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

SPP Pharmaclon

Status: Completed

Conditions: COVID-19 Respiratory Infection; Viral Pneumonia

Treatments: Drug: Interferon Gamma

Study type: Observational

Funder types: Industry

Identifiers

NCT05386459

2GAMMACOVID-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 38 to 84 years old

Volunteers: No 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.

Trial design

36 participants in 2 patient groups

Main

Description:

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

Treatment:

Drug: Interferon Gamma

Control

Description:

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