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.
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 Type
OBSERVATIONAL
Enrollment
36
injection form
City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department
Moscow, Russia
Comparative analysis between treatment groups on the WHO Clinical Improvement Scale
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
Time frame: Day 14
Difference between laboratory LDH values
Difference between laboratory LDH values compared to baseline
Time frame: Day 14
Difference between laboratory CRP values
Difference between laboratory CRP values compared to baseline
Time frame: Day 14
Difference between laboratory ferritin values
Difference between laboratory ferritin values compared to baseline
Time frame: Day 14
Changes in laboratory parameter D-dimer
Changes in laboratory parameter D-dimer compared with baseline
Time frame: Day 14
Comparative analysis of survival between treatment groups
Comparative assessment of CFR mortality rates
Time frame: Day 14
Comparative analysis of survival between treatment groups
Comparative assessment of IFR mortality rates
Time frame: Day 14
Change from baseline patient ratings of subjective outcomes based on various measures
Change from Baseline Patients in Subjective Outcomes Based on: Pulse Oxygen Saturation
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Time frame: Day 14
Change from baseline patient ratings of subjective outcomes based on various measures
Change from baseline patient assessments of subjective outcomes based on the indicator: body temperature
Time frame: Day 14
Change from baseline patient ratings of subjective outcomes based on various measures
Change from Baseline Patients in Subjective Outcomes Based on Indicator: Blood Pressure
Time frame: Day 14
Comparative analysis between groups by indicators
Comparative analysis between groups by indicators: duration of fever
Time frame: Day 14
Comparative analysis between groups by indicators
Comparative analysis between groups by indicators: duration of hospitalization
Time frame: Day 14
Comparative analysis between groups on NEWS-2 indicators
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
Time frame: Day 14
Comparative analysis of the incidence and severity of adverse events
Comparative analysis of the incidence and severity of adverse events according to CTCAE version 4.03 of 2010
Time frame: Day 14