Clinical trial NCT03191097: Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Children 7-12 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 Children 7-12 y.o.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza, Human
Acute Respiratory Infection
Viral Infection
Common Cold
Lead sponsor: Valenta Pharm JSC
Sponsor class: INDUSTRY
Collaborators: name: Atlant Clinical Ltd.
First posted: 2017-06-19
Enrollment: 310
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
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 60 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in 7-12 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 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

Primary outcomes:
measure: Time to resolution of fever
timeFrame: 7 ± 1 days
Secondary outcomes:
measure: Time to resolution of intoxication symptoms
timeFrame: 7 ± 1 days
measure: Time to resolution of catarrhal symptoms
timeFrame: 7 ± 1 days
Other outcomes:
measure: Proportion of subjects with resolution of fever
timeFrame: 7 ± 1
measure: Proportion of subjects with development of complications of Influenza or other acute respiratory viral infection
timeFrame: 21 ± 1
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: Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical University
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Medical University
city: Perm
country: Russian Federation
facility: City Pediatric Outpatient Clinic number 5
city: Rostov-na-Donu
country: Russian Federation
facility: Rostov State Medical University
city: Rostov-na-Donu
country: Russian Federation
facility: Pediatrics outpatient clinic number 4 of Rostov-na-Donu
city: Saransk
country: Russian Federation
facility: Ogarev Mordovia State University
city: Saratov
country: Russian Federation
facility: Saratov State Medical University named after V. I. Razumovsky
city: Yaroslavl
country: Russian Federation
facility: GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation
city: Yekaterinburg
country: Russian Federation
facility: Pediatrician City Hospital number 11
Study officials:
affiliation: Valenta Pharm JSC
name: Ekaterina Zakharova, MD, PhD
role: STUDY_DIRECTOR
References:
citation: I.M. Farber, N.A. Geppe, D.V. Reikhart, V.E. Nebolsin, V.S. Arnautov, A.A. Globenko. Therapy for influenza and acute respiratory viral infection in young and middle-aged schoolchildren: Effect of Ingavirin® on intoxication, fever, and catarrhal syndromes. Ros Vestn Perinatol Pediat 2016; 2:115-120. Russian.
citation: N.A. Geppe, E.D. Teplyakova, A.A. Shuldyakov, E.P. Lyapina, O.A. Perminova, G.P. Martynova, I.G. Sitnikov, V.A. Anohin, G.R. Fatkullina, V.V. Romanenko, A.A. Savisko, E.G. Kondyurina, L.A. Balykova. Innovations in pediatrics: the optimal clinical effect In acute respiratory viral infections treatment In children with complex action drug. Pediatry 2016, 2(95), 97-103. Russian.