Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT05386459
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
38 Years
Maximum Age:
84 Years
Study:
NCT05386459
Study Brief:
Protocol Section:
NCT05386459