The Front Line COVID-19 Critical Care Alliance (FLCCC) recently presented their meta-analysis of randomized controlled trials involving Ivermectin as a treatment option for COVID-19 to the National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel. A few weeks prior, this same group of physicians/researchers presented a similar themes presentation to the U.S. Senate. With a growing number of ivermectin-focused randomized controlled trials around the world, public research agencies’ interest has perked up. Despite vaccines now authorized under emergency use, early onset treatment options are still necessary. The U.S. government continues to pour money into expensive novel monoclonal antibody development recently placing $486 million to develop novel COVID-19 therapies—clearly the need is present, and imminent, with such amounts of money involved. Now the peer-reviewed frontiers in Pharmacology has published an important manuscript authored by FLCCC members Dr. Kory and Dr. Paul Marik as well as a group of esteemed colleagues from the United States and Europe reporting on emerging case evidence for ivermectin. The accomplished physician/researchers were able to manage three stage-gate scientific peer reviews; the full manuscript will be published and available within a few weeks. The scientific paper introduces the discovery that ivermectin, an anti-parasitic medicine, possesses potent anti-viral and anti-inflammatory properties targeting COVID-19. The researchers have already identified a number of repeatable, consistent, and material improvements associated with clinical outcome in over a dozen significant randomized and observational controlled trials in both prophylaxis and treatment regimen for COVID-19. Moreover, the FLCCC physician/scientists identified, researched, and tapped into sizable “real-world” case series-like—large “natural experiments” occurring in various South American nations involving “ivermectin distribution” based community health initiatives. As many developing nations don’t have the financial wherewithal to spend billions on clinical research, and with a raging pandemic, they had to move fast with imperfect information. But as it turns out, local notable public health programs that distributed controlled amounts of ivermectin appear quite successful based on substantial data gleaned and analyzed by the authors. They found that “tight, reproducible, temporally associated decreases in case counts and case fatality rates in each of those regions compared to nearby regions without such campaigns, suggest that ivermectin may prove to be a global solution to the pandemic.”
Real World & RCTs: Ivermectin as Prophylaxis
The manuscript reports on multiple public health efforts far flung places, from Belize and Macedonia to the highly populated ($210 million) state of Uttar Pradesh in Northern India, where local health programs are proving successful in their bid to treat COVID-19 early with ivermectin-based treatment.
The First Global Comprehensive Meta-Analysis
This study appears to be the first report inclusive of sufficient clinical data, that demonstrates a considerable signal to therapeutic efficacy. The FLCCC authors are developing a compelling meta-analysis covering all major randomized controlled studies involving ivermectin. Based on what is now 24 such clinical trials, but also case series and observational studies, FLCCC connected with many studies initially via TrialSite News and then of course accelerated study searchers in published peer-reviewed publications as well as manuscripts uploaded to medicine pre-print servers. The FLCCC articulates for the imminent need for primary national health care agencies to commit sufficient resources, time, and the necessary intent to expedite the validation and confirmation of these studies’ as the promising epidemiological impacts associated with the wide distribution of ivermectin among populations slammed by COVID-19 cannot be ignored anymore.
· Pierre Kory, MD
· Paul E. Marik, MD
· GU Meduri
· Jose Iglesias
· Jospeh Varon
· Keith Berkowitz
· Howard Kornfeld
· Eivind Vinjevoll
· Scott Mitchell
· Fred Wagshul
Call to Action: follow the link to frontiers in Pharmacology.