Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Children 7-12 y.o.

Phase 3

Completed

• Conditions: Acute Respiratory Infection; Viral Infection; Common Cold; Influenza, Human
• Interventions: Drug: Placebo oral capsule; Drug: Ingavirin

• Registration Number: NCT03191097
• Lead Sponsor: Valenta Pharm JSC

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 7-12 years old patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2014-12
• Study Completion: 2015-03
• Status Verified: 2017-06
• Study First Submitted: 2017-06-15
• Study First Submitted QC: 2017-06-15
• Last Update Submitted: 2017-06-15
• Study First Posted: 2017-06-19
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

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 7-12
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo oral capsule	Placebo oral capsule	-
Ingavirin	Ingavirin	-

Primary Outcome Measures

Name	Time	Method
Time to resolution of fever	7 ± 1 days	Time from the start of study treatment to resolution of fever ( t ≤ 36,9 ºС)

Secondary Outcome Measures

Name	Time	Method
Time to resolution of intoxication symptoms	7 ± 1 days	Time from the start of study treatment to resolution of all intoxication symptoms.
Time to resolution of catarrhal symptoms	7 ± 1 days	Time from the start of study treatment to resolution of all catarrhal symptoms.

Trial Locations

Locations (11)

GBOU VPO "Kazan State Medical University" of Ministry of Health of Russian Federation; 🇷🇺 Kazan', Russian Federation

Rostov State Medical University; 🇷🇺 Rostov-na-Donu, Russian Federation

I.M. Sechenov First Moscow State Medical University; 🇷🇺 Moscow, Russian Federation

Ogarev Mordovia State University; 🇷🇺 Saransk, Russian Federation

Saratov State Medical University named after V. I. Razumovsky; 🇷🇺 Saratov, Russian Federation

GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation; 🇷🇺 Yaroslavl, Russian Federation

Pediatrician City Hospital number 11; 🇷🇺 Yekaterinburg, Russian Federation

Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky; 🇷🇺 Krasnoyarsk, Russian Federation

City Pediatric Outpatient Clinic number 5; 🇷🇺 Perm, Russian Federation

Novosibirsk State Medical University; 🇷🇺 Novosibirsk, Russian Federation

Pediatrics outpatient clinic number 4 of Rostov-na-Donu; 🇷🇺 Rostov-na-Donu, Russian Federation