A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Losmapimod in Adult Subjects With COVID-19 (LOSVID STUDY)

Ziegler et al., NCT04511819, LOSVID, NCT04511819, Mar 2021

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https://c19early.org/ziegler.html

RCT 52 hospitalized COVID-19 patients showing no significant differences with losmapimod 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 progression, 18.2% higher, RR 1.18, p = 0.54, treatment 16 of 22 (72.7%), control 16 of 26 (61.5%), death or respiratory failure, day 28.

risk of no recovery, 14.3% higher, RR 1.14, p = 0.64, treatment mean 1.4 (±1.58) n=18, control mean 1.6 (±1.14) n=24, relative reduction in WHO score, mid-recovery, day 7.

risk of no recovery, 10.0% higher, RR 1.10, p = 0.53, treatment mean 2.0 (±1.31) n=22, control mean 2.2 (±0.83) n=25, relative reduction in WHO score, day 14.

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

Ziegler et al., 31 Mar 2021, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT04511819 (history) (LOSVID). Contact: clinicaltrials@fulcrumtx.com.

This Paper Losmapimod All

Late treatment
is less effective

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