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

Phase 4

Completed

• Conditions: Common Cold; Influenza, Human; Acute Respiratory Infection
• Interventions: Drug: Ingavirin; Drug: Placebo

• Registration Number: NCT03154515
• Lead Sponsor: Valenta Pharm JSC

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2010-01
• Primary Completion: 2014-04
• Study Completion: 2014-10
• Study First Submitted: 2017-04-26
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-12
• Last Update Submitted: 2017-05-12
• Study First Posted: 2017-05-16
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 445

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ingavirin	Ingavirin	Imidazolyl ethanamide pentandioic acid 90 mg once daily for 5 days
Placebo	Placebo	Placebo capsule identical in appearance to Ingavirin capsule

Primary Outcome Measures

Name	Time	Method
Time to resolution of fever	7 ± 1 days	Time from the start of study treatment to resolution of fever ( t ≤ 36,9 ºС, till the end of the follow up).

Secondary Outcome Measures

Name	Time	Method
Time to resolution / alleviation of intoxication symptoms	7 ± 1 days	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 to resolution / alleviation of catarrhal symptoms	7 ± 1 days	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.

Trial Locations

Locations (9)

State educational institution of higher professional education "Chelyabinsk State Medical Academy of Federal Agency of Health Care and Social Development"; 🇷🇺 Chelyabinsk, Russian Federation

N.F. Gamaleya Scientific Research Institute of Epidemiology and Microbiology; 🇷🇺 Moscow, Russian Federation

State budgetary health care institution novosibirsk region "city clinical infectious diseases hospital no. 1"; 🇷🇺 Novosibirsk, Russian Federation

North-western State Medical University named after I.I.Mechnikov; 🇷🇺 Saint Petersburg, Russian Federation

Saratov State Medical University named after V. I. Razumovsky; 🇷🇺 Saratov, Russian Federation

Federal State Budgetary Educational Institution of Higher Education "Pacific State Medical University" of the Ministry of Healthcare of the Russian Federation; 🇷🇺 Vladivostok, Russian Federation

Volgograd State Medical University; 🇷🇺 Volgograd, Russian Federation

Yaroslavl State Medical University; 🇷🇺 Yaroslavl, Russian Federation

Federal State Budgetary Institution of Higher Professional Education "Urals State Medical University" of the Ministry of Healthcare of the Russian Federation; 🇷🇺 Yekaterinburg, Russian Federation