Study of the Use of the Ingaron in Volunteers for the Prevention of COVID-19

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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COVID-19 Respiratory Infection

Intervention / Treatment
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* Drug: Interferon gamma human recombinant (IFN-G)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical workers and medical personnel working in the red zone and in contact with patients infected with COVID-19. 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 62 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Drug: Interferon Gamma<br>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) | Drug: Interferon gamma human recombinant (IFN-G)<br>* nasal form<br>* Other names: Interferon gamma human recombinant;|
| Control: No intervention<br>Любой профилактический метод, включающий различные фармакологические методы лечения COVID-19, наряду с применением противовирусных и иммуномодулирующих средств, за исключением препаратов, назначаемых не по назначению или в исследовательских целях, а также IFN-G. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate | 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 | Day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of laboratory confirmation of COVID-19 disease | The frequency of laboratory confirmations of COVID-19 disease when using Ingaron (INN: recombinant human interferon gamma, 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 | Day 35 | 
| Comparative assessment of scores on the WHO scale (0-8) | Comparative evaluation of scores on the WHO scale (from 0 points - not infected, no manifestations or virological signs of infection, up to 8 points - died, death) when using the drug Ingaron (INN: interferon gamma human recombinant, lyophilisate for solution for intranasal administration 100,000 IU) in the mode 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 comparison with the control group | Day 35 | 
| Severity of symptoms | The severity of symptoms of the disease of infected study participants in both groups | Day 35 | 
| Duration of symptoms | The duration of symptoms of the disease of infected study participants in both groups | Day 35 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19 prevention, interferon gamma, nasal drops