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

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ClinicalTrials.gov Identifier: NCT03191097
Recruitment Status : Completed
First Posted : June 19, 2017
Last Update Posted : June 19, 2017
Sponsor:
Collaborator:
Atlant Clinical Ltd.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Influenza, Human Acute Respiratory Infection Viral Infection Common Cold Drug: Ingavirin Drug: Placebo oral capsule Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : August 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Ingavirin Drug: Ingavirin
Ingavirin capsules 60 mg once daily, regardless of meal, for 5 days.
Other Name: Imidazolyl ethanamide pentandioic acid

Placebo Comparator: Placebo oral capsule Drug: Placebo oral capsule
Placebo, capsules daily for 5 days.




Primary Outcome Measures :
  1. Time to resolution of fever [ Time Frame: 7 ± 1 days ]
    Time from the start of study treatment to resolution of fever ( t ≤ 36,9 ºС)


Secondary Outcome Measures :
  1. Time to resolution of intoxication symptoms [ Time Frame: 7 ± 1 days ]
    Time from the start of study treatment to resolution of all intoxication symptoms.

  2. Time to resolution of catarrhal symptoms [ Time Frame: 7 ± 1 days ]
    Time from the start of study treatment to resolution of all catarrhal symptoms.


Other Outcome Measures:
  1. Proportion of subjects with resolution of fever [ Time Frame: 7 ± 1 ]
    Proportion of subjects with resolution of fever by 1st, 2nd, 3rd, 4th and 5th days of treatment

  2. Proportion of subjects with development of complications of Influenza or other acute respiratory viral infection [ Time Frame: 21 ± 1 ]
    Proportion of subjects who developed complications during treatment period (7 ± 1 days) and follow-up period (21 ± 1 days)



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191097


Locations
Russian Federation
GBOU VPO "Kazan State Medical University" of Ministry of Health of Russian Federation
Kazan', Russian Federation, 420012
Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky
Krasnoyarsk, Russian Federation, 660022
I.M. Sechenov First Moscow State Medical University
Moscow, Russian Federation, 119991
Novosibirsk State Medical University
Novosibirsk, Russian Federation, 630091
City Pediatric Outpatient Clinic number 5
Perm, Russian Federation, 614066
Rostov State Medical University
Rostov-na-Donu, Russian Federation, 344022
Pediatrics outpatient clinic number 4 of Rostov-na-Donu
Rostov-na-Donu, Russian Federation, 344065
Ogarev Mordovia State University
Saransk, Russian Federation, 430005
Saratov State Medical University named after V. I. Razumovsky
Saratov, Russian Federation, 410012
GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation
Yaroslavl, Russian Federation, 150000
Pediatrician City Hospital number 11
Yekaterinburg, Russian Federation, 62028
Sponsors and Collaborators
Valenta Pharm JSC
Atlant Clinical Ltd.
Investigators
Study Director: Ekaterina Zakharova, MD, PhD Valenta Pharm JSC

Publications of Results:
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.
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.

Responsible Party: Valenta Pharm JSC
ClinicalTrials.gov Identifier: NCT03191097     History of Changes
Other Study ID Numbers: 4K/2013
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
Influenza, Human
Respiratory Tract Infections
Common Cold
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Picornaviridae Infections