A Clinical Study to Assess the Efficacy and Safety of Amizon® Max in the Treatment of Moderate Covid-19
Status:
Recruiting
Trial end date:
2021-07-01
Target enrollment:
Participant gender:
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 treatment-emergent adverse
events (TEAEs).
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.