Replication data for Safety and efficacy of 3- and 5-day regimens of levamisole in loiasis: a randomized, placebo-controlled, double-blind clinical trial

Résumé 0

Background. Individuals with high Loa loa microfilarial densities (MFD) risk serious adverse events (SAEs) following ivermectin treatment. A single dose of levamisole (LEV) induces a temporary, progressive MFD decrease. We assessed the safety and efficacy of 3- and 5-day LEV (LEV-3 and LEV-5) regimens for loiasis treatment. Methods. A double-blind, randomized, placebo-controlled clinical trial in the Republic of the Congo assigned participants (1:1:1) to receive PLA, LEV-3 or LEV-5. Sample size calculation was based on data from a previous clinical trial evaluating LEV efficacy on L. loa MFD. Safety (occurrence of SAEs, frequency of AEs) was analysed using Fischer's exact test and logistic regression. Efficacy (MFD reduction and proportion of individuals achieving 40% reduction) was assessed through non parametric tests, adjusted for multiple comparisons. A mixed-effects linear model evaluated MFD changes, with post hoc contrasts. Results. No SAEs occurred, and AE grade severity was similar across arms. Compared with PLA (n=30), LEV-3 (n=33) and LEV-5 (n=28) showed greater MFD reductions on D5 (-1.6, 29.3, and 51.4%, respectively; P