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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
| |
| Control: No intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon gamma human recombinant (IFN-G) | Drug | nasal form |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Volunteers working in the "red zone" with patients infected with SARS-CoV-2
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| Name | Affiliation | Role |
|---|---|---|
| Anatoly I Saulin, Master | SPP Pharmaclon Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department | Moscow | 121374 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Myasnikov AL, Berns SA, Zverev KV, Lartseva OA, Talyzin PA. Efficacy of Interferon Gamma in the Prevention of SARS-CoV-2 Infection (COVID-19): Results of a Prospective Controlled Trial. International Journal of Biomedicine 2020; 10(3): 182-188. |
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| 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 |