Evidence analysis of the results of the study of the use of the drug Amizon^® Max in treatment of COVID-19 compared with placebo

Evidence analysis of the study «Multicenter, double-blind, randomized, placebo-controlled study of the effectiveness and safety of Amizon^® Max, 0.5 g capsules, manufactured by JSC «Farmak», in combination with basic therapy, in patients with COVID-19, which is caused by SARS-CoV-2 virus, moderate severity» indicates that this study is planned and conducted in accordance with the principles of evidence-based medicine and has the highest level of evidence, as according to the rating system for assessing the evidence of clinical trials, it can be classified as class I (A), namely a double-blind, randomized, placebo-controlled study. The parameters of the study indicate that it has a high degree of representativeness and its results can be generalized to the target population. The study is in line with Good Clinical Practice principles, as evidenced by an international audit. 592 patients from different regions of Ukraine (14 clinical centers) took part in the study. As a result, the predominant efficacy of Amizon^® Max in the treatment of COVID-19 compared with placebo was proven, namely therapy with Amizon^® Max significantly (p=0.00945; unilateral) accelerates the onset of improvement in patients with COVID-19 by 2 points per modified the World Health Organization’s scale compared to placebo-treated patients. In addition, the use of Amizon^® Max accelerates the recovery process of patients, especially in early use (immediately at the first symptoms), prevents deterioration of the patient’s condition and, consequently, lethal outcome, accelerates the reduction of cough, has more effective effect in patients aged >50 years.