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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Comparative analysis between treatment groups on the WHO Clinical Improvement Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 38 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Interferon Gamma (Drug)
结局指标
主要结局
Comparative analysis between treatment groups on the WHO Clinical Improvement Scale
时间窗: Day 14
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
次要结局
- Difference between laboratory CRP values(Day 14)
- Difference between laboratory ferritin values(Day 14)
- Difference between laboratory LDH values(Day 14)
- Changes in laboratory parameter D-dimer(Day 14)
- Comparative analysis of the incidence and severity of adverse events(Day 14)
- Comparative analysis of survival between treatment groups(Day 14)
- Change from baseline patient ratings of subjective outcomes based on various measures(Day 14)
- Comparative analysis between groups by indicators(Day 14)
- Comparative analysis between groups on NEWS-2 indicators(Day 14)