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

NCT03189537 | Completed Phase 3

• 1 other identifier: 2P/09
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

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

Conditions

Influenza, Human; Acute Respiratory Infection; Common Cold; Flu; Viral Infection

Keywords

Profilaxis; Ingavirin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Ingavirin

EXPERIMENTAL

Ingavirin (Imidazolyl Ethanamide Pentandioic Acid) capsules, 90 mg once daily for 7 days

Drug: Ingavirin (Imidazolyl Ethanamide Pentandioic Acid)

Placebo

PLACEBO COMPARATOR

Placebo oral capsule, once daily for 7 days

Drug: Placebo oral capsule

Interventions

Ingavirin (Imidazolyl Ethanamide Pentandioic Acid) DRUG

Broad-spectrum antiviral agent

Ingavirin

Placebo oral capsule DRUG

Placebo capsule to match Ingavirin capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Anti-virals intake, other then investigational drug, throughout the study
• Pregnant or lactating

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (2)

Research Institute of Influenza

Saint Petersburg, 197376, Russia

Location

Saratov State Medical University named after V. I. Razumovsky

Saratov, 410012, Russia

Location

Related Publications (1)

• 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.

  PMID: 24432596 RESULT

MeSH Terms

Conditions

Influenza, Human; Common Cold; Virus Diseases

Interventions

pentanedioic acid imidazolyl ethanamide

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases; Picornaviridae Infections

Study Officials

• Ekaterina Zakharova, MD, PhD

  Valenta Pharm JSC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 16, 2017
• Study Start: October 3, 2010
• Primary Completion: April 19, 2011
• Study Completion: October 10, 2011
• Last Updated: June 16, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)