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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03154515
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Valenta Pharm JSC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Common Cold Influenza, Human Acute Respiratory Infection Drug: Ingavirin Drug: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 445 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blind
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : January 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ingavirin
Imidazolyl ethanamide pentandioic acid 90 mg once daily for 5 days
 Drug: Ingavirin
Other Name: Imidazolyl ethanamide pentandioic acid
Placebo Comparator: Placebo
Placebo capsule identical in appearance to Ingavirin capsule
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Time to resolution of fever [ Time Frame: 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 :
  1. Time to resolution / alleviation of intoxication symptoms [ Time Frame: 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.


  2. Time to resolution / alleviation of catarrhal symptoms [ Time Frame: 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.



Other Outcome Measures:
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Through study completion, an average of 8 days ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154515


Locations
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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, 454092
N.F. Gamaleya Scientific Research Institute of Epidemiology and Microbiology
Moscow, Russian Federation, 123098
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, 195067
Saratov State Medical University named after V. I. Razumovsky
Saratov, Russian Federation, 410012
Federal State Budgetary Educational Institution of Higher Education "Pacific State Medical University" of the Ministry of Healthcare of the Russian Federation
Vladivostok, Russian Federation, 690002
Volgograd State Medical University
Volgograd, Russian Federation, 400131
Yaroslavl State Medical University
Yaroslavl, Russian Federation, 150000
Federal State Budgetary Institution of Higher Professional Education "Urals State Medical University" of the Ministry of Healthcare of the Russian Federation
Yekaterinburg, Russian Federation, 620028
Sponsors and Collaborators
Valenta Pharm JSC
Investigators
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Study Director: Ekaterina Zakharova, MD, PhD Valenta Pharm JSC
More Information
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Responsible Party: Valenta Pharm JSC
ClinicalTrials.gov Identifier: NCT03154515    
Other Study ID Numbers: 5P/08
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Valenta Pharm JSC:
Respiratory Tract Infections
Acute Respiratory Viral Infection
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Influenza, Human
Respiratory Tract Infections
Virus Diseases
Common Cold
Disease Attributes
Pathologic Processes
 Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Picornaviridae Infections
Pentanedioic acid imidazolyl ethanamide
Antiviral Agents
Anti-Infective Agents