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Completed

NCT Number: NCT05386446

Study of the Use of the Ingaron in Volunteers for the Prevention of 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.

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Key information

Conditions

COVID-19 Respiratory Infection

Age range

21 year–62 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Moscow, 121374, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Interferon gamma human recombinant (IFN-G)

Drug

nasal form

Other names: Ingaron, Interferon gamma human recombinant

Primary outcomes

  1. Incidence rate

    Time frame: 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 outcomes

  1. Frequency of laboratory confirmation of COVID-19 disease

    Time frame: 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

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

    Time frame: 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

  3. Severity of symptoms

    Time frame: Day 35

    The severity of symptoms of the disease of infected study participants in both groups

  4. Duration of symptoms

    Time frame: Day 35

    The duration of symptoms of the disease of infected study participants in both groups

Sponsors and collaborators

Lead sponsor

SPP Pharmaclon Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 23, 2022
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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