Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-01-01 @ 7:48 AM
Study NCT ID:
NCT05386459
Status:
COMPLETED
Last Update Posted:
2022-05-27
First Post:
2022-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Use of the Drug Ingaron in Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}], 'ancestors': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007371', 'term': 'Interferon-gamma'}], 'ancestors': [{'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D016215', 'term': 'Macrophage-Activating Factors'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-23', 'studyFirstSubmitDate': '2022-05-20', 'studyFirstSubmitQcDate': '2022-05-20', 'lastUpdatePostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparative analysis between treatment groups on the WHO Clinical Improvement Scale', 'timeFrame': 'Day 14', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Difference between laboratory LDH values', 'timeFrame': 'Day 14', 'description': 'Difference between laboratory LDH values compared to baseline'}, {'measure': 'Difference between laboratory CRP values', 'timeFrame': 'Day 14', 'description': 'Difference between laboratory CRP values compared to baseline'}, {'measure': 'Difference between laboratory ferritin values', 'timeFrame': 'Day 14', 'description': 'Difference between laboratory ferritin values compared to baseline'}, {'measure': 'Changes in laboratory parameter D-dimer', 'timeFrame': 'Day 14', 'description': 'Changes in laboratory parameter D-dimer compared with baseline'}, {'measure': 'Comparative analysis of survival between treatment groups', 'timeFrame': 'Day 14', 'description': 'Comparative assessment of CFR mortality rates'}, {'measure': 'Comparative analysis of survival between treatment groups', 'timeFrame': 'Day 14', 'description': 'Comparative assessment of IFR mortality rates'}, {'measure': 'Change from baseline patient ratings of subjective outcomes based on various measures', 'timeFrame': 'Day 14', 'description': 'Change from Baseline Patients in Subjective Outcomes Based on: Pulse Oxygen Saturation'}, {'measure': 'Change from baseline patient ratings of subjective outcomes based on various measures', 'timeFrame': 'Day 14', 'description': 'Change from baseline patient assessments of subjective outcomes based on the indicator: body temperature'}, {'measure': 'Change from baseline patient ratings of subjective outcomes based on various measures', 'timeFrame': 'Day 14', 'description': 'Change from Baseline Patients in Subjective Outcomes Based on Indicator: Blood Pressure'}, {'measure': 'Comparative analysis between groups by indicators', 'timeFrame': 'Day 14', 'description': 'Comparative analysis between groups by indicators: duration of fever'}, {'measure': 'Comparative analysis between groups by indicators', 'timeFrame': 'Day 14', 'description': 'Comparative analysis between groups by indicators: duration of hospitalization'}, {'measure': 'Comparative analysis between groups on NEWS-2 indicators', 'timeFrame': 'Day 14', 'description': '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'}, {'measure': 'Comparative analysis of the incidence and severity of adverse events', 'timeFrame': 'Day 14', 'description': 'Comparative analysis of the incidence and severity of adverse events according to CTCAE version 4.03 of 2010'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19 treatment', 'interferon gamma'], 'conditions': ['COVID-19 Respiratory Infection', 'Viral Pneumonia']}, 'referencesModule': {'references': [{'pmid': '33683065', 'type': 'RESULT', 'citation': '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.'}, {'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The study drug was prescribed for therapeutic purposes according to the following scheme:\n\n500,000 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.\n\nThe main stages of the study:\n\nscreening - 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).\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '38 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with novel coronavirus infection COVID-19', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with viral pneumonia according to CT scan, regardless of:\n\n * degree of damage to the lungs;\n * results of a laboratory test for the presence of SARS-CoV-2 RNA;\n * epidemiological history.\n* Patients of both sexes over 18 years of age.\n* Patients who are able to read, understand and independently certify in writing the informed consent form.\n* Negative pregnancy test for female patients of reproductive age with preserved reproductive function.\n\nExclusion Criteria:\n\n* Any clinically confirmed or documented history of disease that may make it difficult to interpret the data being assessed.\n* No symptoms of a respiratory infection.\n* 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).\n* Diseases of the central nervous system with severe impairment of intellectual and mnestic functions.\n* 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.\n* Serious diseases and pathological conditions (PE, oncological diseases, etc.) that require emergency medical care or threaten the patient's life.\n* Mild, subclinical, asymptomatic or severe form of the course of the disease.\n* Acute respiratory distress syndrome, sepsis, septic shock.\n* Contraindications to the use of the investigational medicinal product.\n* Individual intolerance to the ingredients that make up the study drug.\n* Participation in any clinical trial within 1 month prior to baseline visit (Day 0-1).\n* Pregnancy or breastfeeding."}, 'identificationModule': {'nctId': 'NCT05386459', 'briefTitle': 'Study of the Use of the Drug Ingaron in Patients With COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'SPP Pharmaclon Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2GAMMACOVID-19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Main', 'description': 'Ingaron (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', 'interventionNames': ['Drug: Interferon Gamma']}, {'label': 'Control', 'description': 'Only 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'}], 'interventions': [{'name': 'Interferon Gamma', 'type': 'DRUG', 'otherNames': ['Ingaron', 'Interferon gamma human recombinant'], 'description': 'injection form', 'armGroupLabels': ['Main']}]}, 'contactsLocationsModule': {'locations': [{'zip': '121374', 'city': 'Moscow', 'country': 'Russia', 'facility': 'City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Anatoly I Saulin, Master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SPP Pharmaclon Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SPP Pharmaclon Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}