A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Investigate the Efficacy and Safety of BGE-175 in Hospitalized Adults With COVID-19

Wilkerson et al., NCT04705597, NCT04705597, May 2022

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https://c19early.org/wilkerson.html

RCT 194 hospitalized COVID-19 patients showing no significant differences with asapiprant (BGE-175).

Standard of Care (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 for early treatment. Low-cost treatments were excluded, reducing the probability of early treatment due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.

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risk of death, 63.3% higher, RR 1.63, p = 0.21, treatment 16 of 96 (16.7%), control 10 of 98 (10.2%).

risk of ICU admission, 32.1% higher, RR 1.32, p = 0.37, treatment 22 of 96 (22.9%), control 17 of 98 (17.3%).

risk of severe case, 24.0% higher, RR 1.24, p = 0.36, treatment 34 of 96 (35.4%), control 28 of 98 (28.6%).

time to improvement, 33.3% higher, relative time 1.33, p = 0.17, treatment mean 8.0 (±10.0) n=96, control mean 6.0 (±10.1) n=98.

risk of progression, 23.0% higher, RR 1.23, p = 0.43, treatment 31 of 94 (33.0%), control 26 of 97 (26.8%), death or respiratory failure.

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

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

Wilkerson et al., 19 May 2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, critical, trial NCT04705597 (history). Contact: patrick@bioagelabs.com.

This Paper Asapiprant All

Late treatment
is less effective

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