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.”
Dr. Kylie Wagstaff, PhD
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