The TrialSite Network eagerly awaited a pilot clinical trial investigating the safety and efficacy of Ivermectin sponsored by the University of Baghdad in Iraq. Led by Professor Faiq Gorial, this study target 100 patients in a Phase 1 clinical trial investigating the efficacy of add on therapy of a single dose of Ivermectin to hydroxychloroquine (HCQ) and azithromycin (AZT) in COVID-19 patients versus a non-Ivermectin group just having HCQ and AZT. A couple weeks ago, Professor Gorial communicate with TrialSite News that he was trying to publish his results. In the meantime, they have been posted to the medRxiv preprint server, so they are still not “peer reviewed.” The pilot trial conducted on hospitalized adult patients with mild to moderate COVID-19 diagnosed according to WHO interim guidance. 16 patients received a single dose of IVM 200Mcg/kg on admission day as add on therapy to HCQ and AZT and were compared with 71 controls receiving HCQ and AZT matched in age, gender, clinical features, and comorbidities. The University of Baghdad researchers concluded that adding the use of Ivermectin to HCQ and AZT proved to: A) better effectiveness B) shorter hospital stay, and C) relatively safe compared with controls. Professor Gorial, a scientist, acknowledges that a larger prospective study with greater follow up duration could be needed to validate the results. But the results are yet another real world data point that Ivermectin may be a safe and effective treatment for COVID0-19.
Many in the TrialSite Network are keen on the results from the growing numbers of studies currently underway. Although it is not clear if this study will be accepted in a journal, having the information for review is important regardless. This study doesn’t answer any big questions. It simply represents another real world data point, one of many growing real world encounters, and that there may be some merit in taking a deeper look into Ivermectin as an off label drug to treat COVID-19.
The study ultimately included 87 patients (they targeted 100) and the mean age of the patients in the Ivermectin group was similar to controls; [44.87 ± 10.64 (28-60) vs 45.23 ± 18.47 (8-80) years, p=0.78]. As it turns out a majority of the patients in both groups were male but statistically not significant–[11(69%) versus 52 (73%), with male: female ratio 2.21 versus 2.7-, p=0.72). All of the patients in the Ivermectin group were cured compared with the controls[ 16 (100 %) vs 69 (97.2 %)]. Two patients died in the control group (e.g. the group taking HCQ and AZT). Noteworthy, the mean time for patient stay in the hospital was significantly lower in the Ivermectin group when compared to the controls (7.62 ±2.75 versus 13.22 ±.90 days, p=0.00005, effect size= 0.82). No adverse events were observed.
Professor Gorial and team concluded that the add on use of Ivermectin and Hydroxychloroquine and Azithromycin evidences a superior health outcome, shorter hospital stay and relatively safe compared with controls.
Critics will undoubtedly declare this is yet another study that is too small, or lacks sufficient data or isn’t worth a bother unless published in a peer reviewed journal. Any true scientists understands the importance of the continuous scanning of the real world for meaningful observation in their field of study. Of course, the more data the better, and the source does mean something. Real world data needs to be validated and verified. It is fascinating to watch the rush to repurpose expensive IL-6 inhibitors (at great cost and failure) yet if the drug to be repurposed doesn’t fit in a certain paradigm, or assumption, than it cannot be considered. That flies in the face of the scientific method. That the continuous and ongoing openness to new meaningful new information that can help human beings not only understand their world, but to shape it for a better outcome tomorrow than today. That is the basis and foundation for human progress. Unfortunately, as throughout history, at times certain influential or powerful groups, for whatever reason, don’t necessarily desire the best outcome for all. Purported scientists are employed to quickly discount, dissuade and disqualify some emerging and meaningful trend that could lead to a, guess what, surprising outcome. Those defenders of the status quo evidence absolutely no intellectual curiosity as applied to anything that doesn’t fit within the limited confines of their own narrow assumptions.
That a growing number of positive observations associated with human Ivermectin use targeting COVID-19 patients from around the world doesn’t faze them in the least bit isn’t surprising anymore. Although they appear aloof and cold to such information, in fact they tremble in fear.
From hospital approved protocol studies in India and Bangladesh to an entire health system in Dominican Republic to regions in Bolivia and Peru where authorities have approved the use of the anti-parasite drug to Mexico and elsewhere, real world evidence mounts. A successful French venture that has received funding from the Bill and Melinda Gates Foundation just raised funding to commercialize an Ivermectin treatment is yet another example.
In the U.S., Dr. Jean-Jacques Rajter and team at Broward County Health published their results and, big surprise, no takers from the academic journals yet The Lancet almost blindly accepted the Surgisphere study ripping apart Hydroxychloroquine that from the start was apparent to be designed on completely questionable data sources. How could that happen? Why would that be? It took a group of prominent scientists to send a scathing critique to even address the issue.
After all, that is why the U.S. Food and Drug Administration (FDA) established a framework that can be used to survey observational evidence: called Real World Evidence or RWE. It was apparent that with the advent of electronic medical records and other technology advances that there was now potentially useful data that off label treatments could work on different indications, and that the off label use of a particular approved drug would potentially get more patients healthier and faster. In fact, repurposing drugs based on off label use happens frequently.
Ivermectin is an FDA approved, human pharmaceutical. Some cursory tricksters out there are playing a coy but aggressive game by posting articles that Ivermectin is “an animal drug” and shouldn’t be consumed by people. But actually it’s an FDA approved human drug and there also happens to be have animal versions. Several companies, including Merck, manufacture the drug for human administration—see the FDA label for Stromectol.
In fact, so much of this “wonder drug” is prescribed for anti-parasite-based human prescription that its safety profile is well known. So it turns out, Ivermectin is just another off label, approved drug that in the context of COVID-19 first Monash University conducted lab experiments and then hundreds followed. There are now over 30 Ivermectin-based clinical trials published on Clinicaltrials.gov. Censorship isn’t a good thing especially in democracies and particularly during a deadly pandemic. Scientists, be open to meaningful and relevant real world data; and when there is “enough” of it accumulated, consider experiments. What if it actually worked and there was a safe and economical choice on the market that could help health providers combat this horrific pathogen? Could that be a bad thing?