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Efficacy and Safety Study of Ingavirin® to Treat Influenza and Other Acute Respiratory Viral Infections in Patients 3-6 y.o. (ACCORD)

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ClinicalTrials.gov Identifier: NCT02644018
Recruitment Status : Completed
First Posted : December 31, 2015
Last Update Posted : June 9, 2016
Sponsor:
Collaborator:
Atlant Clinical Ltd.
Information provided by (Responsible Party):
Valenta Pharm JSC

Tracking Information
First Submitted Date  ICMJE December 22, 2015
First Posted Date  ICMJE December 31, 2015
Last Update Posted Date June 9, 2016
Study Start Date  ICMJE January 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2015)
Time to decrease in the Influenza and Other ARVI Severity Scale score to 2 points with no more than 1 point at individual subscales and normalization of body temperature [ Time Frame: 5 days ]
Temperature normalization means establishment of body temperature below 37 ° C without raising thereafter till 5 days after the treatment start.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2015)
  • Time to decrease in the Influenza and Other ARVI Severity Scale score to 0 points [ Time Frame: 5 days ]
  • Average score at the Influenza and Other ARVI Severity Scale by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment [ Time Frame: Within 6 days from the start of treatment ]
  • The area under the "Influenza and Other ARVI Severity Scale score - time" curve by the 5th day after the start of treatment [ Time Frame: 5 days ]
  • Time to normalization of body temperature from the start of treatment, measured in hours [ Time Frame: 5 days ]
    Temperature normalization means establishment of body temperature below 37°C without raising thereafter till 5 days after the treatment start
  • The average body temperature by the1st, 2nd, 3rd, 4th and 5th days after the start of treatment [ Time Frame: 5 days ]
  • The percentage of patients with normalization of body temperature by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment [ Time Frame: 5 days ]
  • The area under the "temperature-time" curve by the 5th day after the start of treatment [ Time Frame: 5 days ]
  • The percentage of patients with complications of influenza and other ARVI developed over the period from the 1st to the 6th and from the 1st to 14th day after the start of treatment [ Time Frame: 14 days ]
  • The percentage of patients with severe complications of influenza and other ARVI that have developed over the period from the 1st to the 6th and from the 1st to 14th day after the start of treatment [ Time Frame: 14 days ]
  • Time to onset of complications of influenza and other ARVI from the start of treatment [ Time Frame: 14 days ]
  • Assessment of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 14 days ]
    Assessment of adverse events (AEs) and serious adverse events (SAEs) by means of -
    • Portion of patients who developed one or more SAE during the study
    • Portion of patients who developed one or more AE during the study
    • Portion of patients who developed one or more severe AE during the study
    • Portion of patients who developed one or more AE with definite relationship to the investigational product/ placebo during the study
    • Portion of patients who developed one or more AE with definite or probable relationship to the investigational product/ placebo during the study
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Ingavirin® to Treat Influenza and Other Acute Respiratory Viral Infections in Patients 3-6 y.o.
Official Title  ICMJE Double Blind Randomized Placebo-controlled Multicenter Study to Evaluate Clinical Efficacy and Safety of Ingavirin®, Capsules 30 mg, in 3-6 Years Old Patients With Influenza and Other Acute Respiratory Viral Infections in the Course of Standard Therapy
Brief Summary The purpose of this study is to determine whether Ingavirin ® dosed 30 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in the course of standard therapy in 3-6 years old patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Common Cold
  • Influenza
Intervention  ICMJE
  • Drug: Imidazolyl ethanamide pentandioic acid
    Other Name: Ingavirin
  • Drug: placebo
Study Arms  ICMJE
  • Experimental: Ingavirin
    Ingavirin (Imidazolyl ethanamide pentandioic acid), capsules 30 mg daily for 5 days. The contents of one capsule of Ingavirin, capsules 30 mg should be dissolved in 50-70 ml of water at room temperature or apple juice at room temperature with mandatory stirring for 20 seconds and administered orally 1 time a day regardless of the meal.
    Intervention: Drug: Imidazolyl ethanamide pentandioic acid
  • Placebo Comparator: Placebo
    Placebo, capsules daily for 5 days. The contents of one capsule of placebo should be dissolved in 50-70 ml of water at room temperature or apple juice at room temperature with mandatory stirring for 20 seconds and administered orally 1 time a day regardless of the meal.
    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: December 29, 2015)
190
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The informed consent form signed by the patient's parent/adoptive parent to participate in the clinical study.
  • Male and female patients aged 3-6.
  • Patients with moderate course of influenza or other acute respiratory viral infections.
  • Patients with clinically diagnosed influenza or other ARVI based on the body temperature > 37,5 ° C, not less than 1 of the following other symptoms of intoxication and not less than 1 of the following of catarrhal symptoms:

    • Intoxication symptoms: headache, malaise, myalgia, pain in the eyeballs;
    • Catarrhal symptoms: sore throat, rhinorrhea, cough, nasal congestion.
  • Established diagnosis J06.9, J10, J11, in accordance with ICD-10.
  • Uncomplicated course of influenza and other ARVI.
  • Interval between onset of symptoms and enrollment to the study of not more than 36 hours.

Exclusion Criteria:

  • Complicated course of influenza and other acute respiratory viral infections.
  • Treatment with antiviral drugs (antivirals, interferons and interferon inducers), drugs with immunomodulatory effects or antibiotics with systemic and local action within 14 days prior to the screening visit.
  • Severe influenza or other ARVI with symptoms of cardiovascular disease, and other symptoms of infectious-toxic shock, and meningoencephalitic syndromes.
  • Signs of primary viral pneumonia development (presence of two or more of the following symptoms): shortness of breath, chest pain when coughing, systemic cyanosis, dullness of percussion sound at symmetrical assessment of the upper and lower parts of the lungs.
  • Infectious diseases within the last week prior to enrollment.
  • "RRI children" (incidence of ARVI within the last 12 months is 6 times or more).
  • Asthma history.
  • History of increased seizure activity.
  • 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 and also make it impossible to conduct a clinical study in the patient).
  • Cancer, HIV infection, tuberculosis, including those in history.
  • Hypersensitivity to imidazolyl ethanamide pentandioic acid and/or excipients of Ingavirin product.
  • Diabetes, lactose intolerance, lactase deficiency, glucose-galactose malabsorption, deficiency of sucrase/isomaltase, fructose intolerance, hereditary glucose malabsorption, deficiency of glucose-6-phosphate dehydrogenase.
  • Participation of the patient in any other clinical trial within the last 90 days prior to enrollment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 6 Years   (Child)
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 NCT02644018
Other Study ID Numbers  ICMJE ING-03-02-2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Valenta Pharm JSC
Study Sponsor  ICMJE Valenta Pharm JSC
Collaborators  ICMJE Atlant Clinical Ltd.
Investigators  ICMJE
Study Director: Ekaterina Zakharova, MD, PhD Valenta Pharm JSC
Principal Investigator: Yuriy V. Lobzin, MD, PhD Scientific Research Institute of Children's Infections, Federal Biomedical Agency, Saint-Petersburg, Russian Federation
PRS Account Valenta Pharm JSC
Verification Date February 2016

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