Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Children 7-12 y.o.

Valenta Pharm

Status and phase

Completed

Phase 3

Conditions

Acute Respiratory Infection

Influenza, Human

Viral Infection

Common Cold

Treatments

Drug: Placebo oral capsule

Drug: Ingavirin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03191097

4K/2013

Details and patient eligibility

About

The purpose of this study is to determine whether Ingavirin ® dosed 60 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in 7-12 years old patients.

Enrollment

310 patients

Sex

All

Ages

7 to 12 years old

Volunteers

No Healthy Volunteers

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 7-12
Patients with moderate course of influenza or other acute respiratory viral infections (AVRI)
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
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 7 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