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CMI Communications
By Hiroki Saito, Farah Al-Beidh, Derek Angus and 22 others.
Eritoran, a Toll-like receptor 4 antagonist, and apremilast, a phosphodiesterase 4 inhibitor, were considered therapeutic candidates for COVID-19. The study aims to evaluate their safety and efficacy among patients with COVID-19.
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A randomized controlled trial was conducted among hospitalized patients with COVID-19 within the Randomized, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired Pneumonia. The primary outcome was organ support–free days, an ordinal composite outcome combining death (assigned a label of −1) and days free from organ support through day 21. A Bayesian ordinal model was applied for statistical analysis.
The trial was terminated early due to slow recruitment, before prespecified stopping criteria were met. Among 104 patients enrolled in the double-blind phase (101 noncritically ill, 3 critically ill; median age, 59 years; 47.1% female), 46, 6, and 52 were randomly assigned to eritoran, apremilast, and placebo, respectively. The median organ support–free days was 22 days in both the eritoran and control groups (interquartile range, 22–22) (adjusted odds ratio of 1.01 [95% credible interval, 0.34–2.90]; posterior probability of superiority of 50.6%). The apremilast comparison was not feasible because of insufficient enrolment. Five serious adverse events were reported among 51 patients receiving eritoran, of which four were considered unrelated to eritoran. No serious adverse events were reported in the apremilast arm.
This trial was inconclusive to determine the efficacy of eritoran because of early termination. Enrolment was insufficient to evaluate apremilast. No new safety signals were identified, although the small sample size limits conclusions regarding safety.
Published in CMI Communications. The abstract is shown as published and remains the work of its authors; read the full article at the source.
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