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

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.