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

Valenta Pharm

Status and phase: Completed; Phase 3

Conditions: Influenza; Common Cold

Treatments: Drug: placebo; Drug: Imidazolyl ethanamide pentandioic acid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02644018

ING-03-02-2015

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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190 participants in 2 patient groups, including a placebo group

Ingavirin

Experimental group

Description:

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.

Treatment:

Drug: Imidazolyl ethanamide pentandioic acid

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo