A Phase II Randomized, Double-Blind, Placebo-Controlled Study of LAM-002A for the Prevention of Progression of COVID-19

Young et al., NCT04446377, NCT04446377, Apr 2021

https://c19early.org/young3.html

RCT 142 COVID-19 patients showing no significant differences with apilimod treatment.

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, 198.6% higher, RR 2.99, p = 1.00, treatment 1 of 71 (1.4%), control 0 of 70 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).

risk of death/hospitalization, 100% higher, RR 2.00, p = 1.00, treatment 2 of 71 (2.8%), control 1 of 71 (1.4%).

risk of no recovery, 109.4% higher, RR 2.09, p = 0.43, treatment 4 of 64 (6.2%), control 2 of 67 (3.0%), oxygen saturation <95%, day 11.

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

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

Young et al., 19 Apr 2021, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT04446377 (history). Contact: pyoung@ai-thera.com.

This Paper Apilimod All

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