Study of the Use of the Drug Ingaron in Patients With COVID-19

Completed

Brief Summary: Interferon gamma is a powerful endogenous regulatory cytokine that activates the antiviral immune response, while it also has its own antiviral activity. The objective of this study was to evaluate the effectiveness of the proposed treatment regimen with Ingaron (INN: recombinant interferon gamma human, lyophilisate for preparing a solution for intramuscular and subcutaneous administration of 500,000 IU) in patients with viral pneumonia.

Detailed Description: The study drug was prescribed for therapeutic purposes according to the following scheme:

500,000 IU s / c 1 time per day daily for 5 days. A total of 4 visits were scheduled. Visits 0 and 1 could be combined provided that the chronological sequence of screening and randomization procedures was followed.

The main stages of the study:

screening - lasting no more than 1 day; treatment - within 10-14 days, including the use of the investigational medicinal product for 5 days (from the first day of the basic therapy, daily).

The total duration of observation is up to 14 days. Patients who completed participation in the study or dropped out of the study ahead of schedule were followed up by the attending physician in accordance with the rules for managing such patients for a medical institution.

Recruitment & Eligibility

Inclusion Criteria

Patients with viral pneumonia according to CT scan, regardless of:
- degree of damage to the lungs;
- results of a laboratory test for the presence of SARS-CoV-2 RNA;
- epidemiological history.
Patients of both sexes over 18 years of age.
Patients who are able to read, understand and independently certify in writing the informed consent form.
Negative pregnancy test for female patients of reproductive age with preserved reproductive function.

Exclusion Criteria

Any clinically confirmed or documented history of disease that may make it difficult to interpret the data being assessed.
No symptoms of a respiratory infection.
Severe liver or kidney failure, and/or failure of other vital organs, in the stage of decompensation (kidney - creatinine level> 2X ULN, liver tests: liver enzymes (AST and ALT) > 3X ULN).
Diseases of the central nervous system with severe impairment of intellectual and mnestic functions.
Any other disease or condition that, in the opinion of the investigator, may confound the results of the study, limit the patient's participation in the study, or place the patient at greater risk.
Serious diseases and pathological conditions (PE, oncological diseases, etc.) that require emergency medical care or threaten the patient's life.
Mild, subclinical, asymptomatic or severe form of the course of the disease.
Acute respiratory distress syndrome, sepsis, septic shock.
Contraindications to the use of the investigational medicinal product.
Individual intolerance to the ingredients that make up the study drug.
Participation in any clinical trial within 1 month prior to baseline visit (Day 0-1).
Pregnancy or breastfeeding.

Arm && Interventions

Group	Intervention	Description
Main	Interferon Gamma	Ingaron (INN: recombinant human interferon gamma, lyophilizate for solution preparation for intramuscular and subcutaneous administration 500,000 IU) 1 subcutaneous injection 1 time per day (in the morning) daily for 5 days (5 injections in total) against the background of basic antibacterial and symptomatic therapy

Primary Outcome Measures

Name	Time	Method
Comparative analysis between treatment groups on the WHO Clinical Improvement Scale	Day 14	The assessment was carried out according to the WHO Clinical Improvement Scale from 0 points - not infected, no manifestations or virological signs of infection, up to 8 points - died, death

Secondary Outcome Measures

Name	Time	Method
Change from baseline patient ratings of subjective outcomes based on various measures	Day 14	Change from Baseline Patients in Subjective Outcomes Based on Indicator: Blood Pressure
Comparative analysis of survival between treatment groups	Day 14	Comparative assessment of IFR mortality rates
Comparative analysis between groups by indicators	Day 14	Comparative analysis between groups by indicators: duration of hospitalization
Difference between laboratory CRP values	Day 14	Difference between laboratory CRP values compared to baseline
Difference between laboratory ferritin values	Day 14	Difference between laboratory ferritin values compared to baseline
Difference between laboratory LDH values	Day 14	Difference between laboratory LDH values compared to baseline
Changes in laboratory parameter D-dimer	Day 14	Changes in laboratory parameter D-dimer compared with baseline
Comparative analysis of the incidence and severity of adverse events	Day 14	Comparative analysis of the incidence and severity of adverse events according to CTCAE version 4.03 of 2010
Comparative analysis between groups on NEWS-2 indicators	Day 14	Comparative assessment of the score according to the National Early Warning Rating 2 (NEWS-2), where the minimum score is 0, which corresponds to the general rules for managing a patient, from 7 points or more - emergency medical care is required in the ICU

Locations (1): City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department
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Moscow, Russian Federation