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

Last updated: June 7, 2016
Sponsor: Valenta Pharm JSC
Overall Status: Completed

Phase

3

Condition

Acute Rhinitis

Common Cold

Influenza

Treatment

N/A

Clinical Study ID

NCT02644018
ING-03-02-2015
  • Ages 3-6
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The informed consent form signed by the patient's parent/adoptive parent toparticipate in the clinical study.

  • Male and female patients aged 3-6.

  • Patients with moderate course of influenza or other acute respiratory viralinfections.

  • Patients with clinically diagnosed influenza or other ARVI based on the bodytemperature > 37,5 ° C, not less than 1 of the following other symptoms ofintoxication 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 36hours.

Exclusion

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 actionwithin 14 days prior to the screening visit.

  • Severe influenza or other ARVI with symptoms of cardiovascular disease, and othersymptoms of infectious-toxic shock, and meningoencephalitic syndromes.

  • Signs of primary viral pneumonia development (presence of two or more of the followingsymptoms): shortness of breath, chest pain when coughing, systemic cyanosis, dullnessof percussion sound at symmetrical assessment of the upper and lower parts of thelungs.

  • 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 orconditions that threaten the life of the patient or worsen the patient's prognosis andalso 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 ofIngavirin product.

  • Diabetes, lactose intolerance, lactase deficiency, glucose-galactose malabsorption,deficiency of sucrase/isomaltase, fructose intolerance, hereditary glucosemalabsorption, deficiency of glucose-6-phosphate dehydrogenase.

  • Participation of the patient in any other clinical trial within the last 90 days priorto enrollment.

Study Design

Total Participants: 190
Study Start date:
January 01, 2016
Estimated Completion Date:
May 31, 2016

Connect with a study center

  • GBOU VPO "Kazan State Medical University" of Ministry of Health of Russian Federation

    Kazan,
    Russian Federation

    Site Not Available

  • GBOU VPO "Krasnoyarsk State Medical University n.a.n V.F. Voyno-Yasenetskogo" of Ministry of Health of Russian Federation

    Krasnoyarsk,
    Russian Federation

    Site Not Available

  • FGBU "Scientific center of children health" of the Ministry of Health of Russian Federation

    Moscow,
    Russian Federation

    Site Not Available

  • I.M. Sechenov First Moscow State Medical University

    Moscow,
    Russian Federation

    Site Not Available

  • Moscow Budgetary Public Health Facility "Infectious clinical hospital #1" of Moscow City Health Department

    Moscow,
    Russian Federation

    Site Not Available

  • GBOU VPO "Novosibirsk State Medical University of Ministry of Health of Russian Federation"

    Novosibirsk,
    Russian Federation

    Site Not Available

  • Children's city outpatients clinic № 5

    Perm,
    Russian Federation

    Site Not Available

  • Children's city outpatients clinic № 4

    Rostov-na-Donu,
    Russian Federation

    Site Not Available

  • GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation

    Rostov-na-Donu,
    Russian Federation

    Site Not Available

  • FGBU "Scientific Research Institute of Children's Infections, Federal Biomedical Agency"

    Saint-Petersburg,
    Russian Federation

    Site Not Available

  • FGBOU VPO "Mordov State University n.a. N.P. Ogarev"

    Saransk,
    Russian Federation

    Site Not Available

  • GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation

    Tomsk,
    Russian Federation

    Site Not Available

  • GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation

    Yaroslavl,
    Russian Federation

    Site Not Available

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