Clinical trial NCT05386446: Study of the Use of the Ingaron in Volunteers for the Prevention of COVID-19
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Respiratory Infection
Keywords: COVID-19 prevention
interferon gamma
nasal drops
Lead sponsor: SPP Pharmaclon Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-23
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteers working in the "red zone" with patients infected with SARS-CoV-2

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Medical workers and medical personnel working in the "red zone" and in contact with patients infected with COVID-19.
2. Men and women over 18 years of age.
3. Signing an informed consent form for data processing.
4. Ability and agreement to complete the questionnaire (part 1) of the participant.
5. No symptoms of a respiratory infection.
6. Negative PCR test result for the presence of SARS-CoV-2 RNA according to the biomaterial obtained by nasopharyngeal swab.

Exclusion Criteria:

1. Any clinically confirmed or documented history of diseases that may complicate the interpretation of the data being assessed (HIV, cancer, organ transplantation, etc.).
2. 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.
3. Contraindications to the use of the investigational medicinal product.
4. Individual intolerance to the ingredients that make up the study drug.
5. Pregnancy or breastfeeding.
6. The presence of antibodies to SARS-CoV-2 (IgM, IgG).

Primary outcomes:
measure: Incidence rate
timeFrame: Day 35
Secondary outcomes:
measure: Frequency of laboratory confirmation of COVID-19 disease
timeFrame: Day 35
measure: Comparative assessment of scores on the WHO scale (0-8)
timeFrame: Day 35
measure: Severity of symptoms
timeFrame: Day 35
measure: Duration of symptoms
timeFrame: Day 35
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department
Study officials:
affiliation: SPP Pharmaclon Ltd.
name: Anatoly I Saulin, Master
role: STUDY_DIRECTOR
References:
citation: 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.