NCT05395702

Brief Summary

The primary purpose of this study is to effect of Ingaron®, a lyophilisate for the preparation of a solution for intramuscular and subcutaneous administration of 100,000 IU (LLC NPP Farmaklon, Russia) on the effectiveness of antibiotic therapy in patients with community-acquired pneumonia who fell ill during the epidemiological rise of ARVI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

1.2 years

First QC Date

May 19, 2022

Last Update Submit

May 24, 2022

Conditions

Community-acquired Pneumonia

Keywords

interferon gammaIFN-gantibiotic resistanceCommunity-acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Time to clinical stabilization of the patient's condition

    Assessed by the following parameters: HR \< 100 bpm, RR \< 24 resp./min, systolic blood pressure ≥90 mmHg, blood saturation level ≥ 90%

    Day 33

Secondary Outcomes (16)

  • Change in the level of procalcitonin in the blood

    Day 10

  • Change in the level of C-reactive protein in the blood

    Day 10

  • Change in blood oxygen saturation

    Day 3

  • Change in blood oxygen saturation

    Day 6

  • Change in blood oxygen saturation

    Day 10

  • +11 more secondary outcomes

Study Arms (2)

Drug: Interferon Gamma

EXPERIMENTAL

Antibacterial therapy + IFN-G administered intramuscularly 100,000 IU once a day daily for 5 days

Drug: Interferon-Gamma

Control: No intervention

NO INTERVENTION

Only antibacterial therapy

Interventions

Interferon-GammaDRUG

received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein

Also known as: Ingaron, Interferon gamma human recombinant
Drug: Interferon Gamma

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of the inpatient department of both sexes aged 18 to 60 years.
  • Confirmed diagnosis - community-acquired pneumonia (causative agent not specified) of an uncomplicated typical course without respiratory failure and the duration of symptoms is not more than 14 days.
  • Risk class of lethal outcome I-II according to the Fine scale.
  • Availability of an Informed Consent voluntarily signed by the patient.

You may not qualify if:

  • Increased individual sensitivity to gamma interferon, Ingaron® and / or excipients that are part of Ingaron® or drugs used in antibacterial therapy.
  • The use of immunomodulating, immunostimulating or immunosuppressive therapy later than 1 month before enrollment in the study.
  • Bronchial asthma and/or COPD.
  • Congestive heart failure.
  • Acute diseases of the gastrointestinal tract or other pathologies that may affect the absorption, distribution, metabolism or excretion of drugs.
  • Chronic liver and / or kidney disease or other pathologies that may affect the absorption, distribution, metabolism or excretion of drugs.
  • Oncological diseases, autoimmune, immunosuppressive conditions at present or according to history.
  • Cerebrovascular pathologies.
  • Diabetes.
  • Pregnancy or lactation.
  • Smoking index over 10 pack/years.
  • Data on severe nervous or mental diseases, including history.
  • Violation of consciousness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Moscow, 121374, Russia

Location

Related Publications (1)

  • Belevsky AS, Berns SA, Lartseva OA, Myasnikov AL, Nadaraya VM, Talyzin PA. Efficacy and safety of interferon gamma in the treatment of community-acquired pneumonia: results of an open-label randomized trial IN/100000-317. Meditsina. 2019; 4: 110-25.

    RESULT

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Interferon-gamma

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

InterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsMacrophage-Activating FactorsLymphokinesProteinsBiological Factors

Study Officials

  • Anatoly I Saulin, Master

    SPP Pharmaclon Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2022

First Posted

May 27, 2022

Study Start

May 12, 2017

Primary Completion

July 27, 2018

Study Completion

May 30, 2019

Last Updated

May 27, 2022

Record last verified: 2022-05

Locations

RU(1)