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

NCT ID: NCT04459325

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2020-07-20

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.

Conditions

COVID-19; Coronavirus Disease 2019

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study drug and best available care

Best available care and Tigerase®/nebulised dornase alfa \[2.5 mg BID\] for 7 days

Group Type: EXPERIMENTAL

Tigerase® and best available care

Intervention Type: BIOLOGICAL

Nebulised dornase alfa \[2.5 mg BID\] for 7 days

Control group (best available care)

Patients will receive the usual care in accordance with good practice.

Group Type: OTHER

Best available care

Intervention Type: OTHER

Patients will receive the usual care in accordance with good practice.

Interventions

Tigerase® and best available care

Nebulised dornase alfa \[2.5 mg BID\] for 7 days

Intervention Type: BIOLOGICAL

Best available care

Patients will receive the usual care in accordance with good practice.

Intervention Type: OTHER

Other Intervention Names

Dornase Alfa Inhalation Solution and best available care; 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AO GENERIUM

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oksana A. Markova, MD

Role: STUDY_CHAIR

AO GENERIUM

Locations

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

N.V. Sklifosovsky Scientific Research Institute of First Aid

Moscow, , Russia

Siberian State Medical University (SibMed)

Moscow, , Russia

Countries

Russia

Other Identifiers

#216 eff date 27.05.2020

Identifier Type: OTHER

Identifier Source: secondary_id

DRN-ALI-III

Identifier Type: -

Identifier Source: org_study_id