COVID-19 Clinical Trial
Official title:
A Prospective Open-label Study of the Tigerase® Efficacy and Safety as Part of Complex Therapy in Patients With COVID-19
It is a multicenter, open-label, randomized, parallel-group study of the efficacy and safety of Tigerase® (GENERIUM JSC, Russia) with standard therapy versus standard therapy in patients with COVID-19.
COVID-19 (Coronavirus disease-19) is an acute respiratory infectious disease caused by
SARS-CoV-2 coronavirus. The spread of the disease quickly developed to the global pandemic in
March-April 2020, and was characterized by acute respiratory distress syndrome (ARDS) in
10-15% of cases, which leads to a high frequency of hospitalization in the intensive care
unit and high mortality. The search for effective treatment and reducing the severity of
COVID-19 is a priority in the development of medical science.
One of the key processes of the innate immune system are neutrophil extracellular traps
(NET), formed by neutrophils when they eject their DNA from the cytoplasm. NET is most often
described as a mechanism for capturing bacteria in order to limit their spread. In addition,
NET also plays a role in antiviral immunity. In particular, viral infections lung damage is
at least partially due to NET.
This suggests that drug disruption of NET in COVID-19 is promising. DNase preparations, and
in particular Tigerase®, are safe and effective for the treatment of cystic fibrosis and can
serve as a NET destruction agent in patient with COVID-19.
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