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

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

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

Study Overview

• Status: Completed
• Conditions: Influenza, Human; Common Cold; Acute Respiratory Infection; Flu; Viral Infection
• Intervention / Treatment: Drug: Ingavirin (Imidazolyl Ethanamide Pentandioic Acid); Drug: Placebo oral capsule

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 197376
    • Research Institute of Influenza
  • Saratov, Russian Federation, 410012
    • Saratov State Medical University named after V. I. Razumovsky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

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	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

Collaborators and Investigators

• Sponsor: Valenta Pharm JSC
• Investigators: Study Director: Ekaterina Zakharova, MD, PhD, Valenta Pharm JSC

Publications and helpful links

General Publications

• Shul'diakov AA, Liapina EP, Kuznetsov VI. [Current principles in the chemoprophylaxis of acute respiratory viral infections]. Ter Arkh. 2013;85(11):27-33. Russian.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2010
• Primary Completion (Actual): April 19, 2011
• Study Completion (Actual): October 10, 2011

Study Registration Dates

• First Submitted: June 8, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Profilaxis; Ingavirin
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Respiratory Tract Diseases; Disease Attributes; Picornaviridae Infections; Orthomyxoviridae Infections; Infections; Communicable Diseases; Virus Diseases; Influenza, Human; Respiratory Tract Infections; Common Cold; Anti-Infective Agents; Antiviral Agents; Pentanedioic acid imidazolyl ethanamide
• Other Study ID Numbers: 2P/09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No