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Completed

NCT Number: NCT03206346

Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Patients 13-17 y.o.

The purpose of this study is to determine whether Ingavirin ® dosed 60 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in 13-17 years old patients.

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Key information

Age range

13 year–17 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 13-17
  • Patients with moderate course of influenza or other acute respiratory viral infections (AVRI)
  • 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
  • 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 7 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

Ingavirin

Drug

Ingavirin ( Imidazolyl ethanamide pentandioic acid) capsules, 60 mg once daily, regardless of meal, for 5 days.

Other names: Imidazolyl ethanamide pentandioic acid

Placebo oral capsule

Drug

Placebo, capsules daily for 5 days.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Time to resolution of intoxication symptoms

    Time frame: 7 ± 1 days

    Time from the start of study treatment to resolution of all intoxication symptoms.

  2. Time to resolution of catarrhal symptoms

    Time frame: 7 ± 1 days

    Time from the start of study treatment to resolution of all catarrhal symptoms.

  3. Time to resolution/alleviation of cough

    Time frame: 7 ± 1 days

    Time from the start of study treatment to resolution/alleviation of cough

Other outcomes

  1. Proportion of subjects with development of complications of Influenza or other acute respiratory viral infection

    Time frame: 7 ± 1 days and 21 ± 1 days

    Proportion of subjects who developed complications during treatment period (7 ± 1 days) and follow-up period (21 ± 1 days)

Sponsors and collaborators

Lead sponsor

Valenta Pharm JSC

Industry

Registry information

Official study title

Randomised Double-blind Placebo Controlled Multicenter Clinical Trial of Efficacy and Safety of Ingavirin® Capsules 30mg, in Daily Dose 60mg for the Treatment of Influenza and Other Acute Respiratory Viral Infections at Patients 13-18 y.o.

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jul 2, 2017
Registry last updated
Jul 2, 2017

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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