A strategy for the fight against Coronavirus in which the promotion of clinical trials, with the parallel collection of data necessary for the purpose, is one of the building blocks that make up the action plan of the Agenzia Italiana del Farmaco (AIFA – Italian Medicines Agency) .
As highlighted by AIFA itself in a press release published on its website, a crisis unit has been set up on four fronts: drugs in off-label use; research and development/access to experimental drugs; national management guidelines; and the fight against shortages of medicines at hospital level.
The Ministry of Health also recognised the need for this plan last week. “The vaccine will be the ultimate weapon – said the Minister, Roberto Speranza -. In this world match Italy is with all our scientific community, in a relationship of full collaboration with pharmaceutical companies”. But Speranza also stressed that the measures to manage the COVID-19 emergency are moving to date on the four levels identified by the Agency.
Promotion of clinical trials and off-label use. The evolution of trials
It is mainly on the research front that the most obvious needs have emerged. AIFA has in fact underlined its role in “evaluating all clinical trials on medicines for patients with COVID-19”. In this regard, with the help of the Scientific Technical Commission (CTS), it has activated a “simplified procedure that aims to promote, regulate and supervise access to therapies potentially useful to combat this pandemic”.
In this simplified management of clinical trials, the Agency has prepared an updated list of ongoing trials, but also a list of drugs used outside clinical trials. The National Health Service (by way of derogation from Law 648/96) has therefore included the off-label use of medicines registered and approved for the use of different pathologies. Among these are chloroquine, hydroxychloroquine (two antimalarial drugs with preliminary data on potential antiviral activity); as well as lopinavir/ritonavir and, subordinately to the latter, darunavir in combination with cobicistat or ritonavir (drugs used to treat HIV infection). To these are added the antiviral Remdesvir and the monoclonal antibody Tocilizumab. “Other experimental protocols, both independent and proposed by pharmaceutical companies, are being evaluated, with further therapeutic alternatives that could represent new options”, reads the AIFA website.
The “management” factor and the creation of a Task Force
The other two lines of the AIFA strategy concern the management of the phases necessary to ensure the start of the research. Already at the beginning of last month, the Agency stated that it has started a series of actions to “combat shortages of medicines”, facilitating the import of critical products through contact with marketing authorisation holders (MAHs) and importers to ensure the regularity of supplies of medicines used at hospital level during the emergency. But all this takes place under the lens of the control booth which sees the participation, alongside AIFA, of the Civil Protection and the National Institute for Infectious Diseases Lazzaro Spallanzani (INMI), national reference centre for research and treatment of infectious diseases and WHO Collaborating Centre for highly contagious diseases. This task force has the task not only to develop national management guidelines for COVID-19 cases, but also to follow the progress of clinical trials and to provide all available information on ongoing trials.