COVID-19 Respiratory Infection Clinical Trial
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
| Verified date | May 2022 |
| Source | SPP Pharmaclon Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | October 1, 2020 |
| Est. primary completion date | June 17, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 38 Years to 84 Years |
| Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department | Moscow |
| Lead Sponsor | Collaborator |
|---|---|
| SPP Pharmaclon Ltd. |
Russian Federation,
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.
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Day 14 | |
| Secondary | Difference between laboratory LDH values | Difference between laboratory LDH values compared to baseline | Day 14 | |
| Secondary | Difference between laboratory CRP values | Difference between laboratory CRP values compared to baseline | Day 14 | |
| Secondary | Difference between laboratory ferritin values | Difference between laboratory ferritin values compared to baseline | Day 14 | |
| Secondary | Changes in laboratory parameter D-dimer | Changes in laboratory parameter D-dimer compared with baseline | Day 14 | |
| Secondary | Comparative analysis of survival between treatment groups | Comparative assessment of CFR mortality rates | Day 14 | |
| Secondary | Comparative analysis of survival between treatment groups | Comparative assessment of IFR mortality rates | Day 14 | |
| Secondary | Change from baseline patient ratings of subjective outcomes based on various measures | Change from Baseline Patients in Subjective Outcomes Based on: Pulse Oxygen Saturation | Day 14 | |
| Secondary | 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 | Day 14 | |
| Secondary | Change from baseline patient ratings of subjective outcomes based on various measures | Change from Baseline Patients in Subjective Outcomes Based on Indicator: Blood Pressure | Day 14 | |
| Secondary | Comparative analysis between groups by indicators | Comparative analysis between groups by indicators: duration of fever | Day 14 | |
| Secondary | Comparative analysis between groups by indicators | Comparative analysis between groups by indicators: duration of hospitalization | Day 14 | |
| Secondary | 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 | Day 14 | |
| Secondary | 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 | Day 14 |