Status:
COMPLETED
Study of the Use of the Drug Ingaron in Patients With COVID-19
Lead Sponsor:
SPP Pharmaclon Ltd.
Conditions:
COVID-19 Respiratory Infection
Viral Pneumonia
Eligibility:
All Genders
38-84 years
Brief 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 th...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
April 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05386459
Start Date
April 21 2020
End Date
October 1 2020
Last Update
May 27 2022
Active Locations (1)
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1
City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department
Moscow, Russia, 121374