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:
HCQ+(AZ from day 0): combined mortailty/intubation RR 0.16, p
(0/10 HCQ+AZ and 3/11 placebo, 0.5 added for calculations due to 0)
HCQ+(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.
Dubee et al., 10/21/2020, Randomized Controlled Trial, France, Europe, preprint, median age 77.0, 18 authors.
risk of death at day 28, 46.0% lower, RR 0.54, p = 0.21, treatment 6 of 124 (4.8%), control 11 of 123 (8.9%).
risk of combined intubation/death at day 28, 26.0% lower, RR 0.74, p = 0.82, treatment 9 of 124 (7.3%), control 12 of 123 (9.8%).
risk of combined intubation/death, 85.1% lower, RR 0.15, p = 0.21, treatment 0 of 10 (0.0%), control 3 of 11 (27.3%), continuity correction due to zero event (with reciprocal of the contrasting arm), HCQ+AZ from day 0 subgroup.
Effect extraction follows pre-specified rules prioritizing more serious
outcomes. For an individual study the most serious outcome may have a smaller
number of events and lower statistical signficance, however this provides the
strongest evidence for the most serious outcomes when combining the results of