AzTrials
AzTrials

COVID-19 Respiratory InfectionNCT05386459

Study of the Use of the Drug Ingaron in Patients With COVID-19

An observational study of COVID-19 Respiratory Infection and Viral Pneumonia, 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
Search all trials

Trial summary

Interferon gamma is a powerful endogenous regulatory cytokine that activates the antiviral immune response, while it also has its own antiviral activity. The objective of this study was to evaluate the effectiveness of the proposed treatment regimen with Ingaron (INN: recombinant interferon gamma human, lyophilisate… Read more about this study

Who is it for?
Ages 38 to 84 years
What is being tested?
Interferon Gamma
Type of treatment
Injection or infusion
How many people
36 participants
Where
1 siteRussia
Study dates
21 Apr 2020to 1 Oct 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 38 to 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with novel coronavirus infection COVID-19

Who may be able to join

  • Patients with viral pneumonia according to CT scan, regardless of:
  • degree of damage to the lungs;
  • results of a laboratory test for the presence of SARS-CoV-2 RNA;
  • epidemiological history.
  • Patients of both sexes over 18 years of age.
  • Patients who are able to read, understand and independently certify in writing the informed consent form.
  • Negative pregnancy test for female patients of reproductive age with preserved reproductive function.

Who cannot join

  • Any clinically confirmed or documented history of disease that may make it difficult to interpret the data being assessed.
  • No symptoms of a respiratory infection.
  • Severe liver or kidney failure, and/or failure of other vital organs, in the stage of decompensation (kidney - creatinine level> 2X ULN, liver tests: liver enzymes (AST and ALT) > 3X ULN).
  • Diseases of the central nervous system with severe impairment of intellectual and mnestic functions.
  • Any other disease or condition that, in the opinion of the investigator, may confound the results of the study, limit the patient's participation in the study, or place the patient at greater risk.
  • Serious diseases and pathological conditions (PE, oncological diseases, etc.) that require emergency medical care or threaten the patient's life.
Show all 12Show fewer
  • Mild, subclinical, asymptomatic or severe form of the course of the disease.
  • Acute respiratory distress syndrome, sepsis, septic shock.
  • Contraindications to the use of the investigational medicinal product.
  • Individual intolerance to the ingredients that make up the study drug.
  • Participation in any clinical trial within 1 month prior to baseline visit (Day 0-1).
  • Pregnancy or breastfeeding.

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 Two-week Open-label Application Experimental Randomized Single-center Non-interventional Study of the Drug Ingaron in Patients With a New Coronavirus Infection COVID-19

Interferon gamma is a powerful endogenous regulatory cytokine that activates the antiviral immune response, while it also has its own antiviral activity. The objective of this study was to evaluate the effectiveness of the proposed treatment regimen with Ingaron (INN: recombinant interferon gamma human, lyophilisate for preparing a solution for intramuscular and subcutaneous administration of 500,000 IU) in patients with viral pneumonia.

Read the detailed description

The study drug was prescribed for therapeutic purposes according to the following scheme:

500,000 IU s / c 1 time per day daily for 5 days. A total of 4 visits were scheduled. Visits 0 and 1 could be combined provided that the chronological sequence of screening and randomization procedures was followed.

The main stages of the study:

screening - lasting no more than 1 day; treatment - within 10-14 days, including the use of the investigational medicinal product for 5 days (from the first day of the basic therapy, daily).

The total duration of observation is up to 14 days. Patients who completed participation in the study or dropped out of the study ahead of schedule were followed up by the attending physician in accordance with the rules for managing such patients for a medical institution.

Being tested
Interferon Gamma
Keywords
COVID-19 treatment, interferon gamma
Medical subject headings
Pneumonia, Viral

What participants receive

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

  • Interferon GammaDrug

    Also called Ingaron, Interferon gamma human recombinant

    injection form

Study groups in NCT05386459
Study groupRoleWhat they receive
MainIngaron (INN: recombinant human interferon gamma, lyophilizate for solution preparation for intramuscular and subcutaneous administration 500,000 IU) 1 subcutaneous injection 1 time per day (in the morning) daily for 5 days (5 injections in total) against the background of basic antibacterial and symptomatic therapy
Receives: Drug: Interferon Gamma
ControlOnly basic antibacterial and symptomatic therapy. The use of the study drug was carried out on the basis of the decision of the medical commission with the execution of the protocol and primary medical documentation of the patient

What is being measured

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

  1. Comparative analysis between treatment groups on the WHO Clinical Improvement Scale

    The assessment was carried out according to the WHO Clinical Improvement Scale from 0 points - not infected, no manifestations or virological signs of infection, up to 8 points - died, death

    Measured: Day 14

Secondary outcomes (13)

  1. Difference between laboratory LDH values

    Difference between laboratory LDH values compared to baseline

    Measured: Day 14

  2. Difference between laboratory CRP values

    Difference between laboratory CRP values compared to baseline

    Measured: Day 14

  3. Difference between laboratory ferritin values

    Difference between laboratory ferritin values compared to baseline

    Measured: Day 14

  4. Changes in laboratory parameter D-dimer

    Changes in laboratory parameter D-dimer compared with baseline

    Measured: Day 14

  5. Comparative analysis of survival between treatment groups

    Comparative assessment of CFR mortality rates

    Measured: Day 14

  6. Comparative analysis of survival between treatment groups

    Comparative assessment of IFR mortality rates

    Measured: Day 14

  7. Change from baseline patient ratings of subjective outcomes based on various measures

    Change from Baseline Patients in Subjective Outcomes Based on: Pulse Oxygen Saturation

    Measured: Day 14

  8. Change from baseline patient ratings of subjective outcomes based on various measures

    Change from baseline patient assessments of subjective outcomes based on the indicator: body temperature

    Measured: Day 14

  9. Change from baseline patient ratings of subjective outcomes based on various measures

    Change from Baseline Patients in Subjective Outcomes Based on Indicator: Blood Pressure

    Measured: Day 14

  10. Comparative analysis between groups by indicators

    Comparative analysis between groups by indicators: duration of fever

    Measured: Day 14

  11. Comparative analysis between groups by indicators

    Comparative analysis between groups by indicators: duration of hospitalization

    Measured: Day 14

  12. Comparative analysis between groups on NEWS-2 indicators

    Comparative assessment of the score according to the National Early Warning Rating 2 (NEWS-2), where the minimum score is 0, which corresponds to the general rules for managing a patient, from 7 points or more - emergency medical care is required in the ICU

    Measured: Day 14

  13. Comparative analysis of the incidence and severity of adverse events

    Comparative analysis of the incidence and severity of adverse events according to CTCAE version 4.03 of 2010

    Measured: Day 14

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 start21 Apr 2020
  3. Primary completion17 Jun 2020
  4. Study completion1 Oct 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
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05386459
Sponsor's protocol ID
2GAMMACOVID-19
Status last verified
May 2022
First submitted
20 May 2022
Last updated
27 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Myasnikov AL, Berns SA, Talyzin PA, Ershov FI. [Interferon gamma in the treatment of patients with moderate COVID-19]. Vopr Virusol. 2021 Mar 7;66(1):47-54. doi: 10.36233/0507-4088-24. Russian.

    PubMed 33683065

  • Myasnikov AL, Berns SA, Erhshov FI. Clinical application of interferon gamma in comprehensive therapy of patients with coronavirus infection. Rossiiskii meditsinskii zhurnal (Medical Journal of the Russian Federation, Russian Journal). 2020;26(6):394-401.

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 Respiratory Infection and Viral Pneumonia, 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 7 inclusion and 12 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 27 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?

Comparative analysis between treatment groups on the WHO Clinical Improvement Scale (time frame: Day 14). 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 NCT05386459, which also lists 2 linked publications.

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 27 May 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in