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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
190
GBOU VPO "Kazan State Medical University" of Ministry of Health of Russian Federation
Kazan', Russia
GBOU VPO "Krasnoyarsk State Medical University n.a.n V.F. Voyno-Yasenetskogo" of Ministry of Health of Russian Federation
Krasnoyarsk, Russia
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.
Time frame: 5 days
Time to decrease in the Influenza and Other ARVI Severity Scale score to 0 points
Time frame: 5 days
Average score at the Influenza and Other ARVI Severity Scale by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment
Time frame: Within 6 days from the start of treatment
The area under the "Influenza and Other ARVI Severity Scale score - time" curve by the 5th day after the start of treatment
Time frame: 5 days
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
Time frame: 5 days
The average body temperature by the1st, 2nd, 3rd, 4th and 5th days after the start of treatment
Time frame: 5 days
The percentage of patients with normalization of body temperature by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment
Time frame: 5 days
The area under the "temperature-time" curve by the 5th day after the start of treatment
Time frame: 5 days
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FGBU "Scientific center of children health" of the Ministry of Health of Russian Federation
Moscow, Russia
I.M. Sechenov First Moscow State Medical University
Moscow, Russia
Moscow Budgetary Public Health Facility "Infectious clinical hospital #1" of Moscow City Health Department
Moscow, Russia
GBOU VPO "Novosibirsk State Medical University of Ministry of Health of Russian Federation"
Novosibirsk, Russia
Children's city outpatients clinic № 5
Perm, Russia
Children's city outpatients clinic № 4
Rostov-on-Don, Russia
GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation
Rostov-on-Don, Russia
FGBU "Scientific Research Institute of Children's Infections, Federal Biomedical Agency"
Saint Petersburg, Russia
...and 3 more locations
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
Time frame: 14 days
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
Time frame: 14 days
Time to onset of complications of influenza and other ARVI from the start of treatment
Time frame: 14 days
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
Time frame: 14 days