Ministry of Health Malaysia starts Ivermectin trial for high risk COVID-19 patients (I-TECH Study)
By DG of Health on June 5, 2021

Effective pharmacologic treatments for COVID-19 remains a challenge. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial showed dexamethasone, a steroid, improved mortality outcomes for COVID-19 patients in severe stage of disease when oxygen supplementation or mechanical ventilation is required. But for the management of mild and moderate cases, there is lack of treatment, either to prevent disease progression or cut viral transmission.

The COVID-19 clinical characterisation study by MOH specialists and researchers found that for cases admitted to hospitals, 95% had mild illness but about 3.5% subsequently progressed to severe disease. They were mostly of older age (≥51 years) or had underlying co-morbidities such as chronic kidney disease and chronic pulmonary disease that increased their risk for severe disease. However, for high-risk COVID-19 patients, many repurposed antiviral therapies were found ineffective. The World Health Organization (WHO) COVID-19 Solidarity Trial for COVID-19 Treatments (SOLIDARITY) which included Malaysia, found insufficient evidence for the use of remdesivir, hydroxychloroquine, interferon, lopinavir in terms of mortality outcomes. Currently, the Malaysian Consensus Management Guidelines for COVID-19 maintains Favipiravir, as the only antiviral therapy for the management of COVID-19 cases. Even this recommendation may change as more evidence becomes available.

Ivermectin is an FDA-approved anti-parasitic drug widely used for treating several neglected tropical diseases, including onchocerciasis, strongyloidiasis and helminthiases. The “off-label” use of Ivermectin gained global attention due to some promising results by case studies and clinical trials. Yet, the evidence is inconclusive to recommend routine use of Ivermectin for COVID-19. The FDA has not approved Ivermectin for use in treating or preventing Covid-19 in humans, and the WHO only recommends the use of Ivermectin in the setting of clinical trials, in which patients are monitored closely by experienced clinicians and researchers for safety and efficacy. There is an on-going need for adequately powered, well-designed, and well-conducted clinical trials for evidence-based guidance on the role of Ivermectin in the treatment of COVID-19.

Under the circumstances, the Ministry of Health Malaysia and the Institute for Clinical Research (ICR) have initiated a multicentre open-label randomized controlled trial. The Ivermectin Treatment Efficacy in Covid-19 High Risk Patients (I-TECH Study) headed by Infectious Disease (ID) Physician at Hospital Raja Permaisuri Bainun, Ipoh and a team of specialists and Clinical Research Centres (CRC) at 12 MOH hospitals. The trial was approved by Medical Research and Ethics Committee (MREC), MOH on 25 May 2021. The study compares Ivermectin treatment (specific dose with specific duration) with the standard of care alone. The study will enrol 500 subjects from high risk groups aged 50 years and above admitted to MOH hospitals with mild/moderate COVID-19 symptoms (Stage 2-3). The study aims to determine the efficacy of Ivermectin in preventing the progression of COVID-19 to severe disease (Stage 4-5) and in terms of mortality outcomes. ICR has setup a Data Monitoring Board (DMB) consisting of independent ID physicians, clinical trial pharmacists and methodological experts to safeguard the trial patients on the safety and efficacy of the investigation product set by the National Pharmaceutical Regulatory Agency (NPRA).

The First-Patient-In (FPI) was on 31 May 2021, and to date 8 patients have been enrolled. The study is expected to be completed by September 2021.

Thank you.

Tan Sri Dato’ Seri Dr. Noor Hisham bin Abdullah

Director General Ministry of Health Malaysia

5 June 2021

https://kpkesihatan.com/2021/06/05/ministry...s-i-tech-study/

This post has been edited by cranx: Jun 5 2021, 10:55 PM

uh, wait....I thought he first mentioned about trials in January....may 25 baru approved and start???? Medical Research and Ethics Committee banyak lambat approve!!!

This post has been edited by diffyhelman2: Jun 5 2021, 11:07 PM

Pressured to do it, I guess.

This is in comparison with Pfizer MRNA vaccine.
Pfizer vaccine received EUA on 11th December and less than a month later registered by NPAR for use in Malaysia.

What should have been done is to authorize EUA for Ivermectin immediately. Desperate times call for desperate measure. Given the safety record of Ivermectin over the past 40 years, we have got nothing to lose.

3 months = 90 days
Assuming each day +/-100 death, we are looking at potentially 9000 deaths.

This post has been edited by cranx: Jun 5 2021, 11:20 PM

Cukurr sudah U-turn

Ya lor... all of them later found to be meh.... I wonder how a parasitic drug can be so effective against a viral infection....

tonight, somebody - or a group of somebodies - is actively bringing inactive /kopitiam threads back to the top

Yup.

Brand new mRNA and viral vector vaccine types with no long term safety record very fast approve.

Even the dexamethasone trials were very fast.

But Ivermectin (with 40 year safety record) trials announced in January now only start.

This post has been edited by JohnL77: Jun 5 2021, 11:32 PM

That is irrelevant and not applicable to this thread. TS posted about a letter by DG that was published today. I say that is highly relevant and topical news.

This post has been edited by diffyhelman2: Jun 5 2021, 11:39 PM

If the trial was started in January and proven to work, maybe May wave tak jadi.

Problem - Malaysia invested heavily in vaccines already, signed contracts with many BigPharma companies. With procurement done in such secretive manner, we won't know what are the terms and conditions being imposed on Malaysia as a country.

Do note Ivermectin if proven to be useful, will be vaccines direct competitor.

I sincerely hope there is still humanity in our medical establishment. Human lives above all. Conduct the trial in a fair and transparent manner, Ivermectin is not an experimental drug, it is proven safe and widely used for 4 decades. we should adopt the treatment immediately across Malaysia upon positive result.

Recent studies does show robust antiviral effect.
It has strong basis as antiviral agent.
Considering penicillin importance was accidentally discovered, no surprise it goes for this too.

Since the drug is cheap, its really a wonder why so little noise coming out of clinical research scene in malaysia, considering we have prevalent dengue.
Theres really no downside in starting clinical trial into this.
They say hindsight always 20/20 but Malaysian has always follow tried and proven, rarely deviating.
And degil at that. Professionals not exempted.

Slightly off tangent but cant really blame on our practitioners as such mindset born from cultures that predominantly infested with alternative medicine aka bullshit.
The more bullshit around, the more you yearned for a standard.

I really hope our government can stop stroking ego and start the trials.
And hopefully being discrete and tactful about this.
Malaysian ni bukan boleh buat main.
Vaccine taknak tapi random makjun balun.
We dont even have proper dosing established yet.
Dont need poisoning cases flooding the already limited bed we have.

Not it will not.
That is stupid.
It will be complimentary to vaccination.
We ideally want to cover all bases.
From prevention to mitigation to cure.
Yes its not experimental but for antiviral purpose, its shiny new

This post has been edited by cursetheroad01: Jun 6 2021, 03:40 AM

Ivermectin is used as a prophylactic with promising results, which is what the vaccines was developed for - to prevent infections and serious illness.

However these days the narrative seem to have shifted, more and more media seem to say vaccines cannot prevent infections but it is used for prevention of serious illness.

Come on.
You really think taking ivm everyday, shutting down the main core function of cells nuclear transport, viable as vaccine replacement?
And imagine supplying that to the whole population

It's theorised as prophylactic because of the proposed antiviral use. That's it.
We dont even know the correct dosing for daily intake.
One study used double the dose for it.
Only thing safe regarding ivm right now is because as antihelminthic, we're using them at low dose, once a week.
Any higher and it would cross blood brain barrier, which will definitely cause more side effect.

If the data stands up, ivermectin will surely be a good arsenal to deal with covid in clinical setting and properly assessed outpatient cases but vaccine is still the most economically and clinically viable solution.
It's a godsend drug yes but not a vitamin.

This post has been edited by cursetheroad01: Jun 6 2021, 10:44 AM

The brawl over Ivermectin
Health authorities, experts worldwide divided over use of antiparasitic in Covid-19 treatment

https://www.thedailystar.net/city/news/the-...rmectin-2108881

As Covid-19 cases are on the rise in the country, doctors are once again mulling over Ivermectin as a possible answer. However, controversy continues to follows this drug.

Ivermectin is a pocket-friendly anti-parasitic drug that has for decades been used to treat head lice and river blindness in humans and heartworms in animals.

The drug first came to notice with regards to Covid-19 treatment on April 3, 2020 when laboratory experiments done by researchers at Monash University of Australia found that ivermectin in vitro [performed outside of a living organism] had an inhibitory action on SARS-CoV-2, reducing the load of viral RNA by 5,000 times in 48 hours.

The ivermectin dose used in the study was 5 microgrammes (mcg) and the research was published in the journal Antiviral Research.

On Tuesday, the Indian government's Union Health Ministry dropped Ivermectin from the list of medications approved for the treatment of Covid-19, in its revised guideline.

Meanwhile, the Ministry of Health in Malaysia started an Ivermectin trial for high risk Covid-19 patients five days ago.

On the other hand, American Journal of Therapeutics published a meta-analysis of 18 ivermectin-related studies in their May/June 2021 issue, which concluded that the 18 studies found "large, statistically significant reductions in mortality, time to clinical recovery, and time to viral clearance."

The research was conducted by physicians from University of Wisconsin Health University Hospital and University of Texas Health Science Center, among others.

It is against this backdrop that Prof Dr Md Tarek Alam, head of department of medicine at Bangladesh Medical College and Hospital (BMCH), recommends that Ivermectin not be taken out of the race.

"In fact I think all adults should take a preventive dose of 12 mg of Ivermectin -- one tablet every ten days -- until we can test our antibodies," said Dr Alam.

Dr Alam's appeal comes from a study that physicians of BMCH did last year that was published in the European Journal of Medical and Health Sciences.

The study involved 118 healthy individuals working as healthcare providers in Covid-19 isolation wards in BMCH.

"The individuals were distributed into two groups (experimental and control) -- 60 subjects in control group and 58 subjects in experimental group," said the study, adding that the experimental group received 12 mg of Ivermectin every four weeks for four months.

"Seventy-three point three percent (44 out of 60) subjects in the control group were positive for Covid-19, whereas only 6.9 percent (four out of 58) of the experimental group were diagnosed with Covid-19," said the study.

Dr Alam said, "In May, we applied to the Bangladesh Medical Research Council for a trial but they gave us permission in August. By that time, Ivermectin was being used so extensively that we were not able to find 200 people who had never been exposed to the drug. We only got 35-40 individuals who never took ivermectin."

On December 7, 2020, icddr,b published results of a clinical trial that said "Ivermectin shows promise against Covid-19."

Some 68 patients hospitalised with Covid-19 were divided into three groups and administered Ivermectin, Ivermectin in combination with doxycycline, and a placebo.

"The study demonstrated that patients in the five-day ivermectin group were 77 percent more likely to have early viral clearance on day 14, compared to those who received ivermectin and doxycycline (61 percent) and placebo (39 percent)," said the icddr,b study.

The findings were published in the International Journal of Infectious Diseases (IJID) on 2 December 2020.

A different scenario was perceived in Barcelona, Spain -- according to a study published in the Lancet on January 19, 2021.

The study by ISGlobal and Barcelona Institute for Global Health received a single dose of Ivermectin of 400 mcg per kilogramme of weight, within 72 hours of a patient developing fever or cough.

"There was no difference in the proportion of PCR positives," found the study. "There was however a marked reduction of cough and a tendency to lower viral loads and lower IgG titers which warrants assessment in larger trials."

They concluded that "there is limited evidence to support its clinical use in Covid-19 patients."

Dr Alam said that Ivermectin's strength lies in symptom management. "The virus can stay in the body as long as it is not active. Hospital beds can be emptied faster."

The government gave permission to ten more pharmaceuticals to make Ivermectin, he pointed out. "The main resistance is from World Health Organisation, who says that there are not enough large-scale studies to support its use," he added.

"The current evidence on the use of ivermectin to treat Covid-19 patients is inconclusive. Until more data is available, WHO recommends that the drug only be used within clinical trials," said a statement by WHO released on March 31, 2021.

The US Federal Drug Administration also does not approve of the use of Ivermectin for Covid-19.

"FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. Taking large doses of this drug is dangerous and can cause serious harm," states the FDA on its website.

Even as the Indian health ministry omitted Ivermectin as a cure, the drug has been used in states like Delhi where the curve has gone down -- with the caveat that correlation is not the causation.

"Certain provincial governments have been administering Ivermectin, while others have not. Delhi for example started administering Ivermectin. Health clinics were giving Ivermectin to outpatients and the crisis we were seeing two weeks back is not as acute," said Dr Tarek Alam.

"The pandemic is like a war. Scientific discoveries are so rapidly changing. There is a huge chaos where the WHO is changing its stance all the time. There is nothing called an international standard or a gold standard," said Dr Rubaiul Murshed, the chairperson of Shomman Foundation.

"They were giving this to everyone in Uttar Pradesh before removing it from the guideline. If we are trying to go after the nitty-gritties, which direction will you go?" he said.

"Standard hospitals across the city are all giving out this drug. When there is no cure yet, we are drowning, we are clutching at straws," said Dr Murshed.

As of yet, there is not a clear solution to whether Ivermectin is the silver bullet or not -- but with more questions being asked, more answers are emerging.

Last week, Manitoba Premier Brian Pallister launched a $1 million grant to convince "hesitant" communities to get themselves vaccinated with one of the experimental shots on the market. But if people are hesitant about an experimental gene therapy that has already racked up a record number of serious adverse events on the CDC's Vaccine Adverse Event Reporting System (VAERS), why not spend the money persuading people to get ivermectin, a safe and effective early and prophylactic COVID treatment that has been approved by the FDA and the WHO for other uses for years?

In a recent video clip from one of his forums, Pallister was asked by a caller about another kind of hesitancy – not hesitancy to vaccinate, but "hesitancy to talk about ivermectin" and other early treatments. The caller cited the evidence about this drug, which "does no harm" and causes no risk to try it. The female caller completed her thought by asking him, "Are we doing anything with that, and if not, why not?"

As if to illustrate the caller's point, Pallister responded to her question about hesitancy to talk about ivermectin by ... refusing to talk about ivermectin! Like a programmed robot, Pallister blinked his eyes during her question, then proceeded to answer by discussing more about the vaccine! "We're pursuing domestic research that we hope can lead to better vaccine availability in the future, perhaps not during this wave, but when we need boosters in coming years," answered the Manitoban premier. He then quickly finished the discussion, put on his mask (even though he is vaccinated), and concluded the session.

This video embodies the criminal behavior of the political class in censoring lifesaving, cheap treatments like ivermectin. Even in vaccine-crazed Israel, they found in a small study of 30 patients that all of them recovered with the use of ivermectin, 29 of them within 3-5 days. In India, which was a hot spot until recently, much of the country began using ivermectin. Delhi saw a 99% decline in cases after beginning universal use of ivermectin. While cases were going down everywhere after reaching some level of immunity, a 99% reduction from April 24 to June 7 is remarkable and much steeper than anywhere else in the world following a big wave.



A similar dynamic played out in the state of Uttar Pradesh, which is now 98% off its peak of COVID cases in late April. India's overall reduction since its peak five weeks ago was 76%, more in line with what we saw in the U.S. and Europe, once the peak wave passed and a modicum of herd immunity kicked in.

Despite Fauci warning about the Indian "Delta" variant being more deadly and continuing to push vaccines as the only solution, in reality, India's death rate from COVID — even after achieving what appears to be herd immunity — is just one-seventh of our COVID death rate and that of other European countries! India's death rate is even lower than Israel's and fairly close to that of Finland, which largely escaped the worst of the virus so far.



And no, the secret sauce is not the vaccine, because fewer than 15% of Indians have received at least one dose, while over 50% of Americans and 60% of British citizens have already had one shot.

The secret sauce is natural immunity, which is much stronger than the vaccine, along with arming people with early, cheap treatments to obtain that natural immunity as risk-free as possible.

In a remarkable contrast from the legal establishment in the U.S., the Indian Bar Association served Dr. Soumya Swaminathan, an Indian pediatrician who is the chief scientist at the World Health Organization (WHO), with a legal notice for spreading disinformation about ivermectin. Dr. Swaminathan recently tweeted that the WHO advises against use of ivermectin outside clinical trials:

Some Indian states have taken this guidance to heart. In the southern state of Tamil Nadu, the newly elected governor, M.K. Stalin, excluded ivermectin from the treatment protocol and opted instead for the expensive and ineffective remdesivir. The result? Just the opposite of Delhi. The virus continued to peak for an extra month and only recently began to recede at a much slower rate.

The state of Goa, which is also in the south, began offering ivermectin to all adults on May 11. The 87% drop in four weeks is remarkable.

Ditto for Karnataka, another southern state neighboring Tamil Nadu, that sanctioned the use of ivermectin.

In Uttarakhand, another ivermectin state in the north, cases dropped by 95% since the peak.

The point is that, while herd immunity seems to be the major factor, the states that used ivermectin seemed to experience an earlier peak and a steeper decline in cases than those that shunned ivermectin. The troubling question is what these curves would have looked like had the WHO recommended ivermectin before the virus began to spread and if it had used at the first sign of trouble with the same religious fervor as vaccines, remdesivir, and masks. We will never know, but we can surmise that the curves would have been milder based on the results we are seeing from those countries that used it once they were in a world of trouble.

Mexico experienced a sharp increase in cases during the winter, but enjoyed much success in the regions that used ivermectin. Last month, Mexico City Mayor Claudia Sheinbaum held a press conference where she claimed a study showed ivermectin decreased the likelihood of hospitalization in her large metropolis by between 52% and 76%.

The question everyone needs to answer is this: With all of the adverse reporting from the experimental vaccines, why do the global authorities continue to push them like candy without further study, when they refuse to greenlight ivermectin, with 29 randomized controlled trials vouching for its efficacy with no side effects and 4 billion doses dispensed over decades?

Following the money trail will be very instructive in answering this question. Why would GAVI, the Vaccine Alliance, pay for Google AdWords to warn against ivermectin? Why are Big Pharma and Big Government censoring EVERY alternative treatment, including the ironclad research behind preemptively bulking up one's vitamin D, vitamin C, and zinc levels? Those questions provide the answer to the censorship of ivermectin. According to GAVI's website, the "Gates Foundation pledged US$ 750 million to set up Gavi in 1999" and "the Foundation is a key Gavi partner in vaccine market shaping."

Well, boxing out all alternative treatments is one way to engage in "vaccine market shaping." There's nothing quite like a market with just one show in town.

Indeed, the Wuhan lab is not the biggest story of COVID. It's the global genocide that is taking place at the hands of those who claim to care most about COVID, yet ensure that any effective treatment is not made available to the public.

https://www.theblaze.com/op-ed/horowitz-the...-story-of-covid

This post has been edited by cranx: Jun 11 2021, 01:05 PM

Sen. Ron Johnson, R-Wis., has been suspended from uploading videos to YouTube for seven days and had a video of a speech talking about early treatments to COVID-19 removed by the video-sharing giant.

The video removal and upload ban came after two videos of Senate Committee on Homeland Security and Governmental Affairs hearings he led on early experimental treatments to the novel coronavirus, such as hydroxychloroquine and ivermectin.

Johnson told Fox News that "YouTube's ongoing COVID censorship proves they have accumulated too much unaccountable power."

"Big Tech and mainstream media believe they are smarter than medical doctors who have devoted their lives to science and use their skills to save lives," Johnson said. "They have decided there is only one medical viewpoint allowed, and it is the viewpoint dictated by government agencies. How many lives will be lost as a result? How many lives could have been saved with a free exchange of medical ideas?"

"Government-sanctioned censorship of ideas and speech should concern us all," Johnson added.

A spokesperson for YouTube told Fox News the website took down the video because it violated its COVID-19 "medical misinformation policies."

"We removed the video in accordance with our COVID-19 medical misinformation policies, which don’t allow content that encourages people to use Hydroxychloroquine or Ivermectin to treat or prevent the virus," the spokesperson said.

"YouTube doesn't allow content that spreads medical misinformation that contradicts local health authorities’ or the World Health Organization’s (WHO) medical information about COVID-19," the policy reads.

Specifically, the company will remove content promoting the use of hydroxychloroquine and ivermectin unless there is enough countervailing context, a YouTube blog post explains.

The video in question is of a speech Johnson gave where he torched the Biden and Trump administrations for "not only ignoring but working against robust research [on] the use of cheap, generic drugs to be repurposed for early treatment of COVID" and noted he held two hearings on the matter.

"It always baffled me that there was such a concerted effort to deny the American public the type of robust exploration research into early treatment early in this pandemic," Johnson said, adding that hydroxychloroquine and ivermectin -- two drugs used in early treatments for COVID-19 -- are "incredibly safe."

Additionally, Johnson touched on testimony from one of the hearings he led that spoke about "the four pillars of pandemic response," such as preventing the virus from spreading, vaccines, hospital treatments and early treatments.

Hydroxychloroquine and ivermectin have been on the market for years and are primarily used to treat diseases like scabies and lupus.

Former President Trump touted hydroxychloroquine as an early treatment to COVID-19 for hospitalized patients, invoking scrutiny from the media.

https://www.foxnews.com/politics/ron-johnso...ored-by-youtube

Where did he said January? I thought January was trials for vaccines. Not for ivermectin.

update. sadly taken down.
new link here
https://www.bitchute.com/video/qHjNQIynVb5O/