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Completed

NCT Number: NCT02644018

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

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.

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Key information

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GBOU VPO "Kazan State Medical University" of Ministry of Health of Russian Federation, Kazan', Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Imidazolyl ethanamide pentandioic acid

Drug

Other names: Ingavirin

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Valenta Pharm JSC

Industry

Collaborators

  • Atlant Clinical Ltd.

Registry information

Official study 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

Acronym: ACCORD

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 31, 2015
Registry last updated
Jun 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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