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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Nebulised dornase alfa \[2.5 mg BID\] for 7 days
Patients will receive the usual care in accordance with good practice.
City Clinical Hospital #15
Moscow, Russia
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, Russia
City Clinical Hospital #51
Moscow, Russia
City Clinical Hospital #52
Moscow, Russia
The proportion of patients with mechanical ventilation
Time frame: Day 8
Category change on WHO Ordinal Scale for Clinical Improvement
Time frame: Day 8
The proportion of patients with mechanical ventilation
Time frame: Day 28
Category change on WHO Ordinal Scale for Clinical Improvement
Time frame: Day 28
Proportion of patients surviving 28 days after inclusion in the study
Time frame: Day 28
Number of days of oxygen therapy during the treatment period
Time frame: Day 8
Change in C-reactive protein level
Time frame: Days 3, 5, 8
Change in oxygenation index
PaO2 / FiO2, FiO2 = fraction of oxygen in inhaled air,% PaO2 = partial pressure of oxygen in arterial blood, mm Hg
Time frame: Days 3, 5, 8
Change in SpO2/FiO2 index
SpO2 / FiO2, FiO2 = fraction of oxygen in inhaled air,% SpO2 = hemoglobin oxygen saturation, %
Time frame: Days 1, 2, 3, 4, 5, 6, 7, 8
Change in ferritin level
Time frame: Days 3, 5, 8
Change in D-dimer level
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N.V. Sklifosovsky Scientific Research Institute of First Aid
Moscow, Russia
Siberian State Medical University (SibMed)
Moscow, Russia
Time frame: Days 3, 5, 8
Change in neutrophil-leucocyte ratio
Time frame: Days 3, 5, 8
Change in leucocyte-C-reactive protein ratio
Time frame: Days 3, 5, 8
Change in the level of relative (%) number of lymphocytes of the general blood test
Time frame: Days 3, 5, 8