The Commission has signed a grant of 1 M€ to support the conduct of a clinical trial using Raloxifene for patients suffering from COVID-19. Since January 2020, a number of projects to repurpose existing molecules have been selected for funding through different EU research calls in a competitive process. This grant has been signed under the Emergency Support Instrument (ESI), which provides EU funding to support the generation of clinical evidence that would support an application for a new marketing authorisation. This would repurpose an existing medicinal product to treat COVID-19 patients.
Through the Horizon 2020 Exscalate4CoV supercomputing platform, several promising molecules were identified that might have the ability to fight the Sars-CoV-2. Although already marketed in other indications, Raloxifene emerged from an initial repurposing exercise as a promising agent for preventing the evolution of COVID-19 towards severe and critical disease. The aim of the trial is to assess its efficacy and safety in this regard in association with its capability to reduce the mean time of viral shedding in COVID-19 patients who do not show yet severe symptoms. In the trial, up to 450 participants will receive a treatment of either Raloxifene or placebo capsules. The study will assess how safely and efficiently Raloxifene prevents the replication of the SARS-CoV-2 virus in cells. The trial will be conducted at the National Institute for Infectious Diseases Lazzaro Spallanzani in Rome, and also involves the Humanitas Research Hospital in Milan. Plans are under way to also extend the trial to other European Countries, depending on the results of an initial safety assessment. The operational period will be from November 2020 to April 2021.
• EU coronavirus research and innovation website