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.’
Following a screening questionnaire to confirm eligibility, participants enrolled in the study will be randomly assigned to receive a three-day course of oral ivermectin treatment. They will be followed-up for 28 days and will be compared with participants who have been assigned to receive the usual standard of NHS care only. People aged 18 to 64 with certain underlying health conditions or shortness of breath from COVID-19, or aged over 65, are eligible to join the trial within the first 14 days of experiencing COVID-19 symptoms or receiving a positive test.
People with severe liver disease, who are on the blood-thinning medication warfarin, or taking other treatments known to interact with ivermectin, will be excluded.
The trial can be joined easily from anywhere in the UK either online, over the telephone or via a GP practice, and without the need for face-to-face visits with the trial team in Oxford.
Ivermectin is the seventh treatment to be investigated in the PRINCIPLE trial, and is currently being evaluated alongside the influenza antiviral favipiravir.
In April 2021, PRINCIPLE reported interim evidence of the UK’s first effective drug to treat COVID-19 in patients at home, inhaled budesonide, showing the treatment can reduce recovery time by a median of three days. The treatment has since been included in clinical guidelines for treating early-stage COVID-19 across the UK, Canada and India.
PRINCIPLE is funded by a grant to the University of Oxford from UK Research and Innovation and the Department of Health and Social Care through the National Institute for Health Research as part of the UK Government’s rapid research response fund.
The trial is supported by a vast network of health and care professionals in care homes, pharmacies, NHS 111 Hubs, hospitals and more than 1400 GP practices across England, Wales, Scotland and Northern Ireland.
To find out more about how to join the study, visit www.principletrial.org