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COVID-19 Respiratory InfectionNCT05386446

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

An observational study of COVID-19 Respiratory Infection, run by SPP Pharmaclon Ltd. at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 62 years
Conditions the study is for
COVID-19 Respiratory Infection
What is being tested?
Interferon gamma human recombinant (IFN-G)
How many people
100 participants
Where
1 siteRussia
Study dates
23 Apr 2020to 15 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 62 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Russia1 site

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

    Moscow, 121374

Other trials in Russia

About this study

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

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.

Read the 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.

Being tested
Interferon gamma human recombinant (IFN-G)
Keywords
COVID-19 prevention, interferon gamma, nasal drops

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interferon gamma human recombinant (IFN-G)Drug

    Also called Ingaron, Interferon gamma human recombinant

    nasal form

Study groups in NCT05386446
Study groupRoleWhat they receive
Drug: Interferon GammaIngaron (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)
Receives: Drug: Interferon gamma human recombinant (IFN-G)
Control: No interventionЛюбой 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 being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Day 35

Secondary outcomes (4)

  1. 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

    Measured: Day 35

  2. 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

    Measured: Day 35

  3. Severity of symptoms

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

    Measured: Day 35

  4. Duration of symptoms

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

    Measured: Day 35

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2022
  2. Study start23 Apr 2020
  3. Primary completion10 Jun 2020
  4. Study completion15 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05386446
Sponsor's protocol ID
GAMMACOVID-PROF
Status last verified
May 2022
First submitted
20 May 2022
Last updated
23 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 Respiratory Infection, run by SPP Pharmaclon Ltd. at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate (time frame: Day 35). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05386446, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.

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