Trial | NCT03191097  Report issue

Title

Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Children 7-12 y.o.
Randomised Double-blind Placebo Controlled Multicenter Clinical Trial of Efficacy and Safety of Ingavirin® Capsules 30mg, in Daily Dose 60mg for the Treatment of Influenza and Other Acute Respiratory Viral Infections at Children 7-12 y.o.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ribavirin ...

  • Study Participants

    310
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.
Study Started
Aug 31
2014
Primary Completion
Dec 31
2014
Study Completion
Mar 31
2015
Last Update
Jun 19
2017

Drug Ingavirin

Ingavirin capsules 60 mg once daily, regardless of meal, for 5 days.

  • Other names: Imidazolyl ethanamide pentandioic acid

Drug Placebo oral capsule

Placebo, capsules daily for 5 days.

Ingavirin Experimental

Placebo oral capsule Placebo Comparator

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 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
No Results Posted