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

Valenta Pharm JSC400 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

400

Conditions

Influenza, Human Acute Respiratory Infection Common Cold Flu Viral Infection

Interventions

Ingavirin (Imidazolyl Ethanamide Pentandioic Acid)DRUG

Broad-spectrum antiviral agent

Placebo oral capsuleDRUG

Placebo capsule to match Ingavirin capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Research Institute of Influenza

Saint Petersburg, Russia

Saratov State Medical University named after V. I. Razumovsky

Saratov, Russia

Outcomes

Primary Outcomes

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.

Time frame: Through study completion, an average of 37 days

Secondary Outcomes

Comparative evaluation of prevalence and duration of flu and acute viral respiratory infection at participants who developed flu / avri

Time frame: Through study completion, an average of 37 days

Data from ClinicalTrials.gov

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