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

Primary Purpose

Influenza, Human, Acute Respiratory Infection, Viral Infection

Status

Completed

Phase

Phase 3

Locations

Russian Federation

Study Type

Interventional

Intervention

Ingavirin

Placebo oral capsule

About this trial

This is an interventional treatment trial for Influenza, Human

Eligibility Criteria

13 Years - 17 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 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

Sites / Locations

GBOU VPO "Kazan State Medical University" of Ministry of Health of Russian Federation
City Pediatric Outpatient Clinic number 5
Research Institute of Influenza, Ministry of Healthcare of Russian Federation
Saratov State Medical University named after V. I. Razumovsky
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 oral capsule

Arm Description

Broad spectrum antiviral drug

Placebo capsule identical in appearance to Ingavirin capsule

Outcomes

Primary Outcome Measures

Time to resolution of fever

Time from the start of study treatment to resolution of fever ( t ≤ 36,9 ºС)

Secondary Outcome Measures

Time to resolution of intoxication symptoms

Time from the start of study treatment to resolution of all intoxication symptoms.

Time to resolution of catarrhal symptoms

Time from the start of study treatment to resolution of all catarrhal symptoms.

Time to resolution/alleviation of cough

Time from the start of study treatment to resolution/alleviation of cough

Full Information

NCT ID

NCT03206346

First Posted

June 20, 2017

Last Updated

June 30, 2017

Sponsor

Valenta Pharm JSC

1. Study Identification

Unique Protocol Identification Number

NCT03206346

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

January 2012 (Actual)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Valenta Pharm JSC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Human, Acute Respiratory Infection, Viral Infection, Common Cold

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

161 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ingavirin

Arm Type

Experimental

Arm Description

Broad spectrum antiviral drug

Arm Title

Placebo oral capsule

Arm Type

Placebo Comparator

Arm Description

Placebo capsule identical in appearance to Ingavirin capsule

Intervention Type

Drug

Intervention Name(s)

Ingavirin

Other Intervention Name(s)

Imidazolyl ethanamide pentandioic acid

Intervention Description

Ingavirin ( Imidazolyl ethanamide pentandioic acid) capsules, 60 mg once daily, regardless of meal, for 5 days.

Intervention Type

Drug

Intervention Name(s)

Placebo oral capsule

Intervention Description

Placebo, capsules daily for 5 days.

Primary Outcome Measure Information:

Title

Time to resolution of fever

Description

Time from the start of study treatment to resolution of fever ( t ≤ 36,9 ºС)

Time Frame

7 ± 1 days

Secondary Outcome Measure Information:

Title

Time to resolution of intoxication symptoms

Description

Time from the start of study treatment to resolution of all intoxication symptoms.

Time Frame

7 ± 1 days

Title

Time to resolution of catarrhal symptoms

Description

Time from the start of study treatment to resolution of all catarrhal symptoms.

Time Frame

7 ± 1 days

Title

Time to resolution/alleviation of cough

Description

Time from the start of study treatment to resolution/alleviation of cough

Time Frame

7 ± 1 days

Other Pre-specified Outcome Measures:

Title

Proportion of subjects with development of complications of Influenza or other acute respiratory viral infection

Description

Proportion of subjects who developed complications during treatment period (7 ± 1 days) and follow-up period (21 ± 1 days)

Time Frame

7 ± 1 days and 21 ± 1 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ekaterina Zakharova, MD, PhD

Organizational Affiliation

Valenta Pharm JSC

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Kazan'

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

City Pediatric Outpatient Clinic number 5

City

Perm

ZIP/Postal Code

614066

Country

Russian Federation

Facility Name

Research Institute of Influenza, Ministry of Healthcare of Russian Federation

City

Saint Petersburg

ZIP/Postal Code

197376

Country

Russian Federation

Facility Name

Saratov State Medical University named after V. I. Razumovsky

City

Saratov

ZIP/Postal Code

410012

Country

Russian Federation

Facility Name

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

City

Yaroslavl

ZIP/Postal Code

150000

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

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

Results Reference

result

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

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