Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon Gamma | Drug | injection form |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between laboratory LDH values | Difference between laboratory LDH values compared to baseline | Day 14 |
| Difference between laboratory CRP values | Difference between laboratory CRP values compared to baseline |
Not provided
Inclusion Criteria:
Patients with viral pneumonia according to CT scan, regardless of:
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:
Not provided
Not provided
Patients with novel coronavirus infection COVID-19
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anatoly I Saulin, Master | SPP Pharmaclon Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department | Moscow | 121374 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33683065 | Result | Myasnikov AL, Berns SA, Talyzin PA, Ershov FI. [Interferon gamma in the treatment of patients with moderate COVID-19]. Vopr Virusol. 2021 Mar 7;66(1):47-54. doi: 10.36233/0507-4088-24. Russian. | |
| Result | Myasnikov AL, Berns SA, Erhshov FI. Clinical application of interferon gamma in comprehensive therapy of patients with coronavirus infection. Rossiiskii meditsinskii zhurnal (Medical Journal of the Russian Federation, Russian Journal). 2020;26(6):394-401. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007371 | Interferon-gamma |
| ID | Term |
|---|---|
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 14 |
| Difference between laboratory ferritin values | Difference between laboratory ferritin values compared to baseline | Day 14 |
| Changes in laboratory parameter D-dimer | Changes in laboratory parameter D-dimer compared with baseline | Day 14 |
| Comparative analysis of survival between treatment groups | Comparative assessment of CFR mortality rates | Day 14 |
| Comparative analysis of survival between treatment groups | Comparative assessment of IFR mortality rates | 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 | 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 | 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 | Day 14 |
| Comparative analysis between groups by indicators | Comparative analysis between groups by indicators: duration of fever | Day 14 |
| Comparative analysis between groups by indicators | Comparative analysis between groups by indicators: duration of hospitalization | 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 | 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 | Day 14 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D016215 | Macrophage-Activating Factors |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |