Study of Post-Exposure Ingavirin® Prophylaxis of Influenza and Acute Respiratory Viral Infections

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was to evaluate efficacy of prophylactic Ingavirin intake by people having contact with sick people infected with influenza and other acute respiratory viral infections

Detailed Description
-----------------
The study includes 7 days of treatment period and 30 days of follow-up, 37 days total. The participant was receiving Ingavirin or placebo for 7 days. Then during 30 days the participant was under supervision. Visits were performed at days 2-7 (every day) since inclusion and then every 5 days during follow-up period. Wherever during the study the participant developed symptoms of flu or other acute respiratory viral infection, the participant was taken for medical care to observe his condition, symptoms dynamics, lab tests, including laboratory verification of viral origin of the disease. Medical care was established for 10±2 days since symptoms. Everyday for 3 days and additional visits for 5±1 and 10±2 days of the disease. The patient had the required symptomatic treatment, additionally the patient could be institutionalised if necessary. Wherever the participant developed symptoms during treatment period, the patient was taken investigational drug on schedule.

Official Title
-----------------
Double Blind Randomised Placebo Controlled Trial for Evaluation of Efficacy and Safety of Ingavirin® for Post-exposure Profilaxis During Rise in the Incidence of Influenza and Other Acute Respiratory Viral Infections in Adults

Conditions
-----------------
Flu, Influenza, Human, Acute Respiratory Infection, Common Cold, Viral Infection

Intervention / Treatment
-----------------
* Drug: Ingavirin (Imidazolyl Ethanamide Pentandioic Acid)
* Drug: Placebo oral capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who do have continuous contact with ill person (staff members, dormitory, family members), laboratory confirmed viral origin, during influenza/other acute viral respiratory disease season First exposure with the ill person who is present with symptoms of flu or acute respiratory viral infection (fever, intoxication, catarrhal symptoms) ≤ 48 hours Signed Informed Contest to participate in the study Contraception throughout the study Exclusion Criteria: Interferone or interferone inducers intake, or substances with action on immune system intake less then 3 months before inclusion Anti-virals intake, other then investigational drug, throughout the study Vaccination for Influenza less than 1 year before inclusion Pregnant or lactating

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ingavirin<br>Ingavirin (Imidazolyl Ethanamide Pentandioic Acid) capsules, 90 mg once daily for 7 days | Drug: Ingavirin (Imidazolyl Ethanamide Pentandioic Acid)<br>* Broad-spectrum antiviral agent<br>|
| Placebo Comparator: Placebo<br>Placebo oral capsule, once daily for 7 days | Drug: Placebo oral capsule<br>* Placebo capsule to match Ingavirin capsule<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in incidence of flu / other acute respiratory viral infections between Ingavirin and placebo groups | To evaluate incidence difference between Ingavirin and placebo groups. Incidence defined as ratio between number of people got sick in the group to all people in the group. 1) Efficiency Index (EI) was defined as incidence of flu in placebo group to incidence of flu in Ingavirin group. 2) Efficacy Ratio (ER) defined by formula: ER=(incidence in placebo group - incidence Ingavirin group)*100% then divided by incidence in placebo group. | Through study completion, an average of 37 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative evaluation of prevalence and duration of flu and acute viral respiratory infection at participants who developed flu / avri |  | Through study completion, an average of 37 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Profilaxis, Ingavirin