A Clinical Study to Assess the Efficacy and Safety of Amizon® Max in the Treatment of Moderate Covid-19, Caused by the SARS-CoV-2 Virus
Condition: Covid-19 Disease
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      Adult female and male patients, hospitalized with Covid-19 infection (confirmed by reverse
      transcription polymerase chain reaction [RT-PCR]), will be screened for participation in this
      prospective, multi-center, double-blind, randomised, placebo-controlled trial.

      Enrolled patients will be randomized (1:1) into 2 treatment groups: Group 1 will receive the
      active treatment with Amizon® Max (international nonproprietary name enisamium iodide), one
      capsule (each containing 500 mg of enisamium iodide) 4 times daily every 6 hours for 7 days;
      patients in treatment Group 2 will receive a matching placebo capsule, 4 times daily every 6
      hours for 7 days. Patient observation and follow-up are planned for 29 days, unless
      discharged before Day 29.

      The effect of treatment on Covid-19 will be evaluated by time from day of randomization to an
      increase of at least two points (from the status at randomization) on the severity rating
      scale (SR), the Time to Clinical Recovery (TTCR) of main Covid-19 symptoms / complications
      and the Sum of Severity Rating from Day 2 to Day 15 (SSR-15). Safety and tolerability of the
      study drug will be evaluated based on the intensity and course of adverse events (Es).

      Enisamium iodide is an antiviral small molecule. Enisamium inhibits replication of alpha- and
      beta- coronaviruses (human coronavirus NL63 and SARS-CoV-2, respectively) and influenza virus
      A and B. Mechanism of action against SARS-CoV-2 includes the direct inhibition of the viral
      RNA polymerase.
    

Detailed description: 
      This randomized, prospective, multi-center, double-blind, placebo-controlled trial, is
      conducted to investigate the clinical efficacy and safety of the drug Amizon® Max
      (N-methyl-4-benzylcarbamidopyridinium iodide, international nonproprietary name enisamium
      iodide, lab code FAV00A) in comparison with placebo, for the treatment of hospitalized
      patients with RT-PCR confirmed Covid-19 infection.

      Enisamium iodide is an antiviral small molecule. Enisamium can directly inhibit influenza
      viral RNA replication and has antiviral effect against viruses, including coronaviruses
      (human coronavirus NL63, SARS-CoV-2).Based on the promising in-vitro anti-SARS-CoV-2
      activity, it could be assumed that patients suffering from Covid-19 would benefit from a
      reduced virus load and this could lead to a reduction of Covid-19 typical symptoms that might
      prevent further complications associated with severe Covid-19 (e.g. active mechanical
      ventilation).

      Adult female and male patients, with Covid-19 infection, will be screened (Day 1) to
      participate in this trial. If all inclusion/exclusion criteria are fulfilled, randomization
      to treatment and a start of treatment will occur on Day 1.

      Patients will be randomized into 2 treatment groups (1:1) as follows: patients in treatment
      Group 1 will receive the active treatment with Amizon® Max capsule; patients in treatment
      Group 2 will receive a placebo capsule. The active treatment and placebo capsules are
      identical in appearance and size.

      Patients will take Amizon® Max capsules 500 mg (active ingredient enisamium iodide) 4 times a
      day every 6 hours (total daily dose 2,000 mg) for full 7 days. In the control group, patients
      will take placebo tablets 4 times a day for full 7 days. Patient observation interval is for
      as long as a subject is hospitalized Day 1 to Day 29. A follow-up visit will be performed on
      Day 29 (by phone as applicable for all subjects discharged from the hospital before Day 29).

      The effect of treatment on Covid-19 will be evaluated by the time from the day of
      randomization (Day 0) to an improvement of at least two points (from the status at
      randomization) on the severity rating scale (SR), the Time to Clinical Recovery (TTCR) of
      main Covid-19 symptoms / complications and the Sum of Severity Rating from Day 2 to Day 15
      (SSR-15).

      Additional outcome measures of efficacy include the 'Days Alive' and 'Out of Hospital' from
      Day 1 until Day 15 (DAOH-14), the proportion of subjects discharged by Day 8, 15, 22, and 29,
      the incidence of complications (i.e. pneumonia, need for transfer to intensive care unit
      [ICU]), the incidence and days until occurrence of pneumonia, incidence and days until
      supplemental oxygen / high flow oxygen, incidence and days until (non-invasive / invasive
      mechanical ventilation), incidence and days until transfer to ICU, incidence and time to
      death, time to virus free, measurement of vital signs (i.e. fever (body temperature),
      respiratory rate, peripheral capillary oxygen saturation [SpO2]) and the course of symptoms
      of Covid-19.

      Symptom severity for headache, sore throat, cough, shortness of breath, rhinorrhoea, fatigue,
      myalgia, diarrhoea will be monitored. Safety and tolerability of the study drug will be
      evaluated based on the intensity and course of adverse events (AEs), safety laboratory tests,
      as well as the investigator's and subject's overall assessment of tolerability of the
      treatment.
    

Intervention name(s): Enisamium Iodide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule formulations of the active product (enisamium iodide 500 mg; Investigational medicinal product 1 [IMP-1]).
1 capsule Amizon® Max contains: enisamium iodide 500 mg.
Amizon® Max (active ingredient: enisamium iodide; IMP-1 will be administered as 1 capsule 4 times a day, every 6 hours (total dose 2,000 mg per day). Capsule will be taken orally (swallowed whole), together with a sufficient amount of liquid (preferably water).
Treatment will start on Day 1 (randomization) and for up to 168 hours after the first dose administration i.e. Day 7 or Day 8. The site staff will ensure that the IMP (1 capsule) is taken every 6 hours by the study subjects.
For documentation purposes, the IMP-1 packs (empty blister / blister with unused capsules) will be kept at the site and drug accountability forms are completed.; Capsule formulations of the reference product placebo Amizon® Max (IMP-2), will be identical in appearance (size, shape, and color), taste, and smell as the active formulation capsule.
1 capsule placebo Amizon® Max contains: placebo (no active substance).
Amizon® Max placebo (IMP-2), will be administered as 1 capsule 4 times a day every 6 hours. Capsule will be taken orally (swallowed whole), together with a sufficient amount of liquid (preferably water).
Treatment will start on Day 1 (randomization) and for up to 168 hours after the first dose administration i.e. Day 7 or Day 8. The site staff will ensure that the IMP (1 capsule) is taken every 6 hours by the study subjects.
For documentation purposes, the IMP-2 packs (empty blister / blister with unused capsules) will be kept at the site and drug accountability forms are completed.
Other intervention name(s): Amizon, Amizon® Max
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amizon; Antiviral; Covid-19; Enisamium iodide; Ukraine; FAV00A