The last 27 October, the Italian Medicines Agency (AIFA) has provided, to the Exscalate4cov consortium, the approbation for the clinical human trials to test the use of Raloxifene to treat patients COVID-19 with middle symptoms (https://associazionebigdata.it/2020/11/02/aifa-approves-the-trial-raloxifene-for-covid-19-treatment/).
During the last months, thanks to an approach of drug repurposing, the Excsalate4cov consortium has tested more than 400 000 drugs already on commerce to treat other diseases. The aim has been to identify, among these drugs, the molecules able to counter the development of disease caused by COVID-19. The most promising outcome has been achieved with the Raloxifene that has shown the capability to inhibit the replication of the virus during the in vitro test (https://associazionebigdata.it/2020/09/01/exscalate4cov-raloxifene-against-covid-19/).
The European Commission is supporting the E4C Consortium with EUR 3 million grant through the Horizon 2020 Research Framework Programme. To support the activity of the consortium during the clinical trials, the European Commission will provide an additional EUR 1 million grant through the European Emergency Support Instrument (https://ec.europa.eu/newsroom/sante/newsletter-specific-archive-issue.cfm?archtype=specific&newsletter_service_id=327&newsletter_issue_id=27174&page=1&fullDate=Fri%2013%20Nov%202020&lang=default).
Currently, the clinical trials are taking place in Italy and involve two institutes: the National Institute for Infectious Diseases Lazzaro Spallanzani and the Humanitas Research Hospital. The tests are carried out from November 2020 until April 2021 on 450 participants who will receive the treatment with Raloxifene or placebo capsules. The trial aims is to assess the safety and capability of Raloxifene to prevents the replication of the SARS-CoV-2 virus in cells, reducing the spread of disease in the patients.
Other government-funded research organizations, including Gyeonggido Business and Science Accelerator (GBSA), the National Institute of Health (NIH), and the Korea Institute of Science and Technology Information (KISTI) have achieved similar outcomes, showing the efficiency of Raloxifene against coronavirus.
Last June, the GBSA has announced the results of a joint study with the Korea Disease Control and Prevention Agency (KDCA) that confirmed the suppressive effects of Raloxifene on the COVID-19 virus. In October, the GBSA submitted a Raloxifene clinical trial research plan to the Korean Ministry of Food and Drug Safety, expecting to receive authorization to start the trials very soon.
To allow collaboration between the two consortia, a letter of intent (LOI) for international joint research on COVID-19 treatment has been signed by the EU and South Korea. Three Korean (Gyeonggido Business and Science Accelerator (GBSA), the National Korean Institute of Health (NIH), and the Korea Institute of Science and Technology Information (KISTI)) and two EU-funded research organizations (Dompe Farmaceutici and the national Italian supercomputing center CINECA) have agreed to undertake joint research to accelerate the development of a COVID-19 treatment (https://ec.europa.eu/digital-single-market/en/news/eu-and-south-korean-research-organisations-sign-agreement-work-together-development-covid-19).