10,000 remarkable people from every corner of the UK have signed up to the Platform Randomised trIal of treatmeNts in the Community for epIdemic and Pandemic iLlnEsses (PRINCIPLE). The trial is testing treatments for COVID-19 that can be used at home. Led by the University of Oxford, it began in March 2020 and investigates medicines that could be re-purposed to help people recover quicker and reduce the need for treatment in hospital.
The 10,000-participant milestone was reached at the end of March 2022, and the PRINCIPLE Trial team would like to thank everyone who is making this ground-breaking research possible.
The Trial has led the way in evaluating treatments for COVID-19 in the community over the past two years. It has tested five potential treatments so far, with a further two, favipiravir and ivermectin, still being studied in the trial. PRINCIPLE was designed to rapidly identify treatments that showed promise and rule out treatments that did not work. Early on in the pandemic, the antibiotics azithromycin and doxycycline were being widely used around the world to treat acute COVID-19; PRINCIPLE was the first major trial in the community to show that, in the absence of other indications, these antibiotics did not benefit COVID patients and so merely put them at unnecessary risk of side effects and added to the problem of antibiotic resistance.
PRINCIPLE also found that the anti-inflammatory drug, colchicine, did not help people get better any quicker.
A key finding from the Trial announced in April 2021 was that the commonly used asthma drug, inhaled Budesonide, a steroid, was effective in reducing recovery time by around three days and that there was a high probability that it also reduced hospital admission.
Professor Chris Butler, Professor of Primary Care at Oxford University’s Nuffield Department of Primary Care Health Sciences, and the co-Chief Investigator for the Trial, said;
“‘The findings from the PRINCIPLE trial that are influencing clinical practice around the globe would not have been possible without the contribution of the amazing people who volunteered for the study: your gift of sharing your experiences of COVID in PRINCIPLE is helping doctors and nurses provide better evidence-based care for people with COVID-19 worldwide. PRINCIPLE stands as a monument to the vision of its funders, the UK-wide clinical research networks embedded in the NHS, all the general practices and clinicians who support it, NHS Digital, and Antiviral and Therapeutics Task Force, the regulators, and the hard work and dedication of our study team in the Primary Care Clinical Trials Unit. We have truly been humbled by the response from people across the UK.”
The milestone of the 10,000th participant included in The PRINCIPLE Trial has been passed, as a second platform trial led by the University of Oxford, the PANORAMIC Trial, reaches a world-first 20,000 recruits in just four months. The PRINCIPLE Trial focusses on testing re-purposed drugs for COVID-19 in the community, whereas PANORAMIC is testing novel, specific antiviral agents.
The Platform Randomised trIal of treatmeNts in the Community for epIdemic and Pandemic iLlnEsses (PRINCIPLE) Trial is led by the University of Oxford and funded by UK Research and Innovation (UKRI) and National Institute for Health Research (NIHR).