Table 3.
Safety. AE and SAE rates including relatedness. Losartan is compared with combined control (lopinavir/ritonavir and placebo) and placebo only control. Statistically significant and ‘trend’ comparisons are in bold. Comparison of SAE rate was the study's primary safety outcome measurement.
|
Losartan |
Control (placebo or lopinavir/ritonavir) |
p | 95% CI | Total |
Control (placebo) |
95% CI | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Total | Definitely | Probably | Possibly | Not | Total | Definitely | Probably | Possibly | Not | Definitely | Probably | Possibly | Not | p | |||||
| AEs/subject (mean) | 3.9 | 0 | 0 | 1.0 | 2.9 | 1.0 | 0 | 0 | 1.0 | 0 | 0.3 | −8.3414 to 2.5414 | 0 | 0 | 0 | 0 | 0 | NA | NA |
| SAEs/subject (mean) | 2.0 | 0 | 0 | 0.4 | 1.6 | 0.60 | 0 | 0 | 0.6 | 0 | 0.3 | −4.3144 to 1.5144 | 0 | 0 | 0 | 0 | 0 | NA | NA |
| AKI AEs/subject (mean) | 0.22 | 0 | 0 | 0.11 | 0.11 | 0.20 | 0 | 0 | 0.2 | 0 | 0.95 | −0.7560 to 0.7160 | 0 | 0 | 0 | 0 | 0 | NA | NA |
| AKI SAEe/subject (mean) | 0.11 | 0 | 0 | 0.00 | 0.11 | 0.20 | 0 | 0 | 0.2 | 0 | 0.5 | −0.5160 to 0.9560 | 0 | 0 | 0 | 0 | 0 | NA | NA |
| Hypotension AEs/subject (mean) | 0.33 | 0 | 0 | 0.22 | 0.11 | 0 | 0 | 0 | 0 | 0 | NA | NA | 0 | 0 | 0 | 0 | 0 | NA | NA |
| Hypotension SAEs/subject (mean) | 0.22 | 0 | 0 | 0.11 | 0.11 | 0 | 0 | 0 | 0 | 0 | NA | NA | 0 | 0 | 0 | 0 | 0 | NA | NA |
| Hyperkalemia AEs/subject (mean) | 0.11 | 0 | 0 | 0.11 | 0 | 0 | 0 | 0 | 0 | 0 | NA | NA | 0 | 0 | 0 | 0 | 0 | NA | NA |
| Hyperkalemia SAEs/subject (mean) | 0.00 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NA | NA | 0 | 0 | 0 | 0 | 0 | NA | NA |
| Respiratory failure/COVID-19 PNA AEs rate (mean) | 0.67 | 0 | 0 | 0.33 | 0.33 | 0.20 | 0 | 0 | 0.2 | 0 | 0.2 | −1.2420 to 0.3020 | 0 | 0 | 0 | 0 | 0 | NA | NA |
| Respiratory failure/COVID-19 PNA SAEs rate (mean) | 0.67 | 0 | 0 | 0.33 | 0.33 | 0.20 | 0 | 0 | 0.2 | 0 | 0.2 | −1.2420 to 0.3020 | 0 | 0 | 0 | 0 | 0 | NA | NA |