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

NCT05386446 | Completed

• 1 other identifier: GAMMACOVID-PROF
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Respiratory Infection

Keywords

COVID-19 prevention; interferon gamma; nasal drops

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Frequency of laboratory confirmation of COVID-19 disease

  Day 35

• Comparative assessment of scores on the WHO scale (0-8)

  Day 35

• Severity of symptoms

  Day 35

• Duration of symptoms

  Day 35

Study Arms (2)

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)

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.

Interventions

Interferon gamma human recombinant (IFN-G) DRUG

nasal form

Also known as: Ingaron, Interferon gamma human recombinant

Drug: Interferon Gamma

Eligibility Criteria

• Age: 21 Years - 62 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Volunteers working in the "red zone" with patients infected with SARS-CoV-2

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• SPP Pharmaclon Ltd.: lead

Study Sites (1)

City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department

Moscow, 121374, Russia

Location

Related Publications (1)

• 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.

  BACKGROUND

Study Officials

• Anatoly I Saulin, Master

  SPP Pharmaclon Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 23, 2022
• Study Start: April 23, 2020
• Primary Completion: June 10, 2020
• Study Completion: June 15, 2020
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)