Acute Respiratory Infection, Common Cold, Flu, Influenza, Human, Viral Infection
Conditions
Keywords
Profilaxis, Ingavirin
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.
Interventions
DRUGIngavirin (Imidazolyl Ethanamide Pentandioic Acid)
Broad-spectrum antiviral agent
DRUGPlacebo oral capsule
Placebo capsule to match Ingavirin capsule
Sponsors
Valenta Pharm JSC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in incidence of flu / other acute respiratory viral infections between Ingavirin and placebo groups | 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Russia
Outcome results
None listed