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

Completed

• Conditions: COVID-19 Respiratory Infection
• Interventions: Drug: Interferon gamma human recombinant (IFN-G)

• Registration Number: NCT05386446
• Lead Sponsor: SPP Pharmaclon Ltd.

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.

Study Timeline

• Study Start: 2020-04-23
• Primary Completion: 2020-06-10
• Study Completion: 2020-06-15
• Status Verified: 2022-05
• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-05-20
• Last Update Submitted: 2022-05-20
• Study First Posted: 2022-05-23
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Drug: Interferon Gamma	Interferon gamma human recombinant (IFN-G)	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Severity of symptoms	Day 35	The severity of symptoms of the disease of infected study participants in both groups
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
Duration of symptoms	Day 35	The duration of symptoms of the disease of infected study participants in both groups

Trial Locations

Locations (1)

City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department; 🇷🇺 Moscow, Russian Federation