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.

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.

Study Overview

• Status: Completed
• Conditions: Influenza, Human; Common Cold; Acute Respiratory Infection
• Intervention / Treatment: Drug: Placebo; Drug: Ingavirin

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 Type: Interventional
• Enrollment (Actual): 445
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • Chelyabinsk, Russian Federation, 454092
    • State educational institution of higher professional education "Chelyabinsk State Medical Academy of Federal Agency of Health Care and Social Development"
  • Moscow, Russian Federation, 123098
    • N.F. Gamaleya Scientific Research Institute of Epidemiology and Microbiology
  • Novosibirsk, Russian Federation
    • State budgetary health care institution novosibirsk region "city clinical infectious diseases hospital no. 1"
  • Saint Petersburg, Russian Federation, 195067
    • North-Western State Medical University named after I.I.Mechnikov
  • Saratov, Russian Federation, 410012
    • Saratov State Medical University named after V. I. Razumovsky
  • Vladivostok, Russian Federation, 690002
    • Federal State Budgetary Educational Institution of Higher Education "Pacific State Medical University" of the Ministry of Healthcare of the Russian Federation
  • Volgograd, Russian Federation, 400131
    • Volgograd State Medical University
  • Yaroslavl, Russian Federation, 150000
    • Yaroslavl State Medical University
  • Yekaterinburg, Russian Federation, 620028
    • Federal State Budgetary Institution of Higher Professional Education "Urals State Medical University" of the Ministry of Healthcare of the Russian Federation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ingavirin; Imidazolyl ethanamide pentandioic acid 90 mg once daily for 5 days	Drug: Ingavirin; Other Names: Imidazolyl ethanamide pentandioic acid
Placebo Comparator: Placebo; Placebo capsule identical in appearance to Ingavirin capsule	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	7 ± 1 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	7 ± 1 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	All adverse events recorded and analysed, to compare incidence rate with one of placebo. Complete blood count test performed at the beginning and at the end of the study. Vital signs taken and recorded at each visit throughout the study, usually every day for 7 ± 1 days.	Through study completion, an average of 8 days

Collaborators and Investigators

• Sponsor: Valenta Pharm JSC
• Investigators: Study Director: Ekaterina Zakharova, MD, PhD, Valenta Pharm JSC

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 12, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Respiratory Tract Infections; Acute Respiratory Viral Infection
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Respiratory Tract Diseases; Disease Attributes; Picornaviridae Infections; Orthomyxoviridae Infections; Infections; Communicable Diseases; Virus Diseases; Influenza, Human; Respiratory Tract Infections; Common Cold; Anti-Infective Agents; Antiviral Agents; Pentanedioic acid imidazolyl ethanamide
• Other Study ID Numbers: 5P/08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No