A Study of Brexanolone for Acute Respiratory Distress Syndrome Due to COVID-19

Brown et al., NCT04537806, NCT04537806

Jul 2022

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RCT 28 ventilated patients, showing no significant difference with brexanolone treatment.

Standard of Care (SOC): SOC for COVID-19 in the study country, the USA, is very poor with very low average efficacy for approved treatments1. Only expensive, high-profit treatments were approved. Low-cost treatments were excluded, reducing the probability of treatment—especially early—due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments. This may explain in part the very high mortality seen in this study. Results may differ in countries with improved SOC.

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risk of death, 14.3% higher, RR 1.14, p = 1.00, treatment 8 of 14 (57.1%), control 7 of 14 (50.0%), day 40.

risk of death, 33.3% higher, RR 1.33, p = 0.71, treatment 8 of 14 (57.1%), control 6 of 14 (42.9%), day 28.

respiratory failure or death, no change, RR 1.00, p = 1.00, treatment 10 of 14 (71.4%), control 10 of 14 (71.4%), day 28.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

1. c19early.org, c19early.org/soc/usa.html.c19early.org/soc/usa.html.

Brown et al., 27 Jul 2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT04537806 (history). Contact: info@sagerx.com.

This Paper Brexanolone All

Late treatment
is less effective

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