We are glad to notify you that Medical University of Lodz has signed a contract for the project: EU RESPONSE (GA: 101015736): DisCoVeR clinical trial funded by European Commission within the framework of Horyzont 2020 in COVID-19 pandemic fight. Established by Medical Research Agency, non-commercial clinical trial network POLCRIN has thereby initiated its clinical activity.

The project aims at creating European infrastructure network of clinical research into infectious diseases, COVID-19 in particular, on the basis of the existing initiatives, previous experience and knowledge. More specifically, the network focuses on the implementation of DisCoVeRy, a non-commercial treatment protocol as a clinical trial formula in over a dozen of European countries.  DisCoVeRy (multicentre, adaptation, randomised trial of safety and efficacy of COVID-19 treatment in hospitalised adults) was launched in March this year by the research sponsor, INSERM, French National Institute of Health and Medical Research and by ECRIN, European network of non-commercial clinical research.

In Poland, with regard to data management, the research is coordinated by Prof. Anna Piekarska, Head of Clinical Department of Infectious Diseases and Hepatology MUL, Prof. Wojciech Fendler, Head of Department of Biostatics and Translational Medicine MUL. The Clinical Trial Unit MUL will perform the function of Central Registry.

Initially, DisCoVeRy was to include five therapeutic areas: the first one concerning healthcare standards, three pertaining to a variety of antiviral drugs and the last one regarding interferon β-1a. The adaptive design of the project enabled the modifications to the research arms and the withdrawal of the least effective medication. The current phase of research involves only two research arms.  Patients are randomised to the control group receiving standard healthcare (SoC) and remdesivir + SoC.

Other therapy options may emerge in further research stages.  The projected scenario includes: remdesivir + SoC, remdesivir combined with an immunomodulator (interferon β-1a or anti-interleukin (IL) -6 drug) + SoC, a selected immunomodulator (interferon β-1a or anty-IL-6) + SoC, exclusively SoC.

To date, the study included 769 patients from France, Luxemburg, Austria and Belgium. Three Polish centres which have undergone the feasibility process and have been positively assessed by the Sponsor are engaged in the research.

Project is being implemented in years 2010-2013.

More on the study protocol on: https://clinicaltrials.gov/ct2/show/NCT04315948

Project info: https://cordis.europa.eu/project/id/101015736/pl