Assessment of the effect reached with the different doses of AV5080 on the duration and severity of influenza symptoms based on the incidence of their resolution within 96 hours from study treatment initiation compared to Placebo. The absence of influenza symptoms or their reduction to mild severity for at least 24 hours indicates the resolution of influenza.
The study was a multi-center, double-blind, randomized, parallel- group clinical study to assess the efficacy and safety of different AV5080 doses as compared to placebo in patients with influenza during the 5-day treatment period. The study included only patients with influenza of mild and moderate severity, without complications, both outpatients and those hospitalized for epidemiological reasons. The study included three periods for each patient: Screening, randomization, and study treatment, follow up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
135
City polyclinic №10
Kazan', Russia
Infectious Clinical Hospital No. 1 of the Moscow City Health Department
Moscow, Russia
GBUZ NO Infections Clinical Hospital No.2
Nizhny Novgorod, Russia
Percentage of patients who reported resolution of influenza symptoms within 96 hours from the start of therapy
The absence of influenza symptoms or their reduction to mild severity for at least 24 hours indicates the resolution of influenza.
Time frame: 30 days
Time to symptoms resolution
The time before the resolution of influenza symptoms
Time frame: 30 days
Incidence rate of influenza virus elimination until Day 6
The incidence rate of influenza virus elimination from mucous membranes of the nasopharynx and oropharynx until Day 6
Time frame: 6 days
Change in titer of antibodies on Day 15 compared to baseline;
Change in titer of IgG and IgM antibodies to influenza A and B virus on Day 15 compared to baseline;
Time frame: 15 Days
The incidence rate of influenza complications
Time frame: 29 Days
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