Bill & Melinda & Ivermectin?
So the story goes, Bill & Melinda have decided to fund an Ivermectin trial. What does it look like?
Here’s the trial website:
And the trial definition at ClinicalTrials.gov:
Note: Bill & Melinda aren’t mentioned anywhere in the clinicaltrials definition. I made the connection by the structure of the trial (fluvoxamine, ivermectin, metformin, placebo) and the physical location: Belo Horizonte, Minas Gerais, Brazil was mentioned in both the clinicaltrials link, and also on the togethertrial.com website. I could be wrong about making this connection; the website says trial started Jan 25, 2021, while the clinicaltrials link said the start date was Jan 19, 2021. The alleged sponsor, at clinicaltrials, is “cardresearch” (cardresearch.org), which currently has no website – it is “under development” (“Site em Desenvolvimento”).
And yet – at archive.org – cardresearch.org definitely DID have a presence back in 2018. Not anymore though. Kind of odd, the “sponsor” without even a website – never saw that one before:
CARDRESEARCH is one of largest Brazilian Research Clinic, located at Belo Horizonte, MG, with strong expertise in impatient and outpatient clinical Research protocols.
Actual Study Start Date: January 19, 2021
Estimated Primary Completion Date: February 1, 2022
Estimated Study Completion Date: March 1, 2022
It won’t be completed for another 13 months. The 13 endpoints are between 10 and 28 days long.
Drug: Ivermectin Tablets
06 mg oral tablet: Three tablets if weight 40 – 60 kg, single dose; Four tablets if weight > 60 kg, single dose.
Instead of FLCCC dosing (0.2 mg/kg, x 5 days of treatment, or until symptoms are gone), they use just one day of treatment, at 0.3 mg/kg.
And the oddest thing: patients must have “at least one enhancement factor” from the following list:
Age > 50 years;
Diabetes mellitus requiring oral medication or insulin
Systemic arterial hypertension requiring at least 01 oral medication for BP control;
Known cardiovascular diseases (heart failure, congenital heart disease, valvar heart valve disease, coronary artery disease, cardiomyopathies)
Symptomatic lung disease (emphysema, chronic bronchitis)
Symptomatic asthma patients requiring chronic use of agents for control of symptoms.
Obesity, defined as BMI> 30 kg / m2 body weight
SARS-CoV2 vaccinated patients
Patient with stage IV chronic kidney disease or on dialysis.
Immunosuppressed patients / using corticosteroid therapy (equivalent to at least 10 mg of prednisone per day) and / or immunosuppressive therapy)
Patients with a history of cancer in the last 05 years or undergoing treatment of a current cancer
First, we know that smoking is protective for COVID19. Secondly, isn’t vaccination also supposed to be protective? Why would either vaccination or smoking be an “enhancement”?
My guess: this 13-month trial (for a 4 week endpoint) will eventually fail due to either a) recruitment difficulties (the pandemic will be over by then – not enough recruits), or b) it will show no benefit, due to smokers and vaccinated people selected as patients which will confound the results, or c) not nearly enough ivermectin will be given for this to work, or d) the trial will show benefit, some 13 months later, after most of the world has been “safely vaccinated.”
The togethertrial.com site suggests that results could be available in 2-3 months. Wouldn’t that be nice?
Anyone else have any observations here?
I think you forgot Dependent Lividity. I think that was one used in the UK hydroxy trials to satisfactory results….
Can’t help but think this is simply a stalling tactic. FDA will now say they can’t approve IVM until the trial is done. By the end of the year, vaccines will be widespread & mandatory.
Big Pharma will also be introducing a few expensive new potions of their own, which NIH/FDA will approve under EUA & say make IVM obsolete.
Resistance is futile… IVM can’t win in a world controlled by Big Pharm.
How unethical giving high risk patients placebo, all in the name of preserving the purity of scientific method.
We live in interesting times!
This is the Baker article on the Detailed history on Gain of Function research:
And we were warned, repeatedly. The intentional creation of new microbes that combine virulence with heightened transmissibility “poses extraordinary risks to the public,” wrote infectious-disease experts Marc Lipsitch and Thomas Inglesby in 2014. “A rigorous and transparent risk-assessment process for this work has not yet been established.” That’s still true today….
In 1977, a worldwide epidemic of influenza A began in Russia and China; it was eventually traced to a sample of an American strain of flu preserved in a laboratory freezer since 1950. In 1978, a hybrid strain of smallpox killed a medical photographer at a lab in Birmingham, England; in 2007, live foot-and-mouth disease leaked from a faulty drainpipe at the Institute for Animal Health in Surrey. In the U.S., “more than 1,100 laboratory incidents involving bacteria, viruses and toxins that pose significant or bioterror risks to people and agriculture were reported to federal regulators during 2008 through 2012,” reported USA Today in an exposé published in 2014.
In 2015, the Department of Defense discovered that workers at a germ-warfare testing center in Utah had mistakenly sent close to 200 shipments of live anthrax to laboratories throughout the United States and also to Australia, Germany, Japan, South Korea, and several other countries over the past 12 years….
Fauci’s anti-terror budget went from $53 million in 2001 to $1.7 billion in 2003….
And yet the sole bioterrorist in living memory who actually killed American citizens, according to the FBI — the man who sent the anthrax letters — turned out to be one of the government’s own researchers. Bruce Ivins, an eccentric, suicidal laboratory scientist from Ohio who worked in vaccine development at Fort Detrick, allegedly wanted to boost the fear level so as to persuade the government to buy more of the patented, genetically engineered anthrax VaxGen vaccine, of which he was a co-inventor….
Here is the extensive history:
(This was posted on Rat site but could not be pulled up.)
Thanks for sharing the details of this study. I too was curious as to the start/end dates, and dosage of ivermectin (single dose). Knowing the efficacy of ivermectin, the use of placebo’s should be considered criminal. We live in God forsaken times. Lengthy “studies” while more needlessly die. Insanity.
I must confess when I read that RCT on calcifediol, I was overcome with sadness for all those people who died from not being lucky enough to be in the “treatment arm.” Sacrificed on Fauci’s altar of “not enough evidence.”
“The use of placebos should be considered criminal.” Truer words were never spoken.
That’s just as true with the ivermectin trials too.
If I recall correctly, Fauci & the NIH truncated their trial on remdesivir, stating that as benefit was being seen, it would no longer be ethical to continue giving placebo to that arm of the trial.
I hope those who can will hammer away at this as the Gates IVM trial progresses.
We should keep a tally of Gate’s “sacrificial lambs” who are dying in the placebo group and spread this info wherever freedom of speech is still allowed.
With so many studies already done, peer reviewed & published, I can’t help but think Gates is dancing dangerously close to the edge of the Nuremberg Code & WMA Declaration of Helsinki.
Use of Placebo: “As a general rule, new interventions must be tested against the existing gold standard, the best proven treatment that presently exists. In rare cases, the new intervention may be compared to a placebo (no intervention) when no proven intervention exists or if there is a compelling reason to determine the efficacy or safety of the intervention and there is deemed to be no additional risk to abstaining from treatment.”
The withholding of IVM outside of clinical trials, forcing consent for a chance at effective treatment borders on unethical coercion, which should be exposed with the brightest light we can muster.
“All subjects have been volunteers in the absence of coercion in any form”
“The use of placebos should be considered criminal.” Truer words were never spoken.
That’s just as true with the ivermectin trials too.
FLCCC Open Letter to the Investigators of the Oxford PRINCIPLE Trial on Ivermectin in COVID-19
The Declaration of Helsinki – Ethical Principles for Medical Research involving
Human Subjects” states that “when combining medical research with medical care, patients can only be studied… if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.”
In the next few weeks, the result of four more randomized studies involving more than 3,000 additional patients will provide an even greater understanding of the efficacy of Ivermectin in COVID-19. These studies’ findings will be critical to guide your impressive organization in the ethical design of prospective trials comparing either the timing, dosage, or duration of treatment
I recall that early treatment IVN + Zinc was highly effective. Chris was my source for this information. Neither Zinc nor early treatment is included.
Based on dosage alone this is not an attempt to succeed IMHO but Y R U surprised?
Since the schedule does imply “too late anyway” (unless another variant or the current b117 reverses this expectation) we seem to agree on what to expect from it.
Extremes in: sentiment, risk taking, price multiples, debt, and a great many other statistics are readily apparent along with the contrasting statistics of losses throughout many economies the work at home public is not seeing.
We can’t see the future, merely the paths taken in the dozens of past examples, none of which ended well.
What is different this time is the number of countries with unsustainable debt loads and many of the same conditions. The complexity and inherent stresses within this globalized system seem to suggest a mistake or failure could propagate like tempered glass shattering i.e. rapidly.
Getting prepared is now an urgent priority IMHO.
Thank you for all you both have done on our behalf.
This might be the same study: here’s the PR page from McMaster University in Hamilton, ON.
New study to test drugs for early COVID-19 infection
February 9, 2021
McMaster University researchers are leading a large international study to test drugs to treat COVID-19 patients. The trial will evaluate the effectiveness of ivermectin, metformin and fluvoxamine on preventing COVID-19 disease progression, and the researchers say the results could be known in as short a time as two to three months.
McMaster University researchers are leading a large international study to test drugs to treat COVID-19 patients.
The trial will evaluate the effectiveness of ivermectin, metformin and fluvoxamine on preventing COVID-19 disease progression, and the researchers say the results could be known in as short a time as two to three months.
These drugs have shown mixed results in previous studies but have not been tested in a large clinical trial, said Edward Mills, principal investigator of the Together COVID-19 trial and a McMaster professor of health research methods, evidence, and impact.
“The need for treatments in early disease is paramount. Evidence is quickly emerging that suggests a number of drugs may have a promising effect on reducing COVID-19 disease severity in patients with mild to moderate disease,” said Mills. “Our study has been designed to rapidly recruit patients to evaluate these potential therapeutics.”
The McMaster research team is partnering with research clinic Cardresearch and the Pontifical Catholic University of Minas Gerais in Brazil as well as the University of Stellenbosch in South Africa on an ongoing clinical trial established to answer multiple questions of drug effectiveness over time.
The study is funded in part by the Bill and Melinda Gates Foundation and Fastgrants, a collaboration of technology philanthropists.
The clinical trial is important because although COVID-19 vaccines are being rolled out in high-income countries, it may be years before the vaccines are universally available for low- and middle-income countries, Mills said.
“For this reason, the Together COVID-19 trial was created to evaluate the effectiveness of cheap, widely available drugs in low- and middle-income countries that can be repurposed for COVID-19,” he said.
There are eighteen study sites in Brazil where more than 229,000 have died of the virus since the beginning of the pandemic.
“For Brazil, the high incidence of COVID-19 and no proven therapies on early disease move patients towards study participation,” said co-investigator Gilmar Reis, director of the outpatient research clinic at Cardresearch and associate professor of medicine at Pontifical Catholic University of Minas Gerais.
“There is particularly keen interest in our trial for its evaluation of ivermectin,” he added.
Ivermectin is an inexpensive drug costing less than $5 per treatment which is on the list of essential medicines published by the World Health Organization. Ivermectin is typically used to treat parasitic infections, however emerging evidence from smaller clinical trials may indicate a benefit for COVID-19 patients with early disease.
The study is also evaluating metformin, a drug widely used to treat diabetes, and fluvoxamine a selective serotonin reuptake inhibitor (SSRI) commonly used to treat depression and anxiety disorders.
It is anticipated that there will be up to 3,200 participants in the trial. It the study recruits patients at the same rate as its first evaluations, there could be results within three to six months, said Mills.
“As the pandemic continues with no end in sight for many low- and middle-income countries, there is a growing urgency for effective therapies. This could be a real game-changer,” he said.
“Many countries simply do not have the health care resources to continue the current rate of patients being admitted to hospital with COVID-19. The Together trial hopes to help identify therapies, of repurposed drugs known for decades to be safe, to slow the pandemic while many countries await the delivery of vaccines.”
Besides Mills, co-investigators for the Together trial include McMaster professors Lehana Thabane and Gordon Guyatt.