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

Influenza, Human Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03191097
• Other study ID #: 4K/2013
• Status: Completed
• Phase: Phase 3
• First received: June 15, 2017
• Last updated: June 15, 2017
• Start date: August 2014
• Est. completion date: March 2015

Study information

• Verified date: June 2017
• Source: Valenta Pharm JSC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Common Cold
• Communicable Diseases
• Infection
• Influenza, Human
• Respiratory Tract Infections
• Viral Infection
• Virus Diseases

Intervention

Drug:
• Ingavirin
Ingavirin capsules 60 mg once daily, regardless of meal, for 5 days.
• Placebo oral capsule
Placebo, capsules daily for 5 days.

Locations

Country	Name	City	State
Russian Federation	GBOU VPO "Kazan State Medical University" of Ministry of Health of Russian Federation	Kazan'
Russian Federation	Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky	Krasnoyarsk
Russian Federation	I.M. Sechenov First Moscow State Medical University	Moscow
Russian Federation	Novosibirsk State Medical University	Novosibirsk
Russian Federation	City Pediatric Outpatient Clinic number 5	Perm
Russian Federation	Pediatrics outpatient clinic number 4 of Rostov-na-Donu	Rostov-na-Donu
Russian Federation	Rostov State Medical University	Rostov-na-Donu
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

Sponsors (2)

Lead Sponsor	Collaborator
Valenta Pharm JSC	Atlant Clinical Ltd.

Country where clinical trial is conducted

Russian Federation, 

References & Publications (2)

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.

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 I

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of subjects with resolution of fever	Proportion of subjects with resolution of fever by 1st, 2nd, 3rd, 4th and 5th days of treatment	7 ± 1
Other	Proportion of subjects with development of complications of Influenza or other acute respiratory viral infection	Proportion of subjects who developed complications during treatment period (7 ± 1 days) and follow-up period (21 ± 1 days)	21 ± 1
Primary	Time to resolution of fever	Time from the start of study treatment to resolution of fever ( t = 36,9 º?)	7 ± 1 days
Secondary	Time to resolution of intoxication symptoms	Time from the start of study treatment to resolution of all intoxication symptoms.	7 ± 1 days
Secondary	Time to resolution of catarrhal symptoms	Time from the start of study treatment to resolution of all catarrhal symptoms.	7 ± 1 days