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

NCT04459325 | Completed Phase 3 DMC

• 2 other identifiers: DRN-ALI-III#216 eff date 27.05.2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

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.

Conditions

COVID-19; Coronavirus Disease 2019

Keywords

COVID-19; Coronavirus Infections; Coronaviridae Infections; Dornase alfa; Virus Diseases; Acute lung injury; Acute respiratory distress syndrome; Respiratory Insufficiency; Respiratory Tract Diseases

Outcome Measures

Primary Outcomes (2)

• The proportion of patients with mechanical ventilation

  Day 8

• Category change on WHO Ordinal Scale for Clinical Improvement

  Day 8

Secondary Outcomes (12)

• The proportion of patients with mechanical ventilation

  Day 28

• Category change on WHO Ordinal Scale for Clinical Improvement

  Day 28

• Proportion of patients surviving 28 days after inclusion in the study

  Day 28

• Number of days of oxygen therapy during the treatment period

  Day 8

• Change in C-reactive protein level

  Days 3, 5, 8

Study Arms (2)

Study drug and best available care

EXPERIMENTAL

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

Biological: Tigerase® and best available care

Control group (best available care)

OTHER

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

Other: Best available care

Interventions

Tigerase® and best available care BIOLOGICAL

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

Also known as: Dornase Alfa Inhalation Solution and best available care

Study drug and best available care

Best available care OTHER

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

Also known as: Standard of care

Control group (best available care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent for participation in the study
• Men and women aged ≥18 years
• 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
• 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

You may not qualify if:

• Individual intolerance or hypersensitivity to the active or any of the excipients of the drug Tigerase®
• 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
• Severe competitive respiratory system diseases (bronchial asthma, chronic obstructive pulmonary disease - COPD, cystic fibrosis, interstitial lung disease)
• Positive results of laboratory testing for HIV and hepatitis B and C
• Life expectancy less than 12 months without COVID-19
• 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
• 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)
• Positive pregnancy test in women
• The period of breastfeeding in women
• 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

Sponsors & Collaborators

• AO GENERIUM: lead

Study Sites (6)

City Clinical Hospital #15

Moscow, 111539, Russia

Location

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, 119991, Russia

Location

City Clinical Hospital #51

Moscow, 121309, Russia

Location

City Clinical Hospital #52

Moscow, 123182, Russia

Location

N.V. Sklifosovsky Scientific Research Institute of First Aid

Moscow, 129090, Russia

Location

Siberian State Medical University (SibMed)

Moscow, 634050, Russia

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Coronaviridae Infections; Virus Diseases; Acute Lung Injury; Respiratory Distress Syndrome; Respiratory Insufficiency; Respiratory Tract Diseases

Interventions

dornase alfa; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Lung Injury; Respiration Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Oksana A. Markova, MD

  AO GENERIUM

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 7, 2020
• Study Start: June 1, 2020
• Primary Completion: July 20, 2020
• Study Completion: July 20, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (6)