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

NCT ID: NCT02644018

Last Updated: 2016-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-05-31

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.

Conditions

Common Cold; Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Imidazolyl ethanamide pentandioic acid

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

Imidazolyl ethanamide pentandioic acid

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Other Intervention Names

Ingavirin

Eligibility 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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atlant Clinical Ltd.

OTHER

Sponsor Role: collaborator

Valenta Pharm JSC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ekaterina Zakharova, MD, PhD

Role: STUDY_DIRECTOR

Valenta Pharm JSC

Yuriy V. Lobzin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Scientific Research Institute of Children's Infections, Federal Biomedical Agency, Saint-Petersburg, Russian Federation

Locations

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

Kazan', , Russia

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

Krasnoyarsk, , Russia

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

Moscow, , Russia

I.M. Sechenov First Moscow State Medical University

Moscow, , Russia

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

Moscow, , Russia

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

Novosibirsk, , Russia

Children's city outpatients clinic № 5

Perm, , Russia

Children's city outpatients clinic № 4

Rostov-on-Don, , Russia

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

Rostov-on-Don, , Russia

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

Saint Petersburg, , Russia

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

Saransk, , Russia

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

Tomsk, , Russia

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

Yaroslavl, , Russia

Countries

Russia

Other Identifiers

ING-03-02-2015

Identifier Type: -

Identifier Source: org_study_id