My observations are my own and based on my extensive experience conducting clinical trials. I am sure not everyone will agree with my perspective. I have tried my best to present an "objective" review of this very important Trial.
MY SUMMARY:
An antiviral drug which was historically ineffective in all its potential applications through the years but was promoted as a possibility to treat Covid-19 remains very questionable as a primary treatment drug for Covid-19.
OVERVIEW: The US NIAID (Dr. Fauci) published the results this Friday of the “re-purposed” drug Remdesivir clinical trial in the NEJM.
The agency claims the huge Phase 3 trial with 1,063 participants was a success since they felt it shortened recovery time versus the sugar pill placebo (I sincerely hope it did!) from 15 to 11 days.
As I drilled down into the details and numbers I wasn’t quite so sure this drug should be promoted as the US’s “standard of care” for Covid-19 or that NIAID was being specific enough in their comments to afford intelligent national policy decisions.
FINDINGS: This trial was a well designed Phase 3 trial with 8(!) different categories (arms) of patients conditions and more than 1,000 participants of all ages spread across the 8 conditions as best as possible. Plenty of data and details. So what did I find?
In the 3 critical Covid-19 conditions I examined extremely closely: 1) supplemental oxygen, 2) ventilator, and 3) ECMO... it was clear that Remdesivir only significantly helped those on supplemental oxygen.
CRITICALITY: What is the critical takeaway here?
***No (as in very little) marked benefit from remdesivir was found for those who were healthier and didn’t need oxygen or those who were sicker, requiring a ventilator or a heart-lung bypass machine.***
In fact, which shocked me even more, patients on high-flow oxygen or mechanical ventilator/ECMO did modestly better in the placebo group than those taking remdesivir. Can anyone suggest this drug helps Covid-19 seriously ill patients with this type of result versus a sugar pill? I hope not.
Mortality levels? Pretty much the same between the drug and the sugar pill. Certainly not statistically significant or programmatically significant.
OTHER SIMILAR TRIALS: Unfortunately, I believe these findings repeated the findings of the two (2) Chinese clinical trials with this drug which I reported on many, many weeks ago.
Sharon
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sharoncrayn
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Hi Sharon, I listen to Chris Mortenson and Peak prosperity and he agrees with you completely. He is also wondering what is going on? To be promoting that drug with that little supporting data is puzzling.
Also hydroxychloroquine is getting bad rap. Where is the investigative reporting? All the TV stations are saying how bad it is and how dangerous, which is not true. During the trials it was given to people on death's door.
It must be price driven, where hydroxychloroquine is less than a dollar compared to thousands of dollars for promoted therapy. Mary
I'm not a fan or even a reader of Derek and his blog for obvious reasons so thanks for bringing it to my attention. From what I read, he was looking at HCQ and AZT and lumping HCQ treatment into the basket. He needs to broaden his reading.
I have read all the "medical" literature on HCQ, some credible, some questionable and some juvenile, and have come to the conclusion that HCQ and Zinc (or some other Zinc ionoshore in combination with HCQ which will increase the uptake of Zinc) is beneficial early on in individuals with symptoms.
The later it is applied, the less its effectiveness.
Derek hung his hat on the review of the Lancet article which obviously wasn't a report of a legitimate Phase 3 clinical trial or even close to one. It was purely a collection of observational data from 600+ hospitals which varied considerably in their quality of care and recording of information!
The Lancet included macrolides with HCQ as one type of treatment which apparently is used in some hospitals (none of which I know of in the US). Macrolides are a class of antibiotics used to treat bacterial infections. Duh? This is a virus Derek, not a bacterial infection. You should know better, but obviously you don't. Neither do the people at Lancet who did the study.
The recent trashing of HCQ by MSM out of the blue seems blatantly contrived.
Someone in the know (perhaps at the CDC) was "backdooring" stock purchases to someone on the outside in Gilead way back in late January/early February when volume on Gilead went from about 5 million to 25-35 million overnight according to my brother the financial whiz.
According to him, Moderna (vaccine) stock was even more of a blatant insider trade from about October 15th when it was trading at $15.00 on minimal volume eventually hitting a high of almost $90.00 this week.
Someone at CDC knew something way back then...and forgot to tell almost everyone else but his/her buddies. Of course, those defending CDC will argue that scientists from Duke, Harvard, UNC and UT at Galveston were all connected by the hip to the virology work at Wuhan and certainly could have known that the virus was somehow released and virulent.
This virus was not a surprise to some people. Far from it.
Sharon, what do you think of the new vaccine race and the untested novel processes? I'm definitely not getting one. Every time they show the altruistic, unsuspecting volunteer I just cringe. Mary
The new vaccine "czar" for the US (Dr. Slauhi) is someone who has his fingers in so many "backdoor" pots one wonders who is paying of whom so he can get this job. Joined at the hip and foot to Moderna's vaccine efforts and trial, and so many other drug companies.
So who knew what last year so he could buy all his options in all these companies? A decision to buy all these options didn't come in a dream.
Someone (or more than one) last year knew this crisis was coming down the road with big dollars to be made. BIG dollars.
Exactly! Will this vaccine be mandated around the world? Will there need to be boosters? Are those who stand to make millions, 'messn' with the data? Are they the same ones who are requiring lockdown and masks until we get a vaccine?
Or he lied and never took it as his doctor did not confirm that he did, in the letter from the doctor that Trump claimed was proof that he really did take it. The letter stated that the doctor and Trump were in agreement about hydroxychloroquine, but no where in the letter did he state that he prescribed it and Trump took it.
Well, it probably involved something more than that. I am not dismissing HCQ plus a zinc ionophere. I am simply suggesting his use was not simply predicated on medical advice.
I agree 100%. Remdesivir is marginal at best in the treatment of Covid-19 and I have no idea why Dr. Fauci is pushing this one. It's almost embarrassing to call this any standard of care for patients. It seems as though adequate vitamin d can probably do as well as or better than.
Fauci has several patents on multiple drugs and vaccines from his old days with HIV, SRS-1, and Ebola going all the way back to when he began his patent waterfall to 1995...(notice how Moderna's vaccine and Gilead's drug are very familiar to what we have seen tried years ago by CDC?)
Look at his patents on GP120 or interluken-2. All you need to know. And he is a federal employee paid with tax dollars? How sweet it is.
Operation Warp Speed is a monopoly game played with real money, big, big money. Lots of players all claiming they are "helping us". Hilarious.
if you are interested in an informal update from italy, here they are collecting plasma from the cured people that is then infused to the patients in the Intensive Care Unit. It seems to be the only really effective way for this type of advanced stage patients.
Right now, results from "convalescent plasma" infusions in infected patients are somewhat questionable. The results identified below in the JOID were rather disheartening. Especially in light of testing positive, then experiencing respiratory failure, then obtaining treatment via CP, then testing negative, but almost all of whom then later died.
"Six patients with coronavirus disease 2019 (COVID-19) experiencing respiratory failure received convalescent plasma after the first detection of viral shedding; subsequently all 6 patients tested negative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and 5 patients later died, according to results of a study published in The Journal of Infectious Disease."
5 out of 6 is unreal. Here an ongoing study in Italy.
Plasma efficacy study from convalescent COVID-19 patients
On May 15, he was authorized by the INMI Ethics Committee "L. Spallanzani ”the TSUNAMI study (TranSfUsion of coNvalescent plAsma for the treatment of severe pneuMonIa due to SARS.CoV2). This is a randomized national comparative study to evaluate the efficacy and role of plasma obtained from COVID-19 convalescent patients. It was activated on the advice of the Ministry of Health and is promoted by the ISS and AIFA and currently involves 56 centers in 12 regions.
The primary objective of the study is to evaluate the therapeutic efficacy of the plasma infused on patients suffering from severe respiratory insufficiency for interstitial pneumonia from COVID-19.
Other factors that will be analyzed (as secondary data) will be the clinical course of the patients treated in terms of time interval for extubation, length of stay in intensive care, days in mechanical ventilation, duration of ventilation with CPAP helmet.
Survival will also be assessed on the basis of age and previous concomitant diseases. The reduction of viral load in the nasopharyngeal swab, sputum and bronchoalveolar lavage (BAL) will also be evaluated at 1, 3 and 7 days after plasma infusion. In addition, viraemia and immune response will be monitored.
The inclusion criteria for plasma recipients are:
Signature of informed consent
Major age
Positivity at Sars-CoV2
Severe pneumonia for at least 10 days attested by radiological imaging
Severe respiratory failure
Mechanical or CPAP ventilation required
"By guaranteeing a unique and standardized approach to convalescent plasma therapy, the study will allow us to obtain solid scientific evidence on the role of this therapeutic strategy and to provide, unequivocally, transparently and quickly, information and answers to questions on its safety and efficacy "(AIFA note).
All is well Gio! The virus no longer exists in Italy. (Excuse my Italian.)
"In reality, the virus clinically no longer exists in Italy," said Alberto Zangrillo, head of the San Raffaele Hospital in Milan, which was one of the hardest-hit areas during Italy's COVID-19 outbreak.
"The swabs that were performed over the last ten days showed a viral load in quantitative terms that was infinitesimal compared to the ones carried out a month or two months ago," Zangrillo said.
Sharon, I find you should be agreed with entirely. It's not in the numbers. The flaws are all in interpretation, which we all should know is the source of subjectivity in judgement.
I am reminded of a saying I've never found reason to question: "Figures don't lie, but liars figure." Here's another: "Everybody sells."
People want to gamble? Let them. Nothing like Darwin to cull the deserving from the herd.
The US is now (5/26) over 100,000 deaths in less than 3 months compared to the average number of flu deaths of 37,000 over 12 months using a 10 year average (per CDC estimates using computer models). NO comparison. None.
Countries like Sweden, Brazil, and the UK who went "open door" with "herd immunity" initially are paying the price. Per capita numbers are disturbing to say the least. Brazil will probably infect all of SA. None of the SA countries have adequate medical capabilities to handle this toxic virus.
If China and India would ever report, we would see 500,000 deaths worldwide.
Something went terribly wrong in some class 4 virology lab.
Luc Montagnier is a French virologist and recipient of the 2008 Nobel Prize in Medicine for his discovery of the human immunodeficiency virus (HIV). On April 18, Professor Montagnier appeared on a French TV station (video in French with English subtitles) to comment on the origin of COVID-19, echoing what several other scientists have suggested in saying that the virus had been manipulated by researchers. He also mentioned in his appearance on the program that components of HIV had been inserted into the coronavirus sequence, perhaps in pursuit of an AIDS vaccine.
When asked by one of the commentators if the coronavirus under investigation may have come from a patient who is otherwise infected with HIV, Professor Montagnier said, “No. In order to insert an HIV sequence into this genome, molecular tools are needed, and that can only be done in a laboratory.”
I discussed this several months ago on this forum. Still, several individuals on this forum maintained this virus was simply another form of the flu. At that time, the magnitude of this virus's toxicity was dismissed by almost everyone including the WH "team of experts".
Something to consider with regards to the number of deaths in the US, and perhaps, elsewhere. Debra Birx stated that even if someone died of another cause, it was to be listed as a Covid-19death. Some physicians had to change the cause of death on the death certificate from 'whatever' to Covid-19,
I don't believe she said anything to that effect. Nor do I think a coroner or physician would use the term "whatever" on a death certificate and then change it to Covid-19 without specific knowledge that it was Covid-19 or highly probable. In fact, I believe the NYT ran an article debunking this very idea.
It is possible some physicians used the term "unknown" because the dead person was never hospitalized, or had no known medical records, or had no personal physician, or did not have an autopsy. Think of a homeless person.
Initially confusion existed between Covid-19 and those doctors who thought it was pneumonia, but I assume that issue has been resolved some time ago. If you are a doctor and still don't know the difference, stop practicing.
The homeless, from what I have read, have a low rate of infection from Covid-19. It most likely would from continual exposure to the sun, and vitamin D.
"The homeless, from what I have read, have a low rate of infection from Covid-19."
I doubt it. Very difficult to believe.
COVID-19 Outbreak Among Three Affiliated Homeless Service Sites — King County, Washington, 2020 (CDC report which doesn't say much of anything, but does say about 17% of the homeless tested positive).
For comparison, here are approximate annual U.S. deaths from other leading causes:[4] [4]
Heart disease: 650,000
Cancer: 600,000
Accidents: 170,000
Chronic lower respiratory disease: 160,000
Stroke: 146,000
Influenza and pneumonia: 56,000
Suicide: 47,000
Accurate figures for COVID-19 deaths are not available. Task force member Dr. Deborah Birx stated on Apr 7, 2020, that patients who died of other causes might still be counted as dying of COVID-19 if they had a positive test at the time of their death.[5] [5] Because of delays in data reporting, it will be months before we know whether all-cause mortality for the year is unusual.
Wrong. 10 year average from CDC computer models = 37,000.
"Chronic lower respiratory disease: 160,000"
Debatable since they changed the definition in 1999 which increased the number.
"it will be months before we know whether all-cause mortality for the year is unusual"
We already have a very good idea that it is very, very unusual, and at 12 months it will be substantially higher than the 12 month average for influenza and pneumonia. Not even close! It will probably be ranked #3 exceeding most estimates.
"Other knowledgeable individuals have also noted that the death records system in the U.S. is subjective, incomplete and politicized, and have suggested that citizens should adopt a “healthy skepticism about even the most accepted, mainstream, nationally reported CDC or other ‘scientific’ statistics.”
If I understand the Children's Defense Fund (who are they to make such a comment? Do they have a database that allows them to proclaim their omniscience? ) comment it is that Covid-19 statistics on US deaths are "subjective, incomplete and politicized".
Who knows. They certainly don't. And nobody else does either. So why bother fretting over 5,000 or 10,000 one way or the other. Yes, the other way is a distinct possibility.
Looking for "absolutes" (as in the US has exactly, without question, 104,410 deaths as of 12 noon EDT, Saturday, May 30, 2020) here is like looking for the Holy Grail. Futile.
The CDF should stick to its knitting, and this ballgame isn't.
If you go to their website, run by Robert F. Kennedy, Jr,. they have references that are underlined. The CDC has vested interests that may interfer with their statistics.
The prevailing consensus amongst the doctors I have spoken to is that COVID deaths are likely understated as the corpses of those that die outside of the hospital system are frequently not tested because there is no benefit to the patient/ deceased and the testing infrastructure has been overwhelmed simply keeping up with the living.
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