Trial | NCT03154515  Report issue

Title

Efficacy and Safety Study of Ingavirin® 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in Adults
Randomised Double Blind Placebo Controlled Multicenter Study for Evaluation of Clinical Efficacy and Safety of Ingavirin 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in Adults.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ribavirin ...

  • Study Participants

    445
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.
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).
Study Started
Jan 31
2010
Primary Completion
Apr 30
2014
Study Completion
Oct 31
2014
Last Update
May 16
2017

Drug Ingavirin

  • Other names: Imidazolyl ethanamide pentandioic acid

Drug Placebo

Ingavirin Experimental

Imidazolyl ethanamide pentandioic acid 90 mg once daily for 5 days

Placebo Placebo Comparator

Placebo capsule identical in appearance to Ingavirin capsule

Criteria 

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
No Results Posted