Efficacy and Safety Study of Ingavirin® 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in Adults

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

PHASE4

Total Enrollment

445 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-10-31

Brief Summary

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The purpose of this study is to determine whether Ingavirin® 90 mg once daily is effective and safe for the treatment of influenza and other laboratory confirmed acute respiratory viral infections in the course of standard therapy in patients 18-60 years old.

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Detailed Description

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Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Ingavirin in the Treatment of Influenza and Other Acute Viral Respiratory Infection. Study treatment was 5 days followed by 2 ± 1 days of follow up period. Thus, study participation was 7 ± 1 days (8 days max).

Conditions

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Common Cold Influenza, Human Acute Respiratory Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double Blind

Study Groups

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Ingavirin

Imidazolyl ethanamide pentandioic acid 90 mg once daily for 5 days

Group Type EXPERIMENTAL

Ingavirin

Intervention Type DRUG

Placebo

Placebo capsule identical in appearance to Ingavirin capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Ingavirin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Imidazolyl ethanamide pentandioic acid

Eligibility Criteria

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Inclusion Criteria

* Patients with clinically diagnosed influenza, body temperature ≥ 38 ºС or other acute respiratory viral infection, body temperature ≥ 37 ºС, with no less than 2 symptoms of catarrhal and intoxication each:

* Intoxication symptoms: Dizziness, headache, chills, fever, sweating, fatigue, myalgia, pain while moving eyes, flushing, pale skin, sleep disturbances, decreased appetite, nausea, vomiting, epistaxis, cyanosis, meningeal signs.
* Catarrhal symptoms: Sore throat, rhinorrhea and nasal congestion, difficulty swallowing, hoarseness, stridor, wheezing, rattling dry and wet cough, expectoration.
* Laboratory confirmation of viral origin of the disease
* Uncomplicated influenza and other acute respiratory viral infections
* Interval between onset of symptoms and enrollment to the study not more than 48 hours
* Have read, understood and signed an informed consent form

Exclusion Criteria

* Complicated course of influenza and other acute respiratory viral infections (secondary bacterial infection)
* Pregnancy and Breastfeeding
* 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)
* Cancer, HIV infection, tuberculosis, including those in history
* History of alcohol and drug abuse

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No