Efficacy and Safety of Enisamium Iodide for the Treatment of Acute Respiratory Viral Infections, Including Influenza.
Summary
This randomized, single blind clinical study was conducted to investigate the clinical efficacy and safety of the drug Amizon (enisamium iodide), in comparison with placebo for the treatment of patients with acute respiratory viral infections (ARVI), including influenza. Enisamium iodide is an antiviral small molecule. Adult patients were enrolled and randomised into 2 groups. On the first day of the onset of symptoms of ARVI, one group of patients took Amizon tablets (active ingredient enisamium iodide) for 7 days; the other group of patients took matching placebo tablets for 7 days. Examination and observation of all participants was done for up to 14 days after the first intake of the study drug. The effect of treatment was assessed by subjective reporting of the symptoms of ARVI and influenza, using a predefined symptom scale score system. Objective assessment was performed by measuring vitals signs, laboratory tests (including blood and urine assessment), as well as evaluating the immune status (including measuring the relative concentration of interferon and immunoglobulins).
Timeline
- Start
- 2009-04-13
- Primary completion
- 2010-01-15
- Completion
- 2010-01-15
Outcome
Mixed primary results
registry analysis (superiority test); Group 1 - Active Treatment - Amizon vs Group 2 - Placebo; p = 0.5547; Fisher Exact NCT04682444 ↗
registry analysis (superiority test); Group 1 - Active Treatment vs Group 2 - Placebo; p = 0.0001; Fisher Exact NCT04682444 ↗
registry analysis (superiority test); Group 1 - Active Treatment - Amizon vs Group 2 - Placebo; p <0.0001; Fisher Exact NCT04682444 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | enisamium | Small molecule | 500 mg | Oral |