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

Primary Purpose

Common Cold, Influenza

Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Imidazolyl ethanamide pentandioic acid
placebo
Sponsored by
Valenta Pharm JSC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Cold focused on measuring Ingavirin, Common Cold, Influenza, Acute Respiratory Viral Infections, pediatric clinical trial, Imidazolyl ethanamide pentandioic acid

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ingavirin

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to decrease in the Influenza and Other ARVI Severity Scale score to 0 points
Average score at the Influenza and Other ARVI Severity Scale by the 1st, 2nd, 3rd, 4th and 5th days after 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
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
The average body temperature by the1st, 2nd, 3rd, 4th and 5th days after the start of treatment
The percentage of patients with normalization of body temperature by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment
The area under the "temperature-time" curve by the 5th day after the start of treatment
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
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
Time to onset of complications of influenza and other ARVI from the start of treatment
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

Full Information

First Posted
December 22, 2015
Last Updated
June 7, 2016
Sponsor
Valenta Pharm JSC
Collaborators
Atlant Clinical Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02644018
Brief Title
Efficacy and Safety Study of Ingavirin® to Treat Influenza and Other Acute Respiratory Viral Infections in Patients 3-6 y.o.
Acronym
ACCORD
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valenta Pharm JSC
Collaborators
Atlant Clinical Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold, Influenza
Keywords
Ingavirin, Common Cold, Influenza, Acute Respiratory Viral Infections, pediatric clinical trial, Imidazolyl ethanamide pentandioic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ingavirin
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Imidazolyl ethanamide pentandioic acid
Other Intervention Name(s)
Ingavirin
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
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
Description
Temperature normalization means establishment of body temperature below 37 ° C without raising thereafter till 5 days after the treatment start.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Time to decrease in the Influenza and Other ARVI Severity Scale score to 0 points
Time Frame
5 days
Title
Average score at the Influenza and Other ARVI Severity Scale by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment
Time Frame
Within 6 days from the start of treatment
Title
The area under the "Influenza and Other ARVI Severity Scale score - time" curve by the 5th day after the start of treatment
Time Frame
5 days
Title
Time to normalization of body temperature from the start of treatment, measured in hours
Description
Temperature normalization means establishment of body temperature below 37°C without raising thereafter till 5 days after the treatment start
Time Frame
5 days
Title
The average body temperature by the1st, 2nd, 3rd, 4th and 5th days after the start of treatment
Time Frame
5 days
Title
The percentage of patients with normalization of body temperature by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment
Time Frame
5 days
Title
The area under the "temperature-time" curve by the 5th day after the start of treatment
Time Frame
5 days
Title
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
Time Frame
14 days
Title
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
Time Frame
14 days
Title
Time to onset of complications of influenza and other ARVI from the start of treatment
Time Frame
14 days
Title
Assessment of adverse events (AEs) and serious adverse events (SAEs)
Description
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
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ekaterina Zakharova, MD, PhD
Organizational Affiliation
Valenta Pharm JSC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yuriy V. Lobzin, MD, PhD
Organizational Affiliation
Scientific Research Institute of Children's Infections, Federal Biomedical Agency, Saint-Petersburg, Russian Federation
Official's Role
Principal Investigator
Facility Information:
Facility Name
GBOU VPO "Kazan State Medical University" of Ministry of Health of Russian Federation
City
Kazan
Country
Russian Federation
Facility Name
GBOU VPO "Krasnoyarsk State Medical University n.a.n V.F. Voyno-Yasenetskogo" of Ministry of Health of Russian Federation
City
Krasnoyarsk
Country
Russian Federation
Facility Name
FGBU "Scientific center of children health" of the Ministry of Health of Russian Federation
City
Moscow
Country
Russian Federation
Facility Name
I.M. Sechenov First Moscow State Medical University
City
Moscow
Country
Russian Federation
Facility Name
Moscow Budgetary Public Health Facility "Infectious clinical hospital #1" of Moscow City Health Department
City
Moscow
Country
Russian Federation
Facility Name
GBOU VPO "Novosibirsk State Medical University of Ministry of Health of Russian Federation"
City
Novosibirsk
Country
Russian Federation
Facility Name
Children's city outpatients clinic № 5
City
Perm
Country
Russian Federation
Facility Name
Children's city outpatients clinic № 4
City
Rostov-na-Donu
Country
Russian Federation
Facility Name
GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation
City
Rostov-na-Donu
Country
Russian Federation
Facility Name
FGBU "Scientific Research Institute of Children's Infections, Federal Biomedical Agency"
City
Saint-Petersburg
Country
Russian Federation
Facility Name
FGBOU VPO "Mordov State University n.a. N.P. Ogarev"
City
Saransk
Country
Russian Federation
Facility Name
GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation
City
Tomsk
Country
Russian Federation
Facility Name
GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation
City
Yaroslavl
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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