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

NCT05386459 | Completed

• 1 other identifier: 2GAMMACOVID-19
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Respiratory Infection; Viral Pneumonia

Keywords

COVID-19 treatment; interferon gamma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Difference between laboratory LDH values

  Day 14

• Difference between laboratory CRP values

  Day 14

• Difference between laboratory ferritin values

  Day 14

• Changes in laboratory parameter D-dimer

  Day 14

• Comparative analysis of survival between treatment groups

  Day 14

Study Arms (2)

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

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

Interventions

Interferon Gamma DRUG

injection form

Also known as: Ingaron, Interferon gamma human recombinant

Main

Eligibility Criteria

• Age: 38 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with novel coronavirus infection COVID-19

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SPP Pharmaclon Ltd.: lead

Study Sites (1)

City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department

Moscow, 121374, Russia

Location

Related Publications (2)

• 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.

  PMID: 33683065 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.

  RESULT

MeSH Terms

Conditions

Pneumonia, Viral

Interventions

Interferon-gamma

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Macrophage-Activating Factors; Lymphokines; Proteins; Biological Factors

Study Officials

• Anatoly I Saulin, Master

  SPP Pharmaclon Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 23, 2022
• Study Start: April 21, 2020
• Primary Completion: June 17, 2020
• Study Completion: October 1, 2020
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

RU (1)