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Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Patients 13-17 y.o.

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ClinicalTrials.gov Identifier: NCT03206346
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
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 13-17 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 : 161 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 Patients 13-18 y.o.
Actual Study Start Date : January 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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

Placebo Comparator: Placebo oral capsule
Placebo capsule identical in appearance to Ingavirin 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.

  3. Time to resolution/alleviation of cough [ Time Frame: 7 ± 1 days ]
    Time from the start of study treatment to resolution/alleviation of cough


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



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Ages Eligible for Study:   13 Years to 17 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 13-17
  • 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): NCT03206346


Locations
Russian Federation
GBOU VPO "Kazan State Medical University" of Ministry of Health of Russian Federation
Kazan', Russian Federation, 420012
City Pediatric Outpatient Clinic number 5
Perm, Russian Federation, 614066
Research Institute of Influenza, Ministry of Healthcare of Russian Federation
Saint Petersburg, Russian Federation, 197376
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
Sponsors and Collaborators
Valenta Pharm JSC
Investigators
Study Director: Ekaterina Zakharova, MD, PhD Valenta Pharm JSC

Publications of Results:
A.A.Shul'dyakov, E.P.Lyapina, V.I.Kuznetsov, N.I.Zryachkin, I.G.Sitnikov, O.A.Perminova, V.A.Anokhin4, G.R.Fatkullina. New possibilities in therapy of acute respiratory viral infections in children. Vopr. Prakt. Pediatrii. 2015 vol10 n5 pp21-28. Russian

Responsible Party: Valenta Pharm JSC
ClinicalTrials.gov Identifier: NCT03206346     History of Changes
Other Study ID Numbers: 4P/10
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 2, 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