As part of the epidemiological emergency from Coronavirus, the Italian Medicines Agency (AIFA), through a specific call, has promoted the funding of some studies to acquire new evidence on the efficacy of monoclonal antibodies in the treatment of patients affected by COVID- 19 in an early stage of illness, not hospitalized and whether or not they have risk factors that may aggravate the prognosis.
“AIFA - observes the General Manager, Nicola Magrini - has undertaken to dedicate a portion of research funds to favor independent clinical studies useful for better understanding the therapeutic role of this family of drugs and for promoting comparative efficacy evaluations among the different monoclonals. The large number of clinical trial proposals received testifies to the vitality of collaborative research platforms in Italy ”.
The research call, which closed on 15 February, saw the presentation of 14 research protocols which, after an initial evaluation of compliance with the requirements, were all unanimously admitted to the subsequent evaluation phases.
For the purposes of funding, projects that stood out for their feasibility and practical operation and therefore for the potential for transferring the results into real clinical practice in a strategic perspective for the National Health Service were privileged.
The 4 winning research protocols of the Call will access funding promoted by AIFA for an amount exceeding 2 million euros. The outcome of the evaluation and the funding of the studies were approved by the AIFA Board of Directors.
“The projects selected for funding are characterized by high scientific value and have the potential to be able to usefully contribute to fully defining the role of monoclonal antibody therapy in preventing progression to the most severe forms of COVID-19. I believe that this initiative promoted by AIFA, consistent with a rigorous clinical research approach to this therapeutic option, should be emphasized as a qualifying element for the country ”, says Franco Locatelli, the President of the Commission that evaluated the projects.
