November 09, 2021
High-dose ivermectin for early treatment of COVID-19 (COVER study): a randomised, double-blind, multicentre, phase II, dose-finding, proof-of-concept clinical trial
Lead Author:
Dora Buonfrate
Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore–Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy
Link : https://www.sciencedirect.com/science/article/pii/S0924857921013571
Note that this study was “selected” by the Cochrane Library Issue 6, 2022 as part of 11 Studies in a paper titled “Ivermectin for preventing and treating COVID-19 (Review)”
The Cochrane Library “review” has since been cited by the Pharmacy Guild of Australia as headed by Trent Twomey in their submission to the Australian TGA to extend a ban on prescribing Ivermectin in Multi-Drug Treatments of Covid-19
When an institution sets out to do a study on an existing prescription medication that is widely reported to be a part of a Multi-Drug protocol saving tens of thousands of lives it needs to proceed with extreme caution with any conclusions that it makes that could lead to that medication not being used in Multi-Drug protocols.
There is a duty of care on the institution conducting the Clinical Trial to do all it can to approach the conditions of use of that medication that are reported to be working.
In all but the most conclusive negative findings should an author or institution, in good conscious, intentionally use a study to dissuade the use of a reported life saving component of a protocol widely reported by hundreds if not thousands of doctors to be saving lives that would otherwise have been lost. For if they do dissuade or assist in the prohibiting of the use of that medication they can be contributing to the deaths of thousands of people.
At the time this study was published it was all but common knowledge among doctors on the front line treating Covid-19 with multi-drug protocols that there were peer reviewed studies using Ivermectin to safely treat at risk covid-19 patients.
This study suggesting no efficacy for using Ivermectin was intentionally submitted for publication November 09th 2021
Here is an archived copy of a well known Covid-19 peer reviewed treatment guide that included Ivermectin as part of a Multi-Drug Protocol that predates this publication by over 10 months: Jan 2021 Snapshot - Covid19 Early Treatment Guide
Here is an archived copy of a website that, again, predates this publication by over 10 months where Ivermectin papers were compiled and links to all the studies provided that website concluded:
"The probability that an ineffective treatment generated results as positive as the 35 studies to date is estimated to be 1 in 34 billion (p = 0.000000000029)"
Jan2021 Snapshot - ivmmeta.com
Following Substack and its study/paper is what the Bill and Melinda Gates Foundation should have been dying to fund to demonstrate that Humanity was their primary objective.
In http://tribeqr.com/v/gatessubstack the key traits for looking at any study to see if it is designed to fail
When a study shows a finding so far off that which is observed in a clinical setting (real life) then whether intentional or not there are affiliation links to look out for and their are four (4) key designed to fail characteristics as a good litmus test.
Affiliations:
Look at the Authors and and their Affiliations with institutions receiving funds from the Bill and Melinda Gates Foundation (BMGF) or other World Economic Forum or World Health Organization aligned funding sources.
These institutions are very focused on the success and a world dependence upon controlled and patented medications.
The BMGF Grants Excel File will help you check most papers:
Here is a template form from the New England Journal of Medicine that Authors of this paper must fill out in disclosing conflicts of interests:
Excerpt:
Identified Conflict of Interest
Sitting on the Expanded Board of the International Federation for Tropical Medicine is Paper co-author
Professor Zeno Bisoffi (MD, PhD, DTM&H)
Three months prior to the Publication of this Paper the International Federation for Tropical Medicine received a “Grant” from the Bill and Melinda Gates Foundation for USD 13,300,000
The Lead Author of this Paper is Dora Buonfrate and she is in the Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore–Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy
Designed to fail characteristics; Here you will invariably see one or more obvious design flaws from i),ii),iii) and iv) Identified and tested below:
i) Not done in the early stages (eg Viral replication has taken place)
By the time this study was done it was common knowledge that Ivermectin, when used in the prevention and or treatment of Covid19 is used as part of multi-drug Protocols and is MOST effective when treated in the first 5 days of the disease.
See: https://aapsonline.org/covidpatientguide/
This is the stage when Covid19 is in the viral replication phase
In a trial designed to fail for Ivermectin it would insure Ivermectin was not given in the first 5 days.
In this trial:
“Table 1 Demographic and baseline characteristics of the study participants, overall and by study arms”: Days with symptoms [median (IQR)] 4.0 (3.0–5.5)
In this trial the mean time between giving the limited 5 days course in this study was FOUR (4) days with 25% not receiving the drug within 5.5 Days
ii) Wrong and/or known dangerous dosages
Ticks this Box See the Study : Introduction
"(600 μg/kg plus placebo for 5 days (arm B); and 1200 μg/kg for 5 days (arm C)"
By the time this study was done it was common knowledge that Ivermectin, when used in the prevention and or treatment of Covid19 is used as part of multi-drug Protocols and is MOST effective when used for 5 to 30 days of the disease.
See: https://aapsonline.org/covidpatientguide/
In a trial designed to fail for Ivermectin it would insure Ivermectin was not given for a long enough period
iii) In the absence of known critical partner Drugs - in the case of HCQ and Ivermectin without Zinc
Ticks this Box See the Study : Methods Sub Section Interventions
By the time this study was done it was common knowledge that Ivermectin, when used in the prevention and or treatment of Covid19 is used as part of multi-drug Protocols that includes Zinc
It has been known for years now that Ivermectin is a Zinc Ionophore and that this property alone can account for the results being seen around the globe in clinics using BOTH Zinc and Ivermectin in their Covid-19 treatment Protocols.
See: https://aapsonline.org/covidpatientguide/
The paper below from way back in 2010 showed this path was (or should have been) common knowledge. You and no doubt the Authors of this “study” can and could have seen it in the October 2010 Paper!!
It is worth repeating: at the time of this study it was academic and medical common knowledge that Ivermectin and Hydroxychloroquine were being used as Zinc Ionophores in LIFE SAVING Covid-19 treatments. and this study omitted Zinc!
See: https://pubmed.ncbi.nlm.nih.gov/21079686/
You can also directly download the peer reviewed October 2010 paper below (just in case); some of the “respected” medical journals are now removing both submitted and peer reviewed papers that their sponsors may not like published.
Download
This “study” clearly Ticks this “Failure Design” Box
In a trial designed to fail for Ivermectin it would insure Ivermectin was not given with partner drug Zinc.
iv) Done on a population group where you can expect a good outcome regardless of what was tested hence "no statistical difference" result
Common Trick 1) - Low Risk Age Group - Most participants under the age of 75
Common Trick 2) - Small Study Population - Under 100
Ticks this Box for Trick 1) Low Risk Age Group: “Table 1 Demographic and baseline characteristics of the study participants, overall and by study arm”
The median (IQR) age of the participants was 47 (31-58) years
which uncovers that 75% of the participants were under 58
(IQR) Means the middle 50% of participants in that age range (Namely 31-58)
So a further 25% of the study group are under 31 Years of Age
The chances of Hospitalization because of Covid19 are very low
By the time this study was done it was common knowledge that the hospitalization and death with Covid19 was highly age related because the elderly do not have as strong an immune system as the majority of the population. Median ages of Death “with Covid” was known to be circa 80 years old and above.
From the CDC Website
In a trial designed to fail for Ivermectin it would insure Ivermectin was not given to a large group of the most at risk candidates. Giving an intervention to the least at risk individuals; those with a natural immune system best equipped to deal with an infection will significantly if not completely mask observable differences from the intervention which is reported world wide to reduce hospitalization and death for those at most risk.
If this trial had limited the age of participants to 65 and above they would have been able to observe possible differences of outcomes that were orders of magnitude greater than was possible with the the age group criteria of this study.
Put simply, proposing a trial designed like this one was like saying “we will limit the study to people that we would ordinarily expect to recover without an intervention (young people) and see if the intervention makes any difference.
Ticks this Box for Trick 2) - Small Study Population - Under 100: “Table 1 Demographic and baseline characteristics of the study participants, overall and by study arm” Overall (N = 93) That’s like saying lets see if we show a statistically significant reduction in death where the known likelihood of death is 1 in 1000 chance of dying from the baseline we receive them but lets keep the study group down to under 100 people
Even if you beat the odds by 10 and someone did die in the untreated group you could still state the benefit would be “statistically insignificant”.
And this study had a third “trick”
The study Group was limited to a severity score of 2 or under
See: 2.2. Participants and study sites
To expose this further
“Table 1 Demographic and baseline characteristics of the study participants, overall and by study arm” COVID-19 severity score
Over 80% of the tiny group of 93 patients were Mildillness (Severity 1) with the remaining 15 participants classified as “Moderateillness” with no “no limitation on activities”
Its like saying lets look at iced water and see if ice-blocks will chill the water any further; if they don’t then ice blocks don’t chill water.
To read up more on the “The War On Ivermectin” :
Direct link https://www.amazon.com/exec/obidos/ASIN/151077386X
Share link you can text : http://tribeqr.com/v/cochranetd01
For Another Study Designed to fail see: http://tribeqr.com/v/gatesivermectin01
For yet Another Study Designed to fail see: http://tribeqr.com/v/gatesivermectin02
https://twitter.com/tniwef/status/1663144148818612224
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Ivermectin 03 : Another Sponsored Study With a Design That Will Fail.