Clinical trial NCT02644018: Efficacy and Safety Study of Ingavirin® to Treat Influenza and Other Acute Respiratory Viral Infections in Patients 3-6 y.o.
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Common Cold
Influenza
Keywords: Ingavirin
Common Cold
Influenza
Acute Respiratory Viral Infections
pediatric clinical trial
Imidazolyl ethanamide pentandioic acid
Lead sponsor: Valenta Pharm JSC
Sponsor class: INDUSTRY
Collaborators: name: Atlant Clinical Ltd.
First posted: 2015-12-31
Enrollment: 190
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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
timeFrame: 5 days
Secondary outcomes:
measure: Time to decrease in the Influenza and Other ARVI Severity Scale score to 0 points
timeFrame: 5 days
measure: Average score at the Influenza and Other ARVI Severity Scale by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment
timeFrame: Within 6 days from the start of treatment
measure: The area under the "Influenza and Other ARVI Severity Scale score - time" curve by the 5th day after the start of treatment
timeFrame: 5 days
measure: Time to normalization of body temperature from the start of treatment, measured in hours
timeFrame: 5 days
measure: The average body temperature by the1st, 2nd, 3rd, 4th and 5th days after the start of treatment
timeFrame: 5 days
measure: The percentage of patients with normalization of body temperature by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment
timeFrame: 5 days
measure: The area under the "temperature-time" curve by the 5th day after the start of treatment
timeFrame: 5 days
measure: 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
timeFrame: 14 days
measure: 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
timeFrame: 14 days
measure: Time to onset of complications of influenza and other ARVI from the start of treatment
timeFrame: 14 days
measure: Assessment of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: 14 days
Other outcomes:
Locations:
city: Kazan
country: Russian Federation
facility: GBOU VPO "Kazan State Medical University" of Ministry of Health of Russian Federation
city: Krasnoyarsk
country: Russian Federation
facility: GBOU VPO "Krasnoyarsk State Medical University n.a.n V.F. Voyno-Yasenetskogo" of Ministry of Health of Russian Federation
city: Moscow
country: Russian Federation
facility: FGBU "Scientific center of children health" of the Ministry of Health of Russian Federation
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical University
city: Moscow
country: Russian Federation
facility: Moscow Budgetary Public Health Facility "Infectious clinical hospital #1" of Moscow City Health Department
city: Novosibirsk
country: Russian Federation
facility: GBOU VPO "Novosibirsk State Medical University of Ministry of Health of Russian Federation"
city: Perm
country: Russian Federation
facility: Children's city outpatients clinic № 5
city: Rostov-na-Donu
country: Russian Federation
facility: Children's city outpatients clinic № 4
city: Rostov-na-Donu
country: Russian Federation
facility: GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation
city: Saint-Petersburg
country: Russian Federation
facility: FGBU "Scientific Research Institute of Children's Infections, Federal Biomedical Agency"
city: Saransk
country: Russian Federation
facility: FGBOU VPO "Mordov State University n.a. N.P. Ogarev"
city: Tomsk
country: Russian Federation
facility: GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation
city: Yaroslavl
country: Russian Federation
facility: GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation
Study officials:
affiliation: Valenta Pharm JSC
name: Ekaterina Zakharova, MD, PhD
role: STUDY_DIRECTOR
affiliation: Scientific Research Institute of Children's Infections, Federal Biomedical Agency, Saint-Petersburg, Russian Federation
name: Yuriy V. Lobzin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: