June 23, 2021 ~ Principle: University of Oxford, UK

From today, ivermectin is being investigated in the UK as part of the Platform Randomised Trial of Treatments in the Community for Epidemic and Pandemic Illnesses (PRINCIPLE), the world’s largest clinical trial of possible COVID-19 treatments for recovery at home and in other non-hospital settings.

With Commentary from Mark Bricca, ND

This article doesn’t specify ivermectin dose, although it does lay out the study population: https://www.clinicaltrialsarena.com/news/ivermectin-principle-trial-covid/
The design looks decent, although it would perhaps be even better if they limited study participants to 7 days from symptom onset or positive test results.  Since illness is typically milder in younger people, it is probably good that they plan to enroll younger folks who have pre-existing conditions or symptomatic illness.
I hope they dose ivermectin high enough, preferably at least 0.3-0.4mg/kg/dose, and I wish they would treat for 5 days instead of 3 days.  That said, this looks like a pretty reasonable trial design–a little conservative, could be stronger, but it doesn’t appear designed to fail, at least so far as I can tell.

Led by the University of Oxford, PRINCIPLE is investigating treatments for people at more risk of serious illness from COVID-19 which can speed up recovery, reduce the severity of symptoms and prevent the need for hospital admission. The study has so far recruited more than 5,000 volunteers from across the UK.

Ivermectin is a safe, broad spectrum antiparasitic drug which is in wide use globally to treat parasitic infections.

With known antiviral properties, ivermectin has been shown to reduce SARS-CoV-2 replication in laboratory studies. Small pilot studies show that early administration with ivermectin can reduce viral load and the duration of symptoms in some patients with mild COVID-19. Even though ivermectin is used routinely in some countries to treat COVID-19, there is little evidence from large-scale randomised controlled trials to demonstrate that it can speed up recovery from the illness or reduce hospital admission.

Professor Chris Butler, from the University Oxford’s Nuffield Department of Primary Care Health Sciences, Joint Chief Investigator of the PRINCIPLE trial, said, ‘Ivermectin is readily available globally, has been in wide use for many other infectious conditions so it’s a well-known medicine with a good safety profile, and because of the early promising results in some studies it is already being widely used to treat COVID-19 in several countries. By including ivermectin in a large-scale trial like PRINCIPLE, we hope to generate robust evidence to determine how effective the treatment is against COVID-19, and whether there are benefits or harms associated with its use.’

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