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

Valenta Pharm

Status and phase: Completed; Phase 3

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

Treatments: Drug: Placebo oral capsule; Drug: Ingavirin (Imidazolyl Ethanamide Pentandioic Acid)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03189537

2P/09

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups, including a placebo group

Ingavirin

Experimental group

Description:

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

Treatment:

Drug: Ingavirin (Imidazolyl Ethanamide Pentandioic Acid)

Placebo

Placebo Comparator group

Description:

Placebo oral capsule, once daily for 7 days

Treatment:

Drug: Placebo oral capsule