Efficacy and Safety Study of Ingavirin® to Treat Influenza and Other Acute Respiratory Viral Infections in Patients 3-6 y.o.

Influenza Clinical Trial

— ACCORD  

Official title:

Double Blind Randomized Placebo-controlled Multicenter Study to Evaluate Clinical Efficacy and Safety of Ingavirin®, Capsules 30 mg, in 3-6 Years Old Patients With Influenza and Other Acute Respiratory Viral Infections in the Course of Standard Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02644018
• Other study ID #: ING-03-02-2015
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2015
• Last updated: June 7, 2016
• Start date: January 2016
• Est. completion date: May 2016

Study information

• Verified date: February 2016
• Source: Valenta Pharm JSC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Ingavirin ® dosed 30 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in the course of standard therapy in 3-6 years old patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 6 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 3-6.

• Patients with moderate course of influenza or other acute respiratory viral infections.

• 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.

• Established diagnosis J06.9, J10, J11, in accordance with ICD-10.

• 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 14 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Cold
• Influenza
• Influenza, Human
• Virus Diseases

Intervention

Drug:
• Imidazolyl ethanamide pentandioic acid

• placebo

Locations

Country	Name	City	State
Russian Federation	GBOU VPO "Kazan State Medical University" of Ministry of Health of Russian Federation	Kazan
Russian Federation	GBOU VPO "Krasnoyarsk State Medical University n.a.n V.F. Voyno-Yasenetskogo" of Ministry of Health of Russian Federation	Krasnoyarsk
Russian Federation	FGBU "Scientific center of children health" of the Ministry of Health of Russian Federation	Moscow
Russian Federation	I.M. Sechenov First Moscow State Medical University	Moscow
Russian Federation	Moscow Budgetary Public Health Facility "Infectious clinical hospital #1" of Moscow City Health Department	Moscow
Russian Federation	GBOU VPO "Novosibirsk State Medical University of Ministry of Health of Russian Federation"	Novosibirsk
Russian Federation	Children's city outpatients clinic ? 5	Perm
Russian Federation	Children's city outpatients clinic ? 4	Rostov-na-Donu
Russian Federation	GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation	Rostov-na-Donu
Russian Federation	FGBU "Scientific Research Institute of Children's Infections, Federal Biomedical Agency"	Saint-Petersburg
Russian Federation	FGBOU VPO "Mordov State University n.a. N.P. Ogarev"	Saransk
Russian Federation	GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation	Tomsk
Russian Federation	GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation	Yaroslavl

Sponsors (2)

Lead Sponsor	Collaborator
Valenta Pharm JSC	Atlant Clinical Ltd.

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to decrease in the Influenza and Other ARVI Severity Scale score to 2 points with no more than 1 point at individual subscales and normalization of body temperature	Temperature normalization means establishment of body temperature below 37 ° C without raising thereafter till 5 days after the treatment start.	5 days	No
Secondary	Time to decrease in the Influenza and Other ARVI Severity Scale score to 0 points		5 days	No
Secondary	Average score at the Influenza and Other ARVI Severity Scale by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment		Within 6 days from the start of treatment	No
Secondary	The area under the "Influenza and Other ARVI Severity Scale score - time" curve by the 5th day after the start of treatment		5 days	No
Secondary	Time to normalization of body temperature from the start of treatment, measured in hours	Temperature normalization means establishment of body temperature below 37°C without raising thereafter till 5 days after the treatment start	5 days	No
Secondary	The average body temperature by the1st, 2nd, 3rd, 4th and 5th days after the start of treatment		5 days	No
Secondary	The percentage of patients with normalization of body temperature by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment		5 days	No
Secondary	The area under the "temperature-time" curve by the 5th day after the start of treatment		5 days	No
Secondary	The percentage of patients with complications of influenza and other ARVI developed over the period from the 1st to the 6th and from the 1st to 14th day after the start of treatment		14 days	No
Secondary	The percentage of patients with severe complications of influenza and other ARVI that have developed over the period from the 1st to the 6th and from the 1st to 14th day after the start of treatment		14 days	No
Secondary	Time to onset of complications of influenza and other ARVI from the start of treatment		14 days	No
Secondary	Assessment of adverse events (AEs) and serious adverse events (SAEs)	Assessment of adverse events (AEs) and serious adverse events (SAEs) by means of -; Portion of patients who developed one or more SAE during the study; Portion of patients who developed one or more AE during the study; Portion of patients who developed one or more severe AE during the study; Portion of patients who developed one or more AE with definite relationship to the investigational product/ placebo during the study; Portion of patients who developed one or more AE with definite or probable relationship to the investigational product/ placebo during the study	14 days	Yes