Prospective Open Controlled Non-interventional Study of the Use of the Drug Ingaron (Interferon Gamma Human Recombinant, NPP Farmaklon LLC, Russia) in Volunteers for the Prevention of Coronavirus Infection COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence rate
研究概览
简要总结
The main purpose of this study is to evaluate the effectiveness of the prophylactic use of Ingaron (INN: recombinant interferon gamma human, lyophilisate for solution for intranasal administration 100,000 IU) in the regimen of 3 drops in each nasal passage intranasally every other day for 10 days with a break of 7 days (2 10-day cycles) in volunteers.
详细描述
Distribution between groups is made randomly at the request of the participant. According to the methodology approved by the observational program, the participant must use or not use the investigational drug (depending on the distribution group and their own will) during the 27 days of the prophylaxis course (10 days + 7 days + 10 days). The control group does not receive study therapy.
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
- 21 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical workers and medical personnel working in the "red zone" and in contact with patients infected with COVID-
- •Men and women over 18 years of age.
- •Signing an informed consent form for data processing.
- •Ability and agreement to complete the questionnaire (part 1) of the participant.
- •No symptoms of a respiratory infection.
- •Negative PCR test result for the presence of SARS-CoV-2 RNA according to the biomaterial obtained by nasopharyngeal swab.
排除标准
- •Any clinically confirmed or documented history of diseases that may complicate the interpretation of the data being assessed (HIV, cancer, organ transplantation, etc.).
- •Any other comorbidities or conditions that, in the opinion of the investigator, may distort the results of the study, limit the rights of the volunteer, or put him at greater risk.
- •Contraindications to the use of the investigational medicinal product.
- •Individual intolerance to the ingredients that make up the study drug.
- •Pregnancy or breastfeeding.
- •The presence of antibodies to SARS-CoV-2 (IgM, IgG).
研究组 & 干预措施
Drug: Interferon Gamma
Ingaron (INN: recombinant human interferon gamma, lyophilisate for solution for intranasal administration 100,000 IU) in the regime of 3 drops in each nasal passage intranasally every other day for 10 days with a break of 7 days (2 10-day cycles)
干预措施: Interferon gamma human recombinant (IFN-G) (Drug)
结局指标
主要结局
Incidence rate
时间窗: Day 35
The incidence rate of COVID-19 volunteers when using the drug Ingaron (INN: interferon gamma human recombinant, lyophilisate for solution for intranasal administration 100,000 IU) in the regimen of 3 drops in each nasal passage intranasally every other day for 10 days with a break of 7 days ( 2 10-day cycles) vs control group
次要结局
- Severity of symptoms(Day 35)
- Frequency of laboratory confirmation of COVID-19 disease(Day 35)
- Comparative assessment of scores on the WHO scale (0-8)(Day 35)
- Duration of symptoms(Day 35)