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)

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

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

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

Volgograd State Medical University; 🇷🇺 Volgograd, Russian Federation

Yaroslavl State Medical University; 🇷🇺 Yaroslavl, 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

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