A multicenter double-blind, randomized, placebo-controlled, parallel-group comparative Phase II / III clinical study to assess safety, tolerability, efficacy and optimal dose ranging of XC8 vs. placebo in patients with uncomplicated influenza or other ARVI during a 5-day treatment. The primary objective of the study was to demonstrate the difference in time before the onset of a sustained improvement in clinical symptoms according to the Severity Rating Scale for ARVI, and to determine the optimal dose of XC8 in the treatment of influenza and other ARVI.
Twenty-three Russian centers were approved for participation in this study. Twenty centers were initiated. Patients were enrolled in 18 centers. The study consisted of two parts: phase II and phase III. Each of the parts included 3 periods: screening, treatment, follow-up. In the first part of the study (Phase II), all eligible patients were randomized into 4 groups (groups A, B, C, and D) in a 1:1:1:1 ratio: Group A - XC8 20 mg daily (40 patients); Group B - XC8 100 mg daily (40 patients); Group C - XC8 200 mg daily (40 patients); Group D - placebo (40 patients). Interim analysis was planned after the end of the first part of the study (Phase II). Based on the results of the interim analysis, the most promising XC8 dose group was selected and the necessary set was calculated to compare this group with the placebo group by the primary endpoint in a pooled set using an adaptive design with type I error control. In the second part of the study (Phase III), all eligible patients were randomized into 2 groups (groups C and D) in a 1:1 ratio: Group C - XC8 200 mg daily (80 patients); Group D - placebo (80 Patients). During the treatment period (5 days), patients received XC8 / placebo daily on a background of standard symptomatic therapy. The follow-up period lasted for 9 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
once daily during 5 days.
once daily during 5 days.
once daily during 5 days.
Time to sustained improvement in clinical symptoms
Severity Rating Scale for ARVI (\<2 points, provided that there is ≤ 1 point for one symptom) with temperature normalization (\<37°C) (estimated by Kaplan-Meier), established according to patient diaries.
Time frame: up to Day 5
Body temperature below 37°C without further elevation
Time to normalization of body temperature since the symptoms onset, measured in hours
Time frame: up to Day 8
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once daily during 5 days.
Udmurt Republic Budgetary Healthcare Institution "City clinical Hospital #9 of the Ministry of Health of the Udmurt Republic
Izhevsk, Russia
State Educational Institution for further vocational education "Kazan State Medical Academy of Federal Healthcare Agency", Clinical site - State Independent Healthcare Institution "Republic Infectious Clinical Hospital n.a. professor Agafonov",
Kazan', Russia
State Budgetary Institution of Higher Professional Education "Kuban State Medical University" of the Ministry of Health of the Russian Federation
Krasnodar, Russia
Nizhegorodsky region SBHI Nizhniy Novgorod Infectious Regional Clinical Hospital № 2
Nizhny Novgorod, Russia
Novosibirsk Municipal Healthcare Budgetary Institution "City Clinical Hospital # 19",
Novosibirsk, Russia
Novosibirsk region SBHI "City Infectious Clinical Hospital # 1",
Novosibirsk, Russia
; Moscow region State Budgetary Institution "Podolsk City Clinical Hospital № 3"
Podolsk, Russia
Municipal State Budgetary Institution "Rostov-on-Don City Clinical Hospital# 1 n.a. Semashko",
Rostov-on-Don, Russia
State Budgetary Institution of Higher Professional Education "Ryazan State Medical University n.a. Pavlov" of the Ministry of Health of the Russian Federation, Clinical site - SBHI of Ryazan region "Clinical Hospital n.a. Semashko"
Ryazan, Russia
ArsVite Severo-Zapad LLC
Saint Petersburg, Russia
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