A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Losmapimod in Adult Subjects With COVID-19 (LOSVID STUDY)
et al., NCT04511819, LOSVID, NCT04511819, Mar 2021
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.
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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.
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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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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
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.
Late treatment
is less effective
is less effective
