The University of Oxford soon kicks “the PRINCIPLE Trial” into a higher gear now, in what they consider a pathbreaking “high-quality trial” of Ivermectin, a generic drug already evidencing significant efficacy in over two dozen clinical trials around the world, according to some researchers. The UK government also backs this pivotal study via the Department of Health and Social Care. Searching for early-onset, home-based ambulatory treatments for COVID-19, the PRINCIPLE Trial seeks to meet a gap in research in the world’s richest nations to date. Nearly all of the taxpayer-financed research-based expenditures of governments in the US, UK and Europe, for example, have gone into vaccines, novel monoclonal antibodies, and novel therapeutics, with an emphasis on treating severely ill patients. Ivermectin, hailed as the “wonder drug” or “the People’s medicine” for COVID-19, gains growing attention worldwide made more widely available, frankly, partly due to TrialSite’s consistent chronicling of these trials around the world since the original University of Monash breakthrough. The team discovered that in a lab cell culture, Ivermectin obliterates the novel coronavirus within 48 hours. Since then, TrialSite has covered most studies worldwide, whereas, by the summer, groups in the U.S., such as the Front Line COVID-19 Critical Care Alliance (FLCCC), commenced meta-analysis covering the dozens of Ivermectin studies around the world. According to these physician/scientists, the results reveal compelling data that Ivermectin actually reduces the COVID-19 death rate while accelerating viral clearance and transmission reduction. Enter the preeminent University of Oxford and the PRINCIPLE Trial: the globe’s top investigators now seek to finally test if Ivermectin and antiviral Favipiravir, both low-cost, orally-administered, generally available generic drugs, can be proven safe and effective in a “properly designed trial.” Led by Co-Chief investigator Chris Butler, Professor of Primary Care, Nuffield Department of Primary Care, Health Services at Oxford, the study team is generally upbeat about the prospects. Still, Dr. Butler notes the “gap in the data.” A critically important trial, the PRINCIPLE Trial, is also causing a stir. Groups such as the FLCCC raise the Helsinki Accords: from their vantage, they remind all about the question of ethical conduct—is it right and proper to conduct a randomized placebo-controlled trial when there is sufficient evidence that a drug can save lives? Couldn’t a dose control study or well-designed observational study be run instead to both generate data and protect patients? On the other hand, that Oxford is the first major center to embrace this important generic drug is truly game-changing and demonstrates the leadership position of that research institution again.
