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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
445
State educational institution of higher professional education "Chelyabinsk State Medical Academy of Federal Agency of Health Care and Social Development"
Chelyabinsk, Russia
N.F. Gamaleya Scientific Research Institute of Epidemiology and Microbiology
Moscow, Russia
State budgetary health care institution novosibirsk region "city clinical infectious diseases hospital no. 1"
Time to resolution of fever
Time from the start of study treatment to resolution of fever ( t ≤ 36,9 ºС, till the end of the follow up).
Time frame: 7 ± 1 days
Time to resolution / alleviation of intoxication symptoms
Following symptoms were recorded and rated each visit, to evaluate symptoms progress: Dizziness, headache, chills, fever, sweating, fatigue, myalgia, pain while moving eyes, flushing, pale skin, sleep disturbances, decreased appetite, nausea, vomiting, epistaxis, cyanosis, meningeal signs.
Time frame: 7 ± 1 days
Time to resolution / alleviation of catarrhal symptoms
Following symptoms were recorded and rated each visit, to evaluate symptoms progress: Sore throat, rhinorrhea and nasal congestion, difficulty swallowing, hoarseness, stridor, wheezing, rattling dry and wet cough, expectoration.
Time frame: 7 ± 1 days
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Novosibirsk, Russia
North-western State Medical University named after I.I.Mechnikov
Saint Petersburg, Russia
Saratov State Medical University named after V. I. Razumovsky
Saratov, Russia
Federal State Budgetary Educational Institution of Higher Education "Pacific State Medical University" of the Ministry of Healthcare of the Russian Federation
Vladivostok, Russia
Volgograd State Medical University
Volgograd, Russia
Yaroslavl State Medical University
Yaroslavl, Russia
Federal State Budgetary Institution of Higher Professional Education "Urals State Medical University" of the Ministry of Healthcare of the Russian Federation
Yekaterinburg, Russia