Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Patients 13-17 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 Patients 13-18 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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 161
• 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
  • Perm, Russian Federation, 614066
    • City Pediatric Outpatient Clinic number 5
  • Saint Petersburg, Russian Federation, 197376
    • Research Institute of Influenza, Ministry of Healthcare of Russian Federation
  • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 15 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 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

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; Broad spectrum antiviral drug	Drug: Ingavirin; Ingavirin ( Imidazolyl ethanamide pentandioic acid) capsules, 60 mg once daily, regardless of meal, for 5 days.; Other Names: Imidazolyl ethanamide pentandioic acid
Placebo Comparator: Placebo oral capsule; Placebo capsule identical in appearance to Ingavirin 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
Time to resolution/alleviation of cough	Time from the start of study treatment to resolution/alleviation of cough	7 ± 1 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	7 ± 1 days and 21 ± 1 days

Collaborators and Investigators

• Sponsor: Valenta Pharm JSC
• Investigators: Study Director: Ekaterina Zakharova, MD, PhD, Valenta Pharm JSC

Publications and helpful links

General Publications

• A.A.Shul'dyakov, E.P.Lyapina, V.I.Kuznetsov, N.I.Zryachkin, I.G.Sitnikov, O.A.Perminova, V.A.Anokhin4, G.R.Fatkullina. New possibilities in therapy of acute respiratory viral infections in children. Vopr. Prakt. Pediatrii. 2015 vol10 n5 pp21-28. Russian

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 30, 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: 4P/10

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