ACTT-EU/UK: publication of trial results showing remdesivir speeds up COVID-19 recovery
26 May 2020
An international clinical trial testing the effectiveness of the drug remdesivir on patients hospitalised with COVID-19, has shown “very promising” preliminary results. These results were published last week in the New England Journal of Medicine.
Launched at the end of March, the Adaptive COVID -19 Treatment Trial (ACTT-EU/UK) trial, is taking place in about 75 hospitals globally, with the Medical Research Council (MRC) Clinical Trials Unit at UCL coordinating the trial in the UK and Greece.
The randomised controlled trial, which has recruited more than 1000 patients globally, aims to evaluate the safety and efficacy of the anti-viral drug remdesivir, as a treatment for COVID -19.The drug was originally developed to treat Ebola and Marburg virus infections. The MRC CTU at UCL-led part of this trial has recruited 79 patients, including 46 from the UK, and 33 from Greece, and was closed to new enrolments on 19 April.
Preliminary results published last week (22 May) in the New England Journal of Medicine show the speed of recovery for hospitalised COVID-19 patients treated with the drug was 32% faster than for those patients who had the placebo. These results confirm those released via press release on 29 April 2020.
Specifically, the average time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. Preliminary results also suggested a survival benefit, with 14-day mortality rate of 7.1% for the group receiving remdesivir versus 11.9% for the placebo group.
Recovery in this study was defined as being well enough for hospital discharge, ie either discharged from the hospital or hospitalised for infection control purposes only. In the trial, patients were given remdesivir every day for 10 days while they remained in hospital.
The results show that patients who received remdesivir were no more likely to have serious side-effects than patients who had the placebo.
Based on the results of this trial, the US's Food and Drug Administration authorised emergency use of the remdesivir for treating patients who are hospitalised with COVID-19 on 01 May 2020.
Further results from this part of the trial are expected in June 2020. These will include the full scheduled follow-up for all patients. These updated results for time to recovery are unlikely to be very different from the results published today which is based on most of the expected data, but we should have further data on any differences in the mortality. The data published today are being released now because of the urgency of the COVID-19 pandemic.
Mahesh Parmar, Director of the MRC CTU at UCL, who has overseen the trial in the EU, said: “This is the first large scale international trial to report on the use of the drug remdesivir to treat patients hospitalised with COVID-19.
These results are very promising indeed. They show that this drug can clearly improve time to recovery. The FDA has already approved this drug for use for patients with COVID-19 under their emergency use authorisation scheme and we look forward to a review from the European Medicines Agency in due course.”
Co-study lead, Sarah Pett, Professor of Infectious Diseases at the MRC CTU at UCL, said: “Delivering the results of the first stage of the ACTT study in such a short time is down to the dedication and hard work of the teams in the USA, at UCL, all of the hospitals who participated in this trial, and of course most importantly, the patients who agreed to participate.
The spirit of collaboration has never been stronger, in this time of urgent global need. The reward for all of us has been to provide data which suggests remdesivir helped the patients in the ACTT study recover more quickly. This is a foundation on which to build, and these findings will help other patients with COVID-19.”
Co-study lead, Abdel Babiker, Professor of Epidemiology and Medical Statistics at the MRC CTU at UCL, said: “These are very encouraging results from the first large randomised international trial to report on the treatment of COVID-19. To speed up the identification of effective treatments the design of this trial is adaptive which facilitates the speedy identification of effective treatment by testing promising agents as they come along in different stages of the trial.
These results are from the first stage. The next stage of the trial, which will look at adding an additional drug to remdesivir, is already under way in the USA, and will start in the EU and UK in the next few weeks.”
About the trial
Adults hospitalised with COVID-19 were 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 was double blinded, which means that neither the patients nor their doctors knew if they have received remdesivir or a placebo. This helps investigators tell whether any improvements are due to the study treatment or not. People taking part in the trial were followed up for 29 days. Initially the trial aimed to recruit 440 people but this number was increased to 800, with these numbers being exceeded by several hundred by 19 April. Researchers hoped to have the first results from the trial by the beginning of this summer, but were actually able to find results several months ahead of schedule, due to fast recruitment of patients.
The ACTT-EU/UK trial has an adaptive design, an area which the MRC CTU at UCL has been pioneering for 20 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, Mexico, Japan, South Korea, Denmark, Germany, Greece and there are plans to open it in Spain, Italy and other EU countries.
Further information