Double-blind, parallel-group, randomised, multicentre, placebo-controlled study
Adults (18-70 years of age)
Influenza and influenza-like illness (ILI), ICD10 code: J11.1
Seven influenza symptoms (cough, nasal obstruction, sore throat, fatigue, headache, myalgia and feverishness) will be auto-evaluated daily (in the evening) by the patient on 4-level discrete scales (0=absent, 1=mild, 2=moderate and 3=severe) (Treanor et al., 2000)
Primary End Point: Time to resolution of illness: defined as the time from study drug initiation to time of alleviation of symptoms.
Secondary End points:
Severity of illness, Severity of each individual ILI symptom, Duration of each individual ILI symptom, Functional impairments, Overall health status in the course of the disease.
Rate of Adverse Events
Future Clinical Trial Design
For Cont®aFlu to be registered as a self-treatment of flu, its efficacy has to be proven in a pivotal clinical trial. The optimal study design is described below. You can download a 6-page Clinical Trial Synopsis in pdf format by pressing the red button under the table below.
A detailed quotation for ESTIAR trial from dedicated Contract Research Organization that we worked with during our first trial, can be downloaded here: