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

Sponsor

SPP Pharmaclon Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT05386459

Collaborator

(none)

Enrollment

Location

5.4

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Respiratory Infection Viral Pneumonia	Drug: Interferon Gamma

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.

Study Design

Study Type:

Observational

Actual Enrollment :

36 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Two-week Open-label Application Experimental Randomized Single-center Non-interventional Study of the Drug Ingaron in Patients With a New Coronavirus Infection COVID-19

Actual Study Start Date :

Apr 21, 2020

Actual Primary Completion Date :

Jun 17, 2020

Actual Study Completion Date :

Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Main 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	Drug: Interferon Gamma injection form Other Names: Ingaron Interferon gamma human recombinant
Control Only basic antibacterial and symptomatic therapy. The use of the study drug was carried out on the basis of the decision of the medical commission with the execution of the protocol and primary medical documentation of the patient

Arm

Intervention/Treatment

Main

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

Drug: Interferon Gamma

injection form

Other Names:

Ingaron

Interferon gamma human recombinant

Control

Only basic antibacterial and symptomatic therapy. The use of the study drug was carried out on the basis of the decision of the medical commission with the execution of the protocol and primary medical documentation of the patient

Outcome Measures

Primary Outcome Measures

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

Difference between laboratory LDH values [Day 14]
Difference between laboratory LDH values compared to baseline
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
Changes in laboratory parameter D-dimer [Day 14]
Changes in laboratory parameter D-dimer compared with baseline
Comparative analysis of survival between treatment groups [Day 14]
Comparative assessment of CFR mortality rates
Comparative analysis of survival between treatment groups [Day 14]
Comparative assessment of IFR mortality rates
Change from baseline patient ratings of subjective outcomes based on various measures [Day 14]
Change from Baseline Patients in Subjective Outcomes Based on: Pulse Oxygen Saturation
Change from baseline patient ratings of subjective outcomes based on various measures [Day 14]
Change from baseline patient assessments of subjective outcomes based on the indicator: body temperature
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 between groups by indicators [Day 14]
Comparative analysis between groups by indicators: duration of fever
Comparative analysis between groups by indicators [Day 14]
Comparative analysis between groups by indicators: duration of hospitalization
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

38 Years to 84 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.