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

NCT03191097 | Completed Phase 3

• 1 other identifier: 4K/2013
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 11

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Time to resolution of fever

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

  7 ± 1 days

Secondary Outcomes (2)

• Time to resolution of intoxication symptoms

  7 ± 1 days

• Time to resolution of catarrhal symptoms

  7 ± 1 days

Other Outcomes (2)

• Proportion of subjects with resolution of fever

  7 ± 1

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

  21 ± 1

Study Arms (2)

Ingavirin

EXPERIMENTAL

Drug: Ingavirin

Placebo oral capsule

PLACEBO COMPARATOR

Drug: Placebo oral capsule

Interventions

Ingavirin DRUG

Ingavirin capsules 60 mg once daily, regardless of meal, for 5 days.

Also known as: Imidazolyl ethanamide pentandioic acid

Ingavirin

Placebo oral capsule DRUG

Placebo, capsules daily for 5 days.

Placebo oral capsule

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Valenta Pharm JSC: lead
• Atlant Clinical Ltd.: collaborator

Study Sites (11)

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

Kazan', 420012, Russia

Location

Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky

Krasnoyarsk, 660022, Russia

Location

I.M. Sechenov First Moscow State Medical University

Moscow, 119991, Russia

Location

Novosibirsk State Medical University

Novosibirsk, 630091, Russia

Location

City Pediatric Outpatient Clinic number 5

Perm, 614066, Russia

Location

Rostov State Medical University

Rostov-on-Don, 344022, Russia

Location

Pediatrics outpatient clinic number 4 of Rostov-na-Donu

Rostov-on-Don, 344065, Russia

Location

Ogarev Mordovia State University

Saransk, 430005, Russia

Location

Saratov State Medical University named after V. I. Razumovsky

Saratov, 410012, Russia

Location

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

Yaroslavl, 150000, Russia

Location

Pediatrician City Hospital number 11

Yekaterinburg, 62028, Russia

Location

Related 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. Ros Vestn Perinatol Pediat 2016; 2:115-120. Russian.

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Influenza, Human; Virus Diseases; Common Cold

Interventions

pentanedioic acid imidazolyl ethanamide

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases; Picornaviridae Infections

Study Officials

• Ekaterina Zakharova, MD, PhD

  Valenta Pharm JSC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 19, 2017
• Study Start: August 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: June 19, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (11)