Overview

Efficacy and Safety Study of Ingavirin® to Treat Influenza and Other Acute Respiratory Viral Infections in Patients 3-6 y.o.

Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether Ingavirin ® dosed 30 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in the course of standard therapy in 3-6 years old patients.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Valenta Pharm JSC
Collaborator:
Atlant Clinical Ltd.
Treatments:
Pentanedioic acid imidazolyl ethanamide
Criteria
Inclusion Criteria:

- The informed consent form signed by the patient's parent/adoptive parent to
participate in the clinical study.

- Male and female patients aged 3-6.

- Patients with moderate course of influenza or other acute respiratory viral
infections.

- Patients with clinically diagnosed influenza or other ARVI based on the body
temperature > 37,5 ° C, not less than 1 of the following other symptoms of
intoxication and not less than 1 of the following of catarrhal symptoms:

- Intoxication symptoms: headache, malaise, myalgia, pain in the eyeballs;

- Catarrhal symptoms: sore throat, rhinorrhea, cough, nasal congestion.

- Established diagnosis J06.9, J10, J11, in accordance with ICD-10.

- Uncomplicated course of influenza and other ARVI.

- Interval between onset of symptoms and enrollment to the study of not more than 36
hours.

Exclusion Criteria:

- Complicated course of influenza and other acute respiratory viral infections.

- Treatment with antiviral drugs (antivirals, interferons and interferon inducers),
drugs with immunomodulatory effects or antibiotics with systemic and local action
within 14 days prior to the screening visit.

- Severe influenza or other ARVI with symptoms of cardiovascular disease, and other
symptoms of infectious-toxic shock, and meningoencephalitic syndromes.

- Signs of primary viral pneumonia development (presence of two or more of the following
symptoms): shortness of breath, chest pain when coughing, systemic cyanosis, dullness
of percussion sound at symmetrical assessment of the upper and lower parts of the
lungs.

- Infectious diseases within the last week prior to enrollment.

- "RRI children" (incidence of ARVI within the last 12 months is 6 times or more).

- Asthma history.

- History of increased seizure activity.

- Severe decompensated or unstable medical or psychiatric conditions (any diseases or
conditions that threaten the life of the patient or worsen the patient's prognosis and
also make it impossible to conduct a clinical study in the patient).

- Cancer, HIV infection, tuberculosis, including those in history.

- Hypersensitivity to imidazolyl ethanamide pentandioic acid and/or excipients of
Ingavirin product.

- Diabetes, lactose intolerance, lactase deficiency, glucose-galactose malabsorption,
deficiency of sucrase/isomaltase, fructose intolerance, hereditary glucose
malabsorption, deficiency of glucose-6-phosphate dehydrogenase.

- Participation of the patient in any other clinical trial within the last 90 days prior
to enrollment.