A Phase 3 interventional study of Ingavirin (Imidazolyl Ethanamide Pentandioic Acid) and Placebo oral capsule in Influenza, Human, Acute Respiratory Infection and Common Cold, sponsored by Valenta Pharm JSC. Completed at 2 sites in Russian Federation. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-06-16.
Sponsored by Valenta Pharm JSC · Phase 3, Interventional, and Prevention
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
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 400 is above the median of 120 across 4,200 interventional studies indexed under Infections.
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Exclusion Criteria:
Ingavirin (Imidazolyl Ethanamide Pentandioic Acid) capsules, 90 mg once daily for 7 days
Drug: Ingavirin (Imidazolyl Ethanamide Pentandioic Acid)
Placebo oral capsule, once daily for 7 days
Drug: Placebo oral capsule
Broad-spectrum antiviral agent
Placebo capsule to match Ingavirin capsule
Difference in incidence of flu / other acute respiratory viral infections between Ingavirin and placebo groups
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.
Time frame: Through study completion, an average of 37 days
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
Plan to share: No
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Valenta Pharm JSC