, comprehensive care to patients and their families. For more information please visit http://www.montefiore.org. Follow us on Twitter and view us on Facebook and YouTube.

About Albert Einstein College of Medicine

Albert Einstein College of Medicine is one of the nation’s premier centers for research, medical education and clinical investigation. During the 2019-20 academic year, Einstein is home to 724 M.D. students, 158 Ph.D. students, 106 students in the combined M.D./Ph.D. program, and 265 postdoctoral research fellows. The College of Medicine has more than 1,800 full-time faculty members located on the main campus and at its clinical affiliates. In 2019, Einstein received more than $178 million in awards from the National Institutes of Health (NIH). This includes the funding of major research centers at Einstein in aging, intellectual development disorders, diabetes, cancer, clinical and translational research, liver disease, and AIDS. Other areas where the College of Medicine is concentrating its efforts include developmental brain research, neuroscience, cardiac disease, and initiatives to reduce and eliminate ethnic and racial health disparities. Its partnership with Montefiore, the University Hospital and academic medical center for Einstein, advances clinical and translational research to accelerate the pace at which new discoveries become the treatments and therapies that benefit patients. Einstein runs one of the largest residency and fellowship training programs in the medical and dental professions in the United States through Montefiore and an affiliation network involving hospitals and medical centers in the Bronx, Brooklyn and on Long Island. For more information, please visit http://www.einstein.yu.edu, read our blog, follow us on Twitter, like us on Facebook, and view us on YouTube.

From EurekAlert!

142 thoughts on “Trial for potential coronavirus treatment is underway at Montefiore and Einstein

  1. Tocilizumab is working in italy.. Also Ivermectin has shown to kill the virus in 24/48 hours, https://www.dailymail.co.uk/news/article-8184023/amp/Medicine-prescribed-SCABIES-stops-coronavirus-replicating-cells-48-hours.html?__twitter_impression=true

    Add Hydroxy-chloroquine and Z pac and we have a good cheap treatment plan… That’s if bill gates and fauci don’t vaccinate all of us first, Fauci has dismissed all treatments and just sticks to “the usa must be totally locked down until the last person with the virus is cured” 😐

    The 2.5 million deaths, then 200,000 then 100,000 is all based on a computer model written by a bill gates company..

    • Ivermectin results are from in vivo tests only.

      Surely, there are models from other companies and organizations.

      • OK, vitro is Latin for glass, gives us words like vitreous , shiny glasslike rocks in geology.

        Test tubes are made of glass.

        • And vitrification in which radioactive waste is mixed with sand and melted together into glass waste to contain it within steel canisters.

    • Ivermectin is my go-to wormer in the barnyard. As a drench for the horses and
      as a pour-on to get the creepy crawlers on the other critters. I remember when it
      first came out…it’s the fist of god on parasites.

      From this WSJ Op-Ed —>https://twitter.com/DrJeffColyer/status/1244669297005223936
      The part about the 80 lupus patients on hydroxychloroquine that did not get infected
      while the other 178 patients did get infected tells us where we need to look at this time IMO.
      I’ve been told that there are no infections of lupus or rheumatism patients using it.
      But the media has not put that our for some reason. HCQ is cheap and effective.

      • It’s been pointed out that people with lupus and rheumatism has hyperactive immune systems. Therefore, it might not have anything to do with HCQ in those cases.

        • Scissor, it is exactly the overreacting immune system that is the main problem after the first infection with corona. If that overreaction can be suppressed with HCQ, it may prevent the worst reactions…

          • Perhaps so.

            In any case, the answer is there, it just needs to be found out and it’s good news overall.

          • Is the hyperactive the cytokine storm? Quercetin and ECGC do the same thing don’t they? With no side effects and other benefits.

          • There are separate stages of infection.
            Having a highly reactive and vigilant immune system might prevent people from ever getting pneumonia, by allowing the patient to fight the infection in the initial stages of exposure.
            The end stage when viral pneumonia sets in is after a period in which the virus multiplies rapidly and overwhelms the patients immune system.
            This is the stage that immunomodulation can help.
            And it is only a specific part of the overall immune reaction that causes cytokine release syndrome-like damage…in particular an overproduction of a cytokine called interleukin 6.
            This is how and when the IL-6 blockers are life saving.
            Giving someone an IL-6 blocker before they get sick or in the initial stages of illness may not be equivalent.
            The idea with supportive care is to treat symptoms as they arise.
            Giving oxygen and mechanical ventilation can save people…once they need it…but will not help them avoid getting to the point they need these interventions.
            If the malaria drugs work in pneumonia stage patients via the mechanism of immune modulation, this is not a reason to expect they will block infection if used before a person gets sick.
            This is why clinical trials that gives complete and specific info on each patient is critical: To identify who is helped, and how often, and at what stage of illness.
            Similar logic applies to adding antibiotic to the treatment. If they help by fighting secondary infections in people with lower respiratory infection, which patients become susceptible to because the immune system is overtaxed, and bacterial overgrowth occurs from bacteria which normally cause no problem for a healthy person…if these antibiotics are helpful for that…there is no reason to suppose giving them to asymptomatic patients, or those with mild symptoms, will block the virus from replicating.

          • Hi Nicholas: What I find frustrating is that people know the cytokine storm is really what kills people.

            Quercetin and so many other anti-inflammatory natural substances help mitigate this so it does not happen. As well, it’s a significant ionophore that lets Zn into the cells interfere with RNA replication of the viruses.

            You’d think health authorities would tell people AT A MINIMUM, Take x amount of quercetin, y amount of Zn, and green tea extract. This regimen will make a big difference.

            At a close secondary minimum, hydroxychloroquine should be widely used with Zn and the antibiotic for secondary infection in weaker people. Funny this is cheaper than the natural nutrients I take!

            Meanwhile we can let scientists play around with stuff that works to get double blind tests out while drug companies sway them to use their new improved drugs.

          • Nicholas: Thank you for confirming what seems to be evident that these nutrients work in early preventative stages. When I responded previously, I meant to start out by suggesting the regimen be taken BEFORE as a preventative to get ahead of the virus attack.

        • Those patients use other drugs besides HCQ, it’s those who
          use that specific one that are immune as I understand.

          • IN the age of Covid-19, all it takes to “understand” something, is for an assertion to be made and a rumor passed around.

      • Dan-O
        You said, “I’ve been told …” Can you be more specific? Can you provide even a newspaper citation let alone a peer-reviewed study?

        • I’ve looked high and low online for a citation to no avail.
          It was on Fox News, and one of the docs that were
          being interviewed on either Ingraham or Hannity
          last week. I also heard it from a NYC resident
          on a phone conversation. I believe it to be true
          and that there is a reason this is not being made
          more public.

          • At least one of the people that appeared on Fox and other media outlets was introduced as a doctor, but is in fact no doctor.
            Be skeptical.

    • When 90+ percent of those infected recover all on their own, it is very difficult for a drug trial study to show that the drug actually worked, plus its corollary that it is easy to shoe that it worked if that was your intention. you need large samples, double blinds, and likely more than one corroborative study.

      • The description of the trial states that the treatment is being tested on patients who are hospitalized with severe infections. A significant portion of those patients will require mechanical ventilation and many will die with current treatments. If remdesivir is effective there should be a measurable decrease in adverse outcomes. If there is not, the remdesivir probably is not effective – at least if treatment is deferred until the infection is severe.

        • To date, no antiviral drug or combination has been proven to be effective in everyone who takes it.
          Zero.

          • I do not believe that any drug has proven to be effective in everyone who takes it or will take it.

      • That’s why they are testing it on severe cases, I believe. Ones in which the progression is bad and leads to high mortality. So you raise an important issue.

    • Be careful of ivermectin. The in vitro test levels would require 20 to 30 times the toxic does for humans. So don,t rush out to your barn or farm supply store.
      Don’t do it,

      • why would in vitro need far more?
        truth is prob far less as its not being processed by liver etc before working on cells
        and it IS already used in pill form at a ripoff 70 or so to usa for scabies and a shampoo even more outrageously 300 or so for two treatments for kids etc.
        and in Aus its a stock drench or backliner dermal
        or a chemist available wormer at around 18 for 2 pills giving at least 6mths protection
        I;ll be taking 1.5ml anyway it might work and if ot at least i will be worm free
        lab work showed its good agaist HIV and flu viruses too
        but its NOT a highend moneyspinner so lets puch risky monoclonals huh?
        and im pretty sure they ust pulled the “orphan drug” they were going to push this to as its basially not had a use
        and animal trials of SARS vax worked in mice..until it didnt and they found lung and other damage, I supect this IS that drug

        • Which part of “concentration” did you not understand?
          The level of chloroquine that kills virus in vitro is impossible to achieve in blood plasma in a human being.
          What Ed is saying is that the amount of ivermectin that kills the virus in cells in a glass dish is far higher then what can be given to a person without killing them.

          If you give an antibiotic that only kills the weak bacteria, the result is you are selectively breeding stranger bacteria.
          If you give an amount of something that only kills weak virus, what will be the result?
          Of course, it may be an amount to weak to kill virus will have simply no effect.
          The dose makes the poison.

    • They are not looking for cheap…..

      Remdesivir, an investigational antiviral therapy, was developed by Gilead Sciences, Inc.

      • I note that among the three French MD/prof who are most anti-HCQ, anti-Didier Raoult, media addicted talking heads, exactly three have links with Gilead.

    • What I like about all these complicated models is that they can be replaced with a spreadsheet that comes up with the same answers in 0.1% of the time.

      How many caught the flu in the U.S.? 50 million?
      How much more contagious is COVID19? 2X? So 100 million actual infections?
      What’s the mortality rate range of all cases? 1.5~3% when accounting for the uncounted infections?

      So, what, 1.5~3 million dead without intervention? What’s the middle value? 2.25 million?

      Yeah, that looks like a good upper bound value… and is also what the models say :p

    • You missed the zinc connection. The hydo… is a portal for zinc entering the cell which then inhibits virus replication. It is already being used along with a preventive version(no anti bacterial)

      Stared in S Korea, french added antibacterial drug. Used by Jewish dr. In new York.

      https://techstartups.com/2020/04/05/new-updates-dr-vladimir-zelenko-cocktail-hydroxychloroquine-zinc-sulfate-azithromycin-showing-phenomenon-results-
      900-coronavirus-patients-treated-must-watch-video

      Need to understand

      • One of the now recognised symptoms of Covid-19 infection is a loss of sense of taste and smell.
        This is curious because from the online website What is Zinc? We find that :

        Zinc is also needed for your senses of taste and smell. Because one of the enzymes crucial for proper taste and smell is dependent on this nutrient, a zinc deficiency can reduce your ability to taste or smell.

        It may be that the symptom of loss of smell and taste with Covid-19 infection arises because all of the Zinc inside the infected cells in the nostrils and taste buds has been used up by these cells in fighting the viral infection.

    • Once again I am compelled to point out that it has long been the case that all manner of effects seen in vitro are not replicated in animals with a disease.
      In particular, a large number of substances are found to kill one organism or another in cell culture studies that then fail to have the same effect when given to animals or people.
      At present, this is another drug which is promising and now must be tested in people with the disease.

  2. Today’s (Sunday) UK Covid-10 update is here
    http://www.vukcevic.co.uk/UK-COVID-19.htm
    Yesterday’s count was 4.6% (197 cases) below the trend line, while today’s count is again well below the trend line by 14% (690), but take it with caution since on Sunday part of the administrative personnel may have day off.

    • At some point in the decline phase, it’s likely that the number of deaths will exceed the number of new cases. Like Greg, I have to question the validity of that ratio, particularly at that point.

      It’s possible that cases in the U.K. have peaked (they’re peaking in any case). Hopefully, this is not just from an administrative accounting situation.

      • “At some point in the decline phase, it’s likely that the number of deaths will exceed the number of new cases”
        Scissor, thanks for your observation. Perhaps you misunderstood % numbers. It is ratio of cumulative deaths and cumulative infections to date (and not for any individual day), both are only referring to people hospitalised at some point, either cured, released for home treatment or died, hence there is no likelihood that the total number of dead will exceed total number of infected.

          • No problem, you are welcome.
            According to the WHO official data there are 1,136,851 confirmed cases of infection of which 62,955 have died, which is 5.5%, obviously smaller than the UK’s current 10%, but there is huge deal of uncertainty in both WHO’s and the UK’s data.

        • If the number of infected only includes people who have been hospitalized, that means it specifically does not include people who are infected but not hospitalized…no?
          So there is likely a pool of unknown size of people who have not become ill and gone to a hospital…YET.
          Lets hope that number is small.

          Let’s also keep in mind whatever the numbers are during a phase of extreme self imposed isolation, quarantine, social distancing, and lock down orders, they will increase once these restrictions are relaxed.
          The number of infected will never get down to zero, and large pools of fresh people exist.
          Considering how short a time it took for this virus to spread from wherever it started to worldwide presence, relaxing restrictions will lead to rapid spread once again, or so it seems to me.
          At this point in time, a tiny minority have been tested even once, and few of them have been tested for antibodies.
          I am sure most of us have by now seen the reports that as many as one in three tests give false results.
          If true, that is awfully bad reliability.
          When antibody tests are released, there will remain the question of what level of immunoglobulin G and antibodies is enough to confer resistance or immunity to infection.
          That sort of determination takes a lot of time at careful study…at least it always has before now.

      • Why is New Zealand an outlier in this epidemic? We have about 1000 known cases, less than 20 hospitalised and but 1 death. This is way out of kilter with the rest of the world.

        • NZ has a government that has been decisive? Ardern seems to revel in emergencies. Calm but firm. No name calling or BS. Sticks to the facts and listens to the experts. What you want in a leader at a time like this and is seems the people are trusting and following her.

        • Being an island no doubt helps.
          If everyone coming from some place else is quarantined, that sounds like far more than anyplace else has been able to do.
          But it seems if that is what is going on, it will only last as long as this is kept up.

          And this is the big question everywhere: What is the endgame for these restrictions?
          How is it going to be called off, especially when most people have not been exposed and the number of infections is small relative to total population size?

  3. I love the mug shot of a clinical researcher who has just found a massive multi-billion dollar market for his patented antiviral.

    That photo was taken just after the EU clinical tests protocol was announced including testing hydrocholorquine WITHOUT the associated antibiotic and ONLY under conditions where it has already been shown to be too late for it to be effective.

    In his college days he played mid field and learnt all there is to know about kick-backs.

    • That grin sends the wrong image for sure. But profit is a great motivator to cure people of some illnesses.

      Anyway, GILD looks more like a short candidate to me, though I wouldn’t speculate either way at this point.

    • That was a very sarcastic reply Greg and I would hope you are as wrong as most hardened cynics usually are. How is this his ‘patented antiviral’?

    • The article says he is the “principal investigator Barry Zingman, M.D., professor of medicine at Einstein and clinical director, infectious diseases, in the Moses division of Montefiore Health System. Not an employee of Gilead as that would be a conflict of interest.

      I bought Gilead stock about 5 years ago just before remdesivir, their flagship drug, failed trials as an ebola virus treatment. The price has been depressed since but I decided to let my investment ride on the chance that they find other uses. Given, investing in horse races is less risky than development drug companies. So I hope that smile will eventually be extended to those holding shares in the $98 billion bet and by the corona victims, their medical team and families. Wouldn’t it be great if this drug worked?

      • You think remdesivir is Gilead’s flagship drug?
        They have never sold a single pill, and it is not approved for anything yet.
        They have a vast pipeline, and numerous billion dollar drugs for HIV, HVC, and other conditions.
        Five years ago the big drug was sofosbuvir.
        It is the backbone of several hepatitis C single pill combination therapy drugs.
        It never was anywhere close to as profitable as many thought it might be, mostly because several other companies were only a short time behind them in marketing their own hepatitis C cures.
        In 2019 they sold $4.6 billion in HIV drugs, and only $630 million in HVC drugs, over a hundred million less than in 2018.
        I do not see much reason to think remdesivir will be a huge money maker.
        They are giving away all existing inventory.
        And by year end, they will have at most enough for a million courses of treatment.
        They are under enormous pressure to more or less give it away.
        Still no results announced for any of the trials which began as long ago as February, IIRC, and the first of which ended last week.
        If the drug was a home run for patients getting it, the trials would have been halted and the placebo patients gotten the drug…that is how such trials protocols are written,

        “Benefit: The study hypothesis is unexpectedly proven early within predesignated criteria. Continuing to expose subjects in the inferior arm to additional potential risks or keeping them from benefitting from the therapies in the superior arm is hard to justify ethically. An example is the SPRINT study discussed above.”

        https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024796/

        So far, nothing like this has happened in trials for any of the drugs being tested for COVID 19.
        This means whatever benefit they may have, is less than dramatic and clear cut enough to halt the study.

        No news is bad news for clinical trials in a situation like this.

  4. At this point, with the high mortality rates of people getting this far into the disease to require hospitalization and no doubt some into ICU, why are they giving people a placebo? They can take any number of patients not formally enrolled in the “study” to get the baseline. In NYC there certainly isn’t a lack of subjects.

    Given the choice, if he contracted CV19 and ended up in the hospital, do you think Dr. Zingman would take Remdesivir or not? Sometimes common sense is just thrown out the window. Pity the poor people trusting in the system.

    • rb: +1M They’re treating this like they have a lack of patients. How would you like to find out one of your loved ones died because they were given a placebo?

      • The weird thing is, sometimes placebos work, and even when people know they are placebos. In this case, they wouldn’t know.

        • I don’t think placebos work necessarily in this case. There are going to be a number of patients make it through regardless of taking anything. The question is will Remdesivir reduce the number of deaths, the amount of time the patient remains at risk and reduce the severity of the disease?

          The group of people receiving nothing outside the study can be tapped as the “placebo” group. If the current standard now is giving HCQ and this study wants to exclude that, they can in fact create a placebo group of people not given HCQ. But this brings in a huge ethical question. If HCQ is saving lives and they don’t give a group of people HCQ and some die that would have lived otherwise, it just won’t fly.

          I haven’t seen the study protocol so just exactly what they are going to do I don’t know. But by the time these people reach the hospital they are in the 20% high risk group to start with and they have to be really careful about withholding treatment to anyone, in the study or not. In this case you go to war with the troops you have.

    • “Why are they giving people a placebo?” You mean, using the dying as guinea pigs? Because there’s something in the medical mind that is just f’ing EVIL. I always wondered about the rationalizations of the psychopaths who get up every morning and drive to some lab where they subject an endless stream of healthy puppies to heart attacks induced by silicone injections, then force them to run them on treadmills till they die to “prove” something we’ve known for 100 years; that death of cardiac muscle results in O2 insufficiency. (ref: recent discovery of waste in VA “research” labs).

      Why would doing the equivalent to people be a problem for them?

      These were the kids who used to get their jollies pulling the claws off crabs and the wings off flies.

      • Comments on this site are normally written by well informed, intelligent people that understand the processes and issues.

      • The problem is that we are designing drugs using trial and error.

        There is a new technology that uses a specialized ‘AI’ to ‘design’ the antiviral drug to attack a virus.

        This possible because viruses are discrete entities, predictable and computers using AI techniques can solve complex discrete problems.

        What the AI does is to all try all possible different variations to find the optimum solution and then the testing is on a computer simulation of the biochemistry of a human.

        There is a new antibody that has been produced for covid-19 using this technique. It is currently being tested by the Military and other commercial labs. If all goes well it will be tested on humans sick humans in August. Everyone will get the drug. No placebos.

        • Vaccines are given to people with no illness, so why would anyone give a placebo to such people?

    • The choice to continue a trial or terminate it early is governed by ethics.

      If, early in a trial, there is evidence of toxicity, the trial will be terminated.

      On the other hand, if there is early overwhelming evidence of efficacy, the trial will be terminated and all the subjects will receive treatment. example

  5. This is akin to putting out a forest fire after it is raging over a 100,000 acres instead of with a back pack sprayer when it first starts. At the first sign of elevated temperature perhaps give hydroxychloroquine and z-pak if it gets to the lungs. This procedure was mentioned here several weeks ago on WUWT. Patients from Rockland county N.Y.

  6. I used this z-pal twice myself for pneumonia in the last 5 years and was over it it less than a week.

  7. I certainly hope it works and there is enough supply if it does work.

    Another possible drug that being looked at now is Ivermectin, which works in vivo. This is very common drug, and I actually have some at home for my dog to protect against heart worm. A common product for dogs that contain this is Heartguard in the USA.

    After 48 hours the drug in vivo reduced covid-19 by 99.8 pct.

    Here is study, very interesting it works against other RNA viruses. The possible mechanism of how it might work against covid19 explained.

    https://www.sciencedirect.com/science/article/pii/S0166354220302011

      • I’m going to say “in a test tube” or “in an animal” from now on. I get those confused.

        Anyway, test tube results are very early in the development cycle of a drug candidate. The chance that this drug would work in an animal is not very high.

    • Viva la in vitro but maybe not in vivo.

      What’s the result doc? Absolutely amazing. My post mortem shows no sign whatsoever of Covid19 in the stomach so this here head lice stuff is a real Covid killer. And the lungs? Hmmm….perhaps you’d better speak to the vaping industry about that.

    • Stevek
      “The poison is in the dose” — Paracelsus

      I suspect that there are a lot of things that will kill pathogens in vitro, but could not be used at the same dosage in a living host. In the early years of syphilis, doctors tried to find a balance between the dosage of mercury compounds (and other known poisons) that would kill the spirochete and not the human.

      That is one of the potential problems with hydroxychloroquine. The typical daily dose is half of what the toxic dose is. It has been used in Africa for suicide and abortions.

  8. I see that a Paris trial has just reported negative findings for chloroquine.

    Small trial – around a dozen candidates – and most gravely ill with other major illnesses such as HIV, Cancer…

    These patients were in a severe condition, and chloroquine did not lower viral load. However, the action of chloroquine is to suppress cell infection, and hence viral reproduction. If a patient already has extensive cell infection, then it is likely that the medicine will have little effect, since most cells will already be producing virions.

    This should be well understood. I wonder if the clinical trial was intended to suppress interest in chloroquine?

      • Yes – that second is the one. Doesn’t seem to be a trial of the actual benefits claimed for chloroquine at all…

      • The protocol hydroxychloroquine and azithromycine was never supposed to be used in severe cases with respiratory distress when it is already too late and the virus yield is by that time non existent. The first study is simply garbage. The proof that it works is by lowering the death toll which has already been proven at the IHU at Marseilles.

        • Scientifically, studies like Raoult’s prove nothing.
          Which is the whole problem.
          It is not at all clear that he treated people who were among those who were not very sick.
          And his data collection and methodology is highly problematic for several other reasons.
          No one wants to be pessimistic.
          Some of us want to have quantifiable results that can be compared directly to other groups and other treatments.
          His method does not allow that.

    • The chloroquine question:
      If quinine worked on Coronavirus, why wouldn’t someone have noticed its effect on the common cold Coronavirus at some point in its last centuries of use. It was first used an anti-malarial in 1632. Probably it works just as well as “drink lots of water and rest for 7-10 days” for the common cold, which has proven to be very effective treatment.

  9. If you’re at risk at want to survive this sucker, FULL STOP eating ALL grain products, ALL sugars including fruit, and ALL industrial seed oils RIGHT NOW. Also, toss your BP drugs. BP drugs (a band-aid on symptoms at best) are causing the ACE receptors on your cell surfaces to proliferate, providing an unnatural number of attachment points for COVID-19 viruses. This is why so many people with metabolic syndrome are dying!

    Your hypertension is not bad luck, it’s caused by a diet high in starch and sugar, same as all the other metabolic cluster of diseases (diabetes, obesity, cancer, heart disease) and it will fall precipitately if you drop the carbs. You’ll pee like a demon the first week as you stop retaining water and your whole metabolism normalizes. EAT MEAT, EGGS, FISH, CHEESE, BUTTER, SALT, vegetables only if you want to. This is known as the ketogenic or carnivore diet. Its high satiety will also enable you to eat only twice or even once in 24 hours (intermittent fasting), effortless once the carbs are gone; useful in a crisis where food availability is in question. Do not let ANYONE (big food/pharma and NGO “experts”) tell you that “fat” causes ill health and “healthy grains fruits/vegetables” are necessary to health. That BS will kill you, especially now.

    When you need a ventilator, you’re already screwed. THIS you can do NOW. Yourself. DO IT!

    • WRONG.

      “Just facts states”
      ‘roughly 12,469 people in the U.S. died from the swine flu from April 12, 2009 to April 10, 2010. Unlike Covid-19, which mainly kills older people with preexisting health problems, 87% of people killed by the swine flu were under the age of 65.”

      They cite the following

      “To calculate the burden of 2009 pandemic influenza A (pH1N1) in the United States, we extrapolated from the Centers for Disease Control and Prevention’s Emerging Infections Program laboratory-confirmed hospitalizations across the entire United States, and then corrected for underreporting. From 12 April 2009 to 10 April 2010, we estimate that approximately 60.8 million cases (range: 43.3-89.3 million), 274,304 hospitalizations (195,086-402,719), and 12,469 deaths (8868-18,306) occurred in the United States due to pH1N1. Eighty-seven percent of deaths occurred in those under 65 years of age with children and working adults having risks of hospitalization and death 4 to 7 times and 8 to 12 times greater, respectively, than estimates of impact due to seasonal influenza covering the years 1976-2001. In our study, adults 65 years of age or older were found to have rates of hospitalization and death that were up to 75% and 81%, respectively, lower than seasonal influenza. These results confirm the necessity of a concerted public health response to pH1N1.”

      swine flu ESTIMATES range from 8800 to 18000. for ONE YEAR
      Total 74 days into this scourge we have 8,484.

      from the paper

      “The 2009 pandemic influenza A (H1N1) virus (pH1N1)
      was first reported in the United States on 12 April 2009
      [1, 2]. By 23 July 2009, a total of 43,677 laboratoryconfirmed cases, 5009 hospitalizations, and 302 deaths
      had been reported to the Centers for Disease Control
      and Prevention (CDC),

      “We built a model that enabled us to produce interim
      estimates of cases, hospitalizations, and deaths that
      could be frequently updated as new information became available. Beginning 14 November 2009, the
      CDC published online monthly estimates of deaths,
      hospitalizations, and cases attributed to pH1N1 in the
      entire United States.”

      “To model the impact of pH1N1, we used weekly surveillance
      reports of laboratory-confirmed pH1N1-related hospitalizations
      to calculate a range of rates of hospitalizations per 100,000
      population. We then extrapolated those hospitalization rates to
      the 50 states. During extrapolation, we adjusted for different
      levels of influenza activity by dividing the United States into 3
      groups based on levels of physician visits for influenza-like illness (ILI). We then corrected for underreporting of hospitalizations using previously published multiplication factors [3]
      and then calculated numbers of cases using a previously estimated hospitalization-to-cases multiplier [3]. Finally, we calculated deaths as a percentage of hospitalizations using reports
      of laboratory-confirmed pH1N1-related hospitalizations and
      deaths collected by State Health Departments.”

      ‘we used the data from the week ending 7
      November 2009, when deaths as a percentage of hospitalizations
      in the ADHRA system were: 0–17 years of age, 1.48%; 18–64
      years of age, 5.79%; and 65 years of age and older, 5.76%. To
      simplify the process, we used the following percentages in our
      calculations: 0–17 years of age, 1.5%; adults (all ages), 6.0%. We
      then applied these percentages to all hospitalizations for all time
      periods covered in this paper.”

      “Adjustments for August 2009. For the month of August
      2009 (weeks 31–34), there was insufficient state-level differentiation of influenza activity to readily divide states into 3 categories (as defined by ILI-related visits; see http://www.cdc.gov/
      flu/weekly/weeklyarchives2008-2009/weekly34.htm). Also, for
      this period, many of the EIP sites reported fewer than 3 pH1N1-
      related hospitalizations per week, making it difficult to categorize the sites and calculate median, minimum, and maximum
      values. We therefore adjusted the estimation methodology for
      August by calculating the simple average, minimum, and maximum rates of hospitalizations across all 10 EIP sites, and then
      we extrapolated those to all the 50 states (without any categorization). We corrected for underreporting, proportioned into
      the 3 age groups, and calculated national cases and deaths using
      the methods described above”

    • I read through that “fact sheet” and it misrepresents a number of issues.

      Such as: “Under that worst-case scenario from Wuhan, if the number of people with contagious Covid-19 infections in the U.S. is actually six times the number of people who have been diagnosed with it, the average American would have to come in contact with 198 people to be exposed to one person who has it.”

      – That statement is highly misleading because it simply uses a statistical representation based on whole US population numbers. Certainly the average person in rural Iowa or Montana is going to have to come across a large number of local and traveling people before they are likely to be exposed to an infected-contagious person. But the virus explodes in hot-spots. When flare up when conditions come together to allow a localized outbreak, it does, and transmission rates jump and thus likelihood of exposure in those areas jumps dramatically. That quickly overwhelms the local and regional hospitals systems. Then the likelihood of encountering an infected, contagious person goes up dramatically.
      New York City, New Orleans just after Mardi Gras, Florida Spring-Breakers (gathering partying, kissing, sex and close contact), then dispersing, all are examples of places/events that serve to momentarily concentrate people together and greatly increase exposures and virus transmission and then the subsequent transmission to another area, where another localized hot-spot can occur.

      – Another likely wrong statement is the claim SARS-CoV-2 won’t mutate. The article simply compares this corona virus to Influenza-A seasonal strains which do mutate at at a high rate such that a new vaccine of new strains must be fielded every year to try to cover the expected dominate strains in the next flu season. However this does not imply SARS-CoV-2 will not mutate. In fact we know SARS-CoV-1 did mutate in 2002 between the Spring 2002 circulating strains, and the Fall 2002 resurgent strains. The S (spike) protein had evolved through the summer 2002 period of low prevalence-transmission rates to the Fall to a higher binding affinity for its ACE2 receptor which increased disease severity and lung pathology in that 2nd wave. So clearly, this SARS corona virus may likely evolve through the next few years until effective vaccines and create high enough herd immunity barriers to bring it under control to a sporadic seasonal nuisance for the medical/health care systems.

      • Your critique suffers from very poor comprehension and is already refuted by the article.

        With regard to the likelihood of exposure, the article sates at the outset of that section: “The disease is not equally dispersed throughout the nation, so this figure is much higher in some areas and much lower in others.” https://www.justfacts.com/news_covid-19_crucial_facts#exposure

        The article does not say that SARS-CoV-2 won’t mutate. To the contrary, it cites the Journal of Infectious Diseases stating that ‘All viruses mutate, but influenza remains highly unusual among infectious diseases’ because it mutates very rapidly, and thus, ‘new vaccines are needed almost every year’ to protect against it. While much remains to be seen about the mutations of the virus that causes Covid-19, the early indications are that it will not mutate rapidly and become an ongoing scourge.” https://www.justfacts.com/news_covid-19_crucial_facts#deaths

  10. The clinical history of using nucleotide analogs as mono-therapies against RNA viruses is quite clear what to expect. Resistance evolves in mutational background that is always on-going in RNA viruses where reproductive fitness costs and transmission likelihood are continually playing out against the other.
    The history of AZT, ddI, ddC during the 80’s and early 90’s against HIV are strong lessons to the practical effects of nucleotide analog selective pressure to a highly mutating RNA virus.

    An antiviral to DNA viruses, namely many of the Herpes virus family, is acyclovir. Acyclovir works because DNA viruses suffer much higher fitness costs under high mutational background rates needed to evolve resistance, thus DNA viruses evolve resistance much more slowly. This is seen in HIV/immuno-compromised patients where a herpes viral infection is trying to be controlled with long-term use of acyclovir in the patient. Resistance usually eventually evolves to in the patient to acyclovir.

    Resistant viral phenotypes to the monotherapy are strongly selected for transmission, usually mutations in the viral polymerase that decrease the likelihood of nucleotide analog incorporation, which may slow polymerase processivity (speed of polymerase chain forming reactions). Thus, apply a strongly selecting pressure for transmission and viral fitness may likely diminish, like the ability to replicate to high numbers quickly. In a setting like an acute easily transmitted RNA virus like SARS-Cov-2, you could push the asymptomatic phase even longer without realizing what is happening.

    So it quite predictable how a successful nucleotide analog against an easily transmitted RNA virus pathogen will play out in the wild.

    • It didn’t take very long to gather that that guy is just reading a script and doesn’t have very deep understanding of what he’s talking about. Is he selling something?

  11. This is a deadly virus. Ask doctors in Italy. They divide the lungs into sectors. Each sector is scored and then tries to heal.
    This allowed the researchers to draw two conclusions: “A high viral load in the throat at the very onset of symptoms suggests that individuals with COVID-19 are infectious very early on, potentially before they are even aware of being ill,” explains Colonel PD Dr. Roman Wölfel, Director of the Bundeswehr Institute of Microbiology and one of the study’s first authors. “At the same time, the infectiousness of COVID-19 patients appears to be linked to viral load in the throat and lungs. In hospitals with limited bed capacity and the resultant pressure to expedite patient discharge, this is an important factor when it comes to deciding the earliest point at which a patient can be safely discharged.” Based on these data, the study’s authors suggest that COVID-19 patients with less than 100,000 viral RNA copies in their sputum sample on day 10 of symptoms could be discharged into home-based isolation.

    The researchers’ work also suggests that SARS-CoV-2 replicates in the gastrointestinal tract. However, the researchers were unable to isolate any infectious virus from patients’ stool samples. None of the blood and urine samples tested positive for the virus. Serum samples were also tested for antibodies against SARS-CoV-2. Half of the patients tested had developed antibodies by day 7 following symptom onset; antibodies were detected in all patients after two weeks. The onset of antibody production coincided with a gradual decrease in viral load.
    https://www.eurekalert.org/pub_releases/2020-04/c-ub-cvf040320.php
    You have to take advantage of the fact that the virus is not detected in the patients’ blood and use the plasma of people who have no symptoms. You have to do mass tests.

    • We don’t have to ask the doctors in Italy because the data speak for themselves. It’s a deadly virus for some risk groups, but for the vast majority, meh.

      • A careful look at ALL of the data shows clearly that for many of the people that live, including a lot of young people, the disease is very far from “meh”.
        If you get viral pneumonia and live, please let us all know exactly how “meh” you think the condition is then.
        Is cancer “meh” for anyone who does not get cancer?

        One thing is for sure…the results of this virus are very far from meh for everybody that cares about our economy.

  12. In order to go back to work we need:

    Rapid, point-of-care testing and antibody testing.

    Medications and treatments that can prevent most people from dying who might get the Wuhan virus.

    It looks to me like we are close to attaining both of those things.

    There are probably a lot of people in the population that are already immune to the Wuhan virus. This can be checked with an antibody test. Those who have already had the Wuhan virus can go back to work. This may be a lot of people considering they claim that up to 50 percent of those infected are asymptomatic.

    Those who test negative for the Wuhan virus can go back to work and frequent testing can identify those newly acquired virus cases which can be treated quickly.

    Every person who visits with the president and vice president now takes the 15-minute Wuhan virus test before they meet with them. Something like this will be going on a lot in the future until we can get a vaccine or effective cure.

    If everything works out just right we could be back to work soon, before the economy takes a huge hit. The U.S. is good financially through the end of June because of the relief program signed into law last week.

    We need to get things going again before the money runs out. Right now, the money is holding the economy together, although a lot of it is on pause, but we have to get the economy going in weeks, not months, otherwise serious economic damage will occur and there won’t be a V-shaped recovery, at least not for a lot of people.

    We have about two months to get to the place we need to be (going back to work) to make this all work out financially.

    The good news is that noone wants to get the economy going more than President Trump. I think we can depend on him to push it to the max, within reason, based on what the experts are telling him.

    These drug and therapy trials will be giving us good data in the next few weeks, and the supply of necessary equipment is ramping up very fast. We are in a race with time and a virus.

    I think we are going to win the race. We are going to win the race one way or another, it’s just that one way might cost us a lot more lives, so we are trying the more conservative way first.

    We will have a lot better picture of everything in a couple of weeks.

    • Antibody administration does not guarantee a cure, but in severe cases it is the only chance to stop the virus. The body must make antibodies by itself. Young people may be killed by a cytokine storm. These people can be given antibodies at an early stage of the disease.

    • Good points all.

      My wife was in Singapore and left Jan 14th for the US via Seoul. Four days after she returned she had all the CV19 symptoms as did the person she was traveling with. She mentioned a flight attendant was coughing a lot on the flight from Seoul to Detroit and didn’t appear well. She took about a week to get to a point where she was ambulatory and around 10 days to feel better enough to come downstairs and get back to a more normal life. I spent the days totally avoiding her, wiping down the door handles/switches and feeding her on a tray.

      It will be very interesting to see if she (and I) test positive for the CV19 antibodies. The best thing would be we both had it although it could have just been the flu. If I got it, I really never felt bad. There is a local company in RTP that makes an CV19 home antibody kit and as soon as the tests become more available I’m certainly going to get two kits.

      • I haven’t had the flu or a cold virus in many years, so I’m not really familiar with how these diseases unfold over time. I think I might have had Hong Kong flu back in the day, and it was very serious, the sickest I’ve ever been, but it only lasted about a week, with about three days that were very bad giving me mainly a very high fever and sweating and shivering. My question is it seems that the Wuhan virus lasts a very long time in comparison to other virus infections. Am I correct in assuming this?

        There was a story on tv this morning about a couple who had been outside the U.S. and returned and the husband and wife both got ill, but when they were tested it was found that the husband was positive for the Wuhan virus, and his wife had the flu virus.

        Antibody tests are essential to our future.

  13. The Italians have already mastered the methods of treatment. Medicine in rich northern Italy stands at a high level. Steroids only inhibit inflammation, they cannot guarantee a cure.

      • If they’re fighting the inflammation they’re treating this very incorrectly. We had data very early on that severity increased when using anti-inflammatories (ibuprofen was singled out, but that’s only because that’s what most people have available to them).

          • I didn’t say they were ibuprofen, but they’re definitely and anti-inflammatory… and THAT is the property of ibuprofen (and aspirin) that is believed to be problematic.

            Still, steroids work differently, so the same issue might not apply.

  14. We already have a cheap and effective drug cocktail, hydroxychloroquine, z-pack, and zinc! Why are we not using this already on a mass scale, especially on the 1,000+ that are dying daily!!!!!!!! The FDA approved this for emergency use before the trials are done a full wek ago!!! These people should not be dying right now. WHAT’S UP WITH THAT!?

  15. Here is weird breakthrough. It appear the Chinese have ‘breakthrough’ a covid vaccine in six months.

    Maris Bartiromo is on our side. She is assuming the Chinese are have manufactured the covid-19 vaccine using old technology which is trial and error and hence takes 1 to 1 ½ years to get it right. The Chinese are using our new technology which uses a specialized ‘AI’ and synthetic bioengineering techniques to produce a vaccine in six months.

    https://www.foxnews.com/media/fda-commissioner-hahn-we-have-been-working-with-vaccine-manufacturers-for-weeks

    Hahn made the comment after host Maria Bartiromo asked him, “If the Chinese were to create a vaccine in six months or less and they release it at scale to the U.S., is the FDA ready to quickly review that data to make this vaccine available to the United States?

    The reason why the Chinese can do this technically is they stole synthetic bioengineering (which is an industry changing breakthrough for viruses and drug production) from the US.

    China, then spent billions and billions of dollars on that technology to scale it up. (P.S. Because they had a plan about covid).

    Why did this not happen in the US?

    The US has the synthetic engineering technology.

    The problem is the synthetic engineering technology could not get government funding or pharmaceutical funding as that is not in the pharmaceutical industry’s best stock price interest.

    The problem is Synthetic Engineering enables drugs like vaccines to be designed and produced much faster and cheaper.

    It will reduce the profitability of the entire pharmaceutical industry. It is too good. This what is a called disruptive technology.

    Synthetic engineering makes it much cheaper, safer, and faster to make vaccines, to make medicines. It also enable AI to design products which will eliminate a great number of drugs because it enables microbiological construction and microbiological design that is optimized by specialized ‘AI’s.

    Because of this, the US synthetic engineering could not get funding from the pharmaceutical industry or FDA approvals were slow, as the FDA is now controlled by the industry.

  16. From Italy, reported deaths today are way down, 9 days after their peak. The Chinese pattern is less regular, but a 2-day running filter on the Chinese numbers gives the same result. If the Chinese pattern can serve as a model, Italy has already seen more than 3/4 of the deaths that will occur before the daily number gets lost in other news.
    I suggest this wave of COVID-19 will be a ripple by the time any treatment is found, but the disease is ready to explode again into any vulnerable population. For example, Japan has had exceptional success so far at minimizing deaths but in the last 3 days they have had 20, about 1/4 of their total so far.

    • I think you need to have a caveat re: Italy has seen more than 3/4 of the deaths. I’d say 1/2 or so, but it all depends on what happens in the future. There is a valid concern that restrictions being eased may lead to hot spots. I’m not sure about that as there seems to be something else in play. The flattening the curve model seems to be incorrect.

    • I think what it means is what seems obvious to some of us: The efforts to keep the disease from spreading will only work as long as they are strictly maintained.
      If and when business as usual commences and people are once again mingling in large crowds…the disease will quickly spread from one or a few people to a far larger number.
      IIRC…Japan has a very large elderly population.

  17. “The initial results are excellent so that the admissions in the intensive care unit have been reduced, with shortened hospital stays and radiological and clinical responses that I would dare to define as spectacular. We believe that COVID therapy for pneumonia is corticosteroid therapy at the onset of pneumonia at the stage that we consider mild, particularly in febrile patients from the first week and with analytical abnormalities. Initiating anti-inflammatory therapy prior to the development of severe pneumonia, covering the period of time in which the patient can worsen corticosteroid therapy”

    “The OMS made a contraindicated mistake in the use of corticosteroids in patients with COVID infection 19. In this way, this therapy is postponed until a very serious situation in which the therapy is much less effective. Soon we will have data on all this and we will disseminate it but we will disseminate this information inviting you to try this treatment on the patients that I anticipate. Infection Does Not Kill Them Kills The Inflammatory Reaction To Macrophage Activated Infection”

    ” What we propose and are carrying out with the excellent initial results, ” he continues, “ is to start corticotherapy on the sixth day of the onset of symptoms, keeping it until day 12 so that this inflammatory phase is prevented, that is, the patient who is developing Small infiltrates in chest radiography are at risk of evolving into a distress without our being able to predict which patients will have this evolution or which patients will evolve favorably.
    https://www.elperiodicodeaqui.com/epda-noticias/el-hospital-doctor-peset-de-valencia-aplica–con-mucho-exito–en-pacientes-con-coronavirus-una-terapia-antiinflamatoria-con-corticoides/207638

  18. One thing’s for sure. They’ll have to come up with a treatment within 6 months or the fit and youthful will simply ignore their aged and frail and take their chances with a pandemic as for them the cure will be worse than the disease and who could blame them-
    https://www.msn.com/en-au/news/coronavirus/australians-could-be-in-cooped-up-in-isolation-until-long-after-christmas-with-strict-social-distancing-measures-for-up-to-two-years/ar-BB12aV5G

    A vaccine when there’s been none anywhere for any coronavirus is 18 months away minimum before we could begin sticking it into precious medicos and that’s simply too long for the world to print IOUs instead of real productivity and its concomitant incomes. The economic imperative will simply overwhelm the current medical one and herd immunity and survival of the fittest will rule.

  19. You can see that here already with some truth in both stances-
    https://www.msn.com/en-au/news/coronavirus/furious-jacinda-ardern-takes-aim-at-australia-for-telling-thousands-of-new-zealanders-its-time-to-go-home-amid-coronavirus-pandemic/ar-BB12bRiZ
    Short run vs the long run eh?

    Meanwhile those with some substantial immunity are fast becoming a precious commodity because of their likely productivity with no downsides-
    https://www.msn.com/en-au/news/coronavirus/very-useful-resource-how-australia-could-utilise-people-with-coronavirus-immunity/ar-BB12bB5v

  20. I really hate the double blind system in this severe case. We can cure you or you will die. Let’s play God with these people by random selection.

    • No one knows if any of these drugs is a cure.
      Do you know how many drugs that have gone through trials turn out to be dangerous?
      The number that fail trials due to being unsafe is gigantic in proportion to the number that ever gets approved.
      It is very likely these drugs have the ability to help some people and only at some stage of disease.
      Without trials, no one will ever be able to know any of those particulars.
      Also, the supply will be limited to matter that anyone does…so wasting them means people will die who do not have to.
      Does remdesivir need to be given for tens days, or is five just as effective?
      Not knowing this means that the drugs might go twice as far if it is assumed ten days must be given, but in reality five days works just as well.
      If tens days is required to save lives, then giving it for five days will mean it is largely wasted and people will die despite getting it.
      Clinical trials give information that saves lives.
      Ignorance kills.
      In 2020, what we do not know can end your life.

      • If death is CERTAIN without the drug, the “dangerous” drug starts looking pretty damn good. I thought we actually ironed a lot of this out with the “Right To Try” legislation passed late last year?

        • No matter how you slice it, until we know which work, which do not, and which work best…and when…then everyone is just taking a shot in the dark.

    • A hospital director in New York (didn’t catch his name) just said on tv his hospital was putting every patient who tested positive for the Wuhan virus on hydroxychloroquine.

      • It would be surprising if a hospital was not screening patients for any of the several contraindications for this drug.
        Some of them hardly seem trivial. And some would seem to constitute a substantial set of all people.

        • What we largely know about contraindications are from people who have taken the HCQ for malaria, lupus, and arthritis. There is probably little known about potential interactions with drugs given to someone severely ill with pneumonia. Desperation leads to desperate acts!

          • It really needs to get ironed out.
            What many arm to be overlooking is that there is a list of possible treatments.
            Deciding ahead of evidence what works will mean people are in danger of taking something that does not work, when there is something else that will work or work better.
            If there was only one experimental treatment, then it is easy to decide what to do if death is a foregone conclusion.
            Of course, death for someone who is alive is rarely assured.
            People who are hanging in can pull through.
            Giving them something toxic may actually kill someone at that stage.
            That is not me saying that…it is toxicologists.
            Besides for all of that.
            It is amazing to witness climate skeptics adopt the reasoning of climate alarmists when the subject changes.
            “We cannot afford to take into account all info, or stick to what can be proven.”

  21. Some news on remdesivir availability and production lead times, as well as how many does currently exist.
    It turns out that previously, there were a total of about 140,000 courses of treatment worth in inventory, all of which has been committed to be used in clinical trials at no cost to the people getting it.
    Also, a report in seeking alpha asserts that end to end production time for manufacturing the drug was previously one year, but Gilead expects to shorten this to six months.
    So…it takes between one year to make any of it at all.
    Gilead hopes to make enough for 500,000 treatment courses by October, and another 500,000 by year end.

    What this all ads up to is, it appears that this drug will be in limited supply, even if it turns out to work miraculously well.
    And if it turns out to be approved for usage in the immediate future, there will likely not be enough if it to go around for everyone in the world who needs and would like to have it.
    So that sounds like a very substantial problem: Who will get some, and who will decide, and how will they decide it? It seems that first come first serve would be about the only fair way, to my way of thinking.

    https://seekingalpha.com/news/3558442-gilead-ramps-up-remdesivir-production-ahead-of-approvals

    Confirmation of these assertions is required…I am just reporting what I have found published.

    A recent article in Forbes contains a lot of info on the malaria drugs, including some worrisome findings, prior to this disease outbreak, of substantial percentages of death in mice that were given hydroxychloroquine and metformin, which is a common drug taken by people with diabetes.

    ““To our utter surprise, both HCQ and CQ when combined with metformin resulted in a surprising death rate in 30-40% of mice. In contrast there were no deaths in the single treatment groups,” said the authors.”

    This result is a surprise to researchers, but that these drugs are far less safe for some subset of people is no surprise…this is just one more area of concern regarding these drugs.

    https://www.forbes.com/sites/victoriaforster/2020/04/05/researchers-warn-that-covid-19-treatment-touted-by-trump-may-be-toxic-when-combined-with-diabetes-drug/#4a7f56355f82

    Again, these results are not the last word on anything…mice are not little people, however…it must be looked at very carefully, and handing these drugs out to sick people needs to be done cautiously to avoid making some people worse off than if they received standard of care, or some other treatment.

    • Typo in forst sentence above.
      It should say:
      “Some news on remdesivir availability and production lead times, as well as how many doses currently exist.”

  22. Assuming the drug works. How many trial patients might die who end up being given the placebo?

    • Should we just assume that all drugs that might have some value are safe and 100% effective?
      What is the basis for the justification of making such an assumption?
      Are there any examples of drugs that turned out to be less effective than people were hoping?
      Any examples of experimental drugs that were more dangerous than anyone knew prior to testing them scientifically?

  23. Anyone interested in this drug ought to read this letter from the CEO of Gilead:

    “Daniel O’Day – April 04, 2020
    Over the course of the past week, Gilead has been working in consultation with regulatory authorities to establish additional expanded access programs for remdesivir, our investigational medicine for COVID-19. The programs enable hospitals or physicians to apply for emergency use of remdesivir for multiple severely ill patients at a time. These are patients who cannot take part in clinical trials and where the word “emergency” is all too real for them, their families and the healthcare providers advocating on their behalf.
    We know the desperate urgency of reaching these patients and believe that the expanded access program will help to accelerate the process. New U.S. sites have been initiated and we are adding more on an ongoing basis. We are also making progress in Europe. Yesterday, the European Medicines Agency announced that it has provided EU member states with recommendations on implementing expanded access programs for remdesivir in their countries.
    In addition to the expanded access programs, we continue to provide remdesivir on an individual compassionate use basis for children and pregnant women. More than 1,700 patients have now been treated through these programs.
    Remdesivir is still an investigational medicine and has not been approved by regulatory authorities anywhere in the world. The safety and efficacy are not yet known so while we feel the greatest sense of urgency in our work with remdesivir, we must take the responsible, ethical approach of determining whether it is indeed a safe, effective treatment. This is why multiple clinical trials for remdesivir are underway, involving thousands of patients with COVID-19 across the world.
    We know from the heartbreaking letters we receive, the images we see in the news and the all-too-bleak statistics that the urgency to find broad, effective solutions becomes more intense each day. In the ways we believe it is appropriate for Gilead to play a role today – primarily through clinical trials, as well as expanded access and compassionate use – we are doing everything it takes to meet our significant responsibility with remdesivir.
    Supply and Donation of Remdesivir
    A critical part of Gilead’s responsibility today is ensuring sufficient supply of remdesivir. To provide product for trials, compassionate use and expanded access, we needed to effectively start from ground zero in ramping up our supplies. The progress we have made on this to date is thanks to the actions we have been taking since January to rapidly expand production and increase supply.
    As soon as we knew that remdesivir may have potential in treating the novel coronavirus, our teams began to establish a supply chain for large-scale production. Then, as now, there were many unknowns including how long the outbreak would last, at what scale and whether remdesivir is a safe and effective treatment for COVID-19. We made the decision to invest and scale up regardless, because if remdesivir was going to be needed for patients, we had to be ready.
    We knew there would be challenges in producing the amounts we would ideally want to deliver in a short timeframe. One of these challenges is the length of time it takes to produce remdesivir. It is a linear process that requires specialized chemistry and multiple chemical reactions, some of which can take several weeks to complete. It also calls for scarce raw materials as well as sterile manufacturing capabilities with limited global capacity, which are needed to make finished vials ready for administration to patients.
    Working within these parameters, our teams have found multiple ways of accelerating production. These include process improvements that cut production times. As a result, we have reduced the end-to-end manufacturing timeline from approximately one year, to around six months. We have repurposed some of our own facilities to focus on remdesivir and we have also increased our network of external manufacturing partners around the world.
    In the space of two months, we have significantly increased our available supply of remdesivir using the inventory of active pharmaceutical ingredients we already had on hand. Our existing supply, including finished product ready for distribution as well as investigational medicine in the final stages of production, amounts to 1.5 million individual doses. Depending on the optimal duration of treatment, which is something we are studying in clinical trials, this supply could equate to well over 140,000 treatment courses for patients.
    Our efforts to increase supply continue with a strong sense of urgency. There is a long way to go and a lot of work to be done but I’m pleased that, despite the challenges we have been able to get supply levels to where they are today in a very short space of time – through the resourcefulness of our teams, creative approaches and collaboration.
    Gilead is providing the entirety of this existing supply at no cost, to treat patients with the most severe symptoms of COVID-19. The 1.5 million individual doses are available for compassionate use, expanded access and clinical trials and will be donated for broader distribution following any potential future regulatory authorizations. These doses are for treating patients with severe symptoms, through daily intravenous infusions in a hospital setting. Having a potential treatment in our hands comes with significant responsibility. Providing our existing supplies at no charge is the right thing to do, to facilitate access to patients as quickly as possible and in recognition of the public emergency posed by this pandemic.
    Looking Forward
    While we are working with the utmost sense of urgency on the immediate needs before us, we are also looking forward. Over the next weeks and months, we will be able to further increase our supplies of remdesivir as raw materials with long lead times become available for manufacture. We have set an ambitious goal of producing more than 500,000 treatment courses by October and more than 1 million treatment courses by the end of this year.
    To help us meet and exceed this goal, we are building a geographically diverse consortium of pharmaceutical and chemical manufacturers to expand global capacity for raw materials and production. This collaboration will allow us to achieve far more than any of us could have done working alone. The international nature of the supply chain for remdesivir reminds us that it is essential for countries to work together to create enough supply for the world.
    These are intense, ongoing efforts and while they continue, we must await the data from the clinical trials before we know whether remdesivir is a safe and effective treatment.
    In the meantime, in the face of many unknowns and the exceptional circumstance of this pandemic, we are finding every means possible to meet our responsibilities with remdesivir today, and to be prepared for meeting the needs of patients in the future.”

    https://www.gilead.com/stories/articles/an-update-on-covid-19-from-our-chairman-and-ceo

  24. The simple stated bad news is…it takes 6 months to make even a single dose of remdesivir.

    So it will be in limited supply for a long time, no matter what.

      • From their website: https://www.gilead.com/
        Remdesivir for COVID-19; Manufacturing Process
        Since January, Gilead has invested significant capital to establish a supply chain capable of large-scale production of remdesivir.

        The production of remdesivir is a long, linear chemical synthesis process that must be completed sequentially and includes several specialized chemistry steps and novel substances with limited global availability. The process is both resource- and time-intensive, with some individual manufacturing steps taking weeks to complete. Because remdesivir is administered intravenously, production also requires sterile drug product manufacturing capabilities, which limits the number of organizations capable of manufacturing the medicine. This complex process impacts the ability to rapidly produce large quantities of drug supply in an emergency situation like the COVID-19 pandemic. In light of these realities, Gilead worked early on, before any clinical trials had started, to procure a steady flow of long-lead-time raw materials that will accelerate large-scale production of remdesivir by our current and future partners once these materials become available in significant quantities.

        Over the last several weeks, we have also worked to shorten the manufacturing timeline through process improvements. The typical timeline for manufacturing a drug like remdesivir at scale is nine to 12 months; we have reduced that period to six to eight months. We continue to work on optimizing the chemical synthesis processes to further accelerate product deliveries and volumes.

        Current and Projected Supply
        As of January 2020, we were not actively manufacturing remdesivir. The manufacturing supply chain was scaled to periodically make small amounts of product for a compound in early development. We had inventory of finished product to treat just 5,000 patients.

        Since then, we have proactively and rapidly scaled our supply chain. As of late March, using the active ingredient we already had in our inventory, we have increased our supply to more than 30,000 patient courses of remdesivir on hand, assuming a 10-day course of treatment for patients. As new raw materials arrive over the next few weeks from manufacturing partners around the world, our available supply will begin to rapidly increase.

        Every day we are improving processes, shortening timelines and increasing volumes as we work to bring remdesivir to patients as soon as possible. Our goal is to produce a total of:

        More than 140,000 treatment courses by the end of May 2020
        More than 500,000 treatment courses by October 2020
        More than 1 million treatment courses by December 2020
        Several million treatment courses in 2021, if required

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