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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

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.

Condition or disease Intervention/treatment Phase
Common Cold Influenza Drug: Imidazolyl ethanamide pentandioic acid Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
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.
Drug: Imidazolyl ethanamide pentandioic acid
Other Name: Ingavirin

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.
Drug: placebo



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time to decrease in the Influenza and Other ARVI Severity Scale score to 0 points [ Time Frame: 5 days ]
  2. 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 ]
  3. 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 ]
  4. 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

  5. The average body temperature by the1st, 2nd, 3rd, 4th and 5th days after the start of treatment [ Time Frame: 5 days ]
  6. 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 ]
  7. The area under the "temperature-time" curve by the 5th day after the start of treatment [ Time Frame: 5 days ]
  8. 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 ]
  9. 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 ]
  10. Time to onset of complications of influenza and other ARVI from the start of treatment [ Time Frame: 14 days ]
  11. 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



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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02644018


Locations
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Russian Federation
GBOU VPO "Kazan State Medical University" of Ministry of Health of Russian Federation
Kazan, Russian Federation
GBOU VPO "Krasnoyarsk State Medical University n.a.n V.F. Voyno-Yasenetskogo" of Ministry of Health of Russian Federation
Krasnoyarsk, Russian Federation
FGBU "Scientific center of children health" of the Ministry of Health of Russian Federation
Moscow, Russian Federation
I.M. Sechenov First Moscow State Medical University
Moscow, Russian Federation
Moscow Budgetary Public Health Facility "Infectious clinical hospital #1" of Moscow City Health Department
Moscow, Russian Federation
GBOU VPO "Novosibirsk State Medical University of Ministry of Health of Russian Federation"
Novosibirsk, Russian Federation
Children's city outpatients clinic № 5
Perm, Russian Federation
Children's city outpatients clinic № 4
Rostov-na-Donu, Russian Federation
GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation
Rostov-na-Donu, Russian Federation
FGBU "Scientific Research Institute of Children's Infections, Federal Biomedical Agency"
Saint-Petersburg, Russian Federation
FGBOU VPO "Mordov State University n.a. N.P. Ogarev"
Saransk, Russian Federation
GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation
Tomsk, Russian Federation
GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation
Yaroslavl, Russian Federation
Sponsors and Collaborators
Valenta Pharm JSC
Atlant Clinical Ltd.
Investigators
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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
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Responsible Party: Valenta Pharm JSC
ClinicalTrials.gov Identifier: NCT02644018    
Other Study ID Numbers: ING-03-02-2015
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Valenta Pharm JSC:
Ingavirin
Common Cold
Influenza
Acute Respiratory Viral Infections
pediatric clinical trial
Imidazolyl ethanamide pentandioic acid
Additional relevant MeSH terms:
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Infections
Influenza, Human
Virus Diseases
Common Cold
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Picornaviridae Infections
Pentanedioic acid imidazolyl ethanamide
Antiviral Agents
Anti-Infective Agents