© 2015-2019 by Cont®aFlu. All Rights Reserved.

 

Design:

Double-blind, parallel-group, randomised, multicentre, placebo-controlled study

 

Study group:

Adults (18-70 years of age)

 

Target indication:

Influenza and influenza-like illness (ILI), ICD10 code: J11.1

 

Treatment duration:

7 days

 

 

Assessment instrument:

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.

Safety:

Rate of Adverse Events

 

Study Procedures:

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: