23 June 2021
- PRINCIPLE is one of UK Government’s national priority platform trials of COVID-19 treatments, and the world’s largest currently taking place in community settings looking for treatments at home.
- Ivermectin, a widely used antiparasitic drug, has been added to the trial and is being evaluated in participants from today.
- For COVID-19, ivermectin has shown promising results as a potential treatment in small studies in humans.
- Anyone eligible and with COVID-19 symptoms can join the trial from anywhere in the UK, either online, over the phone or via their health care professional.
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.
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 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
Notes for Editors:
About the PRINCIPLE Trial
The UK-wide PRINCIPLE trial platform is led from the Primary Care Clinical Trials Unit at the University of Oxford’s Nuffield Department of Primary Care Health Sciences. The trial is integrated with the Oxford RCGP Research and Surveillance Centre and works closely with the NIHR Clinical Research Network across England and similar networks in the devolved nations. It is a national urgent public health trial funded 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. Within the University of Oxford, the Nuffield Department of Primary Care Health Sciences is the largest, top-ranked centre for academic primary care in the UK, bringing together academics from many different backgrounds to work together to produce benefits for the NHS, for populations and for patients.
The University of Oxford
Oxford University has been placed number 1 in the Times Higher Education World University Rankings for the fifth year running, and at the heart of this success is our ground-breaking research and innovation. Oxford is world-famous for research excellence and home to some of the most talented people from across the globe. Our work helps the lives of millions, solving real-world problems through a huge network of partnerships and collaborations. The breadth and interdisciplinary nature of our research sparks imaginative and inventive insights and solutions.
About the National Institute for Health Research
The mission of the National Institute for Health Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
- Funding high quality, timely research that benefits the NHS, public health and social care;
- Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
- Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
- Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
- Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
- Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.
NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.
UK Research and Innovation works in partnership with universities, research organisations, businesses, charities, and government to create the best possible environment for research and innovation to flourish. We aim to maximise the contribution of each of our component parts, working individually and collectively. We work with our many partners to benefit everyone through knowledge, talent and ideas.
Operating across the whole of the UK with a combined budget of more than £8 billion, UK Research and Innovation brings together the seven research councils, Innovate UK and Research England.