Amizon Max (enisium iodide) capsules 0.5 g. №10

Table 2

Dynamics of viral antigen detection (number of patients / %)

The results of a phase 3 clinical trial showed that enisemium iodide was well tolerated and clinically effective, as demonstrated by:

• reducing the duration of the period of elevated temperature by 1.1 days;
• reducing the duration of catarrhal and constitutional symptoms;
• reducing the use of expectorants and vasoconstrictors;
• by reducing the number of days of incapacity for work;
• a reduction in the period of viral shedding and a significant reduction in the number of patients in whom viral antigens were detected, compared to the group of patients who received placebo.

Greater effectiveness of enisanium was observed when treatment was started earlier.

In a multicenter, double-blind, randomized, placebo-controlled study of the efficacy and safety of the drug Amizon  Max, 592 patients with moderate severity of COVID-19 were included, who, in combination with basic therapy, received either Amizon Max or placebo. The primary efficacy endpoint of the study was time to improvement, as measured by a 2-point increase in the patient’s baseline modified WHO score (Table 3).

Patients included in the placebo group received orally 1 placebo capsule every 6 hours, 4 times a day. Patients taking Amizon ^® Max received 1 capsule of the drug Amizon Max every 6 hours, 4 times a day. The treatment lasted a full 7 days (168 hours).

The results of the study showed that therapy using the drug Amizon Max significantly (p = 0.00945) accelerates the onset of improvement in the condition of a patient with COVID-19 by 2 points according to the above modified WHO scale, compared to the group of patients who received a placebo. The predominant effectiveness of combined therapy with the use of the drug Amizon Max in the treatment of patients with COVID-19 is also confirmed by the results regarding secondary efficacy endpoints, namely:

• on the 15th day of the study, 85.7% of patients in the placebo group were discharged, and 94.4% of patients in the Amizon Max group. The difference in percentages was 8.6%, and these differences were statistically significant (p = 0.018), which indicates in favor of the prevailing effectiveness of the drug Amizon Max in comparison with placebo;
• a more rapid and reliable decrease in the severity of cough was observed in the group using the drug Amizon Max compared to the placebo group on the 3rd, 4th and 5th days of treatment (p = 0.009, 0.018 and 0.007, respectively);
• the use of the drug Amizon  Max in the complex therapy of COVID-19 reliably (p = 0.016) prevents the deterioration of the patient’s condition and the increase of respiratory failure during the treatment. Thus, the proportion of patients in whom the condition worsened by 1 point according to the modified WHO scale was 8.4% in the placebo group, and 2.1% in the group using the drug Amizon Max , the differences between the groups were significant (p = 0.016 ). The analysis of the time until the patient’s condition worsened by 1 point using the Kaplan-Meier method and using the log-rank criterion for comparing groups proved the greater effectiveness of the drug Amizon Max compared to placebo (p = 0.009) in preventing deterioration of the patient’s condition, development of more severe respiratory failure and development of complications;
• in the group of patients receiving Amizon  Max as part of complex therapy, there were no deaths and all patients recovered within 21 days, while in the placebo group there were three (3) deaths and one patient did not reach the primary endpoint of the period of stay in the study, which is a strong argument in favor of the use of the drug Amizon  Max in the complex therapy of COVID‑19.