Thomas Borody MB,BS, BSc (Med), MD PhD, DSc, FRACP, FACP, FACG, AGAF, touts FDA and TGA approved Ivermectin, which he reports to use regularly in his hospital as it evidences positive results for COVID-19 and should be used immediately to fight the pandemic. The developer of the world’s first cure for peptic ulcers, which saved millions of lives worldwide, employed the same methodology to come up with the Ivermectin triple therapy. With over 30 formal clinical trials, many dozens of observational real-world initiatives and hundreds to possibly thousands of doctors already using the medicine, a particular momentum gains speed for additional randomized controlled trials and, just as importantly, a more serious dialogue about the potential of this approach for pragmatic and economical treatment options for COVID-19.
The Real World Evidence
TrialSite has been tracking the use of Ivermectin since researchers at Australia’s Monash University and Peter Doherty Institute found that in the lab’s cell culture the anti-parasitic absolutely destroyed the pathogen. TrialSite found and interviewed doctors from Bangladesh and India to the Dominican Republic, Peru, Columbia and Iraq to the United States where Broward County Health approved an Ivermectin-based protocol with successful outcomes. A French company called Medincell even announced it would work on commercializing an ivermectin-based COVID-19 therapy. Search TrialSite for what are now many dozens of relevant real world data points.
TrialSite acknowledges the not only the importance of, but the necessity of randomized controlled studies; hence why the continuous reporting of important studies, such as University of Kentucky, Sheba Medical Center, KKR-backed Max Healthcare, Bangladesh Medical College and many other centers around the world.
Additionally, TrialSite is contributing to a significant clinical trial in the works in the United States. Targeting up to 2,000 patients, several hospitals seek to participate. The drug manufacturer will donate the drug and the high profile clinical trial operations experts have been engaged.
TrialSite Cautionary Point
Of course, TrialSite reminds all that despite the potential, this treatment is not approved in the United States nor in most nations, and per the U.S. Food and Drug Administration (FDA) any such health therapy that is associated with a claim must go through formally designed and approved clinical trials unless its use can fit into an acceptable off-label scenario.
Moreover, there is no cure for COVID-19. The only two drugs that are accepted by the FDA at this point are Remdesivir (via emergency use) and Dexamethasone (as it was included in the NIH’s clinical guidelines). The government also has accepted an emergency use protocol for convalescent plasma led by Mayo Clinic.
Of course, the hope is that a combination of safe and effective vaccines combined with advanced therapies in development, such as promising investigational antibodies including REGN-COV2, may help finally beat this pathogen.
Moreover, investigational antivirals or anti-parasitic are not cures either. If found to be safe and effective, they are used as part of a comprehensive COVID-19 management to treat at onset in a bid to reduce the severity of the infection which will hopefully help lessen the strain on the health care system as well as reduce the severity and the duration of the condition which can help society in a number of important ways. Effectively taking on and beating COVID-19 (and any future deadly pathogens) takes a combined and flexible approach based on evidence (from trials and real world).
The Australian Triple Therapy
Although Dr. Borody calls it an “Australian Triple Therapy,” a similar approach is used from Bangladesh and India to South America. Dr. Borody reports the combination of three approved “off the shelf” drugs may point to an answer of Australia’s COVID-19 crisis.
Professor Borody reports:
· “If nothing else, make it available in aged care homes immediately. Our elderly is at the highest risk and this is a very safe option especially when we have nothing else except ventilators.”
· “Also, our frontline workers deserve more protection with a preventative medication like this, and as emergency treatment if they test positive.”
· “An Ivermectin tablet can cost as little as $2 – which could make it by far the cheapest, safest, and fastest cure for Australians and the Australian economy.”
Borody on Safety
The Professor reports that Ivermectin has a good safety profile and, in fact, WHO reports, ‘Mass treatment with ivermectin: an underutilized public health strategy’…”Its time to capitalize on the full public health potential of ivermectin” as an anti-parasitic.
Furthermore in the recent Australian-originated press release: in the Journal of Antibiotics, a 12 June 2020 report on Ivermectin says:
“Several studies reported antiviral effects of ivermectin on RNA viruses such as Zika, yellow fever, West Nile, Hendra, Newcastle, Venezuelan equine encephalitis, chikungunya, Semliki Forest, Sindbis, Avian influenza A, Porcine Reproductive and Respiratory Syndrome, Human immunodeficiency virus type 1, and severe acute respiratory syndrome coronavirus 2.”
Ivermectin Therapy for COVID-19
Professor Borody points to his research that led him to a triple therapy of Ivermectin, zinc and an antibiotic—which are all TGA and FDA approved—which could be the fastest and safest way to stop the Victorian outbreak within 6-8 weeks. For more on this see Professor Borody’s published research papers, see here.
Professor Borody commented, “When State and Federal governments are saying they will do whatever it takes then I believe this is a potential life-saver right now.” He continued, “These medications are already approved. They do not need pre-clinical or clinical trials nor additional TGA approvals unless the aim is to combine in a single capsule, for example. Patient treatment programs have been done in the US and elsewhere which indicate it can work in 4-6 days.”
The professor argues in a recent press release that he has extensively reviewed the key antiviral scientific research literature and identified the combination of three drugs that are in chemists right now and can be prescribed by doctors immediately. Borody believes that the tablets can be taken at home as preventive treatment by high-risk individuals, or by those who test positive to minimize need for hospitalization at the higher curative dose.
What is this triple therapy?
- Ivermectin—TGA and FDA approved as an anti-parasitic therapy with an established safety profile since the 1970s. Known as a “Wonder Drug” from Japan
- Doxycycline—TGA and FDA approved tetracycline antibiotic fights infections such as acne, urinary tract infections, etc.
Thomas Borody, MB,BS, BSc (Med), MD PhD, DSc, FRACP, FACP, FACG, AGAF
Call to Action: TrialSite, an independent online media platform focused on clinical research accessibility and transparency with an emphasis on the research site, continues to accumulate significant data associated with Ivermectin and COVID-19 worldwide. Shortly, a TrialSite produced documentary on the topic in South America will be released to the public. Interested in connecting? Contact TrialSIte News.