Platform Randomised trial of INterventions against COVID-19 In older peoPLE
Sponsor: University of Oxford
CI: Christopher Butler
Approval Date: 11 March 2020
The first clinical trial in COVID-19 patients consulting in primary care, 'PRINCIPLE', will initially test if the anti-malarial drug hydroxychloroquine can reduce the need for people to go to hospital or speed up their recovery. They will recruit patients aged over 65 years (or aged 50-64 years with underlying health conditions), who consult in primary care (this trial is a national platform trial and is potentially available to all GP practices in the UK) and have COVID-19 symptoms. Patients will be tested for COVID-19 where possible, and will receive either the usual care provided plus hydroxychloroquine 200mg twice a day for 7 days, or, soon, azithromycin for 3-5 days, or usual supportive care without any experimental treatment. The trial aims to recruit over 3,000 people, and has been designed to be flexible, so new suitable treatments can be added into the trial when these become available.
COVID-19 disproportionately affects people over 50 years old with comorbidities and those over 65 years old. The infection causes considerable morbidity and mortality in this population group in particular, and is having a devastating effect on people's health and society internationally. So far, there are no treatments for COVID-19 that have been proven in rigorous clinical trials to be effective. It is essential to identify interventions that may favourably modify progression of the infection. An ideal intervention would one that is safe, with few side-effects, helps prevent disease progression, and can be administered in the community using existing NHS processes and capability. We propose establishing a platform randomised controlled trial in primary care that can be rapidly deployed to evaluate low risk interventions for high risk people. In the first instance this platform will evaluate a drug called hydroxychloroquine. This is a drug that is already available within the NHS but that has not been subject to randomised controlled trials for this indication in Europe or in community healthcare settings with the aim of reducing the need for hospital assessment. Using a simple, streamlined open trial design, with procedures embedded in existing health service structures and capabilities, our trial aims to give a rapid answer about the effectiveness of trial treatments in modifying the disease course. The goal is to prevent disease progression such that affected individuals will recover sooner, but critically, avoid the need for hospital assessment and admission. The platform trial will be flexible in that it will operate under a master protocol that will allow the addition of further interventions into the trial while it is in progress, should such suitable interventions become available. The trial will be implemented in the first instance by the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) general practices.
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