To evaluate the efficacy of AV5080 versus Placebo based on time to symptom resolution in patients with uncomplicated influenza.
This study is an international, multicenter, double-blind, randomized, placebo-controlled, phase III clinical trial in parallel groups evaluating the efficacy and safety of AV5080 in patients with uncomplicated influenza. Only patients with mild to moderate influenza, without complications, will be included in the study. Taking into account the seasonality of the pathology and the low percentage of influenza in the general structure of ARVI incidence, for the successful inclusion of all patients in the study during two epidemiological seasons. The study will enroll 700 patients aged 18 to 65 years with a confirmed clinical diagnosis of influenza to treatment (AV5080) and placebo cohorts (1:1).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
700
Specialized Clinical Infectious Diseases Hospital
Krasnodar, Russia
Murmansk Regional Clinic named after P.A. Bayandin
Murmansk, Russia
Federal Research Center Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences
Novosibirsk, Russia
Center for the Prevention and Control of AIDS and Infectious Diseases
Saint Petersburg, Russia
Time to symptom resolution
The resolution of influenza symptoms is confirmed by the absence of symptoms or their reduction to mild severity (0-1 points) and a decrease in body temperature in the armpit to ≤ 37.2 °C for at least 24 hours. The time to resolve the flu symptoms is the start time of the 24-hour (or longer) interval.
Time frame: 30 days
Profile of changes in influenza virus titer versus time (AUC) for 192 hours (in inpatients)
Time frame: 192 hours
Frequency of symptom resolution within 96 hours of initiation of study therapy
Time frame: 96 hours
Frequency of elimination of influenza virus before Day 6
Time frame: 6 Days
The incidence of complications from influenza
Time frame: 30 days
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First Saint Petersburg State Medical University named after I.I. Academician Pavlov
Saint Petersburg, Russia
Research Center Eco-safety
Saint Petersburg, Russia