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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19 Respiratory Infection
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 121374
    • City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 62 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: SPP Pharmaclon Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2020
• Primary Completion (Actual): June 10, 2020
• Study Completion (Actual): June 15, 2020

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: interferon gamma; COVID-19 prevention; nasal drops
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Infections; Respiratory Tract Infections; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Interferons; Interferon-gamma
• Other Study ID Numbers: GAMMACOVID-PROF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No