PRINCIPLE [COVID-19] [UPH]
Platform Randomised trIal of treatmeNts in the Community for epIdemic and Pandemic iLlnEsses
University of Oxford / Clinical Trials and Research Governance
Duration of Study in the UK
2 years, 0 months, 1 days
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.
South Central - Berkshire Research Ethics Committee
Date of REC Opinion
24 Mar 2020