A new study by IRCCS Ospedale San Raffaele, conducted by Giulio Cavalli, immunologist, and coordinated by prof. Lorenzo Dagna, head of the Immunology, Rheumatology, Allergology and Rare Diseases Unit, assess the effectiveness and safety of a molecule - anakinra - able to block the overreaction of the immune system caused by COVID-19.  The results are published in the prestigious journal Lancet Rheumatology.

The trial was conducted on 29 severely ill patients hospitalized at San Raffaele, which received standard care (non-invasive ventilation, CPAP). The research was carried out within the Covid-19 maxi observational clinical study coordinated by Professor Alberto Zangrillo, director of the General Anaesthesia and Intensive Care and Cardiothoraco-Vascular Anaesthesia Unit, and Professor Fabio Ciceri, deputy scientific director of clinical research and director of the Hematology and Bone Marrow Transplantation Unit.

The drug acts by neutralizing Interleukin-1 (IL-1), an inflammatory molecule produced by the immune system in response to viral infections.

 

Immunosuppressive drugs for COVID-19

At this stage, unfortunately, there are still no specific drugs for COVID-19. This is why the experimental therapies tested in the last few months utilize drugs in off-label use, i.e. approved but indicated for other pathologies, or even not yet approved (compassionate use).

"One of the most severe complications caused by COVID-19 is the overreaction of the immune system and the subsequent development of an 'inflammatory storm', which in turn can cause severe pneumonia with respiratory failure. This is the reason why it was used immunosuppressive molecules able to block the immune response and thus contribute to the functional recovery of the lungs" explains Lorenzo Dagna.

 

The results of the study

"To block the excessive inflammatory response caused by the new coronavirus, we used high dose of the arthritis drug anakinra with intravenous injection. In the study, at 21 days, 72% of patients showed progressive improvements in respiratory function and systemic inflammation" explains Giulio Cavalli.

The COVID-19 group of patients treated with high doses of anakinra was compared retrospectively with a control group of 16 patients who received standard treatment. The difference is remarkable: in the control group respiratory function improved only in 50% of patients and mortality was four times higher.

“These encouraging findings need to be validated with a controlled trial, conducted over a longer period of time to check for long-term outcomes. However, what we have described could have an immediate clinical effect since the drug is available in almost every hospital in Italy and around the world: a safe off-label therapy to mitigate the inflammatory storm triggered by the new coronavirus" concludes Lorenzo Dagna.