Summary of COVID-19 selinexor studies
117 patient selinexor late treatment RCT: 286% higher mortality (p=0.07), 39% higher ventilation (p=0.58), 11% higher ICU admission (p=0.71), and 16% lower hospital discharge (p=0.68).
RCT 188 hospitalized patients with severe COVID-19 showing higher mortality (p=0.07) and no significant clinical improvement with oral selinexor (20mg) compared to placebo. In the intention-to-treat analysis, the study failed its primary endpoint, with day 14 clinical improvement rates being numerically lower in the treatment group (53.0%) compared to placebo (54.9%). More concerningly, day 28 mortality was nearly four times higher in the selinexor group (15.2%) versus placebo (3.9%), and mechanical ventilation requirements were also increased (13.6% vs 9.8%) . While the authors focus on a subgroup analysis of patients with low inflammatory markers (low LDH/D-dimer) showing improved discharge rates, patients with high markers experienced drastically higher mortality with treatment (33.3% vs 8.7% in placebo). The study was single-blind, introducing potential bias regarding discharge decisions, and the reliance on post-hoc subgroup analysis to claim benefit despite a failed primary..
Oct 2020, Karyopharm Therapeutics, https://www.karyopharm.com/wp-content/uploads/2020/10/10.2.20-ISIRV-Presentation-FINAL.pdf?utm_source=chatgpt.com, https://c19p.org/geils