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April 14, 2020 The Italian Medicines Agency (AIFA) has authorized the start of the multicenter study INHIXACOVID19 with the low molecular weight heparin anticoagulant (biosimilar of enoxaparin sodium) in the treatment of patients with moderate or severe clinical picture of Covid-19. The trial will evaluate the safety and efficacy of the anticoagulant, administered at different dosages, in improving the course of the disease. The drug will be provided free of charge to the 14 Italian centers involved in the study by Techdow Pharma, the Italian branch of the ShenzenHepalink Pharmaceutical Group.

Enoxaparin sodium is a low molecular weight heparin with a high antithrombotic action which makes it, today, one of the most used anticoagulants for the prevention and therapy of venous and arterial thromboembolism (VTE) and arterial in subjects undergoing surgery or bedridden . All 300 patients admitted to the trial will receive biosimilar enoxaparin subcutaneously.

The study will be coordinated by Pierluigi Viale, professor of Infectious Diseases of the University of Bologna and director of the Infectious Diseases Operating Unit of the Sant'Orsola-Malpighi Hospital. The study started because we know that coagulation alterations and thrombotic complications in Covid-19 patients play a significant role in terms of incidence and clinical relevance, representing one of the most important variables associated with mortality. Not surprisingly, already last January, the World Health Organization (WHO) recommended to prevent venous thromboembolism in subjects infected with SARS-CoV-2 by resorting to subcutaneous administration of heparin, preferably with low molecular weight. The onset of thrombotic events in Covid-19 patients even during prophylaxis at the standard dose, however, shows how this dosage does not always protect against complications.

In light of the scientific evidence collected so far and the encouraging results that come from the studies carried out in China, both in vitro and on patients, the idea was born to promote an experiment also in Italy by using, for therapeutic purposes, a medium-high dosage of the drug. The data coming from the East suggest a role for Inhixa in limiting the pathogenic action of the virus. Heparin has a structure very similar to heparan sulfate, a molecule present on the cell surface of our body and used by SARS-CoV-2 to adhere to the cell, before entering it and releasing toxic substances called cytokines inside. The anticoagulant attracts the virus which attaches itself to the drug molecule: the virus is thus "deceived" and, rather than attacking healthy cells, attacks the heparin. To confirm this, the Chinese tests carried out by Techdow show Inhixa's antiviral efficacy in vitro, associated with the ability to also interfere with the "cytokine storm" that characterizes the hyper-inflammatory phase of the disease, which is the most dangerous for the patient. "Another important piece of our therapeutic armamentarium towards Covid-19 enters the clinical trial phase, which is more necessary than ever to better understand its role and applicability", declares Viale.