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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19 Respiratory Infection; Viral Pneumonia
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 121374
    • City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 84 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with novel coronavirus infection COVID-19

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: SPP Pharmaclon Ltd.

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 21, 2020
• Primary Completion (ACTUAL): June 17, 2020
• Study Completion (ACTUAL): October 1, 2020

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (ACTUAL): May 23, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: interferon gamma; COVID-19 treatment
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia; Lung Diseases; COVID-19; Infections; Pneumonia, Viral; Respiratory Tract Infections; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Interferons; Interferon-gamma
• Other Study ID Numbers: 2GAMMACOVID-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No