RESOLUTION: A Double-blind, Randomized, Placebo-controlled, Phase II/III Study of the Efficacy and Safety of LAU-7b in the Treatment of Adult Hospitalized Patients With COVID-19 Disease
et al., NCT04417257, RESOLUTION, NCT04417257, May 2024
RCT 125 hospitalized COVID-19 patients showing no significant benefits with fenretinide (LAU-7b).
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, 44.1% higher, RR 1.44, p = 0.34, treatment 17 of 174 (9.8%), control 12 of 177 (6.8%), both phases, day 60.
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risk of death, 25.1% higher, RR 1.25, p = 0.67, treatment 14 of 117 (12.0%), control 11 of 115 (9.6%), phase 2, day 60.
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risk of death, 226.3% higher, RR 3.26, p = 0.35, treatment 3 of 57 (5.3%), control 1 of 62 (1.6%), phase 3, day 60.
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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Houle et al., 30 May 2024, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT04417257 (history) (RESOLUTION).