Small early terminated late stage (60% on oxygen) RCT in France showing 46% lower mortality.
mortality at 28 days relative risk RR 0.54 [0.21-1.42]
combined mortality/intubation at 28 days relative risk RR 0.74 [0.33-1.70]
If not stopped early and the same trend continued, statistical significance would be reached on 28 day mortality after ~550 patients (1,300 patients were planned).
Mortality results are not provided for subgroups. For the subgroups receiving AZ:
Q+(AZ from day 0): combined mortailty/intubation RR 0.16, p
Q+AZ and 3/11 placebo, 0.5 added for calculations due to 0)
Q+(AZ later), combined mortality/intubation RR 0.42 [0.05-3.54]
No safety concerns were identified. This study has been presented as negative, however the results do not support that conclusion.
death, ↓46.0%, p=0.21, mortality at day 28
combined intubation/death, ↓26.0%, p=0.82, combined mortality/intubation at day 28
death, ↓84.4%, p=0.21, HCQ+AZ from day 0 subgroup combined mortality/intubation
(adjusted for zero)