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:
No safety concerns were identified. This study has been presented as negative, however the results do not support that conclusion.NCT04325893
Dubee et al., 10/21/2020, Randomized Controlled Trial, France, Europe, peer-reviewed, 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 = 0.48, treatment 9 of 124 (7.3%), control 12 of 123 (9.8%).
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 many trials.