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Completed

NCT Number: NCT03189537

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

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

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Key information

Conditions

Influenza, Human Acute Respiratory Infection Common Cold Flu Infections Orthomyxoviridae Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Viral Infection Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Institute of Influenza, Saint Petersburg, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ingavirin (Imidazolyl Ethanamide Pentandioic Acid)

Drug

Broad-spectrum antiviral agent

Placebo oral capsule

Drug

Placebo capsule to match Ingavirin capsule

Primary outcomes

  1. Difference in incidence of flu / other acute respiratory viral infections between Ingavirin and placebo groups

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

    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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Valenta Pharm JSC

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 16, 2017
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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