Patients with severe COVID-19 are being recruited to test the drug remdesivir as part of a new trial which is being led by the MRC Clinical Trials Unit at UCL. The trial is the first academic study of the drug as a treatment for coronavirus to take place in the UK
The Adaptive COVID-19 Treatment Trial (ACTT-EU/UK) trial, which is taking place in about 75 hospitals globally, recruited its first UK patient this week. The study will initially test the effectiveness of the antiviral drug remdesivir, that was developed to treat Ebola and Marburg virus infections, as a treatment for COVID-19.
UK hospitals taking part in the trial include the Royal Victoria Infirmary, Newcastle; the Churchill Hospital, Oxford; Guy’s and St Thomas’ Hospital,London; the Royal Sussex County Hospital, Brighton, and St. James’s University Hospital, Leeds.
Professor Sarah Pett, co-lead of the study (MRC Clinical Trials Unit at UCL) with Professor Abdel Babiker (MRC Clinical Trials Unit at UCL) said, "In the initial phase of this study we would like to make sure that remdesivir, a drug originally developed for the treatment of Ebola virus, is safe for use in humans with COVID-19, and see if it can improve patients’ health when they are sick and hospitalised, with COVID-19.
"The fast track approval and support provided by the research ethics committee and Health Research Authority, the MHRA and Research and Development departments at the hospitals greatly facilitated the very rapid opening of sites, in response to the urgent need for treatments for this virus.
"It is an adaptive study and randomised trial so as new treatments evolve, we hope to include these quickly as treatments within the trial."
Adults who have been hospitalised with COVID-19 will be allocated at random to receive either remdesivir or a placebo via a drip for up to ten days, while they are in hospital.
The trial is double blinded, which means that neither the patients nor their doctors will know if they have received remdesivir or a placebo. This will help inform investigators whether any improvements are due to the study treatment or not. People taking part in the trial will be followed up for 29 days. Initially the trial aims to recruit 440 people. Researchers hope to have the first results from the trial by the beginning of this summer.
The ACTT-EU/UK trial has an adaptive design, an area which the MRC Clinical Trials Unit at UCL has been pioneering for many years, which means if new treatments are identified that might help patients with severe COVID-19, they can be immediately added to the trial. If this happens, the number of people needed in the trial will change.
The trial, which is funded by the National Institutes of Health (NIH) in the USA and supported by the NIHR, is also taking place in USA, Japan, South Korea, Denmark, Germany, Greece and there are plans to open it in Spain, Italy and other EU countries.