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

Sponsor

SPP Pharmaclon Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT05386446

Collaborator

(none)

100

Enrollment

Location

1.7

Actual Duration (Months)

57.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Respiratory Infection	Drug: Interferon gamma human recombinant (IFN-G)

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 23, 2020

Actual Primary Completion Date :

Jun 10, 2020

Actual Study Completion Date :

Jun 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
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)	Drug: Interferon gamma human recombinant (IFN-G) nasal form Other Names: Ingaron Interferon gamma human recombinant
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.

Arm

Intervention/Treatment

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)

Drug: Interferon gamma human recombinant (IFN-G)

nasal form

Other Names:

Ingaron

Interferon gamma human recombinant

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.

Outcome Measures

Primary Outcome Measures

Incidence rate [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

Secondary Outcome Measures

Frequency of laboratory confirmation of COVID-19 disease [Day 35]
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
Comparative assessment of scores on the WHO scale (0-8) [Day 35]
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
Severity of symptoms [Day 35]
The severity of symptoms of the disease of infected study participants in both groups
Duration of symptoms [Day 35]
The duration of symptoms of the disease of infected study participants in both groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 62 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).