Update on COVAMID trial with Bentrio for acute COVID 19

COVAMID trial: Top-Line Data from COVID-19 Trial: Top-line data from the COVAMID trial in 160 patients with current COVID-19 infection show a trend for a more pronounced improvement in the Bentrio treatment groups on the primary efficacy endpoint, the change in PCR cycle threshold (CT), compared with no treatment. The mean increase in the CT value from baseline to Day 11, was 15.3 for the Bentrio group, 14.1 for the modified-Bentrio group and 13.7 for the untreated control group. An increase in the CT by 1 indicates a decrease in the nasal viral load of 50%.

In the mixed model for repeated measures (MMRM) the difference in the mean change of CT values of the Bentrio group vs. the untreated and the modified-Bentrio groups to Day 11 failed to reach statistical significance (LSmeans 0.8 and 0.64; p = 0.319 and 0.427; 95% CI -0.78 to 2.38 and -0.95 to 2.23, respectively).

More Bentrio and modified-Bentrio treated patients achieved full resolution of COVID-19 signs and symptoms by Day 11 than untreated patients (93.7 and 92.5 vs. 85.0%) and more of them were uninfected or asymptomatic at that time point (59.5 and 65.0 vs. 45.0%). The treatment was well tolerated. The incidence of adverse events in the Bentrio group was 2.4% (mild cases only), 9.5% in the modified-Bentrio group (mild cases only), and 16.3% in the untreated group (all mild, except for 1 moderate case and 2 severe cases / unwitnessed sudden death after Day 11).