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02 May 2020 The Italian Medicines Agency (Aifa) has authorized two new clinical trials for the treatment of Covid-19 and a compassionate use program.

The studies concern one the use of the medicine Sarilumab, an inhibitor of interleukin IL6, and the other the use of hydroxychloroquine in high-risk healthcare workers. The compassionate use program is related to the drug Solnatide. With the two new authorized studies, the clinical trials that have received the green light from Aifa rise to 15.

The first authorized study is a single-arm, open-arm, single-dose "escalation" study involving the use of Sarilumab, an interleukin IL6 inhibitor, for the treatment of Covid-19. The study is aimed at evaluating the safety and clinical efficacy of Sarilumab in adult patients hospitalized due to severe Covid-19 pneumonia based on the percentage of patients showing improvement in respiratory function. The study will enroll 40 adult patients in total over a period of approximately 6 weeks.

The second is a multi-center, multinational study that will evaluate the efficacy and safety of hydroxychloroquine prophylaxis in high-risk healthcare workers. The Agency draws attention to the fact that "the prophylactic use of hydroxychloroquine should be considered only in the context of clinical studies".

The compassionate use program with Solnatide, which concerns the treatment of pulmonary permeability edema in patients with Covid-19 with acute pulmonary insufficiency, has also been approved. Solnatide is a drug that is currently unauthorized, but in clinical development for the treatment of acute respiratory distress syndrome (Ards) and pulmonary edema.