NCT03189537

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Valenta Pharm JSC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Ingavirin (Imidazolyl Ethanamide Pentandioic Acid)	Broad-spectrum antiviral agent
DRUG	Placebo oral capsule	Placebo capsule to match Ingavirin capsule

Timeline

• Start date: 2010-10-03
• Primary completion: 2011-04-19
• Completion: 2011-10-10
• First posted: 2017-06-16
• Last updated: 2017-06-16

Locations

2 sites across 1 country: Russia