Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Patients 13-17 y.o.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-08-31

Brief Summary

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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 13-17 years old patients.

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Detailed Description

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Conditions

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Influenza, Human Acute Respiratory Infection Viral Infection Common Cold

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ingavirin

Broad spectrum antiviral drug

Group Type EXPERIMENTAL

Ingavirin

Intervention Type DRUG

Ingavirin ( Imidazolyl ethanamide pentandioic acid) capsules, 60 mg once daily, regardless of meal, for 5 days.

Placebo oral capsule

Placebo capsule identical in appearance to Ingavirin capsule

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Placebo, capsules daily for 5 days.

Interventions

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Ingavirin

Ingavirin ( Imidazolyl ethanamide pentandioic acid) capsules, 60 mg once daily, regardless of meal, for 5 days.

Intervention Type DRUG

Placebo oral capsule

Placebo, capsules daily for 5 days.

Intervention Type DRUG

Other Intervention Names

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Imidazolyl ethanamide pentandioic acid

Eligibility Criteria

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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 13-17
* 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

Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No