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

Double Blind Randomized Placebo-controlled Multicenter Study to Evaluate Clinical Efficacy and Safety of Ingavirin®, Capsules 30 mg, in 3-6 Years Old Patients With Influenza and Other Acute Respiratory Viral Infections in the Course of Standard Therapy

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.

Study Overview

• Status: Completed
• Conditions: Influenza; Common Cold
• Intervention / Treatment: Drug: placebo; Drug: Imidazolyl ethanamide pentandioic acid

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Kazan, Russian Federation
    • GBOU VPO "Kazan State Medical University" of Ministry of Health of Russian Federation
  • Krasnoyarsk, Russian Federation
    • GBOU VPO "Krasnoyarsk State Medical University n.a.n V.F. Voyno-Yasenetskogo" of Ministry of Health of Russian Federation
  • Moscow, Russian Federation
    • FGBU "Scientific center of children health" of the Ministry of Health of Russian Federation
  • Moscow, Russian Federation
    • I.M. Sechenov First Moscow State Medical University
  • Moscow, Russian Federation
    • Moscow Budgetary Public Health Facility "Infectious clinical hospital #1" of Moscow City Health Department
  • Novosibirsk, Russian Federation
    • GBOU VPO "Novosibirsk State Medical University of Ministry of Health of Russian Federation"
  • Perm, Russian Federation
    • Children's city outpatients clinic № 5
  • Rostov-na-Donu, Russian Federation
    • Children's city outpatients clinic № 4
  • Rostov-na-Donu, Russian Federation
    • GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation
  • Saint-Petersburg, Russian Federation
    • FGBU "Scientific Research Institute of Children's Infections, Federal Biomedical Agency"
  • Saransk, Russian Federation
    • FGBOU VPO "Mordov State University n.a. N.P. Ogarev"
  • Tomsk, Russian Federation
    • GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation
  • Yaroslavl, Russian Federation
    • GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 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 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.

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; 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; Other Names: Ingavirin
Placebo Comparator: 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.	Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Temperature normalization means establishment of body temperature below 37°C without raising thereafter till 5 days after the treatment start	5 days
The average body temperature by the1st, 2nd, 3rd, 4th and 5th days after the start of treatment		5 days
The percentage of patients with normalization of body temperature by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment		5 days
The area under the "temperature-time" curve by the 5th day after the start of treatment		5 days
The percentage of patients with complications of influenza and other ARVI developed over the period from the 1st to the 6th and from the 1st to 14th day after the start of treatment		14 days
The percentage of patients with severe complications of influenza and other ARVI that have developed over the period from the 1st to the 6th and from the 1st to 14th day after the start of treatment		14 days
Time to onset of complications of influenza and other ARVI from the start of treatment		14 days
Assessment of adverse events (AEs) and serious adverse events (SAEs)	Assessment of adverse events (AEs) and serious adverse events (SAEs) by means of -; Portion of patients who developed one or more SAE during the study; Portion of patients who developed one or more AE during the study; Portion of patients who developed one or more severe AE during the study; Portion of patients who developed one or more AE with definite relationship to the investigational product/ placebo during the study; Portion of patients who developed one or more AE with definite or probable relationship to the investigational product/ placebo during the study	14 days

Collaborators and Investigators

• Sponsor: Valenta Pharm JSC
• Collaborators: Atlant Clinical Ltd.
• Investigators: Study Director: Ekaterina Zakharova, MD, PhD, Valenta Pharm JSC; Principal Investigator: Yuriy V. Lobzin, MD, PhD, Scientific Research Institute of Children's Infections, Federal Biomedical Agency, Saint-Petersburg, Russian Federation

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: December 22, 2015
• First Submitted That Met QC Criteria: December 29, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Estimate): June 9, 2016
• Last Update Submitted That Met QC Criteria: June 7, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Influenza; Common Cold; Ingavirin; Acute Respiratory Viral Infections; pediatric clinical trial; Imidazolyl ethanamide pentandioic acid
• Additional Relevant MeSH Terms: RNA Virus Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections; Orthomyxoviridae Infections; Infections; Virus Diseases; Influenza, Human; Common Cold; Anti-Infective Agents; Antiviral Agents; Pentanedioic acid imidazolyl ethanamide
• Other Study ID Numbers: ING-03-02-2015

Plan for Individual participant data (IPD)

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