The Promise, Hope & Disappointment of the PRINCIPLE Trial as Design Concerns Throw Latest Study In Serious Doubt

The Promise, Hope & Disappointment of the PRINCIPLE Trial as Design Concerns Throw Latest Study In Serious Doubt

The University of Oxford PRINCIPLE trial had to evaluate the potential of repurposed drugs such as Ivermectin, Fluvoxamine, Favipiravir, and many more for early COVID-19 treatment. TrialSite first reported on the rumblings from the press in the U.K. back on January 23rd, 2021. We first declared that ivermectin was now a study drug, but we quickly had to change the title to a "consideration." Well, half a year passed, and with more rumblings, media snippets, and a few discussions in our network, we reported on June 23rd that the trial now would include ivermectin. While TrialSite again emphasized this study was late in the pandemic response (given so many other ivermectin studies showed some promise), we nevertheless expressed enthusiasm that the University of Oxford was moving forward. But dozens of researchers, physicians, and scientists with a commitment to economic, early-stage treatments for COVID-19 picked up on some concerning, perhaps even problematic, insight into this particular program associated with the PRINCIPLE trial. TrialSite investigated, interacted with, and elicited some concerns and included them as a summary herein.

The Study's Promise

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