Clinical trial NCT05386459: Study of the Use of the Drug Ingaron in Patients With COVID-19
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Respiratory Infection
Viral Pneumonia
Keywords: COVID-19 treatment
interferon gamma
Lead sponsor: SPP Pharmaclon Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-23
Enrollment: 36
Sex: ALL
Minimum age (years): 38
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with novel coronavirus infection COVID-19

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparative analysis between treatment groups on the WHO Clinical Improvement Scale
timeFrame: Day 14
Secondary outcomes:
measure: Difference between laboratory LDH values
timeFrame: Day 14
measure: Difference between laboratory CRP values
timeFrame: Day 14
measure: Difference between laboratory ferritin values
timeFrame: Day 14
measure: Changes in laboratory parameter D-dimer
timeFrame: Day 14
measure: Comparative analysis of survival between treatment groups
timeFrame: Day 14
measure: Comparative analysis of survival between treatment groups
timeFrame: Day 14
measure: Change from baseline patient ratings of subjective outcomes based on various measures
timeFrame: Day 14
measure: Change from baseline patient ratings of subjective outcomes based on various measures
timeFrame: Day 14
measure: Change from baseline patient ratings of subjective outcomes based on various measures
timeFrame: Day 14
measure: Comparative analysis between groups by indicators
timeFrame: Day 14
measure: Comparative analysis between groups by indicators
timeFrame: Day 14
measure: Comparative analysis between groups on NEWS-2 indicators
timeFrame: Day 14
measure: Comparative analysis of the incidence and severity of adverse events
timeFrame: Day 14
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department
Study officials:
affiliation: SPP Pharmaclon Ltd.
name: Anatoly I Saulin, Master
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.