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March 27, 2020

The Italian Medicines Agency (Aifa) has authorized three new clinical trials on drugs for the treatment of Covid-19 disease.

It is a study on two biological drugs, emapalumab and anakinra , which will involve four Italian hospitals to evaluate their efficacy and safety. The trial will involve 54 patients and will test the ability of the two drugs to reduce respiratory distress in patients with Covid-19. Then authorized one on a drug already in use for rheumatoid arthritis ( sarilumab ) and a study with the drug tocilizumab , also in use for arthritis, in early and severe cases.

Pending the vaccine, which is being worked on in various countries on 44 different projects, the effort is to increase the therapeutic weapons to be used against the coronavirus. At the moment, some drugs already used for other pathologies have proven to be effective: this is the case for some antimalarial and anti-AIDS medicines, for which authorization has now been received which makes them fully charged to the National Health Service (Ssn) . But various experiments on new molecules are also at the starting line. Already used in China for the treatment of Covid-19 infection, antimalarial drugs based on chloroquine and hydroxychloroquine have also been authorized in Italy with the publication in the official journal. They will be fully charged to the Ssn. Also authorized for the same use are the combinations of the anti-AIDS drugs lopinavir / ritonavir, danuravir / cobicistat, darunavir, ritonavir, these also at full charge of the Snn.

To date, underlines the pharmacologist Silvio Garattini, "we do not have a specific drug for the treatment of Covid-19 and in an emergency situation we refer to the drugs already used in China for this epidemic, as in the case of antimalarials and anti-HIV .

The decision on which to use is up to the doctor based on the situation of the individual patient, but to be able to say that one of these drugs is better or more effective than another, one must wait for the results of the controlled clinical studies launched by the Italian drug agency Aifa " In fact, he explains, "the drugs in use, including the various combinations, are still experimental drugs for which we hope to be able to have confirmation of efficacy precisely through the controlled studies launched. In fact, having tried these drugs on a few cases is not enough and the Chinese researchers themselves have not yet published the results on the drugs used. "So," for now we must use the molecules available in an emergency condition, waiting for the trials to prove what is most suitable and effective ".

In addition to the studies already underway, new tests are starting day by day. This is the case of the three clinical studies authorized today by AIFA.

For now, the therapies indicated by WHO as the most promising remain the combination of Lopinavir / Ritonavir anti-aids drugs (now also prescribed by family doctors for the care of home sick people) and the antiviral drug Remdesivir, developed for the disease by Ebola virus. Hope could also come from the plasma of the recovered patients, an approach used in China: a research project between Toscana LifeSciences and Spallanzani, will clone antibodies from convalescent patients to develop a cure and a vaccine.