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

NCT ID: NCT03189537

Last Updated: 2017-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-03
• Study Completion Date: 2011-10-10

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Ingavirin

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

Group Type: EXPERIMENTAL

Ingavirin (Imidazolyl Ethanamide Pentandioic Acid)

Intervention Type: DRUG

Broad-spectrum antiviral agent

Placebo

Placebo oral capsule, once daily for 7 days

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

Placebo capsule to match Ingavirin capsule

Interventions

Ingavirin (Imidazolyl Ethanamide Pentandioic Acid)

Broad-spectrum antiviral agent

Intervention Type: DRUG

Placebo oral capsule

Placebo capsule to match Ingavirin capsule

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valenta Pharm JSC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ekaterina Zakharova, MD, PhD

Role: STUDY_DIRECTOR

Valenta Pharm JSC

Locations

Research Institute of Influenza

Saint Petersburg, , Russia

Saratov State Medical University named after V. I. Razumovsky

Saratov, , Russia

Countries

Russia

References

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.

Reference Type: RESULT

PMID: 24432596 (View on PubMed)

Other Identifiers

2P/09

Identifier Type: -

Identifier Source: org_study_id