(06 Apr 2021) Hydroxychloroquine- in this underpowered trial patients did not experience better clinical outcomes

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

https://doi.org/10.1016/j.cmi.2021.03.005

The trial was stopped after 250 patients were included due to a slowdown of the pandemic in France. The intention-to-treat population comprised 123 and 124 patients in the placebo and hydroxychloroquine groups, respectively. The median age was 77 (interquartile range 58 – 86) years and 151/250 (60.4%) patients required oxygen therapy. The primary endpoint occurred in 9/124 (7.3%) patients in the hydroxychloroquine group and 8/123 (6.5%) patients in the placebo group (relative risk 1.12; 95% confidence interval 0.45- 2.80). The rate of positive SARS-CoV-2 RT-PCR at day 5 and 10 was 72.8% (75/103) and 57.1% (52/91) in the hydroxychloroquine group, versus 73.0% (73/100) and 56.6% (47/83) in the placebo group, respectively. No difference was observed between the two groups in any of the other secondary endpoints. In this underpowered trial involving mainly older patients with mild-to-moderate COVID-19, patients treated with hydroxychloroquine did not experience better clinical or virological outcomes than those receiving the placebo.