Good news on remdesivir
Remember those drug trials that are going on regarding COVID-19? One of them concerns the antiviral remdesivir.
First results are in:
New results from a clinical trial conducted by the National Institute of Allergy and Infectious Diseases establish the drug as the standard of care for Covid-19, which has killed 50,000 people in the U.S. so far, said agency Director Anthony Fauci. He likened the good news about remdesivir to the discovery of the first medicine found to help treat HIV more than three decades ago.
That’s a pretty strong endorsement. And because it’s Fauci saying it and not Trump, the MSM might be a bit less likely to go on the attack.
Hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received placebo, according to a preliminary data analysis from a randomized, controlled trial involving 1063 patients, which began on February 21. The trial (known as the Adaptive COVID-19 Treatment Trial, or ACTT), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19.
An independent data and safety monitoring board (DSMB) overseeing the trial met on April 27 to review data and shared their interim analysis with the study team. Based upon their review of the data, they noted that remdesivir was better than placebo from the perspective of the primary endpoint, time to recovery, a metric often used in influenza trials. Recovery in this study was defined as being well enough for hospital discharge or returning to normal activity level.
Preliminary results indicate that patients who received remdesivir had a 31% faster time to recovery than those who received placebo (p<0.001). Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group (p=0.059).
Several things seem important here. This was a trial of the drug against placebo, one of the first of that type. The patients who received it were already in dire straits, and so it is particularly impressive in that population. The change in death rate isn’t up to what one might hope (it isn’t up to what I hoped, anyway). But it’s still in the right direction, and it’s highly possible that if the drug were given earlier it would be more effective in that regard.
Remdesivir is not an innocuous drug (in fact, I don’t think there is such a thing). So I don’t think it will necessarily be given to patients with mild symptoms, because of possible side effects involving liver enzyme and GI problems. But ultimately it might be very helpful for those with moderate to serious symptoms, and I believe there will be additional drugs proven to be of value as well.
And remember that WHO parroted a negative report from China about remdesivir.
AND China then attempted to patent remdesivir —- despite the fact that it had already been patented.
And China is attempting to grab all the proprietary research. We must be careful about who we accept into our research organizations, both universities and federally funded research labs.
Defund and Decouple is the only rational response.
We cannot trust these slime.
And until the decoupling can be accomplished, label food and drugs with country of origin, even ingredients. We can’t abide by caveat emptor unless we know who is fiddling with these essential items.
And, of course, the fact that it is new drug that costs a $1,000 per dose makes it all the more attractive.
Roy Nathanson, I think many doctors around the country are, in fact, prescribing the despised HCQ and zinc to people with early cases. It’s inexpensive and it appears to help many people. Those who don’t respond will go into the hospital to have Remdesivir infused for 6-10 days.
I think there is a trial ongoing for Remdesivir on less seriously ill patients. I don’t know if that’s also an infusion or if there’s an oral version.
The HydroQ has worked but the media is banning it including facebook and youtube removing videos… (like it did the two doctors about going back to work)… meanwhile… another set of docs are suing to use it and a 3 month child was reportedly saved… however, i noticed that the news was putting it down cause a brazil high dosage study failed (they gave two weeks dosage in one day… but the chemistry doesnt kill the virus, it screws up its replication)… so the left really doesnt care if it kills children, just as long as trump is hated…
on another note… as i said before, lawsuits..
and now, let the lawsuits come..
after all, Blasio decided to threaten the hasidim with jail time.. for funeral
people are amazed, but those who know socialsts who hate jews for never changing and refusal to change, are not surprised at all
but there is going to be a lot of check writing for constitutional reasons.
after all, none of these orders have any power other than assumptive or voluntary
so pretty much everone woh gets fined, imprisoned, etc… is going to get a check
the state has no power to put aside the constitution even in an emergency
and now with the news out that no one died of the flu this year (cause they are all being recorded as covid, where the hospitals get a bonus cash for that – which i pointed out at the begining of all this was a bad problem)…
things going to get interesting if our food supply doesnt collapse
if it does, dont be surprised if there is a war to start…
its probably the only time we will be down this low in the next few decades
that is unless the feminists continue making us afraid, statists who cant think
[see reports of how badly we are now in education!!!]
after all, women wont be fully liberated till we are communist the women say
(other women dont count dont ya know… they arent real women say the real women – but men can be real women say the real women… )
Funny that the devious Fauci outright dismissed the drug hydroxychloroquine which costs pennies and has a mild to nonexistent side effect profile as downright harmful, yet tosses a bone to the expensive remdesivir’s merits, a drug with a much more formidable side effect profile than hydroxychloroquine (yet we are told about the few cases of adverse reactions to it that were clearly due to misadministration with way too high doses).
It’s clear his main goal is to make money for and bring power to the people (Gates) working on a vaccine, hence his desire to shut down the country for years until this relatively harmless cold virus is completely eradicated, but is also willing to help Big Pharma make a buck on treatments like remdesivir in the many years leading up to that time. Otherwise, it makes no sense that he would go out of his way to discount and delegitimize doctors from even trying a cheap and harmless treatment, no matter how many studies showing good results with it (much like this one remdesivir study) are published.
“Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group (p=0.059).”
Sometimes it’s good to be in the placebo group (…thalidomide…).
Apparently, not this time.
Question to the doctors on the board: at what point does it become unethical to stick with a placebo that has demonstrably worse results than the drug on trial?
Also of note:
https://www.politico.com/news/2020/04/27/tracking-the-hunt-for-coronavirus-drugs-and-vaccines-211416
Drugs on trial: Remdesivir — Favipiravir — Tocilizumab — Baricitinib — Acalabrutinib.
Looks like a list of demons (or angels) being summoned by some sorcerer.
Now all we need is a magic wand.
https://www.amazon.com/Donald-Trump-Magic-Wand-2020/dp/B07W1HKN83
So what would be the reason to deny this drug to the cohort of patients most severly affected — people over the age of 60 aren’t generally contemplating having more kids.
This was … interesting.
https://www.politico.com/news/2020/04/29/gilead-coronavirus-remdesivir-220484
At the links from the above:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31022-9/fulltext?utm_campaign=tlpr&utm_source=hs_email&utm_medium=email&utm_content=87146813&_hsenc=p2ANqtz-8ZgigmmMqebccAtwi_pKj91_QjrcDd_ybkHGeKEabjurf8Y1i–iwkp8osglWCTKfgbro242Ru5IIHO1fwnOTEW9B3dQ&_hsmi=87146813
https://www.politico.com/news/2020/04/23/who-gilead-coronavirus-drug-204749
I’m sure it was just a simple mistake.
Per the Politico story, the one that “leaked last week” (it’s getting hard to keep up):
https://www.statnews.com/2020/04/16/early-peek-at-data-on-gilead-coronavirus-drug-suggests-patients-are-responding-to-treatment/
What’s the substantive difference in touting, leaking, and publishing an article that is later removed?
I say: tout away. It’s the only way the general public knows about what’s going on — at least, if they see it before Twitter, YouTube, and FaceBook tank the messages.
But don’t drink the bleach.
Right on both counts, AesopFan. When Remdesivir is clearly better than the placebo, how can it ethically be denied to patients? This was the dilemma that commenter Sharon W.’s husband faced. She reported that Gilead would not break the clinical trial protocol to help her husband. I am so glad he survived anyhow. The FDA needs to approve this, not in just in trials, but for patients all over the country.
And as to the drug which may cause birth defects: The vast majority of people dying of this disease are over 65, and highly unlikely to become new parents after taking the drug — most especially if they’re dead!
One can only hope the President does not endorse Remdesivir
https://www.statnews.com/feature/coronavirus/drugs-vaccines-tracker/
For anybody who’s interested, that’s a link to a site that tracks COVID-19 drugs and vaccines. I have no idea whether it’s complete or unbiased, but it looks like a good place to start.
By the way, I still think that we’re probably a few years away from having billions of people vaccinated with something that works. As a simple nonspecialist reader, I also think that there’s a good chance that an effective vaccine will never be developed. I’m in the camp that favors treatment over vaccination, but hopes for both.
“Japan to approve remdesivir for coronavirus patients in May”
my italian post got swallowed up
A study looking at 65k lupus and others taking hydroxy.. only 20 got sick.. none died..
[Coronavirus, revealed how it works: that’s why hydroxychloroquine could work]
https://www.iltempo.it/salute/2020/04/28/news/coronavirus-farmaci-efficaci-news-danni-cura-annalisa-chiusolo-artrite-terapia-idrossiclorochina-sars-cov2-1321227/
Finally, further confirmation of this hypothesis is the data collected in the register of the SIR (Italian rheumatology society). To assess the possible correlations between chronic patients and Covid19, SIR interrogated 1,200 rheumatologists throughout Italy to collect statistics on infections. Out of an audience of 65,000 chronic patients (Lupus and Rheumatoid Arthritis), who systematically take Plaquenil / hydroxychloroquine, only 20 patients tested positive for the virus. Nobody died, nobody is in intensive care, according to the data collected so far.
Thalidomide is a very interesting case… since the problem with it was from, if i remember correctly, chirality…
An object or a system is chiral if it is distinguishable from its mirror image; that is, it cannot be superimposed onto it. Conversely, a mirror image of an achiral object, such as a sphere, cannot be distinguished from the object. A chiral object and its mirror image are called enantiomorphs (Greek, “opposite forms”) or, when referring to molecules, enantiomers. A non-chiral object is called achiral (sometimes also amphichiral) and can be superposed on its mirror image.
Thalidomide is a chiral molecule and the drug that was marketed was a 50/50 mixture of left and right-handed molecules. While the left-handed molecule was effective, the right-handed one was highly toxic
Artfldgr:
Thanks for posting a link to information about Italian lupus patients taking hydroxychloroquine. I’ve been wondering about that issue.
Unfortunately, for me, this article also asserts that COVID-19 can be be attributed to hemoglobin attack. I’ve been very skeptical about that theory, so I carefully re-read the article, looking for some proof or data, but the author provided none.
The author, Peter D’Angelo, claims that a young pharmacology student by the name of Annalisa Chiusolo developed the hemoglobin-attack theory. Before this, I’ve never heard of Chiusolo, and I can’t find any research publications by her.
Now I don’t know what to think.
Artfldgr – Wikipedia confirms that your memory is correct.
I knew about Thalidomide’s disastrous effects, and that the experience affected the procedures for drug trials and approvals, causing them to become very protracted in the desire to avoid another scandal.
However I didn’t know about the chiral specifics, which were quite interesting.
https://en.wikipedia.org/wiki/Thalidomide
I do know, in a fuzzy way, about the right- and left-handedness of molecules.
https://www.smithsonianmag.com/space/must-all-molecules-life-be-left-handed-or-right-handed-180959956/
Interestingly, most peoples’ faces are slightly asymmetrical, although not technically chiral, which is why we sometimes don’t think that is “really me” in a photograph. We are used to seeing ourselves in a mirror, not the way other people see us, and thus the asymmetries go the “wrong” way, especially if they are relatively pronounced.
Which of course leads us to the best mirror schtick in TV history.
https://www.youtube.com/watch?v=79EnDc-Ucv8
Aesop Fan—I’m going to look into that magic wand. Thanks for mentioning it.
As I’ve commented before, Trump IS the Apprentice’s Sorcerer!
Best magic wand for Wuhan Virus so far is HQ (probably even better than Vitamin D – but I’m taking D plus sunlight, not yet HQ):
https://www.mediterranee-infection.com/wp-content/uploads/2020/04/Abstract_Raoult_EarlyTrtCovid19_09042020_vD1v.pdf?fbclid=IwAR2Bx-Fldm2fFsLg7L06BYUz-8QvwuJ-hAW9uWmwx1KdKzCU0YGHtSwXXWw
Methods
The study was performed at IHU Méditerranée Infection, Marseille, France.
A cohort of 1061 COVID-19 patients, treated for at least 3 days with the HCQ-AZ combination and a follow-up of at least 9 days was investigated. Endpoints were death, worsening and viral shedding persistence. Findings From March 3rd to April 9th, 2020, 59,655 specimens from 38,617 patients were tested for
COVID-19 by PCR. Of the 3,165 positive patients placed in the care of our institute, 1061 previously unpublished patients met our inclusion criteria. Their mean age was 43.6 years old and 492 were male (46.4%). No cardiac toxicity was observed. A good clinical outcome and virological cure was obtained in 973 patients within 10 days (91.7%).
Prolonged viral carriage at completion of treatment was observed in 47 patients (4.4%) and was associated to a higher viral load at diagnosis (p < 10-2) but viral culture was negative at day 10 and all but one were PCR-cleared at day 15. A poor outcome was observed for 46 patients (4.3%); 10 were transferred to intensive care units, 5 patients died (0.47%) (74-95 years old) and 31 required 10 days of hospitalization or more.
Among this group, 25 patients are now cured and 16 are still hospitalized (98% of patients cured so far). Poor clinical outcome was significantly associated to older age (OR 1.11), initial higher severity (OR 10.05) and low hydroxychloroquine serum concentration. In addition, both poor clinical and virological outcomes were associated to the use of selective beta-blocking agents and angiotensin II receptor blockers (P 3 days of HCQ-AZ than in patients treated with other regimens both at IHU and in all Marseille public hospitals (p< 10-2).
I’m wondering the News folk who claim HQ doesn’t work will subject to suits for doctors & hospitals NOT using it, and their patients then dying. Probably not, but they should be subjected to bad PR, at least.
The econ “magic wand” has long been tax cuts plus deregulation — leading to more economic activity and especially more attempts to sell more stuff on the market. With more successes. We need deregulation for more innovation, and more innovation for better solutions.
Thanks, Tom Grey, for that study link and summary.
The Wuhan Institute of Virology, part of the China Academy of Sciences, has applied to patent the use of Gilead Sciences’ remdesivir to treat the current coronavirus outbreak. The company has partnered with Chinese health authorities to run a Phase III clinical trial to assess remdesivir for treatment of the virus. The drug was originally developed to treat the Ebola virus, but wasn’t effective. Preclinical assays have suggested that the drug might be effective against the coronavirus, 2019-nCoV, as was published in the New England Journal of Medicine (NEJM).
but thanks to obama changing patent law to remove first to invent and make us first to patent, the chinese with their government money that the US doesnt do for its lone inventors, means they get to take it all..
ie. we have a lot less inventing in the US given this… if you dont have the money to patent, you might as well not create anything new… only the rich and well connected can now play the patent game..
used to be that if you came up with a great idea, you could register it and protect your right to the patent as the first… but no more… so the economic engine was deflated… not that anyone gives a crap… i know as i stopped my inventing completely.. having never had the help, resources, or such to patent or do that, the chances of any technology i have in my kit, would be nil
or to quote my sister… i have about as much chance as a paper mache dog running to hell to catch a steel cat..
by aligning us with other states… which do not invent so much
he equalized us with those states, rather than have them reach higher
so… if your an inventor..
unless your rich… give up..
your wasting all your time and life as i did
and you will end up stuck wanting to not wake up any more old with no hope
as you cant patent… so you cant secure the idea as a real thing you can sell
and cause you have no such protection, you cant present it to anyone to patent
he put patent trolls on steroids – not cured them
excuse me while i go sit and look at the futility of my life.. 🙁
Focus on selection effects and sample size. From the post, “The patients who received it were already in dire straits, and so it is particularly impressive in that population. The change in death rate isn’t up to what one might hope (it isn’t up to what I hoped, anyway).”
First, the trial is being conducted on people who are exhibiting frank symptoms, which is to say, some (relatively small) fraction of all people currently testing positive for the infection.
Second, the “statistically insignificant” change in the death rate might be an artifact of sample size, and a change from one in eight patients receiving the placebo dying to one in twelve patients receiving the experimental treatment is an improvement of about the same magnitude (thirty percent) as the reduction in days in care.
Well I’m wearing my cynical spectacles here now.
Remdisivir if adopted as treatment plan is going to make some folks, beginning with Gilead CEO and shareholders, it’s going to make them very, very wealthy.
Hydroxychloroquine plus zinc plus z-pack plus Dr Maria’s vitamin C protocol, will not make anybody wealthy, but the combination is doing a hell of a lot of good with virus patients. And, not just early cases. What most people aren’t talking about is that very sick, ICU patients on ventilators have increased chances of surviving with this regimen.
Has become nauseating to see the double whammy of politics and corruption make doctors have to dither around to get it right. The bargain basement treatment, despised as it may be, is saving lives. And I had thought that that was our goal. Huh?
Here is a link to Association of American Physicians and Surgeons to Gov Ducey of Arizona explaining the efficacy of HCQ, yea. The doctors asking the politician to allow them to use a drug that saves patients. Complete insanity.
https://aapsonline.org/aaps-letter-asking-gov-ducey-to-rescind-executive-order-concerning-hydroxychloroquine-in-covid-19/
Autocorrect changed the name twice after I’d checked to make sure it was right.
It is Dr Paul Marik’s vitaminC protocol.
Here is another bargain basement regimen that has become controversial. However, there are people surviving and walking out of ICUs who would normally have died. At least that’s what one ICU doc keeps telling me. He tells me with a look of absolute awe on his face which is most of the time stoic or cynical.
Jaynie:
I wrote a post two years ago about Marik’s vitamin C protocol, which was used for sepsis.
Jaynie:
Neo’s response to your comment rang a bell, so I looked back at her post on Marik’s vitamin C protocol for sepsis.
I added a comment to Neo’s earlier post from about two years ago. Included in my comment was a list of clinical trials undertaken to test Marik’s hypothesis. I didn’t check them all, but the second clinical trial has been completed, and a paper describing the results has been published.
Unfortunately, the conclusion isn’t encouraging:
“In this preliminary study of patients with sepsis and ARDS, a 96-hour infusion of vitamin C compared with placebo did not significantly improve organ dysfunction scores or alter markers of inflammation and vascular injury. Further research is needed to evaluate the potential role of vitamin C for other outcomes in sepsis and ARDS.”
Here’s a full citation for the paper:
Effect of Vitamin C Infusion on Organ Failure and Biomarkers of Inflammation and Vascular Injury in Patients With Sepsis and Severe Acute Respiratory Failure: The CITRIS-ALI Randomized Clinical Trial.
Fowler AA 3rd, Truwit JD, Hite RD, Morris PE, DeWilde C, Priday A, Fisher B, Thacker LR 2nd, Natarajan R, Brophy DF, Sculthorpe R, Nanchal R, Syed A, Sturgill J, Martin GS, Sevransky J, Kashiouris M, Hamman S, Egan KF, Hastings A, Spencer W, Tench S, Mehkri O, Bindas J, Duggal A, Graf J, Zellner S, Yanny L, McPolin C, Hollrith T, Kramer D, Ojielo C, Damm T, Cassity E, Wieliczko A, Halquist M.
JAMA. 2019 Oct 1;322(13):1261-1270. doi: 10.1001/jama.2019.11825. Erratum in: JAMA. 2020 Jan 28;323(4):379.
If you’re interested in checking out the results of other clinical trials, go to clinicaltrials.gov and search for the following trial identification numbers:
NCT03338569,NCT02106975, NCT02734147, ACTRN12617000793314,ACTRN12617001184369,ACTRN12617001392358p) and in combination with hydrocortisone and thiamine NCT03333278, NCT03335124, NCT03258684, NCT 03380507,NCT03422159, NCT03389555).
Of course, a sepsis study isn’t equivalent to a COVID-19 study, but some of the symptoms are similar, so maybe it isn’t a leap to expect that these trials could shed some light on the question of a broader efficacy for Marik’s vitamin C protocol.
Cornflour and Jaynie:
Marik critiqued one study (I don’t think it was the one you cited, Cornflour) for not following his protocol in terms of timing, which he says is all-important. If it’s not begun almost immediately, the damage is done and it will not help, he says. The study you cite, Cornflour (I read the abstract for it) just says that the ARDS and sepsis was present in the patients studied for “less than 24 hours.” That’s not even remotely close to the much narrower window of time Marik says is necessary for it to work.
For what it’s worth, on April 15th, Marik published a very brief article in “World Journal of Diabetes” on the clinical trials being done to test his vitamin C hypothesis.
He says the jury’s still out, but that clinical practice, rather than clinical trials, should always be the final arbiter. He has a point, but it also sounds to me as if he’s drifting dangerously close to a simple argument from authority — his own.
Of course, I still hope that the treatment works. If I ever have the misfortune to develop sepsis, then I’d want my doctor to give it a shot. But, for the time being, I have the luxury of reading clinical trials from the comfort of home. So far, I’m unconvinced.
Link to article:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7156299/
Marik’s conclusion:
“Shortly, the results of multi-center RCTs will be available[23-25]. Many will consider these trials to be the definitive evidence on which to judge the benefit of HAT Rx and to make a jury decision. However, while RCT’s are considered the gold standard, it is important to realize that most RCT’s do not replicate real world experience; mainly, due to the numerous exclusion criteria, enormous patient heterogeneity, non-standardized co-interventions and delays in instituting therapy. In the end, the thoughtful juror (clinician) must weigh the totality of the evidence before rendering a verdict.”