Efficacy and Safety of Enisamium Iodide for the Treatment of Acute Respiratory Viral Infections, Including Influenza.
Condition: Acute Respiratory Viral Infections; Human Influenza
MeSH terms: Infections; Influenza, Human; Virus Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

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).
    

Detailed description: 
      Numerous studies have shown that influenza vaccines, prepared against the relevant epidemic
      seasonal vaccine strains, are an effective remedy in prevention of this mass disease and are
      able to protect about 80% of otherwise healthy children and adults. However, to develop
      vaccines against the emerging new pandemic strain of the influenza virus and produce them in
      the necessary amounts requires at least 6 months. During such interim periods, sufficient
      protection of the population is essential by effective measures for treatment and prevention
      of influenza.

      This randomized, single-blind, clinical study was conducted to investigate the clinical
      efficacy and safety of the drug Amizon (N-methyl-4-benzylcarbamidopyridinium iodide,
      international nonproprietary name enisamium iodide) compared with placebo, for the treatment
      of patients with ARVI, including influenza.

      Enisamium iodide is an antiviral small molecule. Enisamium can directly inhibit influenza
      viral RNA replication.

      The study design was: randomised, single-blind, 2 parallel groups. Adult patients (18-60 y)
      with symptoms of ARVI, including influenza took either Amizon tablets (active ingredient
      enisamium iodide) for 7 days; in the control group patients took placebo tablets for 7 days.
      Study visits occurred on Day 0 (screening, examination, check inclusion/exclusion criteria,
      enrollment, randomization, and first intake of study drug); further study visits were on Day
      3, Day 7, and Day 14.

      The effect of treatment was assessed by questioning the patients regarding ARVI and influenza
      symptoms that included pain, headache, general weakness, sore throat, pain in the joints,
      fatigue, runny and itchy nose. The severity of symptoms was recorded using a 4-point Likert
      scale.

      Further evaluation of the treatment was performed by measuring the vitals signs, laboratory
      tests that included blood and urine analysis, biochemical analysis, as well as assessing the
      immune status (including measuring the absolute lymphocytes count, and evaluating the
      relative concentration of interferon (IFN)-alpha and IFN-gamma, and immunoglobulins (IgA,
      IgM, and IgG).
    

Intervention name(s): Enisamium Iodide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients ingested Amizon tablets after meal without chewing as follows: 2 tablets (total dose 0.5 g) 3 times a day, for 7 days. Each tablet contains 0.25 g of Nmethyl- 4-N-methyl-4-benzylcarbamidopyridinium iodide (INN enisamium iodide).; Patients ingested placebo tablets after meal without chewing in the dose 0.5 g (2 tablets), 3 times a day, for 7 days.
Other intervention name(s): Amizon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Viral infections; Amizon; Enisamium iodide; Influenza