Prominent NYC Trust Awards $1.4m to Monash & Doherty Institute to Advance Ivermectin Research Targeting COVID-19

May 25, 2020 | Blog, COVID-19, Ivermectin, Leading Sites, Leona M. and Harry B. Helmsley Charitable Trust, News, Peter Doherty Institute, Popular Posts, SARS-CoV-2, Site Success, Site Watch, University, University of Melbourne

Prominent NYC Trust Awards $1.4m to Monash & Doherty Institute to Advance Ivermectin Research Targeting COVID-19

The growing interest in ivermectin as a possible treatment for patients infected with SARS-CoV-2, the virus behind the COVID-19 pandemic, was triggered by a laboratory experiment in a cell culture undertaken by Australian-based scientists at Monash University and the Peter Doherty Institute. In preclinical cell culture experiments, they found that the antiparasitic drug zaps the novel coronavirus. Despite some prominent critics, who imply that time shouldn’t be wasted on ivermectin in the context of a COVID-19 treatment, a wave of primarily pilot clinical trials has ensued, including randomized controlled trials at Johns Hopkins University and the University of Kentucky involving ivermectin. Now, the Leona M. and Harry B. Helmsley Charitable Trust (Helmsley Trust) in New York awarded Monash University a donation of $1.4 million to find the optimal dosage to ensure safety and efficacy; along with a commitment to fully fund a rapid-result dosing trial.

The Australian Catalyst Lab Study

TrialSite News was one of the first online media sites to not only report on this study but also initiate engagement with researchers worldwide. The original study was published in Antiviral Research. According to Dr. Wagstaff, “We found that even a single dose could essentially remove all viral RNA by 48 hours and that even at 24 hours there was really significant reduction in it.” A little over a month later Monash University teamed with Taiwan’s Chang Gung University to consider a clinical trial targeting COVID-19 with ivermectin.

A Flurry of Activity

The U.S. Food and Drug Administration (FDA) almost immediately published more than cautionary responses, including the “FDA Letter to Stakeholders: Do Not Use Ivermectin Intended for Animals as Treatment for COVID-19 in Humans,” as well as a question and answer fact sheet titled “FAQ: COVID-19 and Ivermectin Intended for Animals.” The U.S. drug regulatory authority declared that ivermectin should not be taken for COVID-19, regardless of the fact that the antiparasitic drug has well-known approved human uses (e.g. anti-parasitic). The American regulator offered a link to the Monash University and Doherty Institute published study and commented: 

These types of laboratory studies are commonly used at an early stage of drug development. Additional testing is needed to determine whether ivermectin might be appropriate to prevent or treat coronavirus or COVID-19.”

By including this aforementioned statement, the FDA explicitly suggested to the research community for the studies to commence. And they certainly have. In just several weeks, there are now at least 14 known ivermectin-based clinical trials targeting patients mildly ill with COVID-19. Granted, some of the studies are in some form of pilots or some form of proof-of-concept. Nonetheless, growing momentum is building in research communities worldwide in a quest for a low-cost, accessible and effective treatment for the vast majority of COVID-19 cases, which involve mild to moderate severe cold-to-flu like symptoms.   

A Nobel Prize

TrialSite News has spoken with a number of experts—including some scientists who have worked with 2015 Nobel Prize winner William Campbell for work associated with ivermectin. In fact, Dr. Campbell, along with Satoshi Omura, won the prestigious award for their discoveries concerning a novel therapy (ivermectin) against infections caused by roundworm parasites.  

Next Steps: Finding a Safe & Effective Dosage or ‘Optimization’

Along with the dozens of other formalized studies now underway, the original Australian team will work to establish an optimized dosage for the use of ivermectin in humans with COVID-19. Should they produce positive outcomes, clinical trials will ensue. 

The same team that performed the first lab experiment that triggered the push for ivermectin as a possible therapy to treat COVID-19 will lead this next round of important research that could directly lead to an actual Monash and Doherty Institute-sponsored clinical trial funded by Helmsley. 

Dr. Kylie Wagstaff from the Monash Biomedicine Discovery Institute teams with the Peter Doherty Institute of Infection and Immunity (Doherty Institute)—a joint venture involving both the University of Melbourne and Royal Melbourne Hospital to lead the charge progressing ivermectin research from early stage in-vitro research to pre-clinical trials in anticipation of a full-scale human-based clinical trial in Australia.

Now funded for the next step of research, the team will work in an attempt to optimize ivermectin dosage based on safety and efficacy requirements. If this pre-clinical research leads to satisfactory outcomes, Helmsley will fund formal GcP-compliant clinical trials as depicted in the Monash University “Discovery Pathway.”

A Thankful Group of Scientists

According to the recent news release from Monash University, the team led by Dr. Wagstaff was grateful for the financial support from the U.S.-based foundation. With so many lives already lost, not to mention the millions that have fallen ill and the economic carnage caused by this pandemic, such targeted and select funding can lead to a series of incremental, yet in the aggregate, monumental impact. As Dr. Wagstaff commented, “We are conducting a range of optimization experiments that, if positive, will determine the best dosage and treatment regimen to move forward into clinical trials. Our research will be significantly accelerated as a result of this generous contribution.”

The Charitable Trust 

One of the 15th largest in America, this foundation awards over $250 million per year and has given $2.8 billion since 2008. The Leona M. and Harry B. Helmsley Charitable Trust aspires to improve lives by supporting exceptional efforts in the U.S. and around the world in health and select place-based initiatives. 

Walter Panzirer, a Trustee at the Helmsley Charitable Trust, declared: “Medical advances are a critical part of the path out of the global COVID-19 crisis, and we need as many options as possible. The in vitro results of ivermectin are especially encouraging given how inexpensive and accessible the drug is everywhere in the world.”  Mr. Panzirer continued “At Helmsley, we pride ourselves on moving quickly, and providing support that others cannot, which often includes early stage clinical efforts like this ivermectin dose optimization study. If Dr. Wagstaff’s research ultimately yields positive results, ivermectin could become the great equalizer and life-saver in fighting COVID-19, like its been for other devastating conditions.”

Lead Research/Investigator

Dr. Kylie Wagstaff, PhD 

Call to Action: TrialSite News monitors these ivermectin studies and will offer updates as they materialize. Sign up for the daily newsletter for updates.

5 Comments

  1. Hoyt Nelson

    SORRY I left a bit out of point 1. Use this instead!

    So many things wrong with this article.

    1) William Campbell did not knock ivermectin. When asked about it’s efficacy with covid-19, he said he didn’t know — which is the answer any responsible researcher MUST say because the clinical trials are still underway.

    2) Ivermectin isn’t *just* an antiparasitic. If you search PubMed for “ivermectin antiviral” you’ll get 54 hits. It’s been shown to clear the dengue fever virus.

    3) There are 14 ivermectin vs covid-19 trials on ClinicalTrials, as you write — and 2 more on the EU equivalent, plus perhaps 6-8 unregistered trials.

    4) Derek Lowe did very little research for his blog about ivermectin. He originally posted that there was only 1 clinical trial underway when there were 10; he updated later when I let him know there were 10. His argument that the concentration of ivermectin would be too high, based on the Monash result, is just an echo of the two letters that accompanied Monash on Lancet. It’s also just plain bad science, projecting from in vitro results, which Mr. Lowe should know. He may be brilliant on other topics but he’s very very far from an ivermectin expert.

    5) You neglect to mention the amazing “Usefulness of Ivermectin…” study by a team out of UofUtah and Harvard that found that ivermectin lowered fatalities 83%.

    https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3580524

    6) You fail to mention the finding that ivermectin binds to the importin proteins that the coronavirus otherwise uses to enter to nucleus, where it replicates. Ivermectin stops that.

    https://pubmed.ncbi.nlm.nih.gov/32135219/

    If someone hired me to write a hit-piece about ivermectin it would read a lot like this. You insinuate negative opinions that aren’t there. You uncritically cite the comments of an ivermectin amateur. It is not impressive journalism, in my opinion.

    Get in touch if you want me to write a positive article about ivermectin. There is a lot of good news.

    I believe the first clinical trial is scheduled to complete on June 10.

    Thanks for posting this.

  2. bh

    It is interesting how other countries seem interested in finding treatments for Covid. The best our FDA can do is tell everyone it is too dangerous and we need to wait for a couple of years until they decide if it is safe. In the mean time they say don’t do anything and just take your chances with the disease. For them it is better to risk the 5% chance of dying from Covid than to try a drug that might have a .001% chance of having a side effect. Once this pandemic has passed I think the US needs to rethink the roll of the FDA. Maybe the just replace them with something better suited to dealing with pandemics. Everything they do takes years. With a pandemic you do not have years.

  3. Patricia

    Ivermectin DOES work against covid19, it save my family’s life in Iquitos, Peru, including my auntie who is 78 y/o, overweight, and has high blood pressure.

    The most important thing with this drug is TIMING, it must be taken as soon the first symptom appear and IT WILL STOP the virus.

    The dose is: day 1 take 0.2 mg per Kg of weight of patient, take a second dose 24 hrs later, take a 3rd dose 24 hrs after 2nd dose.

    The FDA advising against Ivermectin for animals make sense but Ivermectin for humans is completely safe to take for any human weighting 15kg or more.

    Ivermectin’s been use by humans since the 80’s all over the world, and in many cases saving lives of thousands.

    And by the way, the type of Ivermectin my family took was the one for animals, which was apply as an injection with no side effect. They used that one because there was no other type available and choosing between getting Ivermectin for animals or dying with covid19, they chose Ivermectin, remember in my hometown there are no more hospital taking covid patients, there are no ventilators, no oxygen tanks…

    • TrialSite

      Dear Patricia,
      We are thankful for your visiting the TrialSite News and communication to the TrialSite Network. We must emphasize that this isn’t a site that can dispense medical advice so that whomever has COVID-19 should see a doctor in their community to determine what is the acceptable and legal treatment for that community.

      Yes we have spoken with many doctors and people around the world, including Latin and South America–where Ivermectin is in use. And we have many dozens of accounts now of ivermectin “working” but unfortunately as compelling as these personal accounts may be, we must generate data in such as way that it can be aggregated, analyzed and ultimately published in such a way that the scientific and medical community–not to mention regulatory communities–accept this economical approach for addressing mild cases of SARS-CoV-2. Otherwise it cannot be considered a treatment.

      In regards to the FDA they are actually open-minded to the scientific method. In fact in their Q&A on the topic they declared on the Monash University/Doherty Institute study that these early stage lab studies are common and that “additional testing is needed to determine whether ivermectin might be appropriate to prevent or treat coronavirus or COVID-19.”
      https://www.fda.gov/animal-veterinary/product-safety-information/faq-covid-19-and-ivermectin-intended-animals

      So the FDA is clearly supportive of sponsors setting up and conducting properly designed randomized controlled trials to determine the safety and efficacy of ivermectin. The challenge there is that presently sponsors that are driving expensive clinical trials opt for vaccines and therapies that preclude this approach.

      We can report a growing number of clinical trials involving ivermectin in Egypt, Iraq, Argentina, Mexico, Brazil, the USA and probably more. We got beat up the other day because we were incorrect by a few studies. There are undoubtedly more than we know.

      Additionally we propose some form of global ivermectin registry, where a study group could take data from the many–probably tens to hundreds of thousands of off label use cases, hospital protocols, small non-randomized studies, etc.—and analyze data. Hopefully something like this is in the works.

      The ultimate goal is to contribute to the health for all the world’s people.
      Best Regards,
      Publisher

  4. Payam

    Thank you trial for the latest news on ivermectin🙏🙏✌️🌹

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