NCT04459325

Tigerase® Efficacy and Safety as Part of Complex Therapy in Patients With COVID-19

A Prospective Open-label Study of the Tigerase® Efficacy and Safety as Part of Complex Therapy in Patients With COVID-19

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: AO GENERIUM · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• COVID-19
• Coronavirus Disease 2019

Interventions

Type	Name	Description
BIOLOGICAL	Tigerase® and best available care	Nebulised dornase alfa \[2.5 mg BID\] for 7 days
OTHER	Best available care	Patients will receive the usual care in accordance with good practice.

Timeline

• Start date: 2020-06-01
• Primary completion: 2020-07-20
• Completion: 2020-07-20
• First posted: 2020-07-07
• Last updated: 2020-10-14

Locations

6 sites across 1 country: Russia