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

NCT02644018 | Completed Phase 3

• 1 other identifier: ING-03-02-2015
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 13

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

Keywords

Ingavirin; Common Cold; Influenza; Acute Respiratory Viral Infections; pediatric clinical trial; Imidazolyl ethanamide pentandioic acid

Outcome Measures

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

  Temperature normalization means establishment of body temperature below 37 ° C without raising thereafter till 5 days after the treatment start.

  5 days

Secondary Outcomes (11)

• Time to decrease in the Influenza and Other ARVI Severity Scale score to 0 points

  5 days

• Average score at the Influenza and Other ARVI Severity Scale by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment

  Within 6 days from the start of treatment

• The area under the "Influenza and Other ARVI Severity Scale score - time" curve by the 5th day after the start of treatment

  5 days

• Time to normalization of body temperature from the start of treatment, measured in hours

  5 days

• The average body temperature by the1st, 2nd, 3rd, 4th and 5th days after the start of treatment

  5 days

Study Arms (2)

Ingavirin

EXPERIMENTAL

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.

Drug: Imidazolyl ethanamide pentandioic acid

Placebo

PLACEBO COMPARATOR

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.

Drug: placebo

Interventions

Imidazolyl ethanamide pentandioic acid DRUG

Also known as: Ingavirin

Ingavirin

placebo DRUG

Placebo

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Valenta Pharm JSC: lead
• Atlant Clinical Ltd.: collaborator

Study Sites (13)

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

Kazan', Russia

Location

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

Krasnoyarsk, Russia

Location

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

Moscow, Russia

Location

I.M. Sechenov First Moscow State Medical University

Moscow, Russia

Location

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

Moscow, Russia

Location

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

Novosibirsk, Russia

Location

Children's city outpatients clinic № 5

Perm, Russia

Location

Children's city outpatients clinic № 4

Rostov-on-Don, Russia

Location

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

Rostov-on-Don, Russia

Location

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

Saint Petersburg, Russia

Location

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

Saransk, Russia

Location

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

Tomsk, Russia

Location

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

Yaroslavl, Russia

Location

MeSH Terms

Conditions

Common Cold; Influenza, Human

Interventions

pentanedioic acid imidazolyl ethanamide

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Study Officials

• Ekaterina Zakharova, MD, PhD

  Valenta Pharm JSC

  STUDY DIRECTOR

• Yuriy V. Lobzin, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: December 31, 2015
• Study Start: January 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 9, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (13)