Influenza Clinical Trial
Official title:
Clinical Study to Assess Efficacy, Safety, Tolerability and Optimal Dose Ranging of XC8 in Doses 20, 100 and 200 mg Once Daily in Patients With Uncomplicated Influenza or Other Acute Respiratory Viral Infections (ARVI)
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.
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