Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Children 7-12 y.o.

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 Children 7-12 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 7-12 years old patients.

Study Overview

• Status: Completed
• Conditions: Influenza, Human; Common Cold; Acute Respiratory Infection; Viral Infection
• Intervention / Treatment: Drug: Placebo oral capsule; Drug: Ingavirin

• Study Type: Interventional
• Enrollment (Actual): 310
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Kazan', Russian Federation, 420012
    • GBOU VPO "Kazan State Medical University" of Ministry of Health of Russian Federation
  • Krasnoyarsk, Russian Federation, 660022
    • Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky
  • Moscow, Russian Federation, 119991
    • I.M. Sechenov First Moscow State Medical University
  • Novosibirsk, Russian Federation, 630091
    • Novosibirsk State Medical University
  • Perm, Russian Federation, 614066
    • City Pediatric Outpatient Clinic number 5
  • Rostov-na-Donu, Russian Federation, 344022
    • Rostov State Medical University
  • Rostov-na-Donu, Russian Federation, 344065
    • Pediatrics outpatient clinic number 4 of Rostov-na-Donu
  • Saransk, Russian Federation, 430005
    • Ogarev Mordovia State University
  • Saratov, Russian Federation, 410012
    • Saratov State Medical University named after V. I. Razumovsky
  • Yaroslavl, Russian Federation, 150000
    • GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation
  • Yekaterinburg, Russian Federation, 62028
    • Pediatrician City Hospital number 11

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 7-12
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ingavirin	Drug: Ingavirin; Ingavirin capsules 60 mg once daily, regardless of meal, for 5 days.; Other Names: Imidazolyl ethanamide pentandioic acid
Placebo Comparator: Placebo oral capsule	Drug: Placebo oral capsule; Placebo, capsules daily for 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to resolution of fever	Time from the start of study treatment to resolution of fever ( t ≤ 36,9 ºС)	7 ± 1 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to resolution of intoxication symptoms	Time from the start of study treatment to resolution of all intoxication symptoms.	7 ± 1 days
Time to resolution of catarrhal symptoms	Time from the start of study treatment to resolution of all catarrhal symptoms.	7 ± 1 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with resolution of fever	Proportion of subjects with resolution of fever by 1st, 2nd, 3rd, 4th and 5th days of treatment	7 ± 1
Proportion of subjects with development of complications of Influenza or other acute respiratory viral infection	Proportion of subjects who developed complications during treatment period (7 ± 1 days) and follow-up period (21 ± 1 days)	21 ± 1

Collaborators and Investigators

• Sponsor: Valenta Pharm JSC
• Collaborators: Atlant Clinical Ltd.
• Investigators: Study Director: Ekaterina Zakharova, MD, PhD, Valenta Pharm JSC

Publications and helpful links

General Publications

• I.M. Farber, N.A. Geppe, D.V. Reikhart, V.E. Nebolsin, V.S. Arnautov, A.A. Globenko. Therapy for influenza and acute respiratory viral infection in young and middle-aged schoolchildren: Effect of Ingavirin® on intoxication, fever, and catarrhal syndromes. Ros Vestn Perinatol Pediat 2016; 2:115-120. Russian.
• N.A. Geppe, E.D. Teplyakova, A.A. Shuldyakov, E.P. Lyapina, O.A. Perminova, G.P. Martynova, I.G. Sitnikov, V.A. Anohin, G.R. Fatkullina, V.V. Romanenko, A.A. Savisko, E.G. Kondyurina, L.A. Balykova. Innovations in pediatrics: the optimal clinical effect In acute respiratory viral infections treatment In children with complex action drug. Pediatry 2016, 2(95), 97-103. Russian.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: June 15, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Actual): June 19, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Respiratory Tract Diseases; Disease Attributes; Picornaviridae Infections; Orthomyxoviridae Infections; Infections; Communicable Diseases; Virus Diseases; Influenza, Human; Respiratory Tract Infections; Common Cold; Anti-Infective Agents; Antiviral Agents; Pentanedioic acid imidazolyl ethanamide
• Other Study ID Numbers: 4K/2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No