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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

Tracking Information
First Submitted Date  ICMJE April 26, 2017
First Posted Date  ICMJE May 16, 2017
Last Update Posted Date May 16, 2017
Actual Study Start Date  ICMJE January 2010
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2017)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 12, 2017)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Ingavirin® 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in Adults
Official Title  ICMJE 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double Blind
Primary Purpose: Treatment
Condition  ICMJE
  • Common Cold
  • Influenza, Human
  • Acute Respiratory Infection
Intervention  ICMJE
  • Drug: Ingavirin
    Other Name: Imidazolyl ethanamide pentandioic acid
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Ingavirin
    Imidazolyl ethanamide pentandioic acid 90 mg once daily for 5 days
    Intervention: Drug: Ingavirin
  • Placebo Comparator: Placebo
    Placebo capsule identical in appearance to Ingavirin capsule
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2017)
445
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03154515
Other Study ID Numbers  ICMJE 5P/08
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Valenta Pharm JSC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Valenta Pharm JSC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ekaterina Zakharova, MD, PhD Valenta Pharm JSC
PRS Account Valenta Pharm JSC
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP