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

Completed
COVID-19
Coronavirus Disease 2019

Biological: Tigerase® and best available care

Nebulised dornase alfa [2.5 mg BID] for 7 days
Other Name: Dornase Alfa Inhalation Solution and best available care

Other: Best available care

Patients will receive the usual care in accordance with good practice.
Other Name: Standard of care

Eligibility Criteria

Inclusion Criteria:

1. Written informed consent for participation in the study

2. Men and women aged ≥18 years

3. Laboratory-confirmed diagnosis of coronavirus infection caused by COVID19, moderate
severity *

*Criteria for moderate flow (just one point) Mandatory Criterion

- Pneumonia Additional criteria (used to characterize the disease and are not
required to determine the severity)

- Fever above 38 ° C

- respiratory rate more than 22 / min

- Shortness of breath during physical exertion

- SpO2 <95%

- С-reactive protein (CRP) of serum more than 10 mg / l

4. Patients with pneumonia with a stable level of hemoglobin saturation by oxygen (> 93%)
on oxygen support and / or receiving respiratory support of non-invasive mechanical
ventilation

Exclusion Criteria:

1. Individual intolerance or hypersensitivity to the active or any of the excipients of
the drug Tigerase®

2. The need for invasive mechanical ventilation at the time of inclusion of the patient

3. Patients severe condition (one of the following characteristics):

- Respiratory distress syndrome with respiratory rate ≥30 per minute

- Saturation of hemoglobin with oxygen ≤93% with oxygen support

4. Patient participate in any clinical trials and / or taking the experimental drug
within 30 days before inclusion this trial

5. Severe competitive respiratory system diseases (bronchial asthma, chronic obstructive
pulmonary disease - COPD, cystic fibrosis, interstitial lung disease)

6. Positive results of laboratory testing for HIV and hepatitis B and C

7. Life expectancy less than 12 months without COVID-19

8. Other diseases and conditions, significant laboratory or instrumental deviation,
which, according to investigator opinion, may impact the results of the study, limit
the patient's participation in the trial or create an unreasonable risk for the
patient

9. Patient's unwillingness or disability to comply with the recommendations prescribed by
protocol, as well as any concomitant medical or serious mental conditions that render
the patient unsuitable for participation in the study, limit the legitimacy of
obtaining informed consent or may affect the patient's ability to participate in the
study (including disability to use a nebulizer)

10. Positive pregnancy test in women

11. The period of breastfeeding in women

12. Refusal of male patients and female patients with preserved reproductive function to
use adequate methods of contraception throughout the study and for at least 30 days
after the end of therapy with the studied drug

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Russian Federation
Locations

City Clinical Hospital #15
Moscow, Russian Federation

I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, Russian Federation

City Clinical Hospital #51
Moscow, Russian Federation

City Clinical Hospital #52
Moscow, Russian Federation

N.V. Sklifosovsky Scientific Research Institute of First Aid
Moscow, Russian Federation

Siberian State Medical University (SibMed)
Moscow, Russian Federation

Oksana A. Markova, MD, Study Chair
AO GENERIUM

NCT Number
Keywords
Covid-19
Coronavirus Infections
Coronaviridae Infections
Dornase alfa
Virus Diseases
Acute Lung Injury
Acute Respiratory Distress Syndrome
Respiratory insufficiency
Respiratory Tract Diseases
MeSH Terms
COVID-19
Coronavirus Infections