Hydroxychloroquine in mild-to-moderate COVID-19: a placebo-controlled double blind trial

10/21 Late treatment study

Dubee et al., Clinical Microbiology and Infection, doi:10.1016/j.cmi.2021.03.005 (preprint 10/21) (Peer Reviewed)
Hydroxychloroquine in mild-to-moderate COVID-19: a placebo-controlled double blind trial

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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.

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